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tv   FDA Holds an Open Meeting on the Pfizer- BioN Tech COVID-19 Vaccine - PART 3  CSPAN  December 10, 2020 10:27pm-4:07am EST

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phone calls, facebook comments, text messages and tweets. join us saturday morning as we look back at 20 years to the 2000 election, bush v. gore. >> with coronavirus cases increasing across the country, use our website coronavirus to follow the trends, track the spread with interactive maps, and watch updates on demand any time at >> now back to the fda advisory committee. a vote by the panel leader clears the way for the fda to approve the pfizer biontech coronavirus vaccine across the u.s. >> i would like to welcome everybody to the open public hearing session. please note that both the food and drug administration and the
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public will lead a transparent process for information gathering and decision-making to ensure such transparency at the open public hearings sessions of , fdadvisory committee believes it is important to understand the context of an individual's presentation. for this reason, fda encourages you, the open public hearing speaker, at the beginning of your written or aural statement statement, to describe any financial relationship you may have with a sponsor, its products, or if known, its direct competitors. for example, this financial information may include the youror's payment of travel, lodgings or other expenses in connection with your attendance at the meeting. fda encourages you at
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the beginning of your statement to advise the committee if you do not have any such financial relationships. if you choose not to address this issue of financial relationships at the beginning of your statement, it will not preclude you from speaking. dr. atreya: good afternoon, everyone. i am going to conduct the open public hearing session and i .ill read your name when i call your name, please unmute your phone and start speaking. the first name is [indiscernible]
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>> hello. these are my comments to the vaccine advisory efficacy, structure, benefit, and follow-up. except for aments lot of elderly relatives. the pfizer vaccine appears efficacious based on 95% relative reduction in infections and t cell responses comparable to human convalescence era. andfigure two, page 22 figure two, page 24. some uncertainty is introduced by the possibility of mild asymptomatic infections, statementsplacebo citing effects that may have
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caused the fascinating participants to be [indiscernible] . benefit risk. i have reviewed the available evidence and as a graduate, despite the uncertainties, the structured benefit russ of the pfizer vaccine is very positive. the coronavirus as we have heard is a serious medical condition with 3000 daily deaths. while there are therapeutics, there are no prophylactics against covid-19. even in the event of approval for the fight of vaccines, limited supplies will require eua of other efficacious vaccines when available, such as moderna and others. it benefits of the vaccine include prevention of covid-19. after the second dose, prevention of severe covid-19 and preventing covid-19 after the first dose.
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risks appear to be mild injection site pain, fever, or fatigue. overased -- for recipients 55 is more than offset by the benefits of presenting -- preventing covid-19 cases in older adults with weaker immune systems. note allergy's deceptive individual should be warned -- the next benefit is highly positive. i would recommend the vaccine to my siblings over 80 and my relatives in assisted living facilities where there have been three cases for staff -- staph -- staff and three cases among residents. -- including how long immunization patients are protected, whether the vaccine prevents infections which cause further transmission and how any
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violations of coaching supply, affect efficacy. thank you. they need this vaccine yesterday. >> great. the next speaker is diana zuckerman. >> hi, can you hear me? >> yes. zuckerman, diana president of the national center for health research. our center it scrutinizes the safety and effectiveness of medical products and we do not expect funding from those companies that make those products. my expertise is based on my postdoctoral training in --demiology i have also previously worked at hhs and the u.s. congress.
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today i will focus on two major concerns on how we can improve the data that are already available. number one, the two month median follow-up is just too short to have long-term safety information and long-term efficacy information, so it is essential randomized controlled trials be continued. number two, there is a lack of diversity in covid cases. there were zero black cases in the covid vaccine group and only seven cases in the placebo group up in theases 75 and vaccine group and in the pacifico. the wall street journal did a chart saying it was 100% effective for black patients. for example, so that is one of the reasons why we need more people so we have reasonable data. .
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there are also too few severe cases to draw a conclusion. that is too few to conclude anything. -- long-termients care patients were not in the study. 100 cases --out how do you make an informed decision based on so little information? we need long-term data to fully understand if the benefits outweigh the risks for frail patients and for all races and ethnicities and for all patients, and that is why continuing to randomized controlled trial is so important
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. in conclusion the eua is not approval ended should have more restrictions then you would have for approval. so fda should require rct whileon of the targeting the eua to vulnerable populations. i agree do not let anyone in the placebo group to [indiscernible] the queue. eua it should not allow off label use fort nonpriority groups, whether they are celebrities or anyone else. it could potentially occur under fda's expanded access program. fda should delay access to vaccines by the placebo group unless they are in the priority populations, and i am concerned the blinded cross over would be
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informative if the vaccine is , butong-term efficacious if it was efficacious long-term, we would use that information. thank you very much for the opportunity to speak today. the next speaker is peter d oshey. >> thanks for the chance to speak. i am on the faculty of the university of maryland edit medical journal editor. i have no relevant conflicts of interest and no one has paid for my attendance. slide two, my experience has been the careful review requires significant time and effort. as fda is already review the data i would like to know if the fda is confident in the data collection for the primary endpoint that any unofficial on the blending not affect the results and that fever and pain
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medications did not mask symptoms from preventing case detection. i did not find answers to these questions in the briefing document. slide three. the dramatic difference in the rate of side effects between vaccine and placebo raises questions about how well these trials could be observer blighted. with a subjective endpoint like symptomatic covid is important, but it seems unfair to think people could make reasonable guesses as to what group they were in. in the real world, the mantra has been to test, but this was not the case in the trial. in the seven days after unlesstion, do not test the clinical picture suggests covid rather than vaccine side effects. this basically amounts asking investigators to make guesses as to which intervention group they were in. was this kind of judgment wherever applied in the days it could affect the primary
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endpoint? on blinding would matter lest if the trial had been [indiscernible] hospitalizations as most people assume the trials were set up to do. directly should be testing endpoints that matter. then there is the duration of protection issue. 95%ccine that provides a [indiscernible] but for many people who lack natural immunity and do not get exposed to the virus soon after vaccination protection needs to last much longer. after six months or a year with a vaccine still meet its effective requirement? the trial does not have sufficient data. keeping the trials going with placebo controlled follow-up would help answer the questions that remain. to those who do not wish
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wait for evidence that benefits outweigh risks. access does not require authorization. i want to end by saying whatever fda ultimately does the full trial data must be made publicly available. eggs were offering me the time to speak. >> the next speaker is -- >> thank you, i am professor at mercy college. i have no potential conflict of interest. . vaccine is reported to have an overall impressive efficacy rate of 95%. endpoint of the trial was symptomatic covid-19 deception. [indiscernible] who may have
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developed a semantic -- asymptomatic infection [indiscernible] an emergency use authorization is issued the spectrum of covid-19 infections that this vaccine is efficacious against must be emphasized. foriscernible] is necessary -- the power of this trial are collated at 90% to detect the overall vaccine efficacy and did not allow for some conclusions. next slide. , there were no serious safety concerns, which is partly reassuring. frequent ande were mild [indiscernible] common side effects of vaccines. next slide.
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significance were blind as to whether they received the vaccine or placebo. given the common awareness of vaccine side effects, unintentional on blinding may thisoccurred and potentially [indiscernible] vaccine efficacy. the potential benefits of this vaccine outweigh identified risks. therefore i support the issuance of an eua with the stipulation that the vaccine can protect against symptomatic disease, but at this time it is not known if it prevents infections and transmission. contraindication [indiscernible] are severe allergic reactions and should be included in the eua as well. need fornuing nonpharmaceutical interventions, particularly mask wearing should
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also be noted. monitoring ofng this vaccine is imperative. thank you. >> the next speaker is evan sine. >> i am a phase i participant in the pfizer and biontech research trial conducted at nyu. i have no financial or conflict of interest to disclose. i am speaking to you after conversations with friends, family, and coworkers, i thought it was important to share my experience in this trial and do my part to help years -- eased fears about the vaccine. i think i got the vaccine and other placebo because of mild adverse effects after the second injection. after reporting the side effects , i was called repeatedly by the
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doctors and researchers at nyu to see if i was ok, and i was. nothing felt rushed and i never felt like a guinea pig. the question everyone asked me is what happened in the long-term? are there long-term side effects, and it has been more than five months now since my first shot and i can happily report that there are none. since i participated, i helped out my older parents, and i have exercised in small groups, and i have not gotten covid-19. i also want to emphasize these activities do not represent changes of behavior. these are life activities that i have to do anyway. not all of us are able to lock down and stay at home indefinitely. i still do my best to follow health rules and safety precautions. i understand the concern about whether or not people will trust the vaccine, but there will always be some holdouts. most americans will take the vaccine voluntarily as long as
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we are honest, do not talk down to them, and treat them like autonomous adults. right now demand for the vaccine exceed supply. the skepticism of some does not justify delays were others who desperately want to take it. get people too take the vaccine is to lead by example. i do not think the problem is that the vaccine is gross. the issue is other important innovations are slow down too much by delays and scheduling, lack of funding, and other bureaucratic rules that do little to enhance safety protocols. moderna orbiontech, anyone else have an mrna product that can help people with cancer, dementia, or aids, the fda should accept the data on a rolling basis and work with these companies to get to complete phase three clinical trials within a year or two. 10 years for these trials is not good enough. pfizer is just set the gold
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standard for future clinical trials. emergency, and the burden of proof is on those who do not want to authorize the vaccine. moral andly a unethical to deny the vaccine to health care workers or first responders who want to. an eua must be granted, and it must be granted tonight. as of yesterday the daily death tolls exceeds at the death toll on september 11, 2001. delays on december 10 will be more death on january 10. let's roll. thank you. >> thank you. andy.xt speaker is virologist for global
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health science and security. i am also -- i have an advisory relationship, but i have not been compensated to appear today. i would like to offer some virology testing might better inform our knowledge of how these vaccines are working after they are rolled out to the public. process has moved considerably faster than typical vaccine development timeline, and as such we are inherently limited on the breadth and scope of data available on duration, durability, and effectiveness of the community as well as the respective immune responses. due to excluding criteria in the clinical trial themselves there is limited data on -- and we do not know a lot about how these relations will develop
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antibodies to the vaccines. with the limited supply of vaccines, it is going to be critical to determine who has already been infected with sars coronavirus to in order to conserve the vaccine for equitable access to others in the same priority category. because this rollout will be so highly visible and pivotal, we really need to address potential problems such as outbreaks in nursing homes, hospitals, or populationsk [indiscernible] . testing that also up a different phases. serology testing could assist in prioritizing individuals for vaccination. establishing a baseline in the population to help ensure a secure supply of vaccines initially reaches the most
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vulnerable people. confirmccination it can additional neutralizing antibody responses and help ensure antibody response clears the threshold for protective immunity, and over the long-term 3, 6, 9 months after vaccination it can confirm the duration of routine and provide trials to additional populations and subgroups. finally, it can protect the potential efficacy by distinguishing antibodies from natural infection. but looking for antinuclear caps in bodies you can determine if people who have been vaccinated ever been infected after being vaccinated, and finally after vaccination we can assess better systems and duration of immunity and also informed the requirements of future vaccinations developed on an accelerated timeline such as this one. thank you so much for allowing
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me time to speak. >> thank you. janetxt speaker is >> your -- is jared, the president of the united for action and founder of the vaccine considerations project. i do not have any conflict of interest this year. slide number two. vaccine considerations project as blinken seated -- created -- acknowledge and thank the incredible team behind all of this work. thank you, dr. brown, dr. david berger and are committed and rapidly growing team of graduate students. i have to tell you about the challenges this committee and this agency have been faced with
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and we are living this challenges. i am bringing up the challenges remains universal is widespread concerns it must be adequately addressed in order to assure sufficient by-and-by experts, medical professionals, and the public. we are seeking to establish cuts in confidence in any vaccine you authorize and the evaluation process by being rigorous and transparent. there are limits to what can be addressed any meeting. we are working hard to expend those limits, creating new ways to organize and share information. here you can see how we thoroughly analyzed of the transcript of your previous meetings to extract specific expressed by each committee member. link to our a website where the process is available for people to see. specificas plotted
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concerns from specific individuals to develop a matrix of concerns. by putting each concern as a role and placing each of the committee members in separate columns you can use this matrix to quickly and easily see which members share concerns and which concerns have yet to be addressed or resolved. if you review this document is a living document where each member continues to add and update concerns online and fda staff and committee members can address those concerns. by making this public, things will not fall through the cracks, which reassures the public and professionals relying on you. the matrix of concerns will be available to all. we are using the spreadsheet as a model to demonstrate the concept, but a spreadsheet is limited. [indiscernible] called information -- that provides this functionality at scale. our team is reaching out to stakeholders around the country, expert organizations and associations to build central
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repository of concerns. we want to invite and encourage the committee and fda staff to utilize this technological tool to address concerns. if you appreciate what we have shared, please reach out to us. my team and i look forward to working with you. >> dr. berger. >> thank you for allowing me to speak today. my name is david berger, a board-certified pediatrician. i am one of the few pediatricians who does not discharge families for my practice if they do not wish to follow recommended to see schedule. my comments are mindful of the strong overall benefit our nation will get [indiscernible]
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my presentation today is about vaccine hesitancy and steps that can be taken to increase confidence in the covid vaccine programs. it is very important that we see ongoing bleak transparency about the vaccine in terms of both safety and efficacy. we have seen reports that over 50% of americans and 30% of physicians have some level of hesitancy about covid vaccines. we must allow for meaningful public scrutiny to build public confidence in the vaccine program. . eid's doctors we have a duty to inform our patients about the benefits and risks of any medical procedure. if a person feels she is not given sufficient information out can she provide informed consent. i think it is important to respect people who have concerns about hesitancy about vaccines. i find positive families will proceed with the vaccines if they do not feel their concerns were blown off and to minimize but were respected and tended to.
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while there are many subpopulations that should be studied for increased chance of vaccines that there is concern about those with pre-existing allergic, hyper inflammatory, and autoimmune conditions. four individuals developed [indiscernible] whereas there was no incidents in the placebo group. on the first day of the program that our government as to take its vaccine, divisor vaccine if they have a history of significant allergic reaction after two anaphylactic reactions were seen. it would be difficult to quickly to fully track all 50 states find the frequency of adverse reaction. it is important we have a federal program. us to provide data for know if people who have had covid infections already have an increased or decreased risk of a vaccine reaction. provide comparative data between different products to determine if any brand may have more or different reactions than any other brand. i implore you to put in place a
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very long-term post vaccine program. and hypermmune inflammatory conditions take a while to develop for a patient to seek help. it is also important to have a robust surveillance of covid antibodies so we will have a way of knowing if immunity is waiting. we need to know what is considered a protective antibody levels just as we have for other vaccines that can be commercially tested. if the fda can increase our level of competence, hesitancy will likely decline in the covid vaccine program will have a better chance of success. it will take many good people to defeat covid-19 and i hope i can help you make a difference. thank you very much. i appreciate the time. >> the next speaker is [indiscernible]
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>> dr. wolf, you cannot listen to it -- wolf? >> do you hear meet with the speakerphone on? -- turn youro hear tv on or otherwise we will cure the delay. now.will turn it off right it is off. >> all right. >> can you hear me on speakerphone? >> yes we can. go ahead sir. next i am dr. sidney wolfe. i have no conflicts. ,ith the surging pandemic
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efficacy and safety results made public two days ago we agree with the need for the eua for the covid vaccine. there is an important unresolved conflict though. if it eua is granted for widespread use should the participantss -- who participated in the trial the offered [indiscernible] should provided vaccine recipients be told of their their thereby continuing participation in the trial. you mightnible] otherwise leave the trial to get vaccinated by pfizer or other available vaccine. the unwinding vaccine providing proposal has important advantages. eua is granted the
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ethical obligations as pfizer inform allboth placebo recipients of their status and offer them a vaccine within the context of his trial is met. by retaining trial participants, the trial remains bonded after an eua, more recipients may follow it afterward. the originally next citigroup could be compared to the newly vaccine a group to compare rates ascovid-19 infection as well adverse reactions. fda has said it does not consider availability of a covid-19 vaccine under an eua although in and of itself is grounds for immediately stopping the blended follow-up or offering a vaccine to all placebo recipients. meeting,e october 22 someone asked what about the problem of retaining placebo
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and the post eua, doctor responded with regard to dropouts and ongoing clinical trial is. we do share that concern. i do not have any specific remedies to offer at this time. we have asked vaccine manufacturers to think carefully about how they would ensure critical drought retention. pfizer as stated, and in briefing documents, it intends to continue the pivotal phase three study and about the ascine and placebo groups reasonably allocated for as long as possible. nevertheless we have an ethical responsibility to inform all outgoing -- ongoing rather study theticipants [indiscernible] vaccine made available under an eua. they would accommodate those trial participants wishing to
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leave the trial by reviewing which group they are in, but they can receive a vaccine only when practically eligible, depending upon government specified priority group and available supply. pfizer's real preference, and this is in the briefing documents, is that such placebo individuals are vaccinated within the study in order safety and efficacy data can be caught, we believe this approach [indiscernible] if you are in the trial would you prefer being unblinded only if you wish to leave the trial to seek available or needed vaccine or being automatically unblinded, giving vaccine [indiscernible] to stay in the trial. thank you. the next speaker is jim --
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kim mitsack. >> i am speaking about half of what, a drug organization established after the death of my husband. of the current] drug safety system. i am on the board of directors for usa patient network, an independent board advocating for safe and effective medical treatments. right now the world is looking for hope so they can get back to normal. too many lives have been lost. like many of us we put blind faith and hope in the system that ultimately failed us. i have several concerns about rushing novel vaccines to market. the public needs assurances that the fda's review was thorough and independent given the process for reviewing new products it usually takes six to 10 months. how can the fda be rigorous this
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time? this needs to be available and fda scientists need to be protected from whatever their judgment is and not be political like it has been with many press controversies such as antidepressants and suicide has been handled within the agency. transparency is everything. assuming fda approval, all trial data must be made public. this includes the process like pfizer's data monitoring committee. it's a public? if not, it should be. we need a process for communicating to the public. it needs to be real-time as we saw in the u.k. yesterday with allergic reactions and not reported weeks, months, or years later as history's. post-market reporting will be as important as ever. we do not know long-term arms
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given the short duration. holding staff be up to -- which includes patient narratives in the recording, the fda needs to do the same for [indiscernible] narratives can tell a more complete story without giving away patient details. i have huge concerns about a blending of placebo participants and giving them the actual alludedas pfizer's ceo to doing. if this happens, we lose our control groups. i am directing this comment to the news media. you have a huge responsibility to dig deeper, as political questions, and not be an extension of the manufactured pr department like the wall street or desert a journal article did earlier this week and included a .fizer supply chart
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they should've have sounded alarms and begs for additional questions, and then they would have dug deeper and realized there were not a lot of blacks in the trial. please take out -- seek out independent researchers and others without political or financial agendas. is the real world clinical trial. it is one big human experiment. 100%nly one who could have immunity in this will be pharmaceutical companies. they get all the benefits of sale without any legal liability should something go wrong. thank you for your careful consideration of my comments. the importanced of your advisory committee work. thank you. speaker is -- i am from the eighth treatment activist coalition. i have no public of interest.
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and answer [indiscernible] the benefit ratio are [indiscernible] in my opinion. my written comments have been addressed. one important actual issue involving participants in the placebo after eua as been discussed. it is very reassuring participants [indiscernible] or to receive the vaccine within the study at the appropriate time. design willfully hopefully ensure the study does not crash. and unblinded crossover is probably much more [indiscernible] laypeople have no understanding of the --discernible] except i do have a few important concerns. for pregnantle]
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women should be further along. the safety and efficacy of been established across rate -- race and ethnicity. the analysis of participants includes 0.5% native americans, 19 -- 9.3% black americans in 19% hispanic. [indiscernible] disproportionately affected and will experience greater adverse comorbidities and debts. while my community appreciates the eventual conclusion of people -- inclusion of people with hiv and hpv, the number enrolled is abysmal. hiv and hbv or] people over 75. there is no data vaccine used in these populations. this is especially concerning
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for people with hiv as there is mounting evidence that the spreads as co-infection outcomes. [indiscernible] post eua research to establish efficacy are significant numbers of people over 75 and people of color and people with hiv, hbv were feasible without excluding them from any indication. lagging behind] and enrollment of people of color and research. [indiscernible] and will convene community meetings to discuss trial designs as well as vaccine issues.n and retention this will serve the community and sponsors over many years of successful and beneficial drug development. thank you and the fda for such dedicated service and for the opportunity to comment. >> thank you. next speaker is --
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>> good afternoon, i am peter, president of the nonprofit for science in the public interest and associate commissioner at the fda. interest conflict of to the cause. i would like to think the fda for committing to the advisory committee review process particularly under concerted political pressure. i went to address two issues. based on did data accrued to date the pfizer product demonstrates a striking degree of efficacy in preventing confirm covid-19, one that is shared across a variety of demographic and clinical subgroups. i agree with the reviewers that there is no evidence of a major safety signal. the extent of more minor events is notable, injection site reactions, fatigue, headaches ensures all -- substantially elevated rates in the placebo group. i do not believe these events
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should stand between this product and authorization but i do think the rates of these events are sufficiently elevated to merit open-ended discussion with patients. we are experiencing significant levels of vaccine hesitancy [indiscernible] potentially exacerbating the hesitancy problem. i also welcome fda's i did indication of disproportionate number [indiscernible] hypersensitivity adverse events in the treated group as matters that should continue to be monitored and the buzz marketing phase. the second issue relates to trial design now that at least once a vaccine is been identified. the issues are complex but we want to agree on this. no subject to as a -- put their body on the line should be at a disadvantage in terms of vaccine access as a result of their participation. some observers appear to be advocating for extended periods
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of blighted follow-up even after authorization. this position is hard to justify ethically if it is inconsistent with public health recommendations at the time, particularly with the rising case rates and reported levels of effectiveness for the pfizer and moderna vaccines. the me [indiscernible] following framework. subject should be informed if any vaccine candidate is authorized, not just the one in their trial. like any study subjects those a vaccine trial should be given the opportunity to leave the trial at any time if they so desire. given shortages of available product, subject should be offered vaccination with an authorized vaccine as soon as it is offered to those in their clinical or demographic will group according to federal and state guidelines. those for whom [indiscernible] is not yet recommended to continue to be followed in blended fashion and vaccinations recommended for an individual, a good idea is to do so in a
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blended manner, to facilitate blighted follow-up for long-term safety and efficacy outcomes. this will facilitate the collection of data while borrowing the contributions of tens of thousands of people who altruistic efforts have brought us to where we are today. thank you. >> thank you, the next speaker is andrew spiegel. >> thank you for the opportunity to provide comments. present [indiscernible] of the world patient alliance. i have no disclosures. the global patient alliance is the umbrella organization of 200 patient organizations representing hundreds of millions of patients worldwide.
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threements fall into basic areas, dedication, commitment to science and transparency, and innovation. we went to applaud the dedication of scientists both within the private companies and within the fda. for the last year at scientists and researchers have fought tirelessly to create a vaccine for the novel coronavirus and put it through a processes to ensure its safety and efficacy. knowing thatted in the fda will require rigorous post distribution data monitoring to ensure any vaccines will be safe for the population. we know during these unprecedented times the people of america and the world deserve to know that there governments are working to eliminate this threat. we want to make sure that the fda knows that we will continue
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to hope that it keeps the patients at the forefront of all of its policy and approval decisions on these vaccines as well as other medicines. the entire world will be watching what the fda is doing and are relying upon the fda. as the coronavirus vaccines continue to be using countries around the world, we must continue the process of innovation. developing countries need access to medicines not more than ever. [indiscernible] the vaccine for covid could be manufactured as a pill that would be easily distributed and prescribed in those countries with less access to health care professionals around the world. i am in agreement with other speakers before me on the issue of clinical trials and ensuring toal memos have access
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vaccines. [indiscernible] during these unprecedented times to do what was unthinkable in the past. we thank you for your hard work and your commitment. great, the neck speaker is lisa. lisachod afternoon, i am -- we send our gratitude to the vaccine and related biologic products committee for the opportunity to provide public comment on behalf of consumers. according to deployment of emergency use authorization for the pfizer-biontech covid-19 vaccine. we want to think that food and drug administration, centers for disease control prevention and other health agencies for their commitment to fostering public trust during vaccines relevant and approval process. as consumer advocates if we been
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encouraged by the honesty, transparency, and excess afforded to the public during this critical time. to that point there is never been a more equal time for consumers to have confidence in the fda. the agency has undergone scrutiny from the scientific community for prematurely issuing uas for vaccine therapy -- covid-19 that -- therapeutics -- an eua is not intended to replace long-term randomized clinical trial data associated with the full fda approval. we look forward to continuing guidance as the trial continues to collect safety and efficacy data. we have a great trust in the fda truly is a vigorous vaccine process -- vaccine approval process and call the agency to [indiscernible] to ensure continued safety and efficacy. trial [indiscernible] recall on
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the -- we call on the fda to heed these warnings and [indiscernible] the evaluation and approval of the covid-19 vaccine. consumers will rely on ongoing guidance from public health agencies regarding any potential adverse events on the vaccine. additionally ensuring innovative vaccine methods could address geographic access issues as well as adequately consider diverse health needs, increasing overall uptake. we welcome efforts to ensure diversity in clinical trials for the covid-19 vaccine and we request the fda continued to privatize trial data that reflects diversity as people of color will need to have confidence in the vaccine's efficacy in their community's. the development of a covid-19 vaccine in such record time as
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been a miraculous one. made possible through robust collaboration between private and public [indiscernible] we will continue to support the fda in its efforts to release a covid-19 vaccine safely and efficiently. thank you for your views on this important public health issue. >> thank you. the neck speaker is julie moh andro. >> good afternoon, unaware of any conflict of interest. i will leave you to read through the comments i submitted as you please. they were submitted under the banner of the rogatory [indiscernible] i start with the question. viable 37ua violate of the article of declaration of helsinki which states unproven intervention should not be used in medical practice without informed consent?
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this led to the question whether authorized products are proven or unproven and whether their use as medical practice or research. i concluded eua lies in an ethical gray area following along several continuums. i considered a few such continuums as ethical questions they might raise. i look at ethical standards in the belmont report and the ama code of medical ethics. and 564 of thex cosmetic act and the current status of both informed and consent for eua products. requires informing patients that the product has been authorized for emergency use. the problem is patients do not know what that means. providers and patients are provided with the product fact sheets, all apparently based on the same template. the language address saying the product has been authorized comes from 56 and 64, which is
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not written to inform patients of anything, not written language understandable to patients or providers. there is confusion among manufacturers, providers, and patients regarding the rogatory status of authorized products and what can be expected of their safety and effectiveness. [indiscernible] patients and providers need to understand and where fact sheets fall short. if individuals with the appropriate expertise could evaluate [indiscernible] as they apply to eua along the continuing this could provide a framework for addressing ethical concerns that have emerged with the eua as well as appropriate regulatory oversight and appropriate use of clinical data generated from the use of an eua product. i do not think this type of evaluation is suited for warp speed. in the interim, i asked the committee to consider the risk presented by the eua include not
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only ethical rest by lots of public trust, a serious risk for any public health program. if issues emerge with the use of a new medical product patients and providers will go back to, what was i told? i hope the fda will give serious consideration to moving forward with any covid-19 vaccine initially under expanded access rather than eua to ensure medical -- adequate ethical oversight and continued access to vaccines for the populations that most urgently needed. have anrnible] please irb, take a look at the template for the patient fact sheets. thank you. is --at, our neck speaker >> thank you for this opportunity to comment. my name is andrew west and i'm the president of the u.s. patient network.
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our organization is composed of many patient and family members affected by it pharmaceutical and medical devices that promised hope but left our members or family members harmed with lifelong [indiscernible] and sometimes death. we have no conflicts of interest to report because we are a completely independent voice for our patients and their families. [indiscernible] every person receiving a covid vaccine needs to know the answers to basic questions, such as will this vaccine prevent the most serious symptoms or the spread of the disease? what side effects would occur immediately, midterm, and long-term, and how long will vaccine protection last? it is our opinion that at this time there are too many unanswered questions regarding safety and efficacy to release the vaccine. of these vaccines
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will make participants unwilling subjects and a seemingly uncontrolled clinical trial. we recognize the tremendous pressure being placed on the fda to act. we are asking for reasonable ask that thee release of this vaccine done cautiously and with thoughtfulness for the health and well-being of recipients. we ask that you proceed slowly and on a voluntary basis until a phaseonclusion of the three clinical trials. we ask that you exclude populations that have not been studied or fairly studied, such as pregnant women, elderly persons, and severely compromised -- immuno compromise persons. we ask that you continue clinical trials to include groups of people not yet included in any clinical trials to truly determine safety and efficacy.
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we ask that you monitor vaccine recipients long-term over time by collecting and analyzing data to identify real-world safety and response results. clear instructions and encouragement to vaccine recipients on watch, we, and how to report adverse responses. completeat you give consent information that includes full disclosure of the ingredients in the vaccine, all possible adverse responses, as well as a statement in plain language that the current safety and efficacy information is incomplete and that the vaccines have not yet been studied for safety and effectiveness for everyone or studied for adverse responses or effectiveness over time. we thank you for hearing our concerns.
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>> great, thank you. >> my name is sarah christopherson, the policy ethics director at -- bringing the voices of women to the fda for 45 years. we are supported by our members and do not receive financial support from [indiscernible] and i have no conflicts of interest to report. we apply the fda for their diligent work on desperately needed vaccines. we do have serious concerns moving forward with emergency use authorization based on so little data for so many communities hardest hit by this virus will do little to assuage legitimate concerns and does communities about taking the vaccine. black andndicates indigenous people living in the u.s. are roughly four times more likely to be hospitalized as covid-19 and three times more
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likely to die for the virus than their white counterparts and as we heard at the october 22 meeting members of those communities have expressed a strong interest in knowing that the vaccine will work with people like them. black americans will express high rates of covid vaccine hesitation and for good reason. black americans do not have to look back to the last century or the dusky experiment to see [indiscernible] and blood people negative expenses with the medical system in their own lives. [indiscernible] a clear link between confidence in the military process and americans allowing us to get the vaccine. before authorization is granted, affected communities need to know the vaccine is safe and effective for people like them. efficacy data includes fewer than 2000 black or african-american vaccine recipients and 131 american
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indian or latin american participants. 2060y data included just black seniors 65 or older and 131 american indian or latin american people of any age. if this advisory committee votes to recommend authorization based on the data, fda must ensure robust tracking and bold transparency once the vaccine is taken. near-term side effects of the vaccine, such as fever, chills, pain, fatigue, all of this could be quite alarming to the public, which will further fuel distrust among communities given little reason to trust this process. thank you. >> thank you. the neck speaker is -- is dr. vicki --, i
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have no financial complex. i am a public health scientist and nurse who serves as a [indiscernible] the director of patient safety from the vaccine -- injured by his 15 month will be 68.t in 19 the process normally takes 10 years. when it is accelerated and populations are not large enough , the public assumes unknown and potentially increased risk. under the emergency use authorization, covid-19 vaccines can be approved but remain experimental and unlicensed while manufacturers are shielded from liability if the vaccines cause harm. the eua fact sheet prepared for the public must be transparent and fully disclosed known and unknown risks of the pfizer beyond tech covid-19 -- biontech
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vaccine to ensure decision-making and public confidence. the eua fact sheet should disclose whether the vaccine is at least 94% effective in infection and transmission or only prevents severe disease and death. whether there is evidence for antibody acquired immunity and how long it lasts. ofther there is a risk enhanced covid-19 disease when vaccine recipients are exposed to the virus or have previously [indiscernible] whether there is evidence for immediate or vaccine reactions, especially those who have had covid-19 disease [indiscernible] vaccinations or are chronically ill. the eua fact sheet must clearly identify populations excluded from clinical trials.
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criteria exclude certain people from trials, including pregnant women and children, those with type pressure, obesity, diabetes, kidney disease, and those using certain medication or with a history of vaccine reactions or over age 85. will the vaccine be safe and effective for them? the fact sheet must clearly list all vaccine ingredients and disclose that a [indiscernible] was used to test the vaccine as reported papereptember 2020 published by pfizer and biontech scientists. the fact sheet must it must state that the consumer has the option to receive or deny the vaccine. to take thele vaccine or give it to the children is unethical and unlawful.
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thank you for your attention. >> thank you. is marthapeaker nolan. >> good afternoon. thank you for the opportunity to speak with you today. i am senior policy advisor at healthy women, the nation's leading nonprofit health organization representing more than 18 million women. we provide consumers and health care providers with accurate, evidence-based information about diseases, innovation, research, policy affecting women's access to care. i want to thank you for the work you have been doing today and throughout the pandemic. i commend all of you for your leadership and consideration of the data that is before you. today or in the future, as i know were offered,
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have all had challenges in terms of public trust. the science available is truly remarkable, and the sharing of information regarding work to develop covid vaccine candidates is the first step in bolstering public trust. as you are aware, recent surveys among the general public also somewhat surprising among health care workers reveals concern around the safety of covid vaccines and many myths and misconceptions. all of us who work in public health must work to address this issue, and working together would be particularly critical. that is why healthy women is co-leading an effort with more than 60 other public health organizations representing caregivers, families,
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health-care workers, older americans, veterans, front-line workers, and scientists, to work together to alleviate concerns and hesitancy associated with the covid vaccine. thank you for leading the conversation to ensure equitable access to authorize and improve vaccinations. the key to getting our lives back to normal in the u.s. and across the low hinges on the success of the covid-19 vaccinations, but we also know vaccines are only as effective as they are trusted and taken by the majority of the population. juergen for the work you're doing to ensure the coming vaccines are safe and effective. thank you.
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>> great. thank you so much. >> thank you so much. my name is mitchell warren, and i am the founder of a nonprofit organization. i have no conflicts to declare, and we accept no funding for pharmaceuticals.
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two, the continued enormous need for the inclusion of diverse populations in covid vaccine trials generally, and the data under review today provides limited information about the safety among diverse populations, including those living with hiv and other immunocompromised people. it is important that specific requirements and timelines be articulated so these key populations are not left hind. i want to underscore my colleague's earlier common about the importance he of equity -- the importance of equity in research and review. it is essential that future bla's include at least six months of lower. while recognizing some trial participants will want to exercise their right to leave the trial.
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it will be urgent for the fda and company to rapidly develop xear information, including loosely outlining the benefits, risks, and rights, and we strongly encourage you to the guidance issued earlier. the biggest unknowns remain the durability of vaccine efficacy and if the vaccine prevents a symptomatically disease and will limit transmission. a clear plan to collect and communicate information to inform answers from within the ongoing trial as well as the design of additional trials is essential and should be clearly articulated when any eua is announced and should be strategically linked to other .accine developers as we have seen repeatedly in this pandemic, clear,
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evidence-based information is key. we apply the fda for its commitment to transparency and itsence-based science in decision-making. it is a beacon of independent reviewing transparency that will help foster the trust necessary to rebuild confidence in vaccines. thank you for what you are doing today and throughout this process, and thank you for the opportunity to present, and we look forward to continued engagement in scientific and regulatory processes. >> great. thank you. we tried the last person, and we were unable to reach out. paste already 10 minutes the actual time for the next
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,resentation, but before we go [indiscernible] would like to make a few comments. then we will go to the next presentation. >> thanks very much. toust want to take a moment offer some thanks to various people. first of all, thanks to anyone from the public for tuning in today. i think having this as a transparent process is very important as one of the steps we are taking to try to enhance vaccine confidence across the country. i also want to take a moment to thank all of the advisory committee members and the speaker today. their contributions are immense, and we look forward to their discussion later on today. for melso very important to take a moment to thank a
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group of people at fda that have put an incredible amount of advisoryto this committee meeting while they are simultaneously getting ready for another committee meeting and taking care of many other vaccines in various stages of development. the amount of effort put into this by those setting of these meetings is tremendous. of the like to thank all advisory committee staff, but also, incredible gratitude for all of our reviewers, especially in our office of vaccines research and review. the leadership and staff in that office have worked tirelessly throughout the past weeks and months to get to this point, and that included working diligently
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over this past holiday when they could have been spending their families, so we are very, very grateful for all the work, and grateful to all of you. with that, i want to let this proceeding move on, since it is going to be a long day anyway, but thank you very much. >> thank you. now, the next presentation. the sponsorhave presentation. catherinetor is danson, senior vice president, head vaccine research and development of pfizer, and vivian gruber, senior vice president vaccine clinical research and development at pfizer. you are on.
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>> good afternoon, members of the committee, fda, and ladies and gentlemen in the audience. it is a real pleasure to be with you here today. i'm dr. catherine jensen, and i am senior vice president and head of vaccine research and development for pfizer. i would like to thank fda for organizing this and the members for their time. our presentation today will low i give ada -- after dr. williamsction, will review the development program for all vaccines,
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including nonclinical, clinical safety, and clinical efficacy data. after this, i will come back to review the benefits, risks, and provide conclusions for our .resentation we also have a clinical investigator with us. a professor of microbiology and immunology, chief -- and director of the institute for global health and informational science from the state of new medical science. prevention of covid-19 in individuals 16 years of age and older. at those levels, it's 30 micrograms with two doses, given 21 days apart. the vaccine presentation is
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preservative-free and stored frozen between -80 and -50 degrees celsius until use. since the beginning of the year, we have been facing a devastating situation with disease caused by 2. new coronavirus, sars cov over 1.5 million people have already died. safe from this disease, and certain groups such as health-care workers and first responders, the elderly, and people with underlying diseases, are at particularly high risk. it is now becoming very clear, particularly with the recent increasing rates of covid-19 , that we need a safe
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and efficacious vaccine to stem this devastating pandemic while also deploying other prevention strategies such as infection control, including mask wearing and social distancing. covid-19 that causes thatnew coronavirus in china. late 2019 the virus enters into human cells where it replicates, then spreads to other people, often causing illness in the infected individual. data available from other established that
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antibodies can block the binding of the virus themselves and prevent infection of the human chose our vaccine antigen. specifically, we chose a form of the protein that was engineered but to be a perfusion neutralizing virus antibodies. we chose this platform for number of reasons, and given biontech's long experience with messenger rna vaccines. mrna vaccines are used by cell preproduction processes, using highly defined vaccine components, rna and lipids. immune touce broad
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sponsors well-suited to address a new pathogen in a situation where there is no or limited .nowledge lacks antigensrm that may lower a vaccine-induced immune response. as a consequence, mrna vaccines can be boosted repeatedly. an important consideration when persistence of vaccine immunity is not yet known. can be developed and scaled up quickly, a clear advantage over cell-based production processes when developing a vaccine in a pandemic setting. vaccines work?a we have a deep scientific understanding of how such
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vaccines work. that harbors the information for the vaccine antigen, which is a form of the s protein. the mrna is stabilized to form what we call lipid nanoparticles or lmp's. they allow sufficient entry into human cells. is optimized to enter antigen cells efficient at stimulating a broad immune just -- immune response, which we desire, given that we do not know which best correlates with protection. inside the cell, the mrna is released from the lnp.
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just like any other messenger rna in the cell, the mrna in the vaccine can address the synthesis of the protein by the .ell's own production machinery , the whole protein and its smaller fragments are presented to the human immune system that recognizes the protein as foreign, resulting in stimulation of cells that activate other t cells and antibody producing cells. the antibodies combined to the protein neutralizes the virus, which means the virus is no longer capable of infecting the cell. also produced are cda t cells that can eliminate virally
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infected cells. an important feature of mrna they stimulatet effective cell memory responses, ensuring longer-term protection from viral infection and disease. an additional advantage of the it introduces a response that is linked to protection from viruses and that minimizes the risk of vaccine-enhanced disease. the virus responses a secretion ofy such funds -- the immuno response induced by the vaccine are similar to what you may get
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in response to viral infections, but of course, the mrna vaccine is noninfectious and cannot cause disease. when we started our covid-19 vaccine partnership with biontech, we had a choice of a .umber of vaccine candidates given the enormity of our mission, clinical data was important to us in deciding on ae right candidate for covid-19 vaccine, so we evaluated not just one but 4 different candidates in phase one to be able to make real-time scientific decisions to select the best candidate race on the following major selection criteria. with regard to safety, we were looking for the most favorable safety and tolerability profile
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in both younger and older adults. we were looking for the broadest antiviral immune responses most likely associated with efficacy, and with regards to a rapid pandemic response, we were looking for the candidate that could be developed and produced most efficiently. , weg these criteria the modified rna that contains a link pre-fusion sars covidrotein of two. we must demonstrate that the vaccine is highly effective, meaning that it can help prevent
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covid-19 in at least a majority of vaccinated people. we must demonstrate that the vaccine is safe with a robust safety data set generated in a very large, pivotal efficacy study, and we also must demonstrate that we can consistently manufacture the vaccine to the highest standards . throughout 2020, we have been asked often -- how can this be , when theyear or less process normally takes many years? well, vaccine development or anything else in a pandemic setting, is not normal. it requires a completely different way of thinking and a versusy of parallel sequential r&d. substantial efforts and
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resources were poured into development and manufacturing scale up well before any clinical data were available. seen an unprecedented investment in early development. we worked with the fda and other regulators on a seamless trial which collapsed bases 1, 2, and three, also in an unprecedented way with close to real-time communication and decision-making without ever stopping the trial. other grateful to fda and regulatory agencies who have lent us their enormous support to work on these seamless development timelines. the substantial work already done on mrna platforms with biontech, we were able to
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quickly start clinical development. provide realrt to sars covid toal an covid-19 attack rates in the united states to optimize our selection of trial sites. was but certainly not least the dedication of staff as well as tens of thousands of trial participants. overre able to enroll ensureparticipants and their safety while conducting the trial with strict compliance and uncompromising quality. now, let me introduce to you the
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clear, compelling data package that we believe satisfies the fda guidance for covid-19 vaccine emergency use authorization. we have submitted all of the information required to meet the guidance, and you will hear about them this morning. as for manufacturing data, fda the data submitted today for our vaccine and has determined that the information is adequate to ensure the vaccine's quality and consistency for authorization of the product. now, a discussion of the nonclinical and clinical data sets as well as future plans. >> thank you. it is my pleasure to share with you today the development .rogram for a vaccine candidate
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i will begin with a very brief summary of the data that encouraged us to move forward with the climate, including toxicity studies as well as a study looking at a challenge model. these studies are described in the briefing document. studies, including this vaccine construct, were completed with no safety concerns. development and reproductive toxicity studies are ongoing with preliminary results available by mid-december. two recentoronavirus challenge model, this construct provided complete protection as determined by nucleic acid amplification for sars coronavirus to. this information is now published.
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critically, there was no evidence of vaccine elicited disease enhancement. these findings anticipated results in phase 3 clinical trials in which there is no evidence of enhanced disease. these results were encouraging, satisfied fda guidance criteria, and permitted progression of human clinical trials. i'm now going to share with the ,f the clinical safety immunogenicity and efficacy data from our overall development programs. the two phaseth one studies. study was conducted
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in individuals 18 to 25 years of age. 12 subjects received the vaccine for each dose level. this study evaluated safety, binding and neutralizing antibody responses as well as regulated immune response to .ook at the potential for bias the u.s. study is a seamless study where we had a phase one portion that moved into phase ii two and phase 3. toincluded 18 to 55 and 65 85-year-old individuals.
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anger consistent with reactions observed in other vaccinations. react initially was generally higher after dose two than dose one, and events in older adults were milder and less frequent than those observed in younger adults. now i would like to summarize for you the antibody responses 230-microgramo doses of the vaccine, focusing on the neutralizing antibody
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requirements. these have been published in a peer-reviewed journal and are described in your reading docket. , gmt's28 -- by day 28 are shown at the top of each column. antibody responses are well maintained after day 52 approximately one month after dose in in the younger 18 to 55 years of age group and the older 65 to 85 years of age group. gmt's are shown again at the top of each column. they range in each participant from 1.8 -- [indiscernible] this is very encouraging to us. we were achieving a functional
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antibody response that could be associated with protection. it was also important for us to examine the immune response to be confident we were getting a strong t cell response. these are data from the german trial. this first panel shows intracellular cytokine analysis. we see a substantial increase in h1, labeled hc. t if you look at the middle panel, you can see a relatively higher s compared to cell a lower proportion expressing il4. this emphasizes a th1 bias tha could be associated with protection. only is, not onnly --
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it important to demonstrate the importantses, it was to demonstrate cd8 t cell response in the killing of infected cells. in the right-hand panel, you see a robust t cell response that exceeds the responses observed from natural infection, again labeled hc. on the basis of promising neutralizing antibody response, and cd8ed cd4 response response, we were encouraged to move into the phase three portion within the vaccine construct. outlined here at a high level are the fundamental elements of the trial where our goal is to enroll approximately 440,000. we find it important to make
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sure those individuals with underlying diseases included have the greatest benefit from the vaccine because of their high morbidity associated with covid-19. we also included individuals with stable hiv, hepatitis b and c infections. areeast 40% of participants 56 years of age or older. this is important because we recognize that this population is also particularly vulnerable to severe disease. we also recognize the importance of conducting the study in people of color. we adopted an that approach that ensure a diverse racial and ethnicity profile, including black and african-american populations, asians and hispanic latinx popular since. we excluded immuno copper might individuals. it is yet -- populations. we excluded immuno compromised
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individuals. we will study those populations in future studies. here are the demographics displayed on over 43,000 subjects as of november 14 with good presentation of gender, race, ethnicity and age, with even split between vaccine and ceepo recipients -- placebo recipients. the breakdown is age groups above and below 55 years old. in the older 65 and above groups, note that 9000 of the participants were over six he five years of age. you theme share with data from our phase 2/3 portion of the trial. i wanted to highlight something. we have ongoing safety reviews
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by an independent data monitoring committee. these are occurring weekly. this makes sense in the context of a rapidly enrolling trial. the dmc consists of four adults and pediatric infectious disease experts and one statistician with expertise in assessing vaccine safety, immune response, and efficacy. no safetyentified concerns during the clinical trial and recommended the study continued as planned at all of their safety reviews. datasummarizes the safety based populations submitted to the fda for this review. starting at the bottom, there are over 43,000 study participants with safety data collected in the trial as of the data cutoff november 14. moving up, nearly 38,000 of
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these represent a subset with median follow-up time of two months post dose substitute. this means there are over 19,000 participants for whom state follow-up data is available for at least two months post dosage. of the total safety population, there were over 8000 subjects shown at the top for whom seven days of solicited local and systemic reactions were obtained. shown here is a schematic of how monitoredsubjects was on the left-hand side of the top. were given 28 days apart. the first dose was followed by intense, active surveillance for potential covid-19 symptoms that would trigger a visit and nasal swab. this was both as a safety
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measure and to evaluate efficacy. individuals could either be intent on we were otherwise tracking safety, brands of late. -- safety comprehensively. we used a diary to address vaccinations, encompassing at least 6000 subjects and 500 in each of the countries included in the trial. wee also -- we also captured nonserious adverse events. we will collect adverse serious events for six months post dose two. now let me share with you electronic diary data related to local adverse events. this represents data captured over seven days after dose one and two in 16 to 55 and 56 to
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85-year-olds. i think you can quickly appreciate looking at the two panels that represent dose one and two that redness, swelling, and pain at the injection site, the type of reactions are consistent with commonly licensed recommended vaccines with little redness or swelling. pain was largely mild to moderate. no grade four local reactions were observed. satisfactory safety protocol involving local reactions. we also used the electronic diary to look at systemic events. the orientation of this slide is different in that we are looking first at events seven days after dose one. those that received the vaccine on the top panel compared to those that received the placebo at the bottom. looking at the 16 to 55 -year-olds, you can see the
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reactions fall within a tolerable range compared to other adult vaccines. i would highlight these, because they appear to be the most discriminating compared to the placebo. both were within an acceptable range. now we are looking at systemic events seven days after dose two. you can see a somewhat higher incidence of fever and chills as well as other systemic manifestations compared to a placebo. the only severe solicited adverse event greater than or equal to 2% in frequency after the first or second dose were fatigue at 3.8% and headache at 2% following dose two. one vaccine recipient reported a fever of 41.2 degrees centigrade only on day two after dose two and recorded no fevers for events -- for all other
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recording events. otherwise, no grade four systemic reactions were observed. there was a difference between younger and older individuals. younger individuals tended to have more reactions. in all age groups, the vaccine was well tolerated and reactions were within an acceptable range. if we consider these events over period ---dose two [indiscernible] participants are vaccinated on day one. fever, the leftmost dark blue bar, typically appears on the day after and vaccination and lasts only a single day. otherwise the other colored bars peak at day two, then rapidly decline over the next two days in both age groups. we captured spontaneously reported adverse events by
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system organ class in the nearly mediumsubjects for which safety follow-up was two months after dose two. more details are included in your breathing document. the most common adverse events observed were general disorders and administration site conditions. as shown in the footnote, t he top four classes of unsolicited reactions of the nearly 30,000 participant data set mirror the common reaction captured by the electronic diary in the 8000 participant subset easily described. these include reports of injection pain, fever, myalgia, tervous disorders, headache, no diarrhea and vomiting. termse exclude those
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reflecting local reactions and systemic events typically occurring within seven days of vaccination, we see a more even split of adverse events between the vaccine and placebo. the predominant remaining event is unspecified pain in the vaccine group, 2.4% versus 0.2%. in general, adverse events by system organ class were infrequent and within range of such reactions recorded. events shown by system organ class are consistent with what we typically see in populations that not only include 40% of individuals being older than 55, but over 50% of the population having at least one underlying comorbidity.
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these include observed serious adverse events of special interest designated by the cdc, which are few in number and comparable between vaccine and placebo recipients. a total of six deaths have occurred in this population, with four in the placebo group. none have been considered related by the investigator. further descriptions of these debts and full -- deaths and full safety data as of november 14 are included in your breathing document. ofsummary, the tolerability the safety profile of the vaccine at 30 micrograms administered as a two dose regimen 21 days apart is favorable. significant if he findings other than mild or moderate reactogenicity were identified.
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ouruld like to turn to efficacy guide. let me summarize how we went about determining efficacy. the vaccine doses were administered 21 days apart. to qualify -- [indiscernible] noividuals needed to have evidence of prior or current infection before each dose. that was determined either by a swab at the time of each dose to identify evidence of coronavirus 2 by nucleic acid or obtaining a blood specimen for antigen antibodies at the time of the first dose to indicate evidence of prior infection that may have preceded vaccination by months. this allows us to be confident the individuals for the purpose of this endpoint had no evidence of infection at the time of each dose. this is important because this
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is the group we would anticipate is most motorola -- most vulnerable to covid-19. we have active surveillance for potential covid-19 symptoms that trigger a telehealth or in person visit and nasal swab. we will continue to do this for up to two years after the second dose. to qualify as a case for the first primary endpoint case definition, individuals had to be baseline negative at prior or current infection. then we characterize as needing to include one or more of these symptoms. youe should be familiar to because they largely coincide with symptoms captured by the cdc case destination -- case definition. comparable efficacy observed of the cdc criteria are shown in the briefing document.
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nn the right-hand side, once a individual qualifies for the first two categories, they need a validated pcr. results will be accepted from a local laboratory if it is proved to be the type of testing we agree is valid. all testing was performed blind on the treatment side. it is this combination that determines the case definition for the efficacy results that i will now be sharing. we performed an interim analysis individualsses and without prior infection and observed efficacy of 95.7%. we performed the final vaccine efficacy evacuation against covid-19 from seven days after dose two in 170 cases without prior evidence of prior infection. 95%rved efficacy is high at
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with high confidence based on the parameters shown in the two right-hand columns. 95% probability that efficacy falls in the intervals shown, meaning over 97.5% likelihood that efficacy is greater than 90%. likewise, the probability the vaccine efficacy is at least greater than 30% greatly exceeds fda covid-19 vaccine guidance. this efficacy trial -- [indiscernible] groups. age or ethnic nonetheless we think it will be useful to see the vaccine efficacy broken down by these parameters. observed efficacy was high regardless of age and consistent with overall results. adults 65ere seen in to 74 years of age.
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only one was in the vaccine group. five cases were observed in participants greater or equal to 75 years of age and all were in the placebo group. efficacy was high in both males and females. efficacy was high across racial and ethnic groups. comparable high efficacy was observed across black, african american, other racial groups, and likewise across hispanic and non-hispanic ethnicities with lower bounds of confidence intervals above 80% across these ethnic groups. there were also comparable values of observed efficacy seen across geography. also notcacy trial was powered to evaluate efficacy based on risk groups. nonetheless, we think it would be useful for the committee to see vaccine efficacy broken down by these parameters. the risk groups included individuals with body mass index
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rater than or equal to 30 kilograms per meter squared or those with the comorbidity index of malignancies, cardiovascular disease, diabetes, renal disease, and many others. as you can see, observed efficacy was high regardless of whether the participants were at risk or not, consistent with overall results. likewise, efficacy was high across age groups with or without -- or those with or without obesity. if we break out comorbidity, we see recovers of category, cardiovascular disease, diabetes or additional categories of hypertension, observed efficacy remained high, and for some the nominal lower bound of the confidence intervals were well above two. we can be covenant the vaccine
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is likely to work well -- be confident the vaccine is likely to work well in debilitated individuals. likewise, we evaluated efficacy against covid-19 seven days after dose two for those with and without prior infection. the site of our two primary endpoints. efficacy remains high with similarly high competence based on the parameters shown in the right-hand columns. it was also important to define severe cases both for evaluation of safety and for determinations of efficacy. we used the definition of severe covid-19 based on fda guidance. icu admissions, clinical signs of severe disease, organ failure and death are key features. using the fda definition of severe disease, let's first look at this top table.
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although not statistically significant, protection against a few cases of severe disease occurring at least seven days after dose two, consistent with the overall efficacy results. one case of the vaccine group and three cases in the placebo group and both without prior infection shown here. if one examines the population for severe covid-19 cases after dose one, nine cases are observed in the placebo group for an observed efficacy of 88.9%. the vaccine recipient only met a single fda criterion and was not hospitalized. in contrast, out of the nine placebo recipients with severe morese, six met two or criteria, three were admitted to the icu and one was intubated.
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this was consistent with overall indicates icacy and the bnt 162b2 vaccine is likely to protect well against serious disease. the fda definition does not include hospitalization as a specific criterion, however the cdc definition of severe disease shown in the light blue box includes hospitalizations, severe outcomes of hospitalization and death. we thought it would be useful to perform a post hoc analysis to further assess the impact of the vaccine on this outcome. using this parameter, efficacy against severe disease greater than or equal to seven days after dose two was observed with five cases in the placebo group with theant --
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confidence interval shown. [indiscernible] a lower bounds of 95% confidence interval well above zero. one vaccine recipient was hospitalized 12 days after reserving the first dose of the vaccine, but without additional cdc defined morbidity. in contrast, of the 14 placebo recipients hospitalized, three were committed to the icu and one was intubated or mechanically ventilated. this analysis provides further evidence for vaccine protection against hospitalization. this curve shows the cumulative incidence of all available covid-19 cases beginning after dose one. placebo cases are in red, vaccine cases in blue. darker dots represents severe
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cases using the fda definition. two incidences where cases overlapped in day 8 and day 67 in the placebo. one can see by at least 14 days, curves began to spread. placebo cases continues to increase at the time of this date event, while the vaccine case curve remains relatively black. one can see in this expanded view from dose one to day 21 that the curves begin to spread by as soon as day 14 after the first vaccine dose. this graphic provides -- [indiscernible]
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to assessake a moment pfizer's connection.
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just out of curiosity -- sound check from somebody else, please? >> can you hear me? >> hold on a second. >> pfizer? >> can you hear me? >> we will reach out to our sponsor and tell them they have to connect audio. >> hold on a second. [crosstalk] are you there, pfizer? >> we're here. >> there you go. sir, just go back about one slide to the beginning of this
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slide. we don't want to lose any content, okay? >> thank you. >> not a problem. apologies, everyone. are we ready to roll? >> we will hand it back to pfizer whenever you are ready. >> i'm ready. away.y, take it >> great, thank you. sorry for the technical difficulties. our efficacy conclusions are as follows. both primary efficacy objectives met the success criteria. in individuals without prior covid-19 infection, observed vaccine efficacy occurring at least seven days after dose two was 95%, with high probability, 97.5%, that the true vaccine efficacy was at least 90%. meets the this
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prespecified fda criteria for emergency use authorization. observed vaccine efficacy was greater than 93% for the first primary endpoint across age, race, ethnicity subgroups. ninehe fda definition, severe covid-19 cases were observed in the placebo group and one in the vaccine group and 14 hospitalizations and associated morbidities were seen in the placebo recipient versus one vaccine recipient hospitalization in a post hoc analysis, providing further efficacyto support the of the vaccine against covid-19. from the incidence curve, there is early onset of protection that the diversions of the placebo group and the bnt162b2 group as soon as 12 days and by at least 14 days with steady accumulation of cases of the placebo group while the vaccine group remained virtually blank.
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overall -- virtually black. the efficacy results show the vaccine at 30 micrograms provides protection against covid-19 in participants who our emergency use authorization is based on our safety profile and efficacy against covid-19. they will be seeking an authorization for individuals who are 16 years of age or older. this data includes over 8000 individuals. adverse events in over 7000 individuals with a median of two months follow-up, and adverse events of over 43,000 individuals 16 years of age or older varying degrees. which we plan to submit in 2021, will have over 8000
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individuals and at least 44,000 total participants. safety data will be provided from 6000 participants with a six-month or more follow-up. additional data will include safety in a 12 to 15-year-old population, which is currently undergoing study as part of our current trial. efficacy we have presented to you today is based on more than 164 sars coronavirus immune response 18 years of age or older. this serves as the foundation of data from the dla. additional planned analyses include efficacy against asymptomatic infections, evaluation for persistence of protection, and a 12 to 15-year-old immuno bridging. will note in the pfizer briefing documents, we plan to
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administer vaccines to placebo participants. we have a responsibility to inform participants. we are are currently in discussions about the best way to vaccine participants. eligible participants in the placebo group will have the option to receive vaccine. providetake time to vaccines to over 22,000 placebo recipients. we vaccines to those individuals satisfying emergency use authorization and current cdc recommendations. vaccination of other participants will expand over time. participants will be given the option to remain blinded if they choose to do so through study completion. the study will continue for the planned 24 months regardless.
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pfizer plans to meet fda eua guidance for risk and benefit during the use of the vaccine under the emergency use authorization. first, let's talk about proper vigilance. this vaccine is likely to be administered to millions over a short time. we have expanded our capacity to process reports with an online adverse report. have plans for future clinical studies to expand to more vulnerable populations. second, proactive risk minimization. labeling and come brands of materials will emphasize key messages about appropriate handling, storage, and preparation of the vaccine. and emphasize the importance of following up for their second dose to maximize their protection.
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the cold chain will be monitored in real time. third, pharmacoep idemiology. tos will access information monitor safety events, including adverse events of special interest. we know our vaccine works from the clinical study setting and plan to evaluate real-world use. withinally, collaborating stakeholders. we have heard about the fda and -- for farfor forma michael vigilance -- for pharmacovigilence. after approval, pfizer will with important
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endpoints like hospitalization and emergency department visits in specific populations and to understand efficacy in real-world conditions in broader populations. will complement the cdc planned effectiveness studies. we also intend to conduct a number of studies recognizing there are other populations that stand to benefit and there are other things we need to learn about the vaccine, including boost ability, studies for pediatrics, and use in immuno compromised populations. we also plan to explore a refrigerator stable second-generation formulation. we look forward to expanding the safety and efficacy profile demonstrated today. that ends my summary of the clinical development program, and i am pleased to turn the presentation back over.
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>> we believe that our data has satisfied the requirements for a covid-19 vaccine, as you see on the green checkmarks. we are seeking emergency use authorization for all vaccines for prevention of covid-19 in individuals 16 years and older with or without evidence of prior infection. we demonstrated the positive profile for the vaccine, given the overall efficacy of 95% with high efficacy observed in both younger and older adults, as well as diverse demographics with and without underlying comorbidities.
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and we observed efficacy against severe covid-19. in addition, we have demonstrated the favorable safety and tolerability profile in more than 40,000 individuals. why are we applying for an emergency use authorization now? and a goodfficacy safety profile shown for the vaccine and the pandemic essentially out of control, vaccine introduction is an urgent need. dramatic increases in cases have occurred all over the country, and it is estimated that about 55,000 deaths will likely occur every month over the next few --ths, modeling from the cdc few months. modeling from the cd shows a vaccine with high efficacy can save lives.
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however, a vaccine must be introduced before the peak of case impact, which is best achieved under eua. and biontech wish to thank all of our investigators and etiquette its staff, and we wish to thank our clinical trial participants, without whom we would not be here today. we are also grateful for the guidance provided by the cdc, the fda, and other regulatory bodies, and members of operation warp speed. finally, we want to thank our colleagues at lyons tech, pfizer, and other companies for their tireless work and dedication to develop our covid-19 vaccine candidate. thank you for your attention, and we would be happy to take
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any questions. >> thank you very much to both of you. to first ask dr. gruber about how he is going to be measuring asymptomatic infections. in addition, i wanted to let everybody know that bill gruber is not related to marion gruber. >> [laughter] that is correct. not to my knowledge. if i understood or heard you correctly because there was a little bit of a delay, you were asking about our plans, how to monitor a sum to medic infection? -- asymptomatic infection? our trials were designed not just to look for symptomatic
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covid-19, but also to monitor and explore whether our vaccine is efficacious against asymptomatic infections. and we are monitoring individuals and screening them with a zoological test that measures exposure to infection in protein tests. hope that we will have completed very soon in the new year. >> and you are looking at protections? >> that is correct. collectingtudy with serological samples throughout study, which is 24 month in duration, we have the opportunity to look for
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protection provided that we see enough break in cases over time. vaccine thatth the is highly efficacious, and if it continues to be highly efficacious over time, it may be a little more difficult to define the protection. but nonetheless, we are trying to do that. >> ok. we have many, many questions, and we are going to have to limit them and expect you to stay on for our discussion in about an hour or so because i think we can get to some of the other issues at that point. dr. leavy? >> thank you. the precision vaccine program at boston children's hospital. i would like to thank pfizer for
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its impressive effort and excellent presentation. i have the following questions. for dr. jansen, one regarding mechanism of action. rna's and principle can be recognized via the immune system, particularly specific rna boost activation. it could induce interferons, explain what was observed in the study and may provide an effect, contributing to robust immune responses and the protection observed. recognizing that the vaccine contains modified rna, it may have blunted the activating potential. what is known regarding the leading rma to activate the vaccine isthe ou observed in vitro? my question for dr. bill gruber, regarding the numerical imbalances potentially
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indicating allergic reaction, what is pfizer's response to it allergic reactions to animal models o. dr. gruber described the adaptive response. what about dna? do these correlate with any of the study endpoints? like to actually have our doctor described in detail what we know about the mechanisms of actions. let me start off while the doctor is getting ready to say that one of the reasons why we platform fora our vaccine is the reason that theempers, tones down immune system.
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because as i mentioned earlier, we are looking for a candidate a --would allow us to have or would give us a vaccine with a very favorable safety profile. if i could ask the doctor to come to comment on the more detailed questions about signaling for the vaccine candidates. [indiscernible] question.xcellent [indiscernible] it is driven by a combination of the recognition of messenger rna
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particles, xena correlation. membrane creates innate which stimulation signals we found in activation of the pathway. this we saw in cytokine creation. correlation ofe the blood to the peripheral tissue. >> thank you. bill? do you want to touch on the other part of the question? katherin. if there are additional questions, i think the first question was about adverse
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events within the study. subjects, we saw no serious allergic reaction to the vaccine. there were no substantive differences in standard measuring, in numbers between the bnt construct of placebo groups analyzed under the 38,000 subjects database. within the clinical trial, we have actually not seen evidence related toa signal allergic reaction to the vaccine. obviously, we are conscious of the use in the u.k. while he is preparing, let me deal with the second part of the question, which is the nature of measurement and the like. the measurements that were obtained were the ones i shared with you.
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as of today, my understanding is it has been published from the phase one trial from the german trial, some of which i shared with you. as part of either our phase one trial in the united dates or the phase 2, 3 extension looked specifically at cytokines. >> thank you. >> thank you. dr. moore? >> this is very exciting data. thank you very much. perhaps the most interesting data i have heard during this epidemic. i have two questions for you. the firstated to question, which is modified rna's.
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in a vaccine. do we know anything about whether the modified rna's undergo salvage, stan can be reincorporated into dna, or if could possiblye amplify it or turn it into dna? the second one is among the eight people who were vaccine failures, were you able to sequence the virus that came from those people? and was there evidence of antibody escape from your antigen? i will start with answering your last question, then i would like to get our doctor ready to address your first question. as of the eight individuals that had a vaccine failure in our
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analyzed have not yet immune responses or anything else for those individuals. but we plan to do this. but we don't have the data today. if i could ask the doctor to answer the question that you had about the rna. >> there were two questions. one is it is recycled to other rna's, and the possibility of transforming the rna to dna. we do not have data on recycling of the modified nucleus. although it is theoretically possible for a reversing of the rna, we think the probability is actually quite low that this would occur. the rna sent no signal that would make them [indiscernible]
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have very recent data indicating it is a modest amount of rna that gets to the cell, and we don't see it getting to the nucleus where this would occur. there does not seem to be any greater likelihood that crna would reverse transcribed the cellular rna. >> thank you. >> ok, thank you. >> yes, thank you. this question is probably for bill. first of all, thank you for an excellent presentation. one thing that has been raised is there were roughly 160 participants who got sick who were in the placebo group, which would mean a disease rate of about 0.74%.
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it seems like that might be low. it would be interesting to know whether or not that was lower than the disease rate in the areas where participants were being recruited. the concern is if that is lower than typical that we may have an example of volunteer bias, where the people who volunteered for this trial are more likely to physically distance, more likely to wear a mask, and are more likely to be exposed to a lower inoculum. was that disease rate lower than you were seeing in that area, or was that typical for the areas were recruiting? it is a good question. disease that we were seeing was relatively typical of not only the area, but thinking ahead to the nature of this population. on the one hand, this is a population that we recruited because they were an increased
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risk, but they were also voting with their feet to be part of a vaccine trial. we assume and we certainly encourage them to take the appropriate social distancing measures and asking. -- masking. mindther thing to keep in was a very short duration in terms of getting to our efficacy endpoint. particularly in the united states, where rates dropped, and now we know the horrific situation with over 3000 deaths a day. but it is my sense that part of this is the nature of the trial, both during the time when the rates were high and low, as well as the precautions individuals in the trial took to further reduce that risk. >> thank you. >> thank you.
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>> i just want to thank pfizer again for first of all presenting this data. i want to thank them for adding this data to the public as well, because i think the way they presented this data to the community was really important for many different reasons. i am curious about enrollment related to these categories. the large proportion of people in the trial, i think i characterized 46% who have comorbidities. my curiosity is about timing of enrollment and those high-risk groups. were they more likely to be enrolled in later portions of the trial and have less time
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accumulated and at risk? ho[indiscernible] -- in terms of the outcomes we are seeing. adults 18 and older were part of our study right from the get-go, as well as the risk groups. the only individual participants that were invited later and part of the study were the younger age group, the 12 to 15-year-olds, six to 18-year-olds, -- 16 to 18-year-olds, and adults who had stable underlying disease conditions, such as stable hiv, hepatitis b, or hepatitis c. >> thank you.
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>> thank you. youuestion is, how sure are about the booster dose? the reason i am asking you that, clearly in the paper you can see the responses are much better after they take on those. you show that the pair are separating. they separate at 14 days. the curve remains flat, so i cannot see any effect of second dose of my curve. i wonder if there is a possibility that one dose is enough. if it is not, how do you know it is not? interestedbviously studyluate in our vaccine the persistence of protection over time.
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andthe data we have so far, if i could have the curve, please? if somebody could have that slide up? what you see on that slide is so far -- can we have it up, please? ableee that so far we were to observe a high degree of 105cacy for up to 206 -- days or so. i think it is important that we our protection. to say thatnclude after a single dose we would see a similar persistence of infection, so therefore -- and we have also seen that after two was highest
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doses were given. we have the data to look at one doses versus two doses. we started the study with two doses. predictourse, cannot how a single dose would protect against persistence, which is very important in this setting. >> ok. question that we are going to have in this session, and we will try to pick this up when we have more time in the discussion later on. doctor, what is yours?
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>> make sure you do not have your own phone muted. you are on muted in the system -- you are unmuted in the system. >> i'm sorry, i did not have a question. my question was asked and answered already. >> in that case, we will move on, at least temporarily. please stay available so we can return to some of these questions in the first part of our discussion. on thewould like to call doctor from the fda, who is going to give us the fda's presentation of the data, and also describe the questions we are going to address in the discussion. >> thank you so much. good afternoon, everyone. i will go ahead and present our
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fda review of the clinical data submitted with the pfizer beyond biontechpfizer- covid-19 vaccine. a brief outline here. just to walk you through what we are going to present today, i will start with a brief introduction of the product and an overview of the clinical development program, followed by our efficacy and safety data analyses, then review the pharmacovigilence plan, and finally ending with our benefit risk assessment to help repair the advisory committee to discuss and vote on the topics presented earlier today. first, we will begin with a brief introduction. based on anis antigen encoded by rna, and it is formulated with nanoparticles.
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transmitted with vaccinations to days of her. moving on to a brief overview of their clinical developments program to date. there are two ongoing studies of the vaccine candidate. phase oneongoing study in adults 18 to 15 years of age. second it is an ongoing phase 1, 2, 3 placebo-controlled and individual 12 years of age and older. although as pfizer pointed out that there phase one studies did
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begin at approximately the same time earlier this there -- this year. the overlap candidates allowed -- immunogenicity. be evaluated in a larger study that began in the u.s.. 16201.g at 1bnc levels listed, there were 12 participants. no placebo group. due toety results noilar profiles, there are serious adverse effects reported. t162b2.
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moving onto the immunogenicity results. these results were obtained seven days after phase two. and showed doses of the vaccine were comparable to the they werealescent -- highest -- two doses also binding antibodies. and 80 helper of interfering grandma. datammunogenicity supported larger numbers of subjects. and this the data from the study helped support the final vaccine candidate, select a dose, and
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vaccination schedule. it was determined in 10 to him with the phase one data from another study. on to that study design next. initially, the study was designed to include approximately 30,000 adults 18 have an 85 years of age. the population was expanded after the study was underway to include but is fenced down to 12 years of age and those with chronic conditions and infections such as hiv. to participants were planned receive two doses 21 days apart. dosehase one was for selection. 90 participants, randomized four to one to receive vaccine or placebo. separated into two age groups of participants 18-55 years of age.
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the dosing began at the lower dose levels and the doses escalated only after safety review. the older group was exited with the same group of candidates. participantsf received the various dose levels of the two vaccine candidates displayed there. these results in combination with those found in the study determine the final vaccine candidates to move forward into phase two and three. back here. the study designed for phase two and three included a randomization of one to one for participants to receive either the vaccine candidate or a placebo and evaluate the safety and efficacy of the candidate.
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wereirst 360 participants specified as an extended cohort to further evaluate safety. any covid cases also contributed to the overall phase 3 efficacy population. enrollment was stratified with a aal of a goal representing population at risk for covid-19. the total number of population randomized was 43,551. here is a graphic to show the overall study design as planned. tohave the data to present you today. participants either received vaccine or placebo 21 days apart. surveillance begin after the first dose. wouldesence of these
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trigger an illness visit and collection of a nasal swab for testing. participants had blood drawn prior to dose one as well as nasal swabs prior to each dose to. to evaluate for the evidence of baseline infection. participation -- participants were followed for unsolicited adverse events. and for serious adverse events for six months after their last dose. a subset were designated as the reject -- reactive subset. participants are planned to have two years of follow-up. moving on to the case definitions here.
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on the right-hand side of this slide is the case definition for the primary endpoint, to included at least one of the listed symptoms. obtained within four days of the sentiment of time. on the right side is the case definition for one of the secondary efficacy points. definition was not for confirmed cases as shown on the right but also any of the one severe criteria's. based on vital signs, intervention for respiratory failure. or death. primarynto the endpoint. confirmed covid-19 cases
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primary toward the endpoint. evidence of past infection was based on the baseline blood draw to evaluate for the presence of antibodies. all of which needed to be negative results to be included in the first primary endpoint. the second primary endpoint was described in the same terms participants with and without evidence of prior infection. the second endpoints are listed here based on different case definitions. the first endpoint is for
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confirmed covid-19 cases that occurred at least 14 days after dose to. those without and with and without evidence of past infections. the second is confirmed cases that occurred 14 days after dose two. evidence ofhout past infections. occurring at the same two time points. review of statistical considerations, the vaccine efficacy was evaluated without evidence of prior infections following the second dose. efficacy population defined in the next slide. it was defined in terms of the
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illness rate ratio. aere the irr is calculated as ratio of the first vaccine group. to the corresponding illness rate in the placebo group. success criteria was met if the number was greater than 30%. analyses were planned and 100 202, 92, cases. uponirst analysis was done a case of 94 cases. final analysis was planned after at least 164 cases. conducted ont was accrual of 170 cases on november 14.
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you theefine for analysis population that will show from our data analysis today. populations are numbered. they are presented here. efficacyl available plan to -- participants, they received at least one or two vaccinations. hello? ok. the's efficacy population was a subset of this group. it was used for the primary efficacy population. in terms of the populations analyzed, the all enrolled population include all enrolled
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participants regardless of the duration of follow-up who received at least one vaccination. the study population was the safety population was a subset of this group. they received at least one steady vaccination and were enrolled through october 9 with follow-up through november 14. to review the duration of follow-up, phase two and three participants in terms of our theance for the eua, for study it is important to note the sponsors submitted protocol to increase the sample size. there was a late enrollment. participants in the adolescent age group and those over 85 years of age. and chronic infection such as hiv. populations have less follow-up.
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participants included in the interim analysis conducted november 4 at a follow-up duration of less than two months . interim analysis was successful afternd efficacy of 95.5% the accrual of 94 cases. participants also had a follow-up duration of less than two months. this time point included all of the participants included in the interim analysis. follow-upon of included an interim analysis at the time of the final analysis. on thesed our review data from the final efficacy. includes those from the interim analysis. because the results of the final analysis were consistent and provided more robust data from a greater number of participants.
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the phase 23 safety population includes only phase 23 population thins enrolled through november 9. the medium duration is two months. the all enrolled population includes all enrolled participants regardless of the duration of follow-up. median duration is less than two months. additional safety analysis from the larger database was also reviewed to evaluate for differences compared to the smaller population. moving on to one additional consideration we wanted to point out. implemented for enhanced respiratory disease. the oversight from the data monitoring committee and an unblinded team reviewed cases of severe covid-19 at least weekly to evaluate the number of severe
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cases in each treatment group in terms of the study design criteria and roles outlined in the slide. the criteria was met. to suggest vaccine administration was associate with more severe disease. on i will go ahead and move to our efficacy data analysis. the first slide showing the demographics of our efficacy population. sex, age, race, ethnicity, and the presence of comorbidity. you can see the elderly population is represented with 20% of the population in 65 years of age. approximately 10% identified as black or african-american. a smaller number of participants of american indian, alaska
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native, native hawaiian, pacific islander, and multiracial backgrounds. in terms of ethnicity, approximately 25% of the population identified as hispanic or pop -- latino. approximately 45% of the population had medical core mobility. here there aree a hundred 53 total adolescents. included. the demographics are similar for the safety population. disposition ofhe the population. to understand the reasons for exclusion. analysis of our primary endpoint. starting at the top of the slide. moving down, you will see how many subjects receiving each dose and were included because they did not have evidence of
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prior infections. listede exclusion reason toward the slide. most of the exclusions were because participants did not receive vaccinations within the predefined windows. there were more deviations in the vaccine group than the siebel group read most of them were medication errors such as product storage errors, incorrect dose administration. the wrong products being administered. the next slide here shows the results of the primary efficacy analysis. 170 cases.l of eight and the group. forng an advocacy of 95% covid-19 70 days afterwards.
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the criteria for success was met. the age certifications are also shown here. in the slide, the first row shows the overall second primary efficacy endpoint just covid-19 cases at least seven days after dose two. subjects with and without prior infections. oversee -- who oversee the vaccine will not know the baseline infection status. it was similar to the primary endpoint and has nine cases in the vaccine group and hundred 69 in the placebo group. giving an advocacy of 94%. by ages are shown here and by sex. wasvaccine advocacy consistently high across
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different analyses. with limitations in the adolescent group. as compared to the adult population. vaccines were uniformly high across groups examined with the exception of groups identifying evidenceacial and with of previous covid infection. of which to few cases occurred to interpret data. i think i just described that with the prior slide. the vaccine has to be a point estimate. moving on to one additional
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subgroup analysis. by comorbidity. vaccine pointthe estimates. across subgroups examined. andetes, obesity, hypertension. here shows the secondary efficacy analyses. based on the case definitions, which cases counted as 14 days following day's -- day two. the other secondary efficacy analysis to discuss his severe covid-19 cases.
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cases thatof severe occurred and all efficacy populations at each range of dosepoints shown following one. 10 participants had severe covid-19 disease after dose one. one subject receive the vaccine. vaccine efficacy was 89%. confidence interval. based on review of the case managers, overall, and the overall population, two placebos met severe criteria. six placebo recipients with severe covid-19 refused to be hospitalist. three of which were admitted to intensive care. what seven had at least one risk factor for the disease. thehe bottom row, you see
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case for the primary endpoint evaluation at least seven days after dose two. in which four placebo recipients and one receipt -- vaccine recipient had severe covid. there covid-19 disease met definition because of oxygen saturation's at the time. being less than 93%. the subject was not hospitalized. did not seek further medical care and did not have risk factors for further disease. recipients meto the severe case definition for the following reasons. one subject had oxygen saturation of 92%. of 125.a heart rate one subject was hospitalized for noninvasive hospitalization. one had an oxygen saturation of 92%. and ico admission.
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placebos also had obesity as a risk factor. the other two participants did not have any risk factors for a severe disease. the total number of severe cases is small which limits the overall conclusions that can be drawn. the case does suggest protection from severe covid-19 disease. to one post hoc on the timing of covid-19 cases following dose one. and all available efficacy population. the timing of cases is presented similarly for severe cases. was similar toy results in the vote -- vulnerable parts of the population.
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efficacy after dose one is 82%. based on the number of cases accumulated after dose one and before dose two, you can see there does seem to be some protection against covid-19 disease following one dose. these data do not provide information about longer-term protection beyond 21 days after a single dose. the vast majority of subjects received dose two. our next slide shows one of vaccineanalysis efficacy based on baseline covid to status. only 3% of participants had evidence of prior infections. few cases occurred in these participants over the course of the entire study. nine in the -- group. only one of the 10 cases in the
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vaccine group occurred seven days or more after completion of the two dose vaccine regimen. confirmedoncerned -- covid-19 during the study conduct. these data suggest previously infected individuals can be at risk of covid-19 reinfection. the small numbers of participants with baseline positive status limits the interpretation of the efficacy at this time. we will now focus our attention on the safety data. here's a quick reminder from the graphic about the general study design. review resultsl collected daily for the first seven days. dose one, reactivity shown here.
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it is by age stratification. after dose two, the younger group reported pain more frequently than the young group. it was characterized as moderate with a similar pattern after dose one. redness and swelling was generally similar for both age groups. the younger subjects and overall, there was an onset of local reactions. a few days after the dose. and between one and two doses. the local reaction following dose two is shown here.
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pain,onsistent reports of redness, and swelling. an analysis by various groups shows consistent results. slide shows -- my slides are little behind, i am sorry. unsolicited adverse events following dose one. i apologize for that. here are, let me catch up these are reports of joint pain, diarrhea, and vomiting which were reported equally between the age groups. following dose two, reactions
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are shown here. severity was and higher after dose one that in dose to. except for vomiting and diarrhea, which is generally similar regardless of dose. again, analysis by various demographic subgroups showed inconsistent results. dose to solicited reactions in seven days. here are the numbers for our adolescence. 16 and 17 years of age. for the majority of adolescents, 16 and 17 years of age, local reactions and systemic data were collected as unsolicited. the preferred term shown here.
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seven days for each vaccination as was done for the adult population just shown. these details are not available in 16 and 17-year-olds. based on the unsolicited shown here, the 16 and 17-year-olds had similar symptoms reported but to a lesser degree than the adult population. on to the unsolicited adverse events, subjects are monitored immediately following each vaccination. had an acute allergic reaction. events reported frequently in the vaccine group, they are consistent with reactions recorded from the subset. 18% in the vaccine group versus 3% and the other group, the
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placebo group which was expected. they occurred more in the vaccine group than the placebo group with a possible relationship to vaccinations. finally, -- occurred and for vaccine groups. three cases occurred at three, nine, and 37 days after vaccination. participants with no prior history. resulte was reported as within three days of onset. cases werehree reported as continuing or resolving as of the data cutoff. 16 and 21 daysof respectively. the fourth case had an onset of 48 days after vaccination.
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a prioripant with history of full spalls he and it and it was reported as ongoing. we reported standard measure queries using fda developed software to develop for a constellation of fun unsolicited adverse events. representing various conditions including but not limited to allergic, neurologic, inflammatory, and autoimmune conditions. they revealed a slight imbalance of events representing potentially allergic reactions with more participants reporting hypersensitivity related adverse events. with 0.6 .3% compared to the placebo group.
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with 100 and 11 or 0.51%. there are no and balances between the treatment group and evidence of any other things evaluated. to serious adverse events. reportede six deaths in the study. two in the vaccine group. both word participants over 55 years of age. one death was following a cardiac arrest 62 days after dose two. the other was due to disease after dose one. neither of these deaths were considered related to the vaccine. nonfatal, these included appendicitis in eight vaccine recipients and for placebo recipients. two participants were over 55 years of years -- age. one had appendicitis. none was considered related to
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acts and nation. samehoulder injury in the arm as the vaccine administration was reported which we attribute it as possibly related to the vaccine administration or to the vaccine itself. slide focuses on pregnancy because women were screened for pregnancy prior to each vaccination and were excluded or not vaccinated if they had a positive result. 22of november 14, they were pregnancies reported to be 12 in the vaccine and 11 and the placebo group. the time interval as it relates to the date of the woman's last menstrual. are shownal period here. one was a spontaneous abortion. the of the -- the other was a routine product of conception. the pregnancy outcomes are not
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known at this time as the pregnancies are ongoing. our next slide shows other phases of the evaluation. laboratories. the only common laboratory abnormality reported was a transient decrease one today -- one day to three days. grated 1-2 to severity and normalized within six to eight days and did not occur after dose two. among the phase one participants in this study who received the 30 microgram dose. these occurred and five of 12 participants in the younger age group. and in four of 12 participants in the older age group 65-85 years of age. these changes were not associate it with clinical symptoms.
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overall analysis of previous safety results were assessed by race, ethnicity, and prior covid to infections without any safety concerns identified. our advocacy conclusions are the totality of the clinical data submitted meets the expectations for the duration of follow-up. advocacynal analysis, -- efficacy after seven days was 95%. efficacy outcomes were consistently greater the 93% across demographic subgroups. covid-19against severe was 88.9%. the small number of severe cases is a limitation to the data.
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a trend of potential efficacy is observed in the data. a conclusion is limited because almost all participants received a second dose. safety theary for totality of the clinical data submitted meets the expectations for follow-up for duration of follow-up and evaluation of the all enrolled population. this provided additional safety data, a total of greater than 43,000 participants. were generally more frequent. mostly mild-to-moderate with less week with c and severity in adults over 55 years of age than younger adults. there were no specific safety concerns identified by age, race, ethnicity, medical core mobility or prior infections. four cases of false palsy were
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reported in vaccine recipients. although there is no clear basis a relationship, we do recommend further surveillance if the vaccine is approved. we will move on to the vigilance plan. and the ongoing study plan. jonesonsor submitted a plan to monitor safety concerns i could be associate with the vaccine. the sponsor identified vaccine use inted disease pregnancy and lactation are identified as missing information. in addition to the safety concerns, the fda has requested the sponsor update the vigilance plan to include missing
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information and pediatric participants less than 16 years of age which the applicant agreed to. we recently requested the sponsor at anaphylactic reactions including the pharma coal vigilance plan. the next slide is a graphic to outline activity. vaccineg may come from recipients, vaccination providers, or from the sponsor. vaccine participants will be -- another source of reports is the be safe program, which is a smartphone based program that uses text messaging to check in with the vaccine recipients for health problems after vaccination. reports from vaccine recipients are voluntary.
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wereporting by vaccination providers is mandatory. providersponsoring must report the following information. any vaccine administration errors, whether or not associated with an adverse event, the respective of the vaccination. cases of multisystem inflammatory system -- syndromes. cases of covid-19 resulting in hospitalization or death. the applicant will also conduct periodic aggregate review of safety data and submit safety reports at monthly intervals. each safety report is required to obtain a narrative summary and analysis of events submitted byluding cumulative counts
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age group, special populations, pregnant women, and adverse events of special interest. of adverseen because experience. will take a collaborative approach reviewing. the fda will individually review adverse events on a daily basis. and also examine other sources for adverse events and will perform data mining to determine if adverse events are disproportionally determined. safety signals will be investigated. outlinesslide asilance activities included active surveillance studies. each of which will be conducted
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over a 30 month time. . the first study will be conducted in a survey of 20,000 health care workers. defense will be compared to expected events. the second will be conducted within the department of health system databases. rates of adverse events will be compared to vaccine comparators. the final study will evaluate for ae's of special interest using the veterans health administration electric database. moving on, the next slide here will outline the proposed revisions to the study protocol. showsudy design figure
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the current study design and for participants that were originally vaccine candidates, to decline receiving the vaccine when it is made available. there is no change to the design. will be followed as previously proposed. proposalslide shows a for subjects to receive the vaccine under local and national recommendations at the time of the ua. they can contact their investigator to determine the meat eligibility criteria. they will be unblinded to know if they receive the vaccine or placebo. if they received the placebo, they would receive the vaccine and the study. for 18 months of follow-up. alternatively, the four or six
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months after dose two. subjects who had not met recommendations would be offered the option to receive the vaccine at that time point. if they accept, both the sponsor and the participant would be unblinded and participants who originally received the ceepo would receive vaccines. participants who cross over would get baseline blood drawn prior to the first dose. and nasal swabs. follow-upsthen have at 1, 6, and 18 months. for the total study duration, it would be approximately three years. moving on, i will wrap up now
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with our benefit and risk assessment. in the context of the proposed eua. the known benefits of the vaccine at this time include a reduced risk of confirmed covid-19, at least seven days after completing the two dose vaccine regiment. priorduals without history of infection. efficacy findings are consistent across subgroups including racial and ethnic minorities. adults 65 years of age and older. and individuals with one or more of the following conditions. obesity, hypertension. chronic hyper total pulmonary disease. data and adolescence 16 and 17 years and 17 years in age are limited but can be extracted from adults 18-55. a slide for here is risk. the known risks include local
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and systemic reactions. generally mild-to-moderate and dosefrequent following two. in adults over 55 years of age, they were less frequent compared to the younger adults. adverse events included the shoulder injury we attributed to vaccine administration or to the vaccine itself. there are no specific safety concerns identified in an analysis of the subgroups described. fromata are limited adolescents 16 and 17 years of age but could be extrapolated from the safety profile and adults 18-55 years of age. the risk assessment is limited by the duration of follow-ups. the fact that pregnant women
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were excluded from the study. we are aware of the reports of anaphylactic reactions and we are continuing to collect information to monitor the situation closely. finall move on to my flags to remind the committee of items who would like to discuss. plan for of which is a blinded placebo follow-up. this plan including blinded placebo control follow-up should be discussed. is tocond item to discuss discuss any gaps in briefing documents and the further evaluation of vaccine safety and effectiveness. under eua.
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questionsal slide, for the advisory committee. based on the totality of the scientific evidence available in the benefits of the covid-19 vaccine outweigh its risk for use. an individual 16 years of age and older. with that, i will conclude my presentation and welcome questions. thank you. >> thank you very much. let's have questions for about 10 minutes or so. we are running late. us tok it is critical for entertain some questions now. i should offer questions to the sponsors so we might want to follow up with questions.
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to the sponsor as well. we can sort it out. the direction of the questions, whether it goes to fda or the sponsor. let's start out with mr. tub. >> i read this before. data is now 26 days old. that was the closing date. i asked the question about do we have more recent data? dr. fink does not have any. however, the sponsor here. they will have updated data. some other folks they were asking about it. i have one specific set of data i would like to ask about it. it is about this question of severe disease. pfizer suggests it has been demonstrated the vaccine is
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effective with severe disease but that is not really the case. in your briefing document, you just don't have enough data to know that. is, do we have such data? is an efficacy of 56%, not the other data you talked about from dose one. the actual endpoint and the study came up with 56% efficacy. that is the thing that really matters and we care about. almost nobody cares about covid-19 at all if you have a sore throat. it is in the public interest to know what is the public interest
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in the vaccine. you do not have sufficient data to conclude that as of november 14. can we get data? pfizer which from shows additional cases? such that we can conclude the the criteria meet for severe disease. the second question is if it is not sufficient yet, at what point do we project there might be sufficient data so we can really look at that? -- new >> canvent i ask the pfizer team to respond about additional data? >> i like dr. groover to respond
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in addition to the additional data. when it comes to severe disease, i would like to invite dr. steven thomas to give his of the medical >>ortance of preventing -- we need to keep it brief. >> i can be fairly brief here. to the question as we heard earlier, quite a bit of work to prepare the data package. note november 14, we have done an additional unblinded analysis. we will do that at the direction of the fda. potential to look at
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that again. enough additional cases to enlarge that data. data wherehasize the , in my the 1-9 split compelling for evidence of protection. i think it is just a matter of getting enough cases and we have the potential for more cases over time. >> do you have anything to add? >> agree. those discussions when additional data will be posted. the is not the topic for
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discussion today. >> let's go on. got 10 people who want to ask questions. with the clip. findings of loss of smell and that, his cerebral palsy all, it could not be associated with some sort of immunological response? the second is, looking at the data package, we don't as of yet -- recognized or accepted
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protection. plaza -- convalescent plasma was derived from 38 individuals. 35 of which had mild disease. only one of which was hospitalized. we know the antibody do scale with the infection. it seems like a little bit of a low bar. comparing against people with mild disease. you have crippled in terms of
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innate immune responses to the vaccine. general -- new interferon responses. natural killer responses from the vaccination. or a nonspecific response to the vaccination. measuring the efficacy of your adaptive immune response you are clearly generating? >> dr. rowe shine, please.
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>> given the small numbers of cases we have, it would be difficult to attribute causation at this time. i do see your point. i might actually ask -- had two different panels of convalescent patients.
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i will let pfizer address that question. >> if it is ok, i can answer that. one individual was hospitalized. panel's guidance. for the vaccine induced immune response. [no audio] in terms of the protection. >> we are going to not worry
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about adaptive and innate immune responses right now. we will take that off. dr. perlman, your question? >> i had a question about pregnant women. don't think there will be a pregnant woman immunized. question tofer that dr. fink who was here. asking that for question. i am trying to activate my video. >> i know what you look like. time, we interests of have very limited data in use in pregnancy. developmentalng a study to be subdued to us.
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later this month. that type of data. it typically proceeds life insurance. in terms of inclusion of a woman, we recognize among the groups first there will be many women of childbearing potential including women who are pregnant knowingly or unknowingly. we have no data to speak to orks specific to the woman the fetus. warrant aat would
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contraindication. in the interest of allowing women of childbearing potential would consider taxation population to population, they would be free to make their own decision. in conjunction with their health care provider. >> thank you. to all the presenters and many people who contribute work to these presentations. my question is about the 16-17-year-old group.
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appreciate 16 and 17 years old are down to the age >> maybe i can take that question. that's a decision we would have to make at the time we are considering licensure application. our regulations and laws do allow us to extrapolate effectiveness and safety from adult populations into pediatric populations as you mentioned. 17 are those6 and inlescents that are closest age to adults so that a extrapolation becomes biologically all that more reasonable as well. are at17-year-olds increasing risk of exposure to sars cov 2 because of the
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activity they typically engage in, so as outlined in the doctor's presentation, for the purpose of this, we do consider that safety and effectiveness from adults, and particular younger adults, could be extrapolated to older adolescents at the age of 16 and 17. >> thank you. the last question we have time for right now before we have a very short break is from dr. rubin. please. >> thanks. for your careful analysis. it gets to one of the analyses you did. depends,as if 19 price regardless of whether they were
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vaccine recipients, got -- developed disease within the first 20 days. , theu calculate that rate numbers as much as we have them, that's a pretty high rate of infection. it's a little higher than the the group that was allegedly not immune. i wonder if that brings into question whether or not the antibodies are actually very good because there's a lot of independent evidence suggesting are relatively protected. since our evaluation of a symptom attic disease will depend on that, i wonder if that test was any good. -- symptomatic disease will depend on that, i wonder if that test was any good. >> antibodies have qualified for
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that stage of development. it is not part of their final analysis at this point so it has not been validated to a certain extent so that would be something that we will be discussing further. is also the issue of seasonal coronavirus is. >> yes. -- coronaviruses. >> yes. >> pfizer representative please and then we are going to take a break. >> yes, sorry. i was on mute. a protein to distinguish it in the response but we need to demonstrate asymptomatic -- thatone would be positive
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receives the vaccine. i believe question that you were asking, i'm blinking right now, -- blanking right now, the second part of your question -- >> whether it was a good infection, thehe protein. that was our understanding positivity does indeed develop two weeks after becoming infected. there is of course another way to determining infection which is by a more frequent sampling using pcr. valid approaches from our perspective. otherms of activity with seasonal coronaviruses, what is very important is for us to
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demonstrate it. we havecial test -- evaluated a large number that were collected prior to the and wence of sars cov 2 have not seen any evidence of cross-reactivity to seasonal coronaviruses. >> ok. take a -- looking at the clock -- a break until 10 to 4:00 -- hard start, 3:50. 6:45eeting went until eastern and i don't think we want to go that late tonight. >> with that, we are going to
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take a break. ok. let me tell you -- let me -- let's discuss what we are going to do in the discussion because i have had to cut off questions be given toing to or addressed to the presenters, the sponsor, and fda. what i would suggest is we are discussionwe have a of these two items and ask the sponsor and fda, as we go any items of fact that they can help us in this discussion.
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read to you the discussion items. item one is please discuss pfizer's plan, including how loss of blinded placebo control follow-up in ongoing trials could be addressed. plans talking here about for giving dose three and dose in the lastshown presentation and also gaps in fors described today further evaluation of vaccine safety and effectiveness so i think they are related and i think we need to continue our discussion around both of these points plus any other specific
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questions you have of the sponsors or fda. i think we want to stay away aboutore discussions thingsresponse and other that could be taken off line. introduction, do ctor? >> i had a question regarding un-blinding, if we go forward with the eua. if we did the crossover, how is that actually going to affect
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the bla? all of the data that was -- there is not an unwinding. understand the impact in the eua and by -- >> you are breaking up. >> sorry. >> are other people able to hear. >> no, she is breaking up a little bit. >> sorry about that. hello? >> go ahead. continue. >> my second question, we had a lot of questions about the vaccine. -- asymptomatic -- contagious --
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and it would be very important contact innd -- terms of how people who are already vaccinated -- situation. that, the second part of your question, which we had problems hearing anyway, to the discussion before we get to the voting question, because we are ing to want to have a second round of discussions before we get to the voting question, so is there anybody from fda who wants to address the issue of how the un-blinding issue could affect the bla? anyone? dr. gruber? dr. gruber, let's just make sure
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we unmute you. >> took me a minute. i just wanted to say that starting with the general comment that of course the gold tondards was doing studies address the safety and efficacy of the product was by randomized control, placebo controlled study, and this is why, from a regulatory perspective, of course, we would welcome continuing the publicity bow controls -- placebo controls as long as feasible, recognizing the complexities. morning, we this would of course, you know, be looking at potentially losing longer-term safety follow-up. realizing the gravity of course of the pandemic. if you are really looking at
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having to think about other designs and modification of the protocols, we would be looking at that to see and make sure we have sufficient data regarding safety. effectiveness regarding safety and to support the bla application. if it's no longer feasible, to that from the placebo control and efficacy study, we would look at other approaches to get this data. addaps the doctor wants to to that. thank you. >> actually do not have much to add. i was trying to jump in and the platform was not letting me. there seems to be a delay. nothing. >> thank you. dr. fuller, and let's try to keep to one part questions until we catch up at least.
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dr. fuller. >> yes. yes. thank you. this is a simple question. risk assessment is going to be very critical for the community. once the placebo -- did it only have other materials? in other words, the side effects we saw -- in two months due to only the spike protein because the placebo has the lipid material or is that due to both the lipids and spike protein expression? this will be critical considering most of the people who are getting vaccinated have not yet seen multiple exposures to the coronavirus so what does that mean for long-term effects that cannot even be looked at right now because we just got this?
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[crosstalk] just to answer quickly, the placebo control was a saline control so the vaccine is being compared against a complete placebo, not against the lipid, so the side effects that were observed are due to the accommodation of the lipid and the mrna. >> ok. vaccineve no idea -- into people that is long-term. it has not been done before. and we are going from 20,000 people who get this vaccine to millions who get this vaccine with a very limited amount of -- is that correct? doctor? >> i apologize. i accidentally muted you when i was trying to get off so i did not hear that question.
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at -- yes. we have very, very little information about what happens to people who get the vaccine and get exposed to covid-19, because we have only looked a few months and that included the vaccine with lipid and messenger rna so we don't even know what will happen long-term to people who get these lipid particles. there is such a limited risk assessment that i think the uptake in the community is going to be fairly poor unless something better is done. >> pfizer -- there has been a number of other vaccines that have been mrna vaccines that have been study where people who have gotten these lipids -- ly longer periods of time.
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perhaps we can give pfizer an opportunity to comment on that. >> and also we know that covid-19 is a multi-organ disease so it's not like some of the previous lipid vaccines. this is something we don't know very much about the pathology of this coronavirus. >> doctor? and then we will move on, please. i think you are muted. we actually have evaluated what happens after -- when individuals are being exposed by a covid-19. fewhile we have relatively with of individuals
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covid-19, nevertheless, those individuals showed, as we saw, a profile of severity the under 62 individuals that received a placebo. the other point i would make is we have stated multiple times our trialll follow participants up to the end of the study, which it planned to last for the full duration of 24 months. >> thank you. >> thank you. ok. thanks. my question is for bill from pfizer. about the severe anaphylactic reactions for this reason. we don't know the details of those cases. we don't know specifically what
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was they were allergic to or what their history with severe allergies was. we just know they carried epi-pens. in thelic health people u.k. said if you have a history of severe allergies, you cannot get this vaccine. similarly, they said the same thing. if you have a history of severe allergies, you cannot get this vaccine. there are tens of millions of people in this country who carry epi-pens because they have peanut allergies, egg allergies, who are going to believe they cannot get this vaccine. that's a lot of people. first, we need to drill down those two people in the u.k. but more importantly, dr. gruber, you said that there were no cases of severe allergy in your trial. did you exclude people with a history of severe allergy? that's question one. doi think maybe what i will is defer to our head of safety
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and by -- at pfizer who can describe more what we know about the cases in the u.k. and our plans for moving forward and perhaps we can even include the regulatory view. the nature of what was actually excluded from the trial was really restricted to those severeuals who had had a allergic reaction to a vaccine, and he vaccine previously, or if obviously during the course of the trial, they had gotten the first dose and they had a significant type one hypersensitive response, then that would preclude giving a second dose and we did not encounter that circumstance. the first circumstance, i don't know how many people we screened out. we had a prior issue with having anaphylactic reaction to a vaccine but we did not have to
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exclude anyone from getting the second dose. at least during the course of the trial, we have not seen anything that alerted us to a safety signal associated with the vaccine and potential for anaphylaxis, but maybe what i can do -- go ahead. >> what i am asking is this. do you know whether there were people in the trial who were in the vaccine group who had a history of severe anaphylaxis or a history of carrying an epipen? do you have that data? -- to shareing at with you what we do know in terms of the nature of pre-existing allergic conditions and, you know, the outcomes in the trial, to my knowledge, we did not know anyone who had had a prior history of anaphylaxis, but let me ask the doctor to share with you the information that we do have. >> good afternoon. i am the head of safety for
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pfizer and the chief safety officer. know more about these two cases in the u.k., so let me give you -- for these two cases. in the u.k.,orted which means -- vaccination campaign in the u.k. vaccinated in -- all these vaccinations were performed in hospital settings because their primary targets have kept -- in fact, it happened with these two subjects. the first subject in fact had a medical history of allergic reaction.
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a severe allergic reaction. -- the emergency room, where she needed to have resuscitation and -- so in fact, only a few minutes after vaccination. and finally, the patient recovered. the second patient in fact was which also had a medical history of allergic to drums. we don't know which drugs yet.
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mostly -- shortness of breath, and she required also the administration of epinephrine. it was reported on the second day of vaccination, which was not really a case of -- some -- she she had finally, some -- and and then she went back into a finally alsod fully recovered. at this stage, we don't think -- >> ok. gruber how fda is
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going to respond to these reports? >> you want to answer? >> i think you are speaking of dr. gruber. >> i was thinking of marion gruber. >> ok. i also wanted to say i am not aware that we are related, so we have that discussion. yes, so first of all, we have the in communication with medical health care product regulatory agencies in the united kingdom who made us aware of these two cases of anaphylactic reaction. was just reported about them wasnown about transmitted to spit at this
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point, we are seeking further information under our confidentiality agreement to learn more about this and to really tease that out. i also wanted to remind the committee -- the doctor presented that nicely of the safety analysis that the fda independently conducted by doing standard metrics. events that could potentially include or present allergic reactions. we found a slight numerical imbalance that they reported and presented on. none of these were considered to be serious. none of them received epinephrine injections and none of the events occurred in the immediate post-vaccination period. over the last couple of weeks, we have been working with pfizer on generating fact sheets and prescribing information and we,
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that providing information for this vaccine to include information under contraindications and under warnings so the vaccines in the prescribing information will state that this vaccine should not be administered to individuals with known history of severe allergic reactions to any components of the pfizer's covid-19 vaccine and the warning statement will say appropriate medical treatment manage immediate allergic reactions must be available in the event of an acute anaphylactic reaction occurring after administration of the pfizer vaccine. that is already in the prescribing information weeks ago. we will consider any additional information we will be receiving over the next couple of days and
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factoring this into our decision-making. to decide whether the vaccine and prescribing information may tod to be further revised include additional for cautionary statements. i will leave it >> >> here. thank you. can i offer -- and i will leave it here. thank you. >> if you look at the components of this vaccine which has the longest chemical name of any vaccine i have ever seen, nobody is going to look at that name and say i'm allergic to that. so here's what i would suggest moving forward as a practical solution. studies should be done by pfizer, whomever, where you take people who have a known history allergy, peanut allergy, and give them these vaccines under careful observation to prove that this is not going to be a problem for them because you are talking about tens of millions of people who are not going to get this vaccine because of the comments that were made both by the u.k. and here. i think it's a practical solution because this is not going to die -- this issue is
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not going to die until we have better data. >> ok. >> had. >> and then -- ok. to that, iesponse hear your suggestion, paul. and so did pfizer. to decide onneed the issues of the usa in the next couple of weeks. and we are looking at the question whether the benefits outweigh the risks, you know, under -- >> i agree. if the product is safe and effective for the purpose of licensing it -- thank you. >> let's move on. >> the current -- >> ok. of arst of all, in terms
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current discussion of anaphylaxis, remember, that is recommended for any vaccine that is administered. should be able to handle anaphylaxis reaction from any vaccine. it would not be just for a covid-19 vaccine, number one, and paul, i'm not sure that an albumin reaction to egg would have much bearing on the risks of a reaction to this vaccine. number two, going back to the pregnancy discussion, my concern is that during pregnancy, there is a great deal of replication, dna replication, cellular replication that's occurring in the fetus. and vaccinating a pregnant woman with this messenger rna gives me a little bit of
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and i understand the response, but could there be a retro v.a. -- retrovirus, a migrant tru retrovirus and reverse trend scribed the chromosome into the baby? that is one thought. the next point i agree very much with dr. mark sawyer and his comment about a 16 and 17-year-old. there are only 163 subjects who have been enrolled in the randomized trial. heard the inflammatory response is higher in younger people. i think we need more information before we think about that. and back to -- it is so
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important. vaccine, the very best to develop herd immunity. from an elaove it to a bla as soon as it satisfies the threshold. that the fda will hold this actsing two. there are many reasons to move it to a bla. it will be included in the vaccine injury compensation program. need to move in that direction. thank you. >> i completely agree with you. quickly. perceptiong about more than reality. with those two statements out there, people who have severe
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allergic reaction to not get this vaccine. we need to offer people some solace. i'm not saying this should stop us moving forward. data so wehave some can address it, that is not all. data to address it. that is all i am saying. agree, perception is everything. ofception drives a lot decisions. >> thank you. i have a question for dr. bill gruber. in your study, can you describe for us how the non-solicited adverse experiences collected up
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until one month after dose to were collected? surveillanceive for those events as well? if a subject is unblinded and vaccinated, could you reiterate what safety surveillance you will be conducting in that situation? >> thanks, i may call upon nick to help with some of the details. solicited andas collected for seven days. encouraged towere collect adverse events. the second question was what again? the plans for safety
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collection for subjects who might be unblinded? >> i am going to defer the latest amendment dealing with the placebo recipients. dr. kitchen. >> can you hear me ok? >> yes. >> with respect to solicitation of adverse events. the types of events you are asking about in subjects that were not in the subset, they were elicited the same way. they were not specific leading of events to elicit specifically all those events. that is why you would typically expect to see them at a lower rate when reporting adverse
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events. for rejection -- reaction is best data gives us the profile. with respect to our plans for as a resultillance, extensionligible, our is to not use -- they would have all adverse events elicited for one month after what would be their fourth vaccination but their second active dose. >> 8000 subjects set for common
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events. we probably -- i have sufficient precision. say comeless sense to back and essentially do the diaries again. could potentially mitigate against individuals wanting to participate. >> thank you. >> dr. lee. question is really in blindingbout the of the placebo recipients. why in your home blinding is there not some sort of -- in unblinding is there not some summer of risk factor?
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you are relying on local and natural guidelines. they are going to vary state by state and county by county. if you are going to incorporate the risk factors, you might have more consistency. i don't know if pfizer had considered that at all. >> that moves us back to the discussion topics. >> to explain in detail how we are going to follow vaccine recipients over time? >> it wasn't the question of follow-up. of identifying when someone would be eligible to be unblinded that would include risk factors, not just local and national criteria because they
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will vary tremendously in this country and i suspect elsewhere. >> we obviously -- this is a challenging. . the right path. we wanted to be conscientious about providing vaccines for individuals who would qualify. the onus is on us. take the emergency use authorization to heart. you happen to live in an area where url jubal, we would be hard-pressed to say because we have taken a national recommendation, you do not fit. we have yet to see how that will work and practice. it is our intent to try to do what we think is right to follow
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the guidance and local recommendations. on a national level but internationally. we have a number of countries involved. we have to look at each of those issues and weigh them to make that type of decision. to addhave anything else to that -- >> i know you will be in fda about these as well. >> right. this is a topic for discussion. >> exactly. intention, we would anticipate some of the recommendations following the initial recommendations. we will provide specific guidance.
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more specific than local recommendations. it would follow how a cip would recommend the allocation of doses. as we go forward, pay discussiono the items. we would like to move to a bla submission. promptly or smoothly. i won't say promptly, as smoothly as possible. the answer to some of these issues is going to affect that. dr. moore. >> one question that addresses these discussion items is really central and important. guidance.t ask in its
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-- pfizer has presented no evidence the vaccine has any effect on virus carriage were shedding. which is the fundamental basis for herd immunity. even though the individual efficacy of this vaccine is very you do not right now have any evidence it will have in thect on social wide epidemic. theuld like to ask before unblinding pfizer consider performing nucleic acid analysis. pointt know if the estimate for shedding is going
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to be high enough you are going to see a significant difference. but at least one should try. that is one piece of data we are going to completely lose once blinding occurs. >> let me interrupt and tell you these questions are being addressed by cdc in the observational studies as we go forward because of sample size issues and a lot of issues that are not possible when you are not looking at households where transmission will take place. the cdc would certainly like to the vaccinein companies to perform these very types of studies. if at all possible.
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that would be tremendous. it is so important as of right vaccineher or not this can have an impact on nonvaccinated persons at the risk for wiring infection. >> want to comment? into preciselyng that. not just for prevention of asymptomatic infection but the fortesting to look prevention of virus acquisition. data notind we have from human but a primate study that would argue the vaccine does prevent infection. we have seen it prevents
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infection of the lungs. evidence it some -- the virus is more transiently detected in vaccinated animals compared to control animals. >> we are going to have to move on. dr. kim. >> thank you. this relates to discussion number two. vaccine efficacy data might not for participants. but preliminarily data is available. trial participants were enrolled. pfizer please comment?
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are there any updated information? people with conditions that are forle and meet the criteria vaccination will be standing in line for the vaccine in short time. quiet sweet included individuals in our mission. hiv and hpv, that they have stable infection. solicited, unsolicited. within the population we have so k database, about 120 of these. 196 and the total, 43,000
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database. we will have enough of those individuals to look at. that inse doing association with the file that goes into bla. we just need to have enough of them. we amended the protocol and of july so there is a little bit of delay. that was the only population at what -- apart from the 12-15-year-olds delayed in terms an enrollment in the trial. it is our intent to have more information on that population. >> ok. >> thanks. there areestion about going to be a fair number of
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people who are going to have access to the vaccine. they may not know they are positive or no history of positivity. there is limited data in the trial because of enrollment for people who are previously positive. two questions relating to both of these. thinking about looking at side effects, is there an increased enhancement and side effects? what about people that have known prior positivity? what are you going to do with ?atients in the clinical trial are they going to be offering the vaccine?
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>> i think you are muted. i am sorry, can you hear me now? >> yes, we can hear you. >> i think we may have lost a link. >> we can hear you. good, thank you. i would like to take the first part of the question and then the dr. gruber comment on second half. well we have excluded individuals with known covid. meaning confirmed covid-19, we do have individuals that are positive. exposed torior covid-19. our estimate is about 2-3% of the individuals who were
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positive atg were baseline. >> i think the second question was about the nature of the safety profile in individuals who had prior coronavirus infections. line is this has been cemented to the fda. if you separate out that group, it is a small proportion of the over 150.lation, will 500 and the larger database. looking at unsolicited events. when you compare that to individuals with no evidence of infection, it was basically the same.
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we can't make much of that. these individuals did not fare worse from the vaccine. anything inseen terms of those individuals trekking through the study with rate.icularly high attack >> ok. one part only. >> thank you. if pfizer were to receive and lost theou participants in the trial who were health-care workers, with the remainder still allow you to adequately powered to
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carry on? >> i said one part only. put my hand up again. then you will go to the bottom of the queue. >> that is an important question. have bill like to address this and then we may need help. >> thanks. estimate, about maybe 20% or something north may fit into the health provider category. that leaves 80%. placebo those recipients remain longer.
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we can still track out and get a good measure both for safety and efficacy over the longer term. the bigger challenge relates to how quickly the cdc moves forward to the additional tier and how quickly those populations get emergency use. if we conform to the plan we outlined. curry are head of staff to comment. it is my sense even with 20% loss, we will not have that much difficulty. we were in the 50-60% efficacy category. that could potentially include more challenge. >> those answers are correct. is well-positioned to accrue more cases and answer
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some of these cases. >> thank you you, dr. hildred. toase, let's keep it mainly the discussion items. >> thank you. my question is for pfizer and it relates to the recruitment of minorities into the study which is reference to number two. my understanding is they were recruited fairly late in the process. do we have an adequate follow-up to that group compared to the majority of the participants? the two mark median is what i am referring to. can someone address that? thank you. >> i would like dr. gruber to comment on the demographics. me correct perhaps one incorrect assumption. from the start, we were focused recruitment and
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from racial and ethnic minorities. what we decided to do after we proved successful in terms of the overall success getting to 30,000 and deciding how to move forward, we decide that that point, even we had had some success but we wanted to have siteswe actually informed beyond what they had done, any new recruitment they provided was targeted to minority communities. it was a fact we started from the very beginning. you could feel confident minority communities were recruited throughout, perhaps with a bit more toward the end. supports we had individuals from those communities following us for a long enough time.
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certainly to demonstrate efficacy within the limits of some groups having a smaller number of total cases. not the right assumption we did not start from the very beginning. that was a key ingredient about our intent to bring people of color into the trial. >> dr. leavy, in the discussion items please.
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i think moving quickly now the benefit of the vaccine has been established, would be a good thing to do, something we would be working with the sponsor on. i'm wondering, while i have the floor, i might drive things back to the discussion items. in that regard, we heard this morning from dr. goodman lookstions that we might towards, instead of on blinding, when people become eligible to
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receive a vaccine outside of a design, therossover blinding was maintained. if we wanted to do something like that, that is the last opportunity which we might be able to draw a serum on. whether it would give a chance to look at the question raised earlier as to whether or not people have gotten infected. compare a vaccine versus a placebo. these seem like reasonable things for you to do? instead of doing a crossover, when people become eligible for a vaccine, but also to draw a serum on these individuals before that happens to allow for these kinds of additional looks at the last moment before
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placebos disappear, and one loses that opportunity to prepare the blood's placebos recipient. >> i can take that first question and comment. to we are fully planning actually do the analysis of vaccine protection very soon. beginning aprobably very early in 2021. and so we can take under advisement to see if there is an opportunity or value based on our routine that we do on the purchase offense anyway, given -- participants anyway, given the additional blood draw. given the other questions you have, i would also give it back
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to dr. gruber to comment. thrin., thanks ka the comments have been front and center. we have looked at a potential crossover. although there is potential advantage, some things being -- you sort of have, ostensibly, equalize them in terms of perception on whether they did -- need to come in or not. that's the challenge. deferral in the circumstances is not an option for acip recommended groups. that's a challenge in terms of solving for our obligations to vaccinate folks. there's the logistic approach. when we're enrolling 22,000
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individuals, someone has to be first in line. we can't bring them all in day one. the idea was with the authorization, we could bring them in as that authorization and recommendation expands. on the other hand, talking about a crossover, where everybody is going to have to come in for additional businesses, you're talking about -- >> i think that what you propose is you only bring them in for crossovers, as the otherwise become eligible. -- they otherwise become eligible. >> 44,000 individuals would have to be brought in for two additional visits, and those receiving vaccines would have to, in essence, be re-consented, come back for two additional visits. i heard dr. goodman saying some of these people, and we would
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hope this would be the case, would do this out of the goodness of their hearts. it does mean they have to come back for an otherwise unintended visit back to a medical facility at risk of exposure from that sort of experience. so, the notion of what we're concerned about is when we add this additional piece of work these individuals have to not only agree to, but provide informed consent for two additional visits for both groups, that creates, potentially from their perspective, may be the risk -- maybe the risk isn't that great for me. i'm going to wait until it's my turn and get the vaccine. so, those are things, the logistics are something that are not trivial because we've got to bring in, basically, a lot of people to be vaccinated. if we add 88,000 visits, that's a challenge. we enroll 44,000 people, but it
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took us a number of months to do that. the solution is trying to strike the right balance between getting people timely vaccinations when they're eligible -- there are some advantages to be gained by just having to vaccinate as a placebo. >> of course, one of the questions in the way it's being put to the committee, is if you can't do this and lose the ability to look directly at the duration of echo effect -- at efficacy and the crossover design, lose the ability to, in many people, longer-term follow-up for safety, and of course, as it is the people who are at highest risk, those who are also able to get the earliest vaccination. you will then lose the ability, in continuing your trial, to look at further impacts on the
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disease. what are the ways in which the will bey to get that addressed? how can the american people, as well as the fda and cdc, ensure that we have enough information to perceive, with the vaccine, and understand exactly what the longer-term safety and durability against the efficacy of the disease is? all mean, those are reasonable questions, ones that we're wrestling with. but i think we've already sort of addressed the common reaction. there's not a likelihood you'll get much more precision related to that. if we set that aside, there is this period of time where we expect to continue to be able to
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collect information as the dua rolls out. as i said, maybe 20% of the population would be vaccinated. it will still take time to do that. we may be able to do that in two months. time, weopulation of would be continuing to collect cases. as for a safety is concerned, the same thing. we would have a portion of these individuals looking for longer-term events. as we move further out, the likelihood you have a vaccine related event, or things become small, part of the reason i think we were enamored with the idea of a median follow-up of re going tois if you' do something related to the vaccine, it's more likely to happen in that time span and you've got a significant database. and of course, you don't lose the ability to look at efficacy
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over the long period of time, but placebo recipients moved over to the trial quickly. one of the key features is looking at durability. you can look, comparatively, at the new vaccine. we heard this from dr. goodman. you can the comparatively at the newly vaccinated compared to the previously vaccinated and determine whether or not we're beginning to see those individuals that the previous participants started -- up and suggesting that you're losing protection. now, almost aen blinded follow-up. sorry, i didn't hear that last comment. >> analysis was put forward by dr. foreman, based on an unblined follow-up -- blinded --
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unblinded follow-up. >> -- based on the difference of time. that's predicated on what happens with the pandemic. i'd like nothing better than the pandemic has gone away. but based on what i'm hearing from the experts, some of whom we heard from today, it's our if thoseon that -- attack rates for this people that were remotely vaccinated worked out. >> ok. questionsave two more and then we are going to move into discussion of our voting. question. tor.doc >> i'd like to discuss
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discussion number two. in your presentation, slide number 58, i believe, he spoke about different studies that pfizer might be conducting. but i did not see long-term care facilities residents listed. they are obviously at high risk because of which they are being prioritized to receive the vaccine. and the other one was inclusion trialsuse, [indiscernible] released in the northern hemisphere, this vaccine will be rolled out at the time this will be given. does pfizer have plans for those two popular asian's? -- populations? >> you want me to take that? >> it was addressed to you. >> ok. so, let me address the second question first. i think it was on the fly. atdo have a plan to look
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influenza vaccines. it would be great if we find that this vaccine manages to provide protections that are durable and no one requires additional doses. lookinging to be intently at the durability. if that's not the case and the presumption is we'll get a clue of that, we would be considering looking at administration of influenza vaccine, assuming that would be a timely period for annual vaccination, if protection was not incurred. i think the challenge that we -- we thought seriously about long-term care facilities for a prospective trial, given the closed nature of that informed consent, a lot of logistic issues.
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i think it's common to sponsors. groundoved to be fertile for us to move forward to get a good answer. i think we can take some comfort -- in fact, i'd say a great deal of comfort when we look at the older populations that aren't engaged on trial, showing efficacy, particularly not only people that are older, but with conditions like obesity, conditions that i think would translate well into a high likelihood of protecting against individuals in long-term care facilities. to dr. lewis go dark -- goddard. i know he and his team thought of a long-term follow-up in terms of surveillance. i'm sure the cdc and others will be looking at those, as well. >> thank you very much, dr. gruber. >> very brief, please. >> chief medical officer for
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vaccines. i do not have much to add, but no say that we pla [indiscernible] in the next few weeks. effectiveness selecting specific populations. we are thinking to select long-term care facilities in those. thank you. >> thank you. >> thank you. >dr. cohen? and then we are going to start to discuss the voting question. you're muted. >> still can't hear you. we can't hear you.
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>> ok, i apologize. can you hear me now? >> yes. >> i was wondering if you could tell us what the timelines may be for authorization or approval in the other countries that you argentina, are brazil, germany, south africa, and turkey, and what is the plan in terms of those countries, people continuing in this placebo design versus unblindi ng those participants as well, same time as unblinding in the u.s.? >> take that. >> the brief answer is, again, process isnblinding done with regulatory authorities, both peer as well
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as elsewhere. we will take international recommendations, as well as local recommendations. so, it is conceivable we would be in a position to continue individuals in a placebo-controlled fashion in a blinded way in those countries. but we have to be mindful of our obligations regarding the geography. there are subtle differences that would be easier for us to make those sorts of adjustments than if big health care providers -- chances are we might be providing health care providers across the board. this is something we'll engage in, foreign and domestic. you., thank we are now going to close discussion of the discussion items and move on to discussion of the voting question.
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and could we bring up the voting question? so, anybody who has their hands raised should now lower them because now the next discussion is going to be about the voting question. and can you bring that up/ -- up? we'd better see it before we start talking about it. wodri -- wording is very important.
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and i will even read it even though you can all read it. on the totality of scientific evidence available, do the benefits of pfizer covid-19 vaccine outweigh its 16ks for use in individuals years of age and older?"
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ok? asking to beou recognized again? >> yes, thank you. no, this is a new one. i got my hand up quickly this time. >> let's start with the. >> -- with you. >> i just wanted to comment that i do believe the benefits outweigh the risks. i think the language that i would prefer be added to this language is based on the totality of scientific evidence available at this time. and i do want to ask the fda to comment on potential other indications, besides anaphylactic to a vaccine, or warnings such as persons with rep. posey: or other things that are in consideration. palsy or otherl things that are in consideration.
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>> hi, so this voting question is what we would like the committee to consider at this time, which is an all-inclusive authorization for ages 16 and above. if the committee is -- has concerns that the benefit risk balance is not able to be assessed or unfavorable, that it would preclude inclusion of a specific subgroup, then clearly we would want to hear about that, and would consider the recommendations in contraindications, or in the parameters of the population. about groupson is
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within the 16 years of age or older, such as with some kind of underlying condition. fdahat usually handled by with information warning labels or something like that? it depends on what the reason for concern is. o if there is a clear risk that would make the benefit risk so unfavorable that persons in their group should never be vaccinated, then that would be a contraindication for lesser ancerns than that might merit warning. >> is that something that is voted on at pfizer? >> typically no. those are handled through
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labeling. >> all right. ok. ands go on to next, mr. tom -- >> yes, thank you. so, i'm going to ask the rep,ttee -- i'm a consumer so, good indicator of how we'll be seen by the public. i spent a lot of time reviewing the material. in light of concerns expressed by my colleagues, i do have a compromise proposal. it would be that the dua be limited to the groups that the cdc committee has already identified as a priority. and the data is limited, as we know.
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it's limited in so many ways. it's not compelling at all. the fda says all we can do is suggest protection from severe covid-19 disease. that's one bit of data we need to get. the safety issues are two months of data. i know this has been said many times. 60 weeks -- six weeks is the time before we have a problem, but this is completely untested technology. and then the fda says, as far as a vaccine enhanced disease over time, that's unknown. so, that's a few of the missing pieces of data. given that we don't have the data on effectiveness on the thing that matters, and the safety issues, and there's a question of duration protection, need, ase absolutely others have said, phase three
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trials to continue. and it's going to present a problem. i know that there's workarounds. i understand the blended they're after the placebo benefit. we can go with the standard that people in the study will only be told or offered the crossover orion -- if unblinded offered the crossover option. is what's been talked about state and local standards. out, that isinted really problematic. as an advocate on the state level, we can lobby successfully to get things changed on a state level. maybe that's not so good.
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maybe you need a clear standard. as i pointed out earlier, a lot of the dispense were writing to us -- participants were writing to us, complaining. clearly, if it's granted initially only further two highest groups identified by the cdc, which is health care workers and the nursing home residents to start, that will give us time, give the fda time to thoroughly review the data. they can either come back to this committee or on their own decide we now have enough to go forward into a larger population. the reason i'm suggesting it is the risk-benefit analysis changes. benefit versus the rest. there's not enough to go around.
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even if you agree, it makes no difference in terms of what's going to happen, in terms of getting vaccines out. health care workers -- it only helps health care workers in nursing home residents anyway. what's important is it allows the fda to get real data. i did ask for the data. there are only 10 cases before november 14. i couldn't get -- i'm sure pfizer today knows how many severe cases there were since november 14. but that's the data we need to see, i think. i'd like to make one point about this question of severe disease. it's important and it was covered, to some extent, at the last meeting in october. and that's that we have ample experience, examples of vaccines that protect just as well, if
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not better, against severe disease as they do against mild to moderate disease. so, protection against disease against any severity is a pretty good predictor against protection against severe disease. we have a pretty strong result, in terms of efficacy, with this vaccine based on the available data. in those data we do have for the disease is pointing in the right direction and corroborating what history has shown us. i think that's important. >> not only that, as we will get more data as we start using the vaccine more extensively, because with where outcomes, you have this -- have to start using the vaccine in order to see them, under proper circumstances. i'd like to move on to dr. meisner, who has the next question. >> i'd like to -- thank you.
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with whatke to concur dr. fink just said, that if a vaccine prevents mild disease, i think we can assume it will prevent severe disease. so, i understand that's the most important endpoint. but because of the rarity of the disease, severe disease, it may be difficult to reach that. the other point i wanted to make about long-term safety, we know about the safety of this vaccine through 60 days. think ofpretty hard to a vaccine reaction that occurs after 60 days. and i looked through the vaccine injury table for conventional vaccines. and all of the injuries, except for one, were only up to six
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weeks -- not even eight weeks. the one exception was a polio polioe, alive -- a live vaccine administered to a host. this is not a live polio vaccine. so, i think no one could say there is no long-term enhanced immunity. when -- but, to me, that, i think the safety is pretty well demonstrated. to balance that against over 2500 2500s a day, or deaths a day -- or 2500 deaths a day, i'm comfortable. i am uncomfortable about the
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question as it's written. i do not believe we have sufficient data for 16 and 17-year-olds. inould prefer to say for use individuals 18 years of age or older. children doar-old not get very sick, seldom get hospitalized, and i'll bet it's a very small number of deaths. >> would you like to make a comment? and then i think we should talk about the 16 and 17-year-olds, specifically. >> i just wanted to make a specific comment about safety and duration of the follow-up. i think one of the important things to remember when we're rolling out a vaccine to many people is that it's not just the side effects the vaccine are causing, but it may also be the vaccine side effects that are attributed to the vaccine in which the vaccine didn't
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actually cause there are important. that's one of the reasons why we typically do follow people in critical clinical trials -- legal trials in six months --in clinical trials in six months or older. that's our best way of knowing. and very often, it's the fact we have that follow-up overtime that gives us the ability to say the vaccine didn't cause something at a longer period of time after vaccination. fact,- one could, in argue one could get more placebo-controlled safety follow-ups over the shorter run. that could expand the total safety database. this is proposed at a who meeting where, as long as vaccine supplies are limited, they shouldn't be a prohibition
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against getting additional placebo-controlled follow-ups than people who don't have immediate eligibility for vaccine, that could expand the safety database to much larger numbers than one is capable of doing in these trials. but very often, these kinds of studies were to the benefit of the manufacturers because it allows one to say fairly definitively that the side effects someone thinks the side effects is causing is not being caused by the vaccine. of course, this is something that is a big concern with rapid rollout of a vaccine. in 1975, big problems 1976. the swine flu vaccine, there were more placebo-controlled data, one might have been able to address that at a different level. or that would have required many patients. i'm just pointing out that it's not just the two months
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follow-up in these phase three trials, which are important. but really, placebo-controlled follow-up can play a big role in determining what the vaccine doesn't cause, which is often at least as important as our ability to determine what it does cause. krause. you, dr. to talkanybody want about the 16 and 17-year-old issue? i think that's an important one to get settled because it may be affecting how people would like to vote on this. >> i want to speak to the issue. is that ok? >> yeah, please. >> so, complicated topic, and it can be argued either way. the incidents of severe covid is 16, 17 years of age is not high.
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we've heard from pfizer, and this is typical, that if they do want to get a pediatric indication, and the endgame could look -- we don't know -- we don't have a crystal ball -- but you get this as a pediatric vaccine and it's incorporated into the pediatric immunization schedule, that's a proactive model. so, in terms of achieving population. so, the last, if we take away if we takee loss, away the 16, 17-year-olds, we might lose one of our tools to eventually really conquer this pandemic. so, i'm not so sanguine about removing that group. >> can i respond? >> go ahead. >> thank you. it's a very interesting point.
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i think you're suggesting if a 16 or 17-year-old subject is not delayed, then that would approval or authorization of young children? >i don't think that's the case. you're muted. >> ok, hi. it would reduce the amount of information we have about 16 and 17-year-olds. it would slow down getting the vaccine to them. it would make it that much harder to go down beyond age. i'm thinking about what the endgame is here for the entire world. as we know, these verses don't know national borders. what's realistic is getting vaccines that are safe and effective through the typical vaccine infrastructure of the world.
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most are dessert -- delivered in early life. >> but we don't know if the benefit outweighs the risk. in the two year age group. >> let me interrupt. there was data in our briefing documents about studies going down to, i think 12 years of age. if anything, there were larger numbers there than in some of the 16 and 17-year-olds. sayingleavy, why are you that a vaccine would have to have an emergency use authorization in 16-year-olds, when they are not going to be in the group that's going to get the vaccine? they're not going to be prioritized. i don't see how this interferes with the eventual license for that age group. i think that's the important
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point here is when they come into the phase. i think it's important to study this group, and i think we will have ongoing data on them. the question is, does the risk-benefit outweigh a at this point? proponent of a big any kind of studies related to children. we certainly need it for her immunity. but they are not going to be first in line and i think we shouldn't allow the city to continue that's been proposed and allows people who are already getting vaccinated to have safety data. i would support not occur -- including them. >> other pediatricians? dr. sawyer? did you have something you were --? >> yes.
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thank you. adventuring to get in for a while to -- i've been trying to get a word in. >> sorry. >> what they said, i have the same concern, which is among all of the scientific data for 16ed, either it was and 17-year-olds who, if they been't eligible, would not the granting permissions themselves. they would not be making the decision themselves to get vaccinated or not. the other group was the people who were 75 and older. but because of the very high risk for that group, i think it's reasonable to not put a limit on the edge -- age. fori too would put a vote 16 in order. >> this is mark.
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i would like to join that lineup of people advocating for that. i think the data is very standard. it's inadequate to say we have safety, given the low incidence of disease. i know the argument is they are going to be going off to college, but are not sure how many are going to receive vaccines between now and then given the staging of the release of the vaccine, so i would favor. >> dr. ruben? and i'm going to ask the fda to respond. muted. >> i'm not a pediatrician, so i say this with some trepidation, but you're looking at lots of substance here. we're very focused on safety, as we should be, because these are healthy people. but the efficacy is overwhelming for this vaccine.
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it's very, very strong. we're going to be voting to approve this for native americans -- there are very few of those. nursing residents, which were studied at all. and we think -- blunt studied at all -- weren't studied at all. moree think -- there are 16 and 17-year-olds in the study then there were native americans. i'm sure why we wouldn't want to provide the option of using those. some of these kids are working in supermarkets and are going to be amp's, essential workers. i hate to take that tool away from clinicians. >> can i comment? >> yes, please. then we want to hear from fda, what they would suggest at this point. >> thank you very much for your comment. i think the difference, for example, between american indians, children, is american
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indians have a high rate of disease. 16 and 17-year-old children do not have high rates of disease. so, it becomes a risk that if it balance that worries me. >> another pediatrician, i'd like to chime in as the last pediatrician. here's what i'd say. i'd like to support the statement as written. we certainly know that this vaccine is highly effective for three months after dose one. we know we have a lot of safety data and can say at least we don't have a relatively uncommon side effect. in terms of safety, we're going to be doing follow-ups to make sure like they would be attended to. 16 and 17-year-olds can get this
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infection. it, they get, pleas -- get we've seen them have cardiac anomalies. if we can prevent this disease safely and effectively, we have clear evidence of benefit. all we have on the others is theoretical risk. i'm frankly with with it as written. i agree with dr. gruber. >> can i respond to paul? [laughter] arnold? >> yes, go ahead. , at least asrate far as we know and as was published in the new england journal regarding new york --te, the rates wer etwo were two cases per 100,000 people under 20 years of age. >> there's also vasculitis that
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doesn't meet the criteria. >> well, and that is certainly true. but undressing the rate of disease is so small -- but i'm saying the rate of disease is so small. we had them, too. but i have a little more trouble justifying it in children who are so unlikely to get the disease. can we hear from somebody from fda? on this? i'd just like to hear -- come on. don't i think i really
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want to throw in my own opinion on this. i hear the committee's concern. finkt think that, as dr. discussed earlier on, our speculation permits extrapolations to younger age groups. been, i think, pretty forthcoming, even in our recent document, that it would support an extrapolation. that 16ld also consider and 17-year-olds may transmit disease and the last comment i wanted to make on this one is, if the argument is made that 16 and 17 years old are really not the ones who are high risk group
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and who would get in line to get this disease because they're not in the recommended group, i think you can make the same recommendation for an 18-25-year-old. i don't find that argument compelling. , do we have a strategy that provides other committee members to no longer want to weigh in. i would like for the committee to vote on this question as to really here because we have 23 members and i would like to see the results and then we go to next. that's my recommendation. >> thank you very much. i was hoping for some direction because we are moving around in circles right now. so, we are going to move to the vote. the process is going
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to be this. we will vote. on our computers. the votes will be announced. an then we will have explanation of vote from those who wish to give an explanation of their vote. ok? kathleen? am i correct in the process? >> yes. thank you, doctor. so, our members and temporary footing members you'll be able to see on this slide, excluding representatives, will be voting on this meeting. you'll read the question for the record, and afterward, all members were cast -- will cast their vote bisecting one of the options. we'll have -- by selecting one
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of the options. you'll have two minutes to cast your vote. we'll read the individual votes for the record. you'll have two minutes in the timeframe and you can change your vote in that timeframe. the after your votes are concerned -- closed, all those will be considered final. are there any questions? >> can i ask any question -- a question? i want to vote for this vaccine. i just would like to remove the -- i don't want to vote against the eua just because i'm uncomfortable with -- can we modify the wording if it doesn't pass? >> i think that's what dr. gruber was saying. would you confirm that? >> i thought we just said we
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were not going to modify the wording. so that we could get to a vote. voting on recommend this question as is for now, because we have not heard from all the committee members. >> thank you, dr. gruber. >> kathleen, can ask one last question before we vote? >> sure. >> only about the voting process, not the question. ok, i think we are going to vote. >> great. so, let's pull up the voting question on the slide. you can read the question for the rest of us. >> based on the totality of scientific evidence available, due to the benefits of the
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pfizer biontech covid-19 brexit -- vaccine outweigh the risk of individuals 16 years of age or older? your vote possibilities are yes or no, and if you want to abstain, you just don't vote. is that it? because i thought there was an abstention possibility. selection,an abstain but no vote shows if you haven't made a selection. >> ok. so, you have two minutes to vote. >> go ahead and please cast your vote. >> how do we return the vote for you? can you see when we have voted? >> yes. once you have selected the button, i can see you.
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we have one minute remaining.
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30 seconds. ok, at this time, the two minutes is up. so, if we can please close the vote and broadcast the result and i will read them aloud for the record. dr. moore voted yes. dr. cohen 40 years. dr. ganz voted yes. dr. carrillo voted no.
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dr. rubin voted yes. dr. leave people to guess. -- dr. levy voted yes. dr. chatterjee voted no. dr. fuller voted no. dr. meiser abstained. dr. sawyer voted yes. dr. hildreth voted yes. dr. kim voted no. dr. monta voted yes. dr. tripp voted yes. dr. whorton voted yes. dr. ben flakka voted yes. dr. offutt voted yes. dr. mckennitt voted yes. dr. lee voted yes. mr. taman voted yes. and that concludes the vote. votee do have a favorable
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and that concludes this portion of the meeting, so i will now hand the meeting back over to dr. monto.thank you, everybody. >> ok. marion? do you have anything you want to add at this point? >> we can't hear you, marion. apologize, muted. i just want to thank the committee for voting on this
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very complex topic. i wanted to thank the committee further discussion and their suggestions. we very much appreciate their input on this very important topic. this intol take consideration when deciding on not only the poa insurance, but also how to move on the development of the licensure of this product. thank you so much. our work forore, the day is done. i wanted to thank the committee. and i want especially to thank the fda, because they have been laboring long and hard in doing the analysis, dealing with some thehe issues, such as recent anaphylaxis episodes. and i will therefore close the
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meeting and i believe most of us revisiting some of these issues in about a week. so, thank you very much, good night, and see you soon. [captions copyright national cable satellite corp. 2020] [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit] >> and as we just saw, the advisory committee voted to give the fda give final approval to the pfizer and corona tech for dissipation in the u.s. next week, the same panel will review to meet another panel, the one developed by moderna. live coverage thursday, december 17, on 9:00 eastern on c-span3. >> c-span's "washington journal." yourday, we're taking calls live on the air on the news of the desert -- on the day and discuss policy issues that impact you. coming up this morning, we look
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impacts-19 vaccines and with a medical doctor and senior fellow at the competitive fellow prize institute. and then we will talk about the basic income at the index with natalie foster. watch c-span's washington journal live at 7:00 eastern. be sure to join the discussion with your phone calls, facebook comments, text messages, and tweets. enjoy necessary morning as we bush v.k to push v -- gore. >> here's some of our live coverage friday. on c-span's president-elect joe biden and vice president-elect kamala harris introduced cabinet picks, including the urban development secretary and to leave the agricultural department. that's it 2:30 p.m. eastern. the senate returns at 9:00 a.m.
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for more debate on the bill. the continuing resolution has already passed in the house. at an event hosted by the council, sisi director dr. robert redfield gave his assessment of coronavirus fatalities in the u.s. over the next few months. >> so, my question for you is, why is the u.s. leading the world in deaths? >> you know, it's obviously an excellent question. kind of a sad answer. and i'll give you the answer. i do think your point is important, as i was talking to the chamber of commerce the other day. we are in the timeframe now that, probably for the next 60-90 days, we're going to have more deaths per day than we had at 9/11 or had at pearl harbor. this is really, as i said, this
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is going to be a real unfortunate loss of life as all that we've had so far. in the reality is that vaccine approval this week is not going through the impact it for any degree in the next 60 days. and this is where we have to do everything. when you look at the mortality of this virus, this virus is really -- it's very unusual. influenza can cause death for children. it can cause death for adolescents. it can cause deaths for results. the spectrum of illnesses is pretty across every age group. this verse is very different. really hard to cause any illness in individuals across any ages. dependent and's the elderly. people may not like the answer i'm going to give, while the
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americans are at greater risk for death. because we're an unhealthy or nation. when 30% of our nation is obese, we have very significant number of people in our nation with chronicle mobility. i spent a lot of my life worried about health equity prior to becoming sisi. -- cdc. i really do believe, this really, one of the greatest social injustices in our world is lack of health equity, and whether it's in my own city, a 20 year lifespan difference depending on what the -- was it good you were born in -- what zip code you were born in. healthy ation's less large. and this virus really does exploit certain morbidities of
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heart disease. and i think that's actually the reason. i think our medical treatment is really very good. as we've gone from april, it was a 25-30% mortality if you are 70 years old and admitted to a hospital. it was summer between 3-8%. health care facilities understanding how to take care of patients better, when to ventilate, obviously the advancements of remdesivir. plasma foral for outpatients. most of the therapies we have pushed forward, these are therapies based on antibodies. they need to be positioned and given before people are sick enough to go into the hospital.
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the basic reason is we have more people with comorbidities, and this virus really does exploit comorbidities. redfieldthe cdc's dr. was asked about headlines that there is political interference at the cdc. >> the question of political is asian of the cdc, there are allegations -- this person you for what had allegedly political interference or attempts, the more ability them publicationgarded
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and this subcommittee on the coronavirus crisis that wants to interview you will you go and do that? policymakersle, have to balance science with implementing things. i don't envy people who have to make tough decisions, but is there a role for politics in the agency, and how has political pressure affected it? dr. redfield: a lot of stories and speculation. really the one you referred to, i would never delete an email. it is archived forever at cdc. i would never tell somebody to delete an email. i instructed cdc to ignore dr.
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alexander's comments. congress iied before ,m committed to the integrity it does not work at the pleasure of the cdc director. it has its own independent group. i stand by that. it does not mean people not try to accuse her makeup their own point of view, but i can say on my watch it is science-based data-driven. the agencies maintain their integrity. it is not always easy. i do not think these agencies should be politicized. druthers, the fda director would be appointed like the fbi director for 10 years.
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it should not be in the political mix. i'm not, i'm a doctor and clinical researcher. i was asked to serve the president and the nation. coming 23 years out of walter reed and the army, i said yes. i don't think the science-based -- they need to be grounded in science and data. >> with coronavirus cases increasing across the country, use our website. navirus to/coro follow the trends, track the spread with interactive maps, and watch updates anytime. c-span's "washington journal," every day we take your
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calls live on the air on the news of the day discussing policy issues that impact you. this morning we look at covid-19 vaccines and government mandates with a medical doctor at senior fellow institute. we will talk about the concept of the basic guaranteed income in the u.s. with the economic security project. watch "washington journal," live at 7:00 a.m. eastern this morning. join the discussion with your phone calls, facebook comments and tweets. join us saturday morning as we look back 20 years to the 2000 election, bush v gore. >> here is some of our live coverage friday, president-elect biden introduces a handful of cabinet picks, including the housing and urban development secretary and agricultural
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department. on c-span two, the senate returns in the morning for more debate on the defense programs bill, and a bill pending for one week. the continuing resolution has already passed in the house. 117unday night on q&a, the women serving come the most ever. we will talk to republican representative elect of florida and california about their background and what they plan to accomplish in congress. >> i think government operates best small and accountable and transparent. people have the power to control that. i don't think people should work to serve the government and build big bureaucratic programs. an a conservative member but
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american first. i will work with members and those who make our country a better place. generation that have never known a day in our adult lives that the united states has not been at war. i was in middle school on september 11. hadnow the cost that has domestically, and on our generation. one thing i want to focus on is rebuilding america's standing around the world, and make sure we end the forever wars. and ink about how we can craft foreign policy that will address the challenges of the future, that we are rebuilding for future challenges like global pandemics, climate change. >>


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