c-span.org or on the free seat expand radio app. >> use our website, c-span.org/coronavirus to follow trends, track the spread with interactive maps, and watch withme on demand c-span.org/coronavirus. >> the fda is recommending emergency use authorization for the pfizer covid-19 vaccine. committee heard testimony regarding issues related to pfizer's vaccine including its safety and effectiveness, distribution and ethical considerations for ongoing vaccine trials. here is some of that session leading up to the approval vote.

this is for the prevention of covid-19 in individual 16 years of age and older. to kick the meeting off, i would graham to goon dr. through the roll call, the introductory committee and administering of statements as .e go around so, please. the 100 60 seconds --

160 second meeting of the vaccine and related biological products advisory committee. everyoneike to welcome to the virtual meeting. all of you mentioned the topic for today, the emergency authorization of the pfizer pfizer-biontech covid-19 vaccine emergency use 16horization for individuals years of age and older. i would like to introduce the staff for remarks. providing support today in this meeting. , to direct the media

and today'sedia we will take a roll call. [indiscernible] please turn your video camera off. we can proceed to the next person. [indiscernible] dr. manto, let's start with you. well, all right.

i'm professor of epidemiology from the university of michigan school of public health. dr. [indiscernible] we cannot hear you. shortly.ll be on we will go to the next one. >> dr. [indiscernible] >> good morning. i am a dean. i am a specialist. >> thank you.

cody meisner. dr. meisner. >> thank you. i'm cody meisner. i am a professor of pediatrics in infectious disease in tufts university school of medicine and tufts children's hospital in boston. >> dr. [indiscernible] >> good morning. i am professor of pediatrics at the pediatric -- it's great to be here. >> thank you. dr. [indiscernible] >> good morning. i am the director of clinical

innovation at the national center for advancing translational science within the national institute. most of by professional career has been involved in infectious disease, drug and vaccine development. hi i am paul. i am a professor of of pediatrics in the division of infectious diseases and the children's hospital of philadelphia and the school of medicine at the university of pennsylvania. >> good morning. i'm paula. i lead clinical global development for vaccines at -- and i'm here today as the nonvoting industry representative. >> excellent. thank you. [indiscernible]

mr. [indiscernible] dr. [indiscernible] good morning. can you hear me? thank you. good morning. i am an attorney. i represent clients mostly in the health area. i am employed by new haven legal group. i'm here today in a personal capacity. dr. [indiscernible] >> hi everyone i am steve perkins. i am an assistant professor at the university of washington. i focus on infectious diseases. can we go to the next slide

please? dr. [indiscernible] i am dr. fuller. i am an associate professor of microbiology at the university of michigan medical school and a member of the african studies center in the international institute and i am a overall just -- by training. >> i am david kim. director, office of infectious disease. under the office of the assistant secretary. dr. eric rubin. >> i am editor-in-chief and at the great

women's hospital. dr. [indiscernible] >> good morning. thank you. >> dr. [indiscernible] >> good morning. i am jeanette lee. i am a professor of biostatistics at the university of arkansas for medical sciences. >> next slide please.

>> good morning. i'm in infectious disease clinician at the mayo clinic in phoenix, arizona. >> dr. [indiscernible] >> good morning. i'll mark sawyer. i am a professor of pediatrics at the university of california, san diego. i am a pediatric infectious disease specialist. caller: >> >> dr. melinda watson. >> i am melinda whorton. i am a director of the immunization services position at the center for disease control and prevention. >> thank you. morning, i am the director of the precision vaccine program and professor of harvard medical school.

>> great. >> good morning, i worked at the national institution of health. >> next. patrick at the university of pittsburgh. >> good morning. i might share a vaccine therapeutics there. >> next. we cannot see you.

can you adjust the volume? >> i am from the university of iowa in the department of microbiology and and the analogy a pediatric. i'm a long-term coronavirusologist. we cannot hear you. good morning. sorry for the technical difficulties. i'm chief medical officer at the center for immunization and respiratory diseases. i am a pediatrician by training. expertise in vaccines and pediatrics. >> let's introduce the staff

great i would like to introduce the head of the center, dr. marks. >> thank you very much. peter marks. i want to take a moment to thank all of the committee members as well as everybody who is turning in right now. usually,, thank you very much. let's move on to the director of the office of the vaccine. good morning. i am the director of the office of vaccines research and review. for the center of biologics and

research. on behalf of my colleagues i want like to welcome the leaders of pfizer and biotech -- and biontech. i would like to thank the members of this community for taking time out of their busy schedules to provide perspectives and advise regarding the advocacy of the scientific evidence presented by pfizer and the fda today. to discuss the benefits of the pfizer-biontech. much appreciates the committee's input on this topic. i look forward to today's discussion. >> thank you. i would like to acknowledge the

deputy directory -- the deputy director. i will now proceed. this is the one city second meeting. meeting. the acting chair for this meeting. the committee will meet to discuss the emergency use authorization of this. this is for individuals 16 years and older.

with the exception, special government employees. federal lawsect to and regulations. asksollowing information for committee complaints. toluding but not limited taking section 208 provided to participants and to the into the public. members with government employees [indiscernible] thoroughly screened for [indiscernible] [indiscernible]

[indiscernible] [indiscernible] interests thatde were choir negotiations. -- require negotiations. under section 208, congress has authorized to grant waivers to special government employees who have financed the concept. it is determined that the agency -- outweighs the potential for the concept created by pfizer with financial interests.

it has to be deemed likely. [indiscernible] [indiscernible] [roll call] there has been only one concept issued in connection to this meeting. [indiscernible] a special government employee has been issued information for this meeting.

[indiscernible] [indiscernible] this brings general industry perspective to the committee. [indiscernible] special government employees are screened and cleared prior to this. today's meeting. we have three speakers. figure government employees having cleared to participate as

speakers for today's meeting. speaker is an associate dean for clinical at stanford. [indiscernible] [indiscernible] we would like to remind members that the discussion on the todayrm not on the agenda said that [indiscernible]

at this time, i would like to hand over the meeting to our chair. thank you very much. >> thank you. here i am. technical issues. they are going to be one of our biggest problems that i predict during the day. thank you for getting the meeting kicked off. first, we are actually running a little early to call upon the doctor of the situationk about the that we are facing and the

presentation of the description of the emergency use authorization. >> good morning. i am the deputy director. within this office a research and review. dr. fink: convened on october trey second to discuss -- the emergency use authorization of covid-19 vaccine. since that meeting, covid cases and associations have increased substantially in the u.s. and worldwide. 20, pfizer submitted an emergency use request for it for the covid 19 vaccine.

is a vaccine administered as a two-dose regularreg men 21 -- administered 21 days apart. we'll hear more about the vaccine and proposed use in later presentation. they use being requested for emergency authorization is for active immunizations to prevent covid-19 caused by sars cov 2 in individuals 16 years of age and older. the information submitted with the request includes safety and efficacy data from a large, randomized, blinded, placebo-controlled phase three trial. and the data will be discussed in detail in our afternoon session. today we'll be considering whether to make available to millions of americans and as yet investigational vaccine

that has been developed, tested, and reviewed in record time with additional testing still underway in ongoing studies. the american public demand and deserves a rigorous, comprehensive, and independ -- independent review of the data. fda scientists, all of us have been doing over days, nights, weekends, and, yes, over the thanksgiving holiday. this is in addition to months of review they were already completed on information previously submitted in preparation for eua requests. since its omission on november 20, they review has been conducted. -- since it's submission.

review ofncluded a clinical data integrity, pfizer analyses, independent analyses, using data sets divided in the submission. ongoingcontinued an review of chemistry, manufacturing, control information, nonclinical data, and review of clinical essays, including information that was presented shortly prior to the eua requests. we have been reviewing and revising along with visor -- along with pfizer fact sheets. these will be necessary to vaccinend instruct recipients and health care providers during use of the vaccine under eua. these materials are necessarily reformed by our view of the data. we have sent and received back answers to multiple information

requests, addressed to pfizer to clarify questions related to the data. last but not least, we have been preparing for today's meeting. today's meeting, in which the committee will advise fda with its own independent assessment of the data. this continues the expediting of the changes in process. it is data-driven. the legal authority for emergency use authorization was established in in section 564 of the federal food drug and cosmetic act. this legal authority allows for fda authorization of unapproved medical product or unapproved uses of approved medical products to address public health emergencies related to biological, chemical, or nuclear agents.

issuance requires prior determination of a threat and a declaration of circumstances uae toying the need for a address the threat, and the secretary of homeland security for health and human services. to that end, secretary azaar issued a declaration on march 27th of this year justifying emergency use authorization of drugs and biological product to address the covid-19 pandemic. but that declaration has been issued. there are four criteria ha must -- that must be met in order to issue a eua. the agent referred to in the declaration can cause a serious or life threatening disease or condition. we know this to be true for sars coronavirus 2 and covid-19. the second and third criteria are closely linked.

there must be a reason to believe that the medical product may be effective to prevent, diagnosis, or treat the serious or life threatening conditions caused by the agent. and the known potential benefits of the product that can outweigh the known and potential risks of the product. there are special considerations for a covid-19 vaccine anticipated for wide spread deployment for millions of individuals and these will be discussed in my next slide. the final criterion is that there should be no adequate approved available alternative to the product for treating the disease or condition. at this time the only approved product is remdesivir, an anti-viral agent approved for treatment of covid-19. not prevention. additional product has been issued under emergency use authorization and not fda approved.

none of these products is authorized for use to prevent covid-19. at this time, there is no adequate approved and available alternative to a covid-19 vaccine or preventing covid-19 caused by sars coronavirus 2. in october of this year, fda released guidance outlining our expectations for submissions requesting emergency use authorization of covid-19. these expectations were discussed at the meeting in october. there are three main areas covered by our expectations. first, data to demonstrate manufacturing quality and consistency.

this will not be discussed in detail further at this meeting. second, we expect clear and compelling safety and efficacy data to support a favorable benefit risk of the vaccine when rapidly deployed for administration to millions of individuals including healthy people. finally, we expect plans for further evaluation of the vaccine safety and effectiveness including an ongoing clinical trial, active and passive safety monitoring during the use under ua as well as observational studies. in terms of clinical data expected to support an eu a submission for a covid-19 vaccine. we expect a high bar for efficacy. data from at least one well-designed trial could

againstate protection disease with a point estimate of at least 50% compared to placebo. additionally the appropriately adjusted confidence interval lower bound around that point estimate to be greater than 30%. this is to ensure a widely deployed covid vaccine will have an appreciable impact. in terms of safety data, we expect the data from throughout clinical development to evaluate reactive serious adverse events and adverse events of special interest. we expect a hyper person of study subjects will be followed for at least one month. we have an additional expectations for follow up i'll explain on the next slide. we recognize a planned case to reviewto be able

cases of severe covid-19 that have occurred in clinical trial participants to assess for signals of enhanced disease and also, if possible, assess for luminary evidence of protection against severe disease. we recognize a planned case driven interefficacy analysis and associated safety analysis at the same time could provide data to support an emergency use authorization. we have explained we expect these analyses to include a median follow up duration of at least two months after completion of the full vaccination regmen. the reason for that is it allows time for potential immune mediated adverse events to be evaluated. understanding uncommon but clinically significant adverse

generally have onset within the first six weeks following vaccination. immediate follow-up is that further vaccine evaluation would adaptive or memory immune responses rather than innate responses are mediated protection. this allows for early assessment of waning protection and signals that enhance disease. following issuance, we understand and expect that further vaccine evaluation would be needed for ongoing benefit risk assessment to support continuation of the eua. equally important this further , vaccine evaluation would be to support life issuance.

this further vaccine evaluation following issuance of an eu a would include longer term follow up for safety including in larger number of vaccine recipients and in populations with lower representation man trials.in critical further evaluation would allow review of precise vaccine in specific populations. example, asymptomatic infection. this further evaluation would characterize the duration of protection, investigate immune biomarkers that might predict protection, and with the ongoing monitoring for signals of enhanced disease. issuance of an eua would be

dependent on vaccine evaluation which would include longer term follow up for safety including for example, vaccine events reporting system. observational studies including those that leverage health-care claims databases. finally, continuation of blinded placebo controlled follow-up for andong as is feasible strategies to handle loss of follow-up. we acknowledge placebo-controlled line did follow-up cannot continue indefinitely, as more information about a vaccine safety and effectiveness becomes available. however, fda does not consider issuance of an eua for a

necessitatecine to in blinding of clinical trials. participants may choose to withdraw for any reason. including to rick seeing -- receive vaccines. --may be possible to offer the does not compromise the integrity of the trial. these considerations will be discussed further this morning. when an eua is issued, it will specify conditions of use that have undetermined to be favorable. including those populations to

be included or excluded from the eua. conditions for vaccine distribution and administration requirements for safety monitoring and recording of it adverse effects. vaccine will include provision of information to vaccine recipients and health care providers via prescribing information and fact sheets. these materials will describe the product remains investigational will inform about the known and potential benefits and risks. it will also make clear what are the available alternatives and the option to refuse vaccination. issued, it may be revised or revoked for a number of reasons. first of all, if circumstances

justifying the eua no longer exists. if criteria for issuance are no longer met. any other circumstances that that warrant changes necessary to protect public health or safety. the circumstances may be based on new information based on vaccine effectiveness. quality. covid-19 epidemiology. the agenda for today's meeting will include following the first,ion of my talk three presentations from the cdc. providing an update on covid-19 epidemiology, plans for vaccine safety and effectiveness operationaland distribution plans for the vaccine. we will then hear about

considerations for placebo-controlled trial design if an unlicensed vaccine becomes available. following lunch, we will have an open public hearing. and then we will dive into a discussion of the data. pfizera presentation by and then an fda presentation. at the end of the day, we will have a committee discussion and a vote. we have two questions we would like the committee to consider for discussion. these will not be voting questions. proposed aer has plan for continuation of blinded placebo-controlled follow-up if the vaccine were made available under ua. we would like the committee to discuss the plan including placebo-controlled follow-up.

second, we would like the committee to discuss any gaps in plans describes today and in the briefing documents for further evaluation of vaccine safety and effectiveness in populations who receive the vaccine. following discussion of these items, we will have a single question for the committee to vote on. the question is based on the totality of scientific evidence available through the benefits of the covid-19 benefits outweighs risks for individuals 16 years of age and older. this concludes my presentation. thank you very much. >> thank you for a very clear presentation.

we have a fair amount of time before the next scheduled presentation which is very good because i think there are some questions of clarification the committee may have about our andelines for discussion for our eventual vote. committee members, please raise your hands if you would like to some specific questions. we don't want to start our discussion of the points raised about theiscussion emergency use authorization and guidelines. your hand.e i may be having some technical difficulty. >> i got it. go ahead. dr.he first one we have, sawyer. would you go ahead and turn your

camera on? issues relatedd to manufacturing can be one to revise or revoke. what is the monitoring process going forward from this point with regard to manufacturing process? >> thank you. continues to engage with the vaccine manufacturer concerning manufacturing quality and thesel issues to ensure remain adequate to support use of the vaccine. invite any of my fda colleagues to comment further.

>> can you hear me? mr. chairman? >> yes, we can. >> thank you very much. i think it was said, it is true the monitoring, the chemistry control information is currently of course-- we will get additional data from the manufacturing, the different manufacturing sides. will begin with this information and work together with the vaccine manufacturer to make sure the product made and , ofrated is adequate adequate consistency and quality. this is work that is going to be ongoing over the next month.

>> thank you very much. >> are you able to see wax i see but there is no activity there. >> that is all right. >> why don't you manage -- >> we will take care of that. i don't know why my camera is not working but it says it is on. understand the question we are being asked to vote on is what pfizer has

requested. if i understood your talk correctly, the fda can limit the actual -- can place limits on the target population for the specific indications regarding the eua. my question is how do you view the investigational status of the product under an eua? >> thank you for the question. a product that is made available under an eua is an unapproved product. it's not been fda licensed. can just follow up with that. if you limited the eua to a specific set of populations,

even those populations that have the eua, placebo-controlled trials would be possible? >> we'll have a discussion on those considerations later this morning. in fda's view, issuance of an eua for a covid-19 vaccine should not preclude the conduct of the placebo controlled trial. in particular situations where that vaccine made available is available only in limited quantities. wax -- >> okay. i can see now.

thank you for fixing it. dr. lee? havee of the questions i is a little bit more general. i recognize we are considering the pfizer product. future applications, if for example there's a vaccine bla, vacciner a number one, let's call it that number. will it make it more challenging for future products to reflect the eua? >> i think what you are getting the fourth criterion for issuance of an eua which says there must not be any adequate, approved, and available alternative therapy. >> correct. availablene is made under an eua it's not approved. that would not preclude issuance

for another vaccine. if a vaccine is approved, it would not necessarily prelude issuance of an eua or another investigational covid-19 vaccine. for example, if the approved vaccine is available in limited quantity, then it may not be considered adequate to address the public health emergency. second of all, if the vaccine is approved for use only in a approved is approved for use only in a limited population, then that vaccine may not be considered adequate to address the needs of the public health emergency for other populations. thank you. >> thank you.

members, you did a wonderful job. >> can you speak a little louder, please? thinking dr.ing -- fink. two questions. theis you indicated sense permission came in from pfizer, you have had a lot of discussions. is, does thattion include updated data? date, it is november 14, 20 six days ago, almost a month without half of the entire time. have you gotten more requests and gotten more recent data? the second question is a follow-up. have given us only one

question. yes or no to recommending approval for the entire amount, is population pfizer requesting, 16 and over. certainly the committee could view this as something they a for.like to grant a eu it may be different for different populations. we may want to recommend it for a smaller set than pfizer's asking for it. i was wondering if you have a backup question that might be used. in the past, with the dengue review -- say your last question, we can bring that up during the discussion later on. i am going to excuse dr. fink from having to answer that part of the question. >> thank you.

your firstr question, no. we have not received additional data sets beyond the data sets that were submitted to us. date ofsing a cut off november 14. as you can imagine, there is tremendous amount of work that goes into preparing a data set for submission so it really is infeasible for the sponsor and for fda to be chasing our tails trying to get data sets that encompass more and more data as time goes on. that being said, if the sponsor becomes aware of or if we become aware of any data that would potentially impact our benefit risk assessment we do have discussions with the sponsor regarding those data.

>> and we will be able, mr. teldman, to ask questions of the sponsor after their presentation later on. so we can revisit this issue. next, dr. perlman. >> so i just had a question about the last part of what you were talking about, when you talked about how pfizer is going to deal with the issue of placebos going off the vaccine trial. and you asked for advice from the committee. is that part of the eua vote or is that a second issue? >> that is not a question for vote. it is just an item for discussion. we'd like to hear the committee's thoughts on the plan that is being proposed by pfizer which you will hear about in greater detail later today.

>> dr. mcginnis. >> i have a question that's sort of a follow up from what mike carella originally started. given this is an investigational product, i'm assuming that any manufacturer cannot actually market such an investigational vaccine. is that correct? >> emergency use authorization which does not allow for commercial distribution of the vaccine via the usual marketing that would be available to a licensed vaccine. so i hope that clarifies things. if anyone else from fda wants to chime in, i'd welcome the additional remarks. >> so doran, thank you, i'm happy to get the comments. i'm just trying to understand. it's not marketed traditionally

but compensation for an investigational vaccine is possible under an eua, like with a government entity? again not my area of , this is not my area of expertise. >> i understand. >> emergency use authorization may include conditions related to advertising and other similar issues. in terms of transfer of money between vaccine recipients and providers or between u.s. government and the manufacturer, i can't speak to those. >> dr. meissner. thank you.

i would like to thank dr. marks and dr. fink and dr. gerber and everyone else at the fda. because the amount of work that you have done is just extraordinary. and the briefing packets that have been circulated are clear and extremely helpful. so thank you very much for your ongoing work. the question i have for you is it will be advantageous for a number of reasons to have one of the covid-19 vaccines available under a biologic license application instead of an eua. and i realize it's a difficult question but can you offer any comments about the route or the pathway forward for the fda to

begin to think about when you've reached the point that you would consider a bla? >> yes. so first of all we do want any vaccine that is made available under an eua to continue its testing, to allow for its licensure as soon as possible after issuance of the eua. so this continued evaluation, as i explained in my presentation, i think first and foremost, would include some longer term follow up of participants enrolled in ongoing studies, as well as safety and effectiveness data coming out of use of the vaccine under the eua. this additional evaluation would then meet our usual expectations for clinical data to be included

in a licensure application. there are some other sources of information that involve many factories -- manufacturing and facilities and potentially non-clinical studies as well that we would typically require to support a licensure application but are not absolutely necessary to support issuance of an eua. >> is it possible to predict or estimate when conditions of safety and efficacy might be satisfied? for bla? >> in terms of the time it would take? yeah, i couldn't predict. but i will say that we typically ask for at least six months of follow up in a substantial number of clinical trial participants to constitute a safety database that would

support licensure. >> thank you. >> and finally, dr. fuller. >> my question -- did i understand you to say that the fda, in the october 22nd meeting, looked at the manufacturing quality of the pfizer vaccine and that was satisfactory? and if so, how will that be evaluated in the actual distribution of the vaccine? and will we talk about that later? >> >> to clarify what i said earlier, as part of the eua submission and in information submitted prior to the eua, fda has been conducting an ongoing

review of manufacturing quality consistency and control. and we have found this information to be adequate to support emergency use authorization of the vaccine. we are not intending to discuss details of the manufacturing process, many of which are proprietary, during today's meeting. but as dr. gruber and i discussed in response to previous questions, our review of the manufacturing information is an ongoing process and will continue even after the vaccine is authorized if that is the decision that we make. >> ok, thank you. >> thank you, dr. fink. you've kicked us off with a lot of information which we're going

to be coming back to later on this afternoon. i'd like next to call on dr. aaron hall from cdc, who is the co-lead in the epidemiology task force and he is going to give us an update about the current situation. >> all right, thank you very much, good morning. can you hear me ok? >> yes, we can. >> wonderful. so, good morning. i'm dr. aaron hall, co-lead of the epidemiology task force and cdc's covid-19 response and chief of the respiratory viruses branch. to help frame subsequent discussions today about covid-19 vaccines, i would like to provide a brief update on the current epidemiology of covid-19 in the united states. as of december 8, over 14.8 million covid-19 cases and over

280,000 associated deaths have been reported in the united states. the initial peak in early april was driven largely by elevated activity in the new york metro area, followed by a second larger peak in late july, primarily due to increased activity across much of the southern u.s. since mid-september, daily counts of new cases have again been on the rise, with even sharper increases since mid-october. since submission of these slides in advance of this meeting, we have now surpassed 15 million cases, and 285,000 deaths nationally, with over 200,000 new cases, and over 2500 new deaths reported yesterday. in addition to reported cases, cdc uses several other systems to track the pandemic, which are compiled in the weekly surveillance summary called covid view.

this weekly report includes the percent positivity of molecular tests for sars-cov-2, the virus that causes covid-19, shown in blue, as well as syndromic surveillance for covid-19-like illness, or cl-1, among ambulatory patients shown in red. both of these leading indicators have been increasing since september. also included in covidview are weekly hospitalization rates shown in gray, which are currently at the highest point since the beginning of the pandemic. and also the percent of deaths due to covid-19, influenza, or pneumonia based on death certificates, shown in green, both of which are lagging indicators that have been increasing since october. one component of the weekly covidview report is an assessment of covid-19 hospitalizations through covid net.

covid net conducts hospitalization surveillance in 14 states, representing about 10% of the u.s. population. patients must be a resident of the surveillance area and have a positive sars-cov-2 test within 14 days prior to or during hospitalization. medical chart reviews are conducted by officers and data are updated weekly on an interactive website. while focused on the more severe end of the illness spectrum, covid net provides active population-based surveillance, thus overcoming some of the biases with past surveillance and providing robust data on the epidemiology of covid-19. looking at weekly hospitalization rates by age, we see that each of the peaks in april, late july, and currently , have been most pronounced among adults aged 65 years and older.

hospitalization rates in children have been considerably lower than those among adults, but have remained stable or increasing since the spring. note that the last few data points are subject to reporting lag, and may increase subsequently. looking at the cumulative hospitalization rates through late november from covid net and stratifying by age group, we see a strong increasing trend with increasing age. as of november 28, adults aged 65 years and older had a cumulative rate of 756 per 100,000, which is roughly equivalent to one in every 130 people in this age group being hospitalized with covid-19. this rate is approximately 4.5 times greater than that of adults aged 18 to 49. covid net surveillance has also helped to identify significant racial and ethnic disparities in the rates of covid-19.

shown here are age adjusted cumulative hospitalization rates by race and ethnicity, demonstrating rates are three to four times greater among persons that are hispanic or latino, non-hispanic american indian or alaska native, or non-hispanic black or african-american, compared with those that are non-hispanic white. these disparities are likely multifactorial, including prevalence of underlying medical conditions, access to care and other socioeconomic factors. to help further keep apart these issues and identify risk factors for severe covid-19, cdc and public health partners analyzed the relative rates of in hospital mortality from covid net using models that adjust for age, sex, race and ethnicity, smoking, and several underlying medical conditions.

as shown in the red box, older age was the strongest independent risk factor for in hospital deaths and the risk increased with increasing age. other characteristics significantly associated include male sex, immunal disease, chronic lung disease, cardiovascular disease, neurologic disorder, and diabetes. combining data from covid net with population-based data from the behavioral risk factor surveillance system, or brsss, we likewise developed models to assess risk for covid-19 hospitalization among adults with specific underlying conditions. again, after adjusting for age, sex, and race and ethnicity, the risk for covid-19 associated hospitalization was greatest for adults with severe obesity, chronic kidney disease, and diabetes, as shown in the red box.

compared with adults without these conditions, those that have them were three to five times more likely to be hospitalized for covid-19. furthermore, the risk of covid-19 hospitalization increased with the number of underlying medical conditions, as shown in the red box on this table. while specific risks varied depending on the specific underlying medical condition, adults with three or more conditions had five times the risk of covid-19 hospitalization, compared to adults with no conditions. due to increased age, underlying medical conditions, and the congregant living situation, residents of long-term care facilities have been disproportionately impacted by covid-19. as shown here, residents of these facilities comprise nearly 50% of covid-19 hospitalizations among adults aged 75 to 84 years, and nearly two-thirds of

covid-19 hospitalizations among adults aged 85 years and older. as such, the advisory committee for immunization practices, or acip, recently recommended long-term care facility residents as a priority group to receive initial doses of covid-19 vaccines once approved. similarly, health care personnel have been prioritized for vaccination to preserve capacity to care for patients with covid-19 and other illnesses. again, based on covid net data, 6% of adults hospitalized with covid-19 were health care personnel, with nursing related occupations being most frequent. health care personnel hospitalized with covid-19 had similar prevalence of underlying medical conditions, most notably obesity, as that observed among adults hospitalized with covid-19. all adults.

likewise, a similar proportion of severe clinical outcomes, including icu admission, mechanical ventilation, and death, occurred among health care personnel as that across all adult covid-19 hospitalizations. as we prepare for covid-19 vaccines, it's important to establish baselines to assess their future impact and maintain ongoing assessments of the total burden of sars-cov-2 infections in the u.s. to that end, cdc has implemented a nationwide prevalence survey to help track the number of people with evidence of previous sars-cov-2 infection, including milder infections that do not result in care seeking or testing for acute infection. these involve biweekly testing of approximately 50,000 residual specimens from commercial laboratories for antibodies against sars-cov-2.

through the first few rounds of this survey, estimated seroprevalence has ranged from 0.4 to 23% across u.s. jurisdictions. however, as of late september less than 10% of specimens from most jurisdictions have evidence of previous sars-cov-2 infection. in general, the highest seroprevalence was observed among children and adults aged less than 50 years, and lowest among older adults, aged 65 and older. using the different multiplier modeling approach, which uses reported cases and other data sources to then account for under-detection and under-reporting, cdc recently released estimates of the total number of hospitalizations, illnesses, and infections with sars-cov-2 in the u.s. this analysis estimated that one of every 2.5 hospitalized cases

and one of every 7.1 non-hospitalized cases may have been nationally recorded. applying these multipliers to reported cases through the end of september, you'll get a national estimate of 2.4 million hospitalizations, 34.8 million illnesses, and 52.9 million total infections. as the figure to the right shows, most estimated hospitalizations occurred among older adults, while most illnesses and infections were among younger adults. so in summary, now, as of december 9, over 15 million cases and over 285,000 deaths associated with covid-19 have been reported in the united states. however, based on seroprevalence surveys and models the total estimated number of infections

is likely two to seven times greater than reported cases. though, less than 10% of the population in most states had evidence of previous infection through september. factors associated with increased risk for severe covid-19 include older age, racial and ethnic minority group membership, and several specific underlying medical conditions. ongoing surveillance and epidemiologic studies will help further implementation of candidate vaccines, including assessment of their impacts, safety and effectiveness. lastly, even with the promising advent of covid-19 vaccines, there's continued need for non-pharmaceutical interventions, including mask use, physical distancing, and hygiene and environmental disinfection, to help bring an end to this devastating pandemic. finally, i would like to acknowledge the thousands of

public health professionals that have worked tirelessly over the last 11 months on the cdc covid-19 response, including the dedicated staff from the respiratory viruses branch. thank you. >> i think i wasn't on at first. thank you so much for being clear about the differential impact of covid-19 and the u.s. population. we have time for a relatively few questions. i see dr. meissner. do you have your hand raised? >> yes, sir. thank you very much for that presentation, doctor.

i would like to ask you about the severity of disease, particularly in older adolescents. that is, individuals who are 16 and 17 years of age. because they have been included in the company's request for an eua. i assume -- i know -- i assume it's unlikely that hospitalizations and disease are broken down by age. but is it safe to assume that adolescents who are 16 and 17 years of age are similar in the five through 17-year-old age group? >> thank you for that question. so, of course, as we refine to smaller and smaller age brackets, the numbers get smaller, particularly in

children. where overall we see lower rates, particularly of severe disease, of hospitalization. in general, we do see higher rates of hospitalization among children aged zero to five relative to those aged five to 17. of course, this is potentially confounded by differential rates of care seeking. as you might imagine, there are certainly lower thresholds for care seeking for the very youngest and most vulnerable children. however, as we start to look at the more mild end of the illness spectrum, and look at rates of detection of sars-cov-2 virus, we do see indication of higher rates of infection among older children, among adolescents, particularly then as we move into kind of older teenagers and people in their young 20's. much of this may have been driven in part by outbreaks in the fall among institutes of higher education.

but the broader impacts in children perhaps are not entirely clear until the full resumption of normal activities ensues in the united states, including in-person education across all schools in the united states. so, we'll continue to monitor closely. but thus far, the indication is the highest rates of illness, severe illness in young children, but higher rates of infection in older children. >> thank you. >> dr. rubin. >> thanks, dr. hall. i was interested in the multiplier that you described. that applies to the diagnosis of infection. do you think that applies to deaths as well?

>> yeah, so we have used at cdc the same multiplier model previously for tracking influenza and generating in-season estimates of the disease burden. and that same approach has been used previously to estimate deaths in the same manner that i presented today for hospitalizations and milder illness. there, of course, are differential multipliers that would have to be considered for deaths as the rates of underreporting of deaths are different than those for milder infection. in general, we have better capture of deaths. we have lower rates of underreporting and underascertainment for deaths. but as folks are aware, the dynamics of the pandemic itself have greatly changed those multipliers, and so there's also a considerable time component that needs to be factored in when using these multiplier models. so the underreporting of deaths, for example, has changed over

time, and the attribution of deaths to covid-19 has changed over time, which complicates interpretation. but we do have several efforts under way using these models and other approaches to generate estimates of death. and we do feel, as with hospitalizations and illnesses, that the reported number of deaths is likely an underestimate of the true number of deaths. >> thank you. >> thank you. dr. ganz, we're going to go over a little bit. please keep your question short. >> thank you very much. thank you for that, and i agree, heroic effort to all of the people who are working on this. i had two quick questions. the data concerning the immunocompromiser is not really granular enough in something we can use in terms of how we're thinking about high-risk populations.

there are registries looking at this, but it would be nice if there were some national information that you could provide to us as well, as i didn't see any information from pregnant women, which is a population which we're all concerned about and we've definitely seen post-natal transmission to very young infants who end up being hospitalized, if you would take those up. >> thank you for those comments. absolutely, there are numerous surveillance efforts currently underway to assess the impacts of covid-19 in pregnant women. in the interest of time, unfortunately today i didn't have a chance to present those. but through covid net, as described today, as well as another surveillance system called set net, which was established during the zika epidemic, we have been very closely monitoring the impacts of covid-19 in both pregnant women and subsequently following up with their infants. thankfully, the rates overall have been relatively low thus

far, but as we continue to accumulate a critical mass of data in this demographic, we indeed do hope to have more specific estimates of the risks that are posed to pregnant women and their infants. the early indication is that there may be a risk, higher risk of pre-term delivery among pregnant women infected with covid-19, relative to women without covid-19. but there's ongoing efforts to assess those and other potential pregnancy-related risks and fetal outcomes. >> thank you very much, dr. hall. and it's now time for our morning break. we've eaten into the time a little bit, but i do want to start again at 10:30 eastern. so we can hear from dr.

messonier from cdc. >> we are next going to hear from, again, the centers for disease control. we are going to have a few presentations and questions afterwards. first, we're going to hear a presentation from dr. nancy messonnier, the director of the center for immunization and respiratory diseases on vaccine safety and effectiveness monitoring. and then from anita patell, the deputy of the vaccine task force on operational distribution plans. dr. messonnier. >> thank you, dr. monto, and thank you for the opportunity to speak today on this really auspicious day. despite the completely appropriate size and scope of the clinical trials, it's always important to continue to monitor

vaccines post-licensure, post-authorization, and that is certainly especially true with covid vaccines. so i'm going to talk about the u.s. government plans for monitoring of safety and effectiveness. first, safety. the rapid implementation of safety monitoring under an eua requires a whole of u.s. government approach with an initial focus on the early populations targeted for vaccination. voluntary active surveillance of adverse events focused on health care worker vaccination, and rapid follow up of reported serious adverse events. as the program continues and more vaccine is given, active surveillance systems will provide increasingly useful information on safety in different populations. close collaboration of safety experts across the usg will facilitate data sharing and rapid recognition of responses to safety signals.

now, there is a quite extensive plan for safety monitoring. but i'm just going to summarize a few high points. on day one of the covid-19 vaccine programs, systems will be in place to monitor the safety of vaccine recipients. these include the traditional systems that we use, which is a national spontaneous reporting system monitored and implemented by cdc and fda, but also similar programs at d.o.d. and the v.a., as well as the national health care safety network, or nhsn, which is an acute care and long-term care facility monitoring system. cdc, the system is stood up, that provides individual case consultation. but in addition, to really enhance this period, cdc has stood up a new system called v-safe. it's an active surveillance tool that uses text messaging and web-based surveys to monitor

vaccine recipients for adverse events. recipients complete brief surveys up to really intermittent surveys to 12 months following vaccination. then as part of the program, recipients that report a significant health event that impacts their daily activities or leads them to seek medical attention will be called for more information and report will be generated. this is an opt-in system, and so we're going to have a heavily enhanced engagement around implementation of the program. we really need people to sign on to this system to give us the best data possible. large link database monitoring systems will provide safety data when vaccine becomes more widely available in the priority groups and the general public. this includes, again, existing

systems like vsd, the fda's extensive system, and systems from d.o.d. and v.a. we're enhancing this by genesis, which is a new collaboration with nih and brown university, to monitor safety and long-term care facility residents. this system operates nationally, and has near-realtime data for 250 facilities. to look at this another way, this is a table that showcases the systems that we'll be using to monitor safety in the populations that, based on acip recommendations, will be vaccinated first, specifically health care workers and long-term care facility residents. so you'll see that early on we have a series of systems to monitor health care workers and long-term care facility residents. it will be enhanced during this time period, especially around long-term care facility residents, to ensure that we're getting those reports, and then

v-safe, which will specifically target health care workers. and then you'll see all the systems that are going to be in place for later monitoring and all of those populations. i think the team has done a really good job of thinking through what systems we have, how to enhance those systems, and looking for any weaknesses and attempting to fill them in . and i'm giving it short, by going through it so quickly, but hopefully you'll understand how robust these systems are. in addition, the acip covid vaccine safety technical sub-group was established to abide expert consultation on covid-19 safety issues. this group, which we call vast, was built off lessons learned . finalized and vast is ready to begin reviewing data once implementation commences. the group is co-chaired by a member of acip and a member of the national vaccine advisory

committee, or nvac. there are 10 independent expert consultants that make up the group as well as ex-officio members of nih, and ihs, and we also have representatives from from the v.a. and the d.o.d. now to briefly summarize our efforts around post authorization vaccine effectiveness. post authorization, or post licensure d.e. estimates, are needed to address important evidence gaps on phase 3 clinical trials, particularly for secondary end points that may not be adequately addressed. for example, the trials may be limited in their ability to address ve against secondary end points, like infection transmission, or in some populations -- and we won't have rate data early on on the duration of protection. we also believe it's important

to evaluate the real world performance of vaccines as protection may differ from efficacy under trial conditions. so, this table attempts to lay this are going to leave meeting, you can watch the rest on c-span.org. we go live now to a conference with washington governor jay inslee. very happyning, i am to be delivering hopeful news and great news this morning for the state of washington. i am joyous to be able to say that the federal government has authorized the use of the covid-19 vaccine. i am thrilled that washington and weas done our review are authorizing the use of the vaccine and we are ready to go. we believe that