December 2020 ACIP Meeting – Welcome & COVID-19 vaccine

>> Dr. Romero, would you like to call the meeting to order? >> I would Thank you very much, Dr. Cohn So, I’m gaveling the meeting to order This is the Emergency Meeting of the Advisory Committee on Immunization Practices, ACIP, November 27, 2020 I will turn it back over to Dr. Cohn Thank you, Dr. Cohn >> Good afternoon, everyone Next slide Welcome to the December 1st, 2020, Emergency ACIP Meeting On our ACIP website, you will find the agenda, the webcast link, and the Federal Register Notice will be posted in the next 24 hours regarding this meeting Next slide Copies of the slides presented at today’s meeting are also available on the ACIP website With apologies, they may not be available right this minute, but they are being put up as we speak The live webcast videos will be posted on the ACIP website after the meeting Meeting minutes are posted on the ACIP website generally within 90 to 120 days of the meeting However, a short summary of the — of the meeting minutes will be available at the end of this week For your background information, if you wish to read the brief summary from the meeting that occurred a week ago last Monday, that meeting summary has been posted on the ACIP website Next slide I’m going to review several meeting logistics For those of you who have been at these meetings, you’ll know how it goes, but there will be several new people at the meeting today So, the ACIP members, liaison members, and ex officios, as well as the speakers, are in this meeting through a Zoom call The rest of the audience is watching this meeting on a live webcast We ask that all of the individuals on the Zoom call mute your lines at all times until you’re called on for discussion And when Dr. Romero opens the meeting for discussion, please virtually raise your hand During the discussion period, Dr. Romero will take questions first from the voting ACIP members And then, from ex officio members and liaison representatives Please disable your picture — your video for now if you’re a liaison member During the discussion period, we will be asking the ACIP voting members to turn on their videos so we can identify who’s speaking during the discussion Next slide The meeting’s oral and written public comment processes are designed to accommodate increased public interest in ACIP’s work, maximize opportunities for comment, make public comment more transparent and efficient, and create a fair process for assigning limited oral public comment time There is a docket that is available to input your written public comment on the Federal Register The docket number is CDC-2020-0121 The docket is open now and will be open through December 3rd of this week I also want to acknowledge that we had over 75 requests for oral public comment, and we had to limit that number to 10 So, if you were unable to make an oral public comment, we encourage you to submit a written public comment Additionally, if you sent public comment to the ACIP mailbox or to any individuals, please — please go back and submit that in the Federal Registry if you would like for that comment to be reviewed and on the record Next slide Members of the ACIP agreed to forgo participation in certain activities related to vaccines during their tenure on the committee For certain other interests that potentially enhance a member’s expertise while serving on the committee, CDC has issued limited conflict of interest waivers Members who conduct vaccine clinical trials or serve on data safety monitoring boards may present to the committee on matters related to those vaccines, but these members are prohibited from participating in committee votes on issues related to those vaccines Regarding other vaccines of the concerned company, a member may participate in discussions with the provision

that he or she abstains on all votes related to the vaccines at the company — of that company At the beginning of this meeting during roll call, ACIP members will state any conflicts of interest Of note, the proposed recommendations that we are asking for ACIP’s advice on today are general recommendations regarding COVID-19 vaccines and do not — and are generalizable to all companies And so, therefore, while conflicts of interest will be stated, all ACIP members will — will be able to vote today Before I turn it over to Dr. Romero, I would like to briefly review the agenda You can find this agenda on the ACIP website But after introductions, we will have a session reviewing the allocation of initial supplies of COVID-19 vaccine during Phase 1a And then, clinical considerations for populations included in Phase 1a Following that, there will be a discussion — there will be a presentation on the post-authorization safety monitoring update And then, there will be time for discussion Prior to the break at 4 PM, if ACIP is ready, we will ask for ACIP to put a motion on the table for consideration After the break, we will come back at 4:10 for public comment We ask that all public comments focus on the motion that has been put on the table for consideration and that all public comments be related to COVID-19 vaccines for this meeting And after the 30-minute public comment period, we will have a vote on the allocation of initial supplies of COVID-19 vaccine We anticipate adjourning the meeting today at 5 PM Eastern Standard Time Next slide Thank you all for listening and watching today I’m going to turn it back over to Dr. Romero to take roll call of the ACIP members and to — and the ex officios and liaison members Thank you >> Thank you very much Let me begin by correcting an error It is the December 1st, 2020, ACIP meeting So, I will call the voting members’ names Please indicate your affiliation and if you have any conflicts of interest So, I will begin José Romero I’m the Chair, Secretary of Health for the state of Arkansas I’m a Professor of Pediatrics, Pediatric Infectious Diseases at the University of Arkansas for Medical Sciences And no conflicts of interest Dr. Atmar Thank you, Dr. Romero Robert Atmar I’m a Professor in the section of Infectious Disease, Department of Medicine, Baylor College of Medicine As a conflict, I’m a Co-Director of the Clinical Operations Unit of the NIH-funded Infectious Diseases Clinical Research Consortium that is working with the COVID-19 Prevention Network or CoVPN to evaluate SARS-CoV-2 vaccine candidates in Phase 3 clinical trials, including those produced by Moderna, AstraZeneca, Johnson, Novavax, and Sanofi And I have participated in the conduct of the Moderna Phase 3 trial Over >> Welcome and thank you Dr. Ault >> My name is Kevin Ault, and I’m a — pardon me I’m a Professor of Obstetrics and Gynecology at the University of Kansas in Kansas City, Kansas, and I have no conflicts of interest >> Thank you Welcome. Ms. Bahta >> Good afternoon This is Lynn Bahta I’m a Public Health Nurse and serve as the Immunization Clinical Consultant at the Minnesota Department of Health, and I have no conflicts Thank you >> Thank you Welcome. Dr. Bell >> This is Beth Bell I’m a Clinical Professor in the Department of Global Health at the University of Washington, and I have no conflicts >> Welcome, and thank you Dr. Bernstein >> Good afternoon I am a Professor of — this is Hank Bernstein I’m a Professor of Pediatrics at Zucker School of Medicine at Hofstra and Northwell, and I have no conflicts >> Welcome, and thank you Dr. Frey >> Good afternoon This is Sharon Frey I’m a Professor of Internal Medicine in the Division of Allergy and Infectious Diseases at Saint Louis University, and I am currently a Site PI for the Moderna study and the Janssen vaccine study >> Welcome, and thank you Dr. Hunter >> Paul Hunter, Associate Professor of Family Medicine and Community Health at the University of Wisconsin

in Madison, Wisconsin I own a small amount of Pfizer stock I have a very small grant from Pfizer Corporation regarding a quality improvement project related to pneumococcal vaccines Thanks >> Thank you, and welcome Dr. Lee >> Grace Lee I’m Associate Chief Medical Officer at Stanford Children’s Health, Professor of Pediatrics at Stanford University School of Medicine, and I have no conflicts >> Thank you, and welcome Ms. McNally >> Veronica McNally, President of the Franny Strong Foundation based in Michigan, and I have no conflicts >> Welcome Thank you Dr. Poehling >> Good afternoon This is Kathy Poehling I am a Professor of Pediatrics and Epidemiology and Prevention at Wake Forest School of Medicine I also serve as the Director of Pediatric Population Health Thank you >> Thank you, and welcome Dr. Sánchez >> Hi, José This is Pablo Sánchez I’m a Professor of Pediatrics in the Divisions of Neonatology and Pediatric Infectious Diseases at Nationwide Children’s in Ohio State University in Columbus, Ohio I have no conflicts >> Thank you Welcome. Dr. Szilagyi >> Hi. Peter Szilagyi I’m Professor of Pediatrics at UCLA and Executive Vice-Chair and Vice-Chair for Research in the Department of Pediatrics, and I have no conflicts >> Welcome, and thank you Dr. Talbot >> Hi. I’m Dr. Talbot at Vanderbilt University Medical Center where I’m an Associate Professor in Infectious Diseases >> Any conflicts, Dr. Talbot? >> Sorry. No conflicts >> Thank you very much Welcome. I’ll now turn to the ex officio representatives I will name only the centers from which you’re at, and please indicate your name, and will go forward First, Centers for Disease Control and Prevention >> Nancy Messonnier for CDC Thank you >> Welcome Centers for Medicare and Medicaid Services >> Mary Beth Hance for CMS Thank you >> Thank you Food and Drug Administration >> Good afternoon Doran Fink for FDA CBER Office of Vaccines >> Thank you, and welcome Health Resources and Services Administration >> Captain [inaudible] Division of Injury Compensation Programs >> Thank you, and welcome Indian Health Service >> Good afternoon Jillian Doss-Walker, Indian Health Service >> Welcome National Institutes of Health >> Good afternoon John Beigel from the NIAID, NIH >> Thank you Welcome. Office of Infectious Disease and HIV/AIDS Policy >> David Kim, OIDP >> Thank you Next will be the liaison representatives I will again list your institution Please provide us your name To begin, American Academy of Family Physicians, please >> Pamela Rockwell, present >> Thank you American Academy of Pediatrics >> Bonnie Maldonado, Professor of Pediatrics, Epidemiology, and Population Health, Stanford University >> Welcome American Academy of Physician Assistants >> Good afternoon Marie-Michèle Léger, American Academy of PAs >> Thank you Welcome. American College of Nurse Midwives >> Carol Hayes, present >> Thank you American College of Health Association >> Sharon McMullen, Cornell University, and joined by my Co-Liaison, Thevy Chai, University of North Carolina at Chapel Hill >> Thank you Welcome, both American College of Obstetricians and Gynecologists >> Dr. Eckert, present >> Thank you American College of Physicians >> Dr. Jason Goldman, Assistant Affiliate Professor at Florida Atlantic University and Nova Southeastern University, present >> Thank you, and welcome American Geriatrics Society >> Ken Schmader for AGS Thanks >> Thank you America’s Health Insurance Plan >> Yeah. This is Bob Gluckman I’m an Internist, Chief Medical Officer for Providence Health Plans, here for AHIP Thank you >> Thank you American Immunization Registry Association >> Good afternoon Rebecca Coyle, representing AIRA >> Welcome American Nurses Association >> Chad Reynolds, representing the ANA >> American Medical Association >> Sandra Fryhofer, Adjunct Associate Professor of Medicine, Emory University School of Medicine, and Liaison for the American Medical Association >> American Osteopathic Association

>> Stan Grogg, present >> Thank you American Pharmacists Association >> This is Steve Foster >> Thank you Association of Immunization Managers >> Hi. This is Molly Howell, Immunization Manager for North Dakota and Liaison for AIM >> Welcome Association for Prevention Teaching and Research >> This is Paul McKinney I’m a Professor at School of Public Health and Information Sciences, University of Louisville >> Thank you Association of State and Territorial Health Office — Officials >> This is Nirav Shah, the Director of the State of Maine Center for Disease Control, here on behalf of ASTHO >> Thank you Biotechnology Innovation Organization >> Good afternoon Phyllis Arthur, Vice President, Infectious Diseases and Diagnostics Policy >> Welcome Council of State and Territorial Epidemiologists >> Dr. Christine Hahn, State Epidemiologist of Idaho >> Thank you Canadian National Advisory Committee on Immunization >> Caroline Quach, NACI Chair Good afternoon >> Good afternoon, and welcome >> Infectious Diseases of Society of America >> Carol Baker, here >> Thank you International Society for Travel Medicine >> Elizabeth Barnett, Boston Medical Center for ISTM >> Thank you National Association of County and City Health Officers — Officials, excuse me >> Matt, Zahn, present >> Thank you National Association of Pediatric Nurse Practitioners >> Patsy Stinchfield for NAPNAP >> Thank you National Foundation for Infectious Diseases >> Marla Dalton for NFID >> Welcome National Medical Association >> Pat Whitley-Williams, Professor of Pediatrics, Rutgers, Robert Wood Johnson Medical School Thank you >> Thank you, and welcome Pediatric Infectious Diseases Society >> Sean O’Leary, University of Colorado, present >> Welcome Pharmaceutical Research and Manufacturers of America >> Good afternoon Corey Robertson, present >> Thank you Society for Adolescent Medicine — I’m sorry, Adolescent Health and Medicine >> Hi. It’s Amy Middleman for SAHM Thanks >> Welcome Society for Healthcare Epidemiology of America >> This is Marci Drees, Chief Infection Prevention Officer at ChristianaCare, representing SHEA Thank you >> Welcome Thank you Did I miss anybody by? Thank you All right So, thank you all for giving up your afternoon or late morning, depending on your time zone We’ll begin now So, we will discuss COVID disease 2019 vaccines Dr. Beth Bell will give an introduction Dr. Bell, please >> Thank you, Dr. Romero And welcome, everyone Thank you for participating in the first emergency ACIP meeting in which we’ll be having a vote I’ll just mention that this is a particularly difficult time in the United States I just noted that since we’re averaging one COVID death per minute in the United States right now, in the time it takes us to have this ACIP meeting, 180 people will have died from COVID-19 So, we are acting, I guess, none too soon First slide, please So, as a reminder, at the November 23rd ACIP meeting, ACIP reviewed the Evidence to Recommendation Framework, focusing on the Public Health Problem, Resource Use, and Equity Domains And then, the Values, Acceptability and Feasibility Domains And we discussed in some detail the Phased Allocation of COVID-19 Vaccines Next, please During November, the COVID-19 Vaccine Work Group focused our discussions on further issues around Phase 1a populations and the clinical considerations surrounding those populations that are proposed to be included in Phase 1a Next, please Now, as you heard from Dr. Cohn, today’s agenda includes a discussion of allocation of initial supplies during Phase 1a by Dr. Kathleen Dooling, a presentation about clinical considerations for populations included in Phase 1a by Dr. Sara Oliver,

post-authorization safety monitoring by Dr. Tom Shimabukuro, we will have time for public comment, and then there will be a vote on an interim recommendation for the allocation of initial supplies of COVID-19 vaccine in Phase 1a Next, please I just wanted to mention one additional update from my last presentation on this subject, which was not very long ago, which is just to remind everyone that there are now two COVID-19 vaccine manufacturers who — that have announced filing with the FDA for Emergency Use Authorization Pfizer/BioNTech announced a submission to FDA on November 20th, and Moderna announced submission to FDA on the 30th of November Next. So, that’s it for me Again, taking this opportunity to show the names of all of the participants in the COVID-19 Vaccine Work Group, which gives me an opportunity to thank them for their dedication and their input Next, please And all the CDC participants, again, to provide me with an opportunity to thank all of the CDC participants for their efforts in this regard here And I think that’s it for my slides Yes. Thank you very much And we’ll proceed with the rest of the agenda >> Thank you, Dr. Bell So, next is Dr. Kathleen Dooling, who will discuss allocation of initial supplies of COVID-19 vaccine Phase 1 Following this, we will entertain questions regarding her presentation and not discussing the populations at this point Dr. Dooling, please >> Thank you, Dr. Romero, and good afternoon everyone Today, we will revisit phased allocation of COVID-19 vaccine in order to answer the following policy question, “Should healthcare personnel and long-term care facility residents be offered COVID-19 vaccination in Phase 1a?” After we have reviewed the evidence, then clinical considerations and safety monitoring presented by my colleagues, we’ll return to this policy question Recall that during the ACIP meeting last week, we reviewed evidence in three domains to inform allocation decisions For the science pillar, the Work Group examined COVID-19 disease burden, as well as the balance of benefits and harms in each group Of course, details of the Phase 3 data will further inform this area when they become available For implementation, the Work Group took into consideration the values and acceptability, as well as the feasibility of implementation in each group And finally, the ethical principles that apply to each group, namely, to maximize benefits and minimize harms, promote justice, mitigate health inequities, and promote justice — or promote transparency throughout the policy process We used those three pillars to evaluate the proposed groups for Phase 1a — for Phase 1 vaccination ACIP discussed phased allocation with healthcare personnel and long-term care facility residents in Phase 1a, essential workers who do not work in healthcare in Phase 1b, and adults with high-risk medical conditions and adults who are 65 and older in Phase 1c In order to address the policy question before the ACIP today, we’ll focus on the rest of this presentation on healthcare personnel and long-term care facility residents Let’s take a moment to review who these groups include Healthcare personnel are defined as essential workers, paid and unpaid, serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials There are approximately 21 million healthcare personnel working in settings such as hospitals, long-term care facilities, outpatient settings, home healthcare, pharmacies, emergency medical services, public health, and others The group under consideration — or sorry, the second group under consideration are residents of long-term care facilities About 3 million adults in the U.S. live in long-term care facilities, which provide a spectrum of medical and non-medical services, usually to frail or older adults unable to reside independently in the community

There are several different categories of long-term care facilities including skilled nursing facilities In general, those provide higher acuity care including rehabilitation services There are also assisted living facilities where residents are provided help with activities of daily living, but may live in their own room or apartment within that facility Other residential care facilities may provide specific services or cater to specific populations Now, let’s review the science For healthcare personnel, as of November 30th, there have been at least 243,000 confirmed COVID-19 cases with 858 COVID deaths Long-term care facility modeling that was presented to ACIP in August predicts more cases and deaths averted at a facility among everyone by vaccinating staff compared to vaccinating residents COVID-19 exposure both inside and outside the healthcare setting results in absenteeism due to quarantine, infection, and illness Vaccination has the potential to reduce healthcare personnel absenteeism Older adults in congregate settings are disproportionately affected by COVID-19 Long-term care facility residents and staff accounted for 6% of cases and 40% of deaths in the U.S., despite the fact that long-term care facility residents account for less than 1% of the U.S. population The skilled nursing facility population is approximately 1.3 million and as of November 15th had experienced almost half a million confirmed and probable cases and more than 69,000 COVID-associated deaths Assisted living facilities are home to approximately 800,000 residents across the nation And although surveillance is less systematic for these types of facilities, 28,000 confirmed and suspected cases were reported over 28 states, and more than 5000 deaths were reported over 20 states This figure shows the proportion of COVID-19-associated hospitalized patients in the COVID-NET surveillance system who were admitted from a long-term care facility As you can see, more than 30% of hospitalized patients aged 65 to 74 were admitted from a long-term care facility, and more than half of hospitalized patients, COVID patients, 75 and older were admitted from a long-term care facility Now, let’s review the implementation considerations A Harris Poll was completed in August, and surveyed respondents were asked, “Which of the following groups should receive priority when a COVID-19 vaccine is available?” Survey respondents most strongly supported early allocation of vaccine to healthcare workers and seniors While not expected to exactly predict COVID-19 uptake, influenza vaccine among healthcare personnel may give us some indication of COVID-19 vaccine acceptance Overall, influenza vaccine coverage is high among healthcare personnel with the highest rates of uptake among hospital workers and lower rates among workers in the long-term care setting Another early indication of long-term care facility acceptance of COVID-19 vaccination is the overwhelming response to the Pharmacy Partnership for Long-Term Care Program CDC is partnering with two national pharmacy chains to offer on-site COVID-19 vaccination services for residents and staff of skilled nursing facilities and assisted living facilities To date, 99% of skilled nursing facilities nationwide have enrolled in this program The program provides end-to-end management of COVID-19 vaccination process, including cold chain management, on-site vaccination, and fulfillment of reporting requirements But even with the Pharmacy Partnership for Long-Term Care Program, COVID-19 vaccination implementation and achieving high levels of coverage in the long-term setting will still be challenging This slide is an example of a simulation of one and two-dose coverage among skilled nursing facility residents over time Even if acceptance is high and three vaccination visits are made, because of the high turnover, the proportion of current residents who are vaccinated decreases over time The situation will improve, of course, when vaccine is readily available in the community and adults can be vaccinated prior to admission Now, on to ethics Vaccinating healthcare personnel supports the principle

of maximizing benefits and minimizing harms through what we are calling the multiplier effect In other words, protection of healthcare personnel leads to preservation of healthcare capacity and better health outcomes for all Vaccinating healthcare workers promotes justice because healthcare personnel put themselves at risk and will be essential to carry out the vaccination program Vaccinating healthcare personnel also has the potential to mitigate health inequities because the group includes a broad range of occupations, inclusive of low-wage earners and racial and ethnic minority groups Vaccinating long-term care residents maximizes benefits by directly preventing disease in a high-risk group and minimizes harms by potentially reducing the burden on hospitals The Federal Pharmacy Partnership Program can promote justice by facilitating equal access to vaccine across most long-term care facilities The program has the potential to mitigate health inequities by reaching long-term care facilities across the socio-economic spectrum In summary, the Work Group felt that early vaccination of both healthcare personnel and long-term care facility residents was strongly supported by science, implementation, and ethical considerations Here are some additional important considerations the Work Group wanted to share for Phase 1a What’s presented here are interim guidance for Phase 1a Allocation policy will need to be dynamic and adapt as new information, such as vaccine performance and supply and demand, become clear To that end, we will need gating criteria to move expeditiously from one Phase to the next as demand saturates And it’s important to keep in mind that following vaccination measures to stop the spread of SARS-CoV-2, such as masks and social distancing, will still be needed And ultimately, this interim allocation is a short-term measure The U.S. government has stated its commitment to making COVID-19 vaccines available to all residents who want them as soon as possible During the last ACIP meeting, there were a number of important issues raised, and we wanted to take this opportunity before the vote to provide some additional information on those issues And to summarize, for healthcare personnel, ACIP members and liaisons expressed a need for guidance on sub-prioritization of healthcare personnel when vaccine supply is very limited in the beginning, to address vaccination in pregnant or lactating healthcare personnel, as well as how to approach expected reactogenicity following vaccination For long-term care facility residents, ACIP members requested more information on consent and assent within the facilities and plans on interpretation of reactogenicity and safety monitoring in this specific population So, that concludes my comments for the moment, and I return the microphone back to Dr. Romero Thank you very much, Dr. Dooling, for that excellent presentation We will now open it up to the voting members for questions regarding the presentation only, please So, I see Dr. Atmar has his hand up >> I do. Thank you, Dr. Romero Thank you, Dr. Dooling, for a very clear presentation I have a question about the Pharmacy Partnership One of the arguments for performing vaccination in long-term care facilities at the prior meeting was that both the persons — the healthcare personnel working in the unit or the facility and the residents could be vaccinated at the same time Does the Pharmacy Partnership vaccinate healthcare personnel or is it only for the residents? And if it’s the latter, can you further address that question about a potential advantage? Thank you >> Thanks for that question The Pharmacy Partnership for Long-Term Care will, in fact, vaccinate residents as well as staff in the facilities >> Before I take the next question, does anyone else have a comment or question to dovetail on to Dr. Atmar’s? Okay, Dr. Frey, please >> Thank you I don’t know if this is a fair question to ask at this time If not, just please tell me But there was a slide earlier that looked at, I believe, one in two doses of vaccine, and I was wondering

if we have any evidence for any kind of efficacy after administration of a single dose of vaccine at this time Thank you >> We don’t have any evidence right now, but that is one of the questions that we’ll be asking of the Phase 3 data once it becomes available >> Again any comments or questions that tail with Dr. Frey’s question? >> This is Dr. Atmar I have a brief followup on the same issue, but it — it doesn’t relate to efficacy, but it relates to the challenge with, you know, the declining population and what the implementation plans would be to basically keep and complete vaccination in long-term care facilities So, it seems to be quite an implementation challenge Over >> Thank you for that I agree that it will be a challenge The pharmacies that have signed up for this program have agreed to make three visits — separate visits to the facility in order to vaccinate all persons who wish to be vaccinated And again, once vaccine is more available in the community, this will be less of an issue >> Any other comments in that vein? Okay. Dr. Frey, your hand is still up Is there anything else? >> No >> Thank you I’m just — I’m just making sure that everybody has a chance to speak Dr. Goldman, please, go ahead >> Thank you First, thank you to the committee and the staff for all their hard work and consideration on this difficult issue I did want to stress a few points in concerning the Phase 1 prioritization, especially of healthcare workers and guidance on sub-prioritization You know, the outpatient community physician and small private practice, truly being the backbone of the healthcare system, I’m pleased to see it’s considered in healthcare first Phase, but we need to really look at the outpatient offices being most at risk There was a recent study out of the University of Pennsylvania that showed small community and outpatient physicians may be at a higher risk of death than the inpatient And when you look at potential mitigation strategies, for example, an ICU physician, while seeing sicker patients, may have greater access to PPE compared to small offices I’m greatly concerned about the ability for the small and private practice to be able to get appropriate vaccination, especially from large healthcare systems Additionally, you know, the office staff is critical to running the small practices, almost as much as the necessity of the physician being there, and they truly are the frontline workers So, I would hope that the committee would greatly look at the guidance and sub-prioritization, especially with vaccine distribution, for those offices who are not employed by hospitals and not associated with large healthcare systems to make sure we are truly getting the vaccines to the people on the frontlines who need it the most More specifically, the small private and independent community primary care physicians Thank you >> Thank you, Dr. Goldman Does anyone have a comment or a question to tail on to Dr. Goldman’s topic? I see none or hear none >> Dr. Romero >> Please, go ahead, and speak up Don’t — don’t hold your hand up, just to add to that Go ahead, please >> Yeah. This is Sean O’Leary with the Pediatric Infectious Diseases Society I want to second Dr Goldman’s point there about outpatient providers and just add that also consideration should be given to other people that work outside of hospitals like home health aides and EMS, etc., that plans should be made for those providers as well >> Thank you very much Anybody else to add a comment to what has already been said? >> Oh, sorry >> Dr. Sánchez I hear you Go ahead >> No, I just want to re — to echo that because I do think that with sub-prioritization and a lot of it, I think, will be left to jurisdictions, presumably I do think that — that the availability of PPE will be critical in terms of what sub-specialty and what practices should — they should be allocated to first So, I do want to agree with that >> Thank you very much, Dr. Sánchez Anybody else adding to Dr. Goldman, Dr. O’Leary, or Dr. Sánchez’s comments?

>> Sandra Fryhofer, American Medical Association I also wanted to emphasize the importance on making sure that small community practices have access to COVID-19 vaccines >> Thank you very much So, there is — there is some data in Dr. Oliver’s next presentation that deals with this So, if you have other comments, we’re fine to take them, but there will be some information coming Anyone else wish to make a comment? >> Dr. Romero, this is Jeff Duchin from IDSA Can I make a comment? >> Please No, of course Please do, sir >> Thank you I would just like to add that on the science front, that the transmission dynamics of COVID-19 also suggests that those providers that care for patients earlier in their course of illness may be at higher risk, and this is supported by information the CDC has recently published as well, and that would include outpatient healthcare providers Thank you >> Thank you Anyone else before I take Dr. Bernstein’s question? I hear none Dr. Bernstein, please, go forward >> Thank you First, I wanted to thank Dr. Dooling again for an excellent presentation, as she always gives My question relates to the long-term care facilities and the potential for sub-prioritization Is it envisioned that the healthcare personnel will first get vaccine in a long-term care facility if supply is constrained before giving it to the residents or is there another sub-prioritization scheme? >> Dr. Bernstein This is Amanda I would — most — I would assume that most planning around long-term care facilities would — would have a long-term care facility vaccinate both residents and healthcare personnel working in that facility at the same time, but there will be some jurisdictions that will likely start with healthcare personnel and then vaccinate residents It’s very dependent on supply and local context >> Thank you >> Thank you, Dr. Cohn Anybody wish to add additional questions or comments to the topic brought up by Dr. Bernstein? >> Yes, Dr. [inaudible] I — I have similar concerns about making sure that the staff in long-term care facilities are getting vaccinated They, too, as mentioned by others, are often less equipped in terms of personal protective equipment and have certainly had a huge burden of disease among them >> Very good Thank you That was Ms. Bahta, a voting member of the ACIP I’m just stating your name for whoever is transcribing Are there any other comments in this — on this topic? >> Hi, this is Marie-Michèle Léger from AAPA This is in relationship to the long-term care residents I know in previous discussion we made mention that there’s a high turnover of the residents and usually within a 30-day time period So, the question is more from an implementation and followup of those residents for their second dose — — and the challenge that that may entertain because of that >> This is Dr. Cohn I can respond to that You are highlighting one of the many challenges with ensuring high coverage among long-term — in long-term care facilities, both of residents and staff The turnover in long-term care residents, it tends to be a portion of residents turn over frequently and then the — the additional residents are more long-term So, there will need to be additional visits to the long-term care facility, and we have data systems in place to support those individuals who leave the facility in getting a second dose, but that will be a challenge particularly in the first couple of months of vaccination where the places where you can get vaccinated will be more limited than — than when we have more supply >> Thank you, Dr. Cohn >> Yeah, this is Bob Gluckman from AHIP You know, I — I do feel that the opportunity to immunize residents at the same time as the healthcare workers in long-term care facilities is — is important because logistically, it’ll be much easier to get people administered at the same time Really, the question that it’s asking is, “What’s the recall system?” It would seem to me that the skilled nursing facilities could

schedule people for one of the subsequent second or third days that the pharmacy is coming on-site again And then, it’s just a transportation issue I think there are ways to do this logistically, and I really do endorse the efficiency that can be gained by co-administering residents and healthcare workers at the same site at the same time Given the relatively small numbers, it doesn’t have a meaningful impact on delaying vaccination for other populations such as essential health workers or others that would be phased in at a later place So, I think the logistics can be overcome with thoughtful planning >> Thank you, Dr. Gluckman Anybody else that wishes to add to this train of questioning and comment? >> Yeah, this is Peter Szilagyi I was thinking exactly the same as Dr. Gluckman, that — that it just seems efficient to vaccinate both the residents and the healthcare personnel around them And I did have a question about the type of personnel — the type of residents who are in the long-term care facilities, and I — I do know that there are those who kind of cycle through very quickly and then the long — then proportions stay very long Do we know about the COVID deaths or — and which of those groups? My guess is that the vast majority of the COVID deaths are not the ones who are in long-term care facilities for rehab for a very short amount of time, but sort of the other more truly long-term patients >> This is Dr. Cohn We don’t have that data at our fingertips, but that is a good question, and we will look into that Thank you >> This is Bob Gluckman I would just comment, I don’t know that we know that I mean, some of the patients that are in long-term care facilities are for acute medical illnesses where they need some short-term health I can tell you that from our diagnoses from — as from a health plan point of view, there are lots of patients who need short-term help with conditions like sepsis, post-pneumonia care, congestive heart failure It’s not just joint replacements Those are not in long-term care facilities as much as they used to be So, I’d be cautious about pre-judging who’s at most risk and picking if they’re short-term residents or not Thank you >> Thank you very much We’re going to move on to the next question There’ll be plenty of time for — during the discussion section to add more to this if you — if you wish So, let me turn to the next hand that’s elevated — that’s raised, excuse me Dr. Frey, do you wish to ask — ask another question? >> Yes, please So, I just want to mention that if people in long-term care facilities, particularly the elderly, are going to be batch vaccinated, if you will, that this is another situation where there’s going to be a lot — we’ll need to have a lot of guidance post-vaccination to evaluate symptoms or adverse events or side effects because if the elderly suffer from fatigue or even a little fever, you know, they — people worry about them having underlying infections and those sort of things So, if there’s more than just a few people suffering from those side effects, it will perhaps cause issues at the home >> Thank you for that comment, and I’d like to say that our next presenters will address exactly those issues >> Thank you very much Dr. Drees >> Oops, sorry I couldn’t get myself unmuted fast enough No, I think I was just going to say something along the same lines around healthcare personnel as well, and I think — it sounds like it will be covered in the next presentation around having very specific guidelines around managing symptoms >> Thank you very much Dr. O’Leary >> Yeah. Could you just clarify — so, there are pediatric long-term care facilities, and could you just clarify for the jurisdiction that we’re just — we’re talking about adult facilities? Or since the Pfizer vaccine may go down to age 16 in its approval process, are those 16 and 17-year-olds in long-term facilities considered in this vote as well? Thank you >> The recommendation that we’ll be voting on today pertains to adults, and the specifics of the age cutoff will be determined once we have a specific vaccine that has been authorized >> Thank you >> Are there any other questions or comments before I close this presentation? I see none and hear none Thank you all very much So, we’ll move on to the next presentation by Dr. Sara Oliver

on the clinical considerations for populations included in Phase 1a Dr. Oliver, please >> Thank you So, good afternoon This afternoon, I will be presenting clinical considerations for populations discussed for potential inclusion in Phase 1a, healthcare personnel and long-term care facility residents This includes sub-prioritization, reactogenicity, and considerations for implementation One or more COVID-19 vaccines may be authorized by FDA for use in December However, the initial doses of any COVID-19 vaccine will be limited We expect a constrained supply environment for some months and need to make the best use of available vaccine By the end of December, the number of doses available will be around 40 million, enough to vaccinate around 20 million people That won’t all be available at the same time, however We anticipate 5 to 10 million doses per week post-authorization, which could lead to a need for sub-prioritization of the initial populations, at least for the first several weeks Next, for healthcare personnel Where sub-prioritization of healthcare personnel is needed consider individuals with direct patient contact who are unable to telework This includes personnel who provide services to patients or patients family members and persons who handle infections — infectious materials This can also include both inpatient and outpatient settings Also, consider personnel working in residential or long-term care facilities and personnel without known infection in the prior 90 days Reinfection appears uncommon during the initial 90 days after symptom onset preceding infection However, serologic testing is not recommended prior to vaccination Next, for pregnant or breastfeeding women, as has been discussed over the last several ACIP meetings, 75% of the healthcare workforce are female, and there could be over 300,000 healthcare personnel who are pregnant or recently postpartum at the time of vaccine implementation Data demonstrate potentially increased risk for severe maternal illness and preterm birth due to COVID-19 disease However, this must be balanced with the fact that there are no data on the use of mRNA vaccines in pregnant or breastfeeding women We await Phase 3 data, an FDA assessment, and the EUA Conditions of Use Once reviewed, we anticipate further guidance around the use of COVID-19 vaccines in pregnant or breastfeeding Phase 1a populations Reactogenicity post-vaccination will be a concern among vaccinated healthcare personnel We will have additional data soon from the Phase 3 trials This is the current data from the Phase 1/2 trials with vaccine doses used in the Phase 3 trials While the numbers here are quite small, you can see that systemic symptoms are more common after the second dose There are several considerations for implementation Healthcare systems and public health should work together to ensure vaccine access for healthcare personnel who are not affiliated with hospitals, which could include home health, community services, or broad practice types Next, consider staggering vaccination of personnel from similar units or positions In addition, consider planning that personnel could have time away from clinical care if healthcare personnel experience systemic symptoms post vaccination And on that issue, we wanted to let you know that there is additional CDC guidance forthcoming describing the approach to systemic symptoms in healthcare personnel after COVID-19 vaccination This will provide detailed information for how to handle these systemic symptoms in healthcare personnel It isn’t ready to share today, but it will be available

on the CDC website before any vaccine doses are administered Next, for clinical considerations for long-term care facility residents As was mentioned before, long-term care facilities provide a spectrum of medical and non-medical services to frail and older adults unable to reside independently in the community Skilled nursing facilities and assisted living facilities are both considered types of long-term care facilities Skilled nursing facilities are engaged primarily in providing skilled nursing care and rehabilitation services for residents who require care because of injury, disability, or illness Assisted living facilities provide help with activities of daily living However, residents often live in their own room or apartment within buildings or group of buildings Regarding COVID-19 disease among the long-term care facilities, as of November 26, there have been around 730,000 COVID-19 cases and 100,000 deaths among long-term care facility residents and staff As of mid-November, skilled nursing facilities have reported nearly 500,000 cases and 70,000 deaths through CMS Reporting varies for assisted living facilities, but through October 15th, 23 states reported nearly 28,000 cases, and 20 states reported 5500 deaths Therefore, where sub-prioritization of long-term care facilities is needed, consider skilled nursing facilities which care for the most medically vulnerable residents Then, after skilled nursing facilities, consider broadening to other facility types including assisted living facilities, residential or intermediate care facilities, or State Veterans Homes Next, reactogenicity for the older adult populations While we don’t have data from long-term care facility residents specifically, we do have data from the Phase 1/2 trials among community-dwelling older adults with the ages listed here Systemic symptoms are generally lower among the older adult populations The one severe reaction post-dose 2 in the Moderna trial was a report of grade 3 fatigue There are considerations for implementation among long-term care facility residents Federal pharmacy partners supporting the long-term care facility program will be required to adhere to all EUA Conditions of Use, including providing fact sheets to recipients In addition to the fact sheets for staff and residents getting vaccinated, they will provide — they will be provided to families and medical proxies as applicable CDC will also provide language clarifying that while there is available data on safety and efficacy among adults 65 and older, there are no data on individuals in long-term care facilities And importantly, consent or assent will be obtained from residents or families or medical proxies and documented in the patient’s chart as is standard practice for other vaccines So, in summary, sub-prioritization may be required with an initial limited supply of vaccine Implementation of vaccination programs for healthcare personnel will need to consider reactogenicity post-vaccination, and additional guidance is forthcoming from CDC Reactogenicity appears lower in the older adult populations for mRNA vaccines, but there is no reactogenicity data in long-term care facility residents specifically And safety monitoring, which will be described in detail in our next presentation, will be critical post-authorization for all populations in Phase 1a, especially long-term care facility residents Thanks, and I’m happy to take any questions >> Thank you, Dr. Oliver, again, for another well-presented topic Dr. Atmar, I see your hand is up >> Yes, sir Thank you And thank you, Dr. Oliver I just have a comment about — a cautionary comment about comparing the community-dwelling older adults to the younger adults living in the community, 2 out of 12 versus 1 out of 12 is hardly reassuring, so I don’t think we can really draw any conclusions about the relative frequency of side effects based on this limited dataset I know we’ll have the data from the Phase 3 trial, which should provide us a lot more information, but I think it’s too early to draw conclusions about the relative reactogenicity of the vaccine

in these two different age groups Over >> Thank you Dr. Hunter, please >> Yeah, I just wanted to commend you all on a little detail about not having everybody who works on a particular unit get the vaccine at the same time I had never thought about that, that, you know, the convenience of doing a vaccination unit by unit would be pretty high within a healthcare system, but that would — could wipe out that unit for a day, you know, 2 to 3 days later when the people have their reactogenicity, or at least it could, you know, have quite a few of those people out of work So, I think that that level of detail is really highly valued by people who are actually going to be implementing this, and I just want to commend you on including that Thank you >> Right. And let me just add a comment It goes without saying that this applies also to emergency personnel If you have a mass vaccination of EMTs, you could be extremely short of these individuals in the community Dr. Sánchez, please >> That was an excellent presentation, Sara Thank you I just think that we should separate the lactating mother from the pregnant woman because although we may not have data on lactation and transmission or, you know, safety there, we know that women with COVID-19 can breastfeed safely, and I really think that a healthcare woman who recently gave birth who is working frontline and at high risk, I think that that woman should be — personally, I think that woman should be vaccinated despite — even — and continue breastfeeding as well So, I think that those are two different situations with much more safety in my mind in a woman who is only providing breastmilk >> Thank you, Dr. Sánchez Dr. Maldonado >> Thank you so much for these great presentations, and it’s really been helpful for us in thinking about how to allocate across healthcare systems And I think when you talk about the science implementation and ethics, we talk about disease burden, balance of benefits and harms, values of the entire group, etc., I think sub-allocation really comes into play here in much more granular ways when we really start looking at the tiered approach to these smaller aliquots of vaccines So, for example, I wonder if we could get some guidance when we’re trying to look at our healthcare worker population And all things being equal, if your populations are equally exposed — likely to be exposed in the healthcare setting and you look at frontline workers, the question is, “When do you weigh, for example, age greater than 65 among your healthcare population versus risk of exposure versus racial and ethnic disparities and risk for community transmission at home?” So — so, basically, the bottom line is, are you really trying to prevent transmission in the hospital setting? Are you trying to prevent transmission to the healthcare worker specifically? And if so, which risks — how do you balance those risks? That is, is the higher-age individual much more at risk than the person who comes from a racial or ethnic demographic that puts them at higher risk in communities? And then, finally, what is the risk — when you’re trying to reduce disease burden, obviously the healthcare place is important, but are you trying to reduce community transmission for those individuals as well? So, these are really a very entangled concept, and I think we look to CDC and ACIP for further guidance on those — on those very critical questions >> Thank you Dr. Szilagyi Yeah, I was going to make very similar points to Dr. Maldonado I’m on multiple groups that are trying to sub-prioritize within healthcare systems, and everybody’s looking for guidance from ACIP or CDC, so I just want to emphasize the importance of guidance and the balance between being specific enough to help health systems, but allowing and suggesting and encouraging some flexibility because the health systems know their own populations the best And I did have a question about when the — as the guidance comes out, will there be discussion about sort of coordination with SHEA or other groups that are — that are also in the space working on guidance for healthcare — for healthcare facilities

and sub-prioritization >> Dr. Romero, this is Amanda I just want to level set as we continue this conversation — this discussion, which is incredibly helpful We anticipate having about 40 million doses, so enough to cover somewhere between 15 and 20 million individuals, which does cover a large portion of healthcare workers by the end of December And then after that, each week, we anticipate having somewhere between, you know, 5 and 10 million doses, in that arena So, in essence, we’re talking about sub-prioritization, but it is for a limited period of time in this population And I think Dr. Oliver has some additional comments to address All of you all’s comments have been incredibly helpful >> Thanks I just wanted to provide a little context around the Work Group discussions around this I think the protection for healthcare personnel is both the direct protection for that individual, as well as for the healthcare system as a whole, and each individual healthcare system is going to need to figure out their additional — if they have additional sub-prioritization balanced based on, you know, doses and staff that they have, as well as weighing the individual privacy and protection around the individual healthcare personnel Thanks >> Thank you Dr. Hunter? >> Yeah, thanks I actually do have another question You’re saying that 20 million people could get vaccinated with the 40 million doses, but I’m wondering are you saying that those — you’re anticipating that those doses will be in people’s arms by the end of December or that they will be available to be distributed by the end of December? >> I’m saying that they — if — if jurisdictions and providers place orders, they will be available, and we anticipate that most of those doses will be distributed This depends on the — the — this goes back to the storage and handling requirements, but we are — the jurisdictions have very detailed plans about how to ensure maximizing doses in clinics That being said, it won’t be 40 million doses equals 20 million people vaccinated because we can’t directly — there will be some dose mismatching in some areas >> And this is Dr. Messonnier I just want to add that in discussions with the jurisdictions, most of them believe that they can vaccinate all of their healthcare workers within 3 weeks Now, that’s certainly dependent on workforce and the hope that — that there will be so much support for the vaccine that — that the workforce will be able to kind of be drawn together, but from an operational standpoint — — most of them are planning, frankly, some far less than 3 weeks, but to be able to actually vaccinate their healthcare workers quickly, if that helps put this in perspective in terms of sub-prioritization Thank you >> Thank you Dr. Drees Sorry. Dr. Hunter, did I cut you off? >> No. I was just saying thank you for that answer >> Thank you Dr. Drees, please >> Yes. Thank you Marci Drees I just wanted to first comment that, yes, SHEA is very interested in working with CDC around healthcare worker sub-prioritization, as well as managing the reactogenicity of the — of the vaccines in this population, and that work has already started The other thing I wanted to call out was just the logistics involved with what’s kind of a disconnect You know, on the one hand, because of the characteristics of the vaccine, we really are looking at a high throughput centralized vaccine distribution system, which then goes at odds with staggering vaccine across different units and departments, as well as requesting that people schedule their vaccine, you know, before they have a day off already scheduled, and those things are going to be very logistically challenging to manage And I think, you know, from a large healthcare system, you know, I won’t be able to manage, you know, which people on which units get vaccines on which days We’re really just going to have to manage that even at the unit level as much as possible And then also, I think, you know, the smaller hospitals are going to have a really hard time

You know, when they have a 100-bed hospital, you know, they don’t have enough staff to vaccinate or, you know, they’re — you know, they’re going to have to order enough vaccines that would, you know, potentially vaccinate their entire staff within a day or two, which sounds like we don’t want to do So, I think there’s going to be a need for a lot of partnership between local and state health departments and smaller hospitals to distribute the vaccine in a way that makes sense and allows them to stagger it out over time Over >> Thank you Dr. Poehling >> Good afternoon This is Kathy Poehling I wanted to thank Dr. Oliver for a very clear presentation And in particular, I thought the reactogenicity that’s available from the trials, Phase 1/2 trials is particularly helpful as everybody’s looking to identify how best to move these forward And so — and it does highlight the importance of staggering, which is not going to be easy, but it does provide important information Just saying thank you >> Thank you very much Ms. McNally, please >> Thank you How is the EUA fact sheet for recipients different from a Vaccine Information Statement? >> This is Dr. Cohn The EUA fact sheet will actually be very similar to a VIS statement The VIS statements are also reviewed and coordinated with FDA, but there will be some — it will be differently formatted, but a lot of the content will overlap, although it will be made more clear that this is under an Emergency Use Authorization and — and make sure that the individual understands what that means >> Dr. Romero, may I ask one followup question? >> Of course you may >> How often would the EUA fact sheet be updated with the accumulation of new data? >> Dr. Fink, are you on the phone and available to respond to maybe this one and clarify my response to the earlier one? >> Hi, could you repeat the question, please? >> Yes, I’m wondering how often the EUA fact sheet would be updated with the new information? >> Right. The EUA fact sheet would be — would be updated with any new information that — that FDA considers important to allow healthcare providers and vaccine recipients to understand the benefits and risks and options related to use of the vaccine under the Emergency Use Authorization I can’t give you a specific timeframe in terms of how often this might occur because that would depend on when we might receive information that would warrant a change Over >> Dr. Romero, I apologize One more followup question I had understood that the Vaccine Information Statement had a public comment session Is it similar for an EUA fact sheet? >> This is Dr. Cohn Dr. Fink, you may have additional comments, but there — there’s not a public comment period for an EUA fact sheet It is developed as part of the EUA authorization between FDA and the manufacturer Dr. Fink, anything else? >> Nothing to add Thank you >> Ms. McNally, any other questions? No need for apology The floor is yours until you are — until you cede it >> I appreciate it Nothing else at this time Thank you >> This is Dr. Atmar I have a followup on that, though >> Go ahead, please, Dr. Atmar >> And that’s just a point of clarification The EUA fact sheet is given to all vaccine recipients, not just those working within long-term care facilities Is that not correct? >> Yes, that is correct Additionally, there are fact sheets for both the providers and the individuals receiving vaccine >> This is Kathy Poehling I have another followup on that, and I wanted to clarify, that EUA fact sheet would be available when any vaccine is authorized by the FDA, is that correct? >> Yes, there will be individual — and this is actually another difference between the VIS statements and the EUA fact sheets

Each product will have an individual fact sheet whereas for the VIS statements, it’s for the specific — the type — the disease in which it prevents or the type of vaccine, but each — an individual will receive the fact sheet for the vaccine product that they receive, and this is all part of the EUA package, and providers will be trained rapidly on how to provide EUA vaccines under an EUA including ensuring that their — that patients have this fact sheet >> Are there any more questions or comments on this topic? It seems to be particularly — >> One more question Thank you for the great set of comments and questions And I know this is asking a lot, but I do wonder — and all of it will depend on what the Phase 3 efficacy and safety data look like, if there are going to be differences in the benefit/risk sort of counseling that’s intended with the EUA fact sheet, and I think Dr. Atmar was getting at this, which was, is it — is it plausible that it might be reasonable to have one that is tailored to long-term care facilities, for example, that would be different than generic EUA fact sheets specific for a healthier population? >> So, Dr. Lee, this is Amanda again So, the EUA fact sheets that are FDA authorized and — and sent with the — by the manufacturer will be the same for every individual However, CDC is developing specialized toolkits for communications materials that will provide additional information and context around COVID vaccination, maybe not specific to each product, that should be available soon, and there will be — the first one to roll out will be specifically for healthcare systems vaccinating healthcare personnel And then, the second one right after that will be the long-term care facility toolkit, which will have information about what vaccination means for a long-term care facility resident and their family members >> Thank you If I could just make one more comment, which is to say a huge thanks for putting together these implementation toolkits I recognize how challenging it is to develop these communications in the absence of having the Phase 3 clinical trial data in hand, and I also recognize that we as providers and healthcare delivery systems need to partner with you at CDC and our states and our jurisdictions in order to support these communications and that it will be an iterative process, as it should be, in part because everything is happening on such a compressed timeline But, you know, I just wanted to say and recognize how much work and effort I know that your team is putting in to help us be able to do this well So, thank you >> Thank you >> Dr. Atmar One more question related to the EUA Are there any sort of IRB reporting requirements if there are adverse events or will that all be covered in the next presentation? >> Dr. Fink, do you want to respond to that? He — he may be away >> Yeah, hi So, the — the EUA, if issued, will lay out requirements for adverse event reporting >> Thank you >> Next question by Dr Stinchfield, please >> Patsy Stinchfield from NAPNAP I just wanted to comment on the — some of the practical considerations as we sub-prioritize So, I’m already working on this in my healthcare institution at Children’s Minnesota Our total employee population is 5300, and our direct care providers are 3300, and I think knowing we can only get data — so, we don’t have birth dates of people in their files We have their month and their — their day, but not their year for age discrimination reasons We may not have race and ethnicity We certainly don’t have medical records and their own personal medical histories in an occupational health setting And so, we can only go down so far in terms of those sub-prioritizations and mostly direct and indirect patient care providers So, as we ask those other 2000 folks to hold on, Nancy, your comments about talking about weeks as opposed to months is very helpful to give people the guidance on when

to expect their doses So, there’s a lot of enthusiasm, and understanding the timeframe is really, really helpful Thanks >> Thank you >> Dr. Romero, this is Jeff Duchin Can I add to that comment? >> Of course, please Please >> Thank you Jeff Duchin, IDSA So, I am a member of the COVID-19 Vaccine Work Group, and I wanted to make sure that the ACIP — the voting members are clear about whether they feel the level of sub-stratification guidance is adequate given what we expect with respect to supply And with all due respect, you know, we are never able to predict the future, and the supply issues may — although I hope not, they may go on longer than anticipated And so, should we have issues with supply exceeding — insufficient to meet demand, do we feel that the sub-stratification guidance, for instance, for healthcare facilities who have more healthcare workers and can be vaccinated, should there be any further guidance around equity considerations or other considerations in determining who gets vaccine first? And for example, should more facilities be given fewer doses or should fewer facilities be given more doses? I’m interested in the comments of the ACIP overall and particularly those members who work in clinical care delivery settings Thank you >> Open for comments >> This is Grace Lee I’ll express my opinion So, you know, I certainly believe that our goal in Phase 1a with regard to healthcare personnel is to preserve the workforce and healthcare capacity, regardless of where exposure occurs And so, you know, I do feel strongly that those who need to be in the workplace interacting with patients, families, and staff for their job function — and I want to highlight that this includes clinical support services such as nursing assistants, medical aides, environmental services, you know, food services, front desk staff, are all a critical component of how we deliver healthcare I am very mindful of the equity considerations that we all have been throughout all these discussions, so making sure it reflects the distribution of the workforce early on will be important and the workforce that’s actually in place that needs to come into work to be able to, you know, function their job I think — just a couple of comments on discussion items related to medical conditions of healthcare workers and age — and those are clearly going to be important in Phase 1c I think my concern about the equity issue is that if we ask people to self-disclose, that it may inherently create some unintended inequities in that I think some healthcare workers are more easily able to self-advocate and feel comfortable in their position in being able to declare medical conditions So, I worry by creating that as a construct that we might actually, again, unintentionally create more inequity in that if our lower-wage workers don’t feel comfortable self-disclosing medical conditions, you may effectively not be putting them, you know, in the, you know, front of the line as they should be given that I know, at least in some institutions and in the national data, our lower-wage workers are actually faced with higher rates of infection, whether it be from the community or whether it be in the workplace And I think that if we run into supply issues for a longer period of time, it will be important for us to make sure that we are focusing on Phases 1b and 1c And then, as need be, our workforce who can stay from home and shelter in place until the spring or summer, you know, certainly as they meet 1c — or 1c conditions, should get vaccinated in that Phase, but there are a portion of our workforce who can work from home without coming into the workplace until spring or summer And so, I will have a hard time personally allocating early on when I know that there are so many individuals out there who are in need >> This is Paul Hunter Can I respond to Jeff Duchin’s comment? >> Yes, go ahead, Dr. Hunter >> Thanks So, Jeff, I think — what I’m thinking of is a process that’s related to venues and related to gathering people who are making the decisions at the venue level, that is,

the unit of the healthcare delivery system, the healthcare delivery system itself, the local health department, pick your size of venue you want to — you want to use as a unit, that those people, if they were brought together in relatively real time, maybe every week or so, to discuss the issues they’re facing with allocation issues on a state level, on a federal level, on an organizational — national organizational level, in some kind of forum where they could discuss the issues they’re having, compare it to what the — — consensus in a large group setting either statewide or nationwide is of how to interpret the general guidelines that the ACIP votes on That’s the way I think, in practice, I would see your issue being addressed of how to have enough specificity in ACIP recommendations without at the same time having enough flexibility to implement them I think it’s going to require some national group having regular discussion sections of people who are actually doing it on the local and sub-unit level That’s just my opinion >> Thank you I was muted there Thank you, Dr. Cohn, for stepping in So, we will go forward, then Dr. Goldman? >> Thank you First, thank you to Dr. Oliver for a wonderful presentation, as always Back to my earlier comments and on a more granular level concern for the implementation to the small community practices and getting out to the community, you know, when we look at these hospital systems, the CDC, we really need both guidance and perhaps oversight and really detailed gating criteria because I would hate to see a large system get a huge amount of vaccine, vaccinate everyone including those not necessarily at risk, like those working perhaps in the IT department who are not in patient care but are employed by a hospital, and it’s not getting out to the community where it needs So, I suggest or I don’t know if it is even in the purview of the committee, but to make sure that the hospitals, the distribution sites, have some gating criteria, some mandatory outreach to the community, so that we’re getting the vaccines where they need to be because even rural areas there may be many physician practices for buyers, etc., who don’t even know where to go to get the vaccines or who’s even distributing them if it’s only being localized to those large healthcare systems So, on a granular level, we really need detailed guidance on how to get the vaccines implemented, especially to the community where it may be needed the most as opposed to just the hospital systems itself So, that’s one of my concerns And hopefully, the committee can see some way to ensure those vaccines are implemented properly Thank you Over >> Thank you Dr. Fryhofer >> Sandra Fryhofer, American Medical Association I have a couple of comments On Dr. Oliver’s slide seven on reactogenicity, does this refer to just healthcare personnel or is that to all adults? >> That — this is Dr. Oliver The slide was all adults that received — from the Phase 1/2 trials that received the dose that is given in the Phase 3 trials, regardless of their occupation >> Thank you My next comment is about the EUA, the Emergency Use Authorization form Is this something that a patient signs? And, you know, one thing I worry about in, you know, talking about frail — the frail elderly is making sure they really understand what they’re getting and what the side effects from the vaccine would be, and if these patients aren’t able to sign on their own, is their outreach to family members, whoever has their power of attorney, to sign for them? And I — >> Yeah. This is Dr. Messonnier We can refer you back to the previous presentation where we went through in detail We agree with your concerns It’s very important for the frail elderly, not only to ensure that they are understanding the vaccine that they’re getting, but that also their family members do,

and that’s why we have put in special provisions in this long-term care facility program to ensure that that happens We’re happy to send you those slides again But again, you know, this is a space where we have been very concerned, and I think part of the issue is that we really are going to need everybody pulling together and working together to ensure that we’re harmonious with our messages As Dr. Cohn said, a big effort for us over the next, frankly, 2 weeks is to push out as much communication material as possible And we really hope that, as the ACIP community, we can make sure that you’re fully briefed on our efforts so that you can then be briefing your counterparts So, definitely agree with your concern, and we’ve definitely put provisions in place We hope to really manage that Thank you >> Dr. Messonnier, this is Sandy Fryhofer again, and thank you so much for that comment And when you say that, I know you really mean it, so thank you And my third comment is to echo Dr. Goldman’s concerns about the importance of community outreach to healthcare people that might not be in the hospital to make sure that they get vaccinated Thank you >> Thank you Dr. Duchin, please >> I neglected to put my hand down Thank you >> Thank you, sir Pablo — Dr. Sánchez, please >> Yes, I just had another question in terms of the sub-prioritization And I think that, you know, certain individuals, particularly those receiving biologics, just so — and I know we probably will not have some data, but I think that it will be important to include some of those in terms of what is — what would we be recommending to those individuals >> Thank you I think we’re going to have to stop here and move on to the next presentation There will still be a discussion following that presentation We can cover any of the three — two previous discussions So, with that in mind, I’m very sorry I’m going to ask Dr Shimabukuro to come forward and to present post-authorization safety monitoring update >> Can you hear me okay? >> Yes, we can Thank you very much >> All right Great. Next slide So, I’m going to start with the safety monitoring timeline and covered populations in early vaccination Next slide So, I’m going to basically build out a timeline here where I — where I’m going to show our safety monitoring systems and when they come online And so, when I start with the very early monitoring systems, they are ordered from top to bottom They will all be active and functional when vaccine becomes available I’ve ordered them in the order which I think data may become available in them And so, I would like to start — next slide — by mentioning v-safe, which is a new vaccine safety monitoring system that CDC has stood up for COVID-19 It’s an active surveillance program that uses smartphone-based tools to conduct check-ins, and we’re doing primary data collection on adverse events that individuals might be experiencing after vaccination, and we also have the capability to do phone followup and take adverse event reports if these individuals report a significant health event This should start — this requires registration, but it’s going to start collecting data immediately on day zero and collects data out to 12 months after the second dose of vaccination Next slide So, I want to also mention our passive surveillance or spontaneous reporting system, which is the Vaccine Adverse Event Reporting System, which is co-managed by CDC and FDA, and VAERS is — will be available immediately when vaccine becomes available, and we’ve ramped up to anticipate additional reporting for COVID What you see on top there are some systems that report or feed into VAERS DoD and VA actually run their own spontaneous reporting systems in their healthcare systems, and they report into VAERS, and we’ve also done work with the National Healthcare Safety Network to increase awareness of adverse events and to encourage reporting to VAERS Next slide And the Clinical Immunization Safety Assessment Project at CDC, which is a collaboration between seven medical research centers and CDC, conducts individual case consults They are — they are staffed up and ready to go to start doing case consults, and that often gives us an early look at unusual

or unexpected adverse events, which come to the attention of healthcare providers, which are requesting assistance with the review Next slide So, shortly after vaccine becomes available, if there — if the — if the projections that we anticipate materialize, we’ll begin to accumulate substantial data in our large-linked database monitoring systems, on many of which we conduct near real-time sequential monitoring or Rapid Cycle Analysis This includes the CDC’s Vaccine Safety Datalink, the FDA’s surveillance programs like their collaboration with CMS and BEST and PRISM, the VA Electronic Health Record and Data Warehouse, and the Defense — Department of Defense Defense Medical Surveillance System And then, later on, I’m going to describe this new initiative with Genesis Next slide This is just a table describing these systems in a little more detail, to include the population and whether there is coverage for healthcare workers or long-term care facility residents So, VAERS, which is our system that monitors safety in the general population, to include also NHS and acute care and long-term care facilities, will have coverage on healthcare workers and long-term care facility residents For v-safe, all COVID-19 vaccine recipients will be eligible to participate in v-safe, provided they have a smartphone and can access these surveys And we anticipate that a substantial number of healthcare workers will participate in v-safe However, due to technical limitations and maybe even some physical limitations, there may be limited capture of long-term care facility residents in v-safe Then, we move on to these large-linked database systems, which at the top there you see the Vaccine Safety Datalink That includes insured patients in the VSD sites There are a substantial number of healthcare workers in these VSD sites Some of these sites are the — are large Kaiser programs There is also a substantial number of adults 65 and older in VSD The ability to identify nursing home residents is challenging in these sites, so we think there may be limited visibility on long-term care facility residents For the FDA-CMS collaboration, this is 90-plus percent of older adults in the U.S., including 650,000 long-term care facility residents, which they can identify and monitor separately from the community-dwelling older adults There may be limited healthcare workers just due to the age demographics there, but definitely capture of long-term care facility residents BEST and PRISM is similar patient populations to the VSD The VA Electronic Health Record and Data Warehouse includes enrolled VA patients, so it’s likely limited healthcare workers, but the VA does run their own nursing homes It’s a relatively small population, but these are captured as enrolled VA patients, and we will have information on them from the VA data sources The Defense Medical Surveillance System primarily focuses on active duty military, and there’s limited information on beneficiaries So, there will be substantial capture of healthcare workers and likely limited capture of long-term care facility residents The Genesis HealthCare data is a new collaboration CDC is working with Brown University and NIH And the Genesis HealthCare has electronic health record information on long-term care facility residents, of which there are approximately 35,000 long-stay residents They currently are not capturing information on healthcare workers, although there are some discussions on that, but definitely capturing information on long-stay residents in their EHR Next slide This is more of a reference slide showing our systems broken down by routine or established or traditional systems on the left side there and then new systems on the right And then on the top, systems that are used for signal detection And then on the bottom, systems used for signal assessment You’ll see there is overlap between signal detection and signal assessment For example, we do Rapid Cycle Analysis in VSD, and we also go in and assess signals in VSD as well

Next slide So, now I’m going to get a little more specific on safety monitoring in long-term care facility residents Next slide But I want to mention that VAERS is the nation’s early warning system for vaccine safety and will — will be the system that captures information on long-term care facility residents the quickest and will provide data — the quickest data for CDC and FDA on safety in this particular demographic Next slide Again, VAERS has all U.S. residents as a covered population, all ages, races, occupations, including healthcare workers, healthy people, those with chronic conditions, those in long-term care facilities, and older adults living in the community Next slide The VA Adverse Drug Event Reporting Systems — System, which I previously mentioned, that’s the VA’s spontaneous reporting system This — although VA healthcare workers may not be enrolled VA patients, many of them are vaccinated in occupational health at the VA and are eligible — or captured — will be eligible to be captured by the VA ADERS It also includes the 8000 residents per day in VA long-term care facilities And as you see on the right there from this VHA directive from 2020, by policy, reports — vaccine adverse event reports captured in the VA ADERS are reported to VAERS Next slide So, this is a screenshot of the language for the adverse event module for the National Healthcare Safety Network There is another screenshot, which I didn’t include because it would it would have made them so small, which shows the capture of doses administered And this is — that’s basically a weekly count of doses administered by product type And what you see here — actually, let me back up They are roughly 17,000 long-term care facilities in NHSN And what you see here is a shot of the language for the adverse event module It includes aggregate voluntary reporting of vaccine doses administered and counts of non-specific adverse events So, you can see there in — in Section 5, you’ll have weekly counts of adverse events But I think importantly, it has guidance on reporting adverse events to VAERS, which you see circled there at the top in red with a — with a link to the VAERS website where you can report electronically and also instructions to include the NHSN Org ID number in Box 26, which allows us — basically, that’s coding NHSN reports by site and allows CDC to do queries and identify those reports that originate from NHSN sites Next slide So, I think Dr. Dooling previously mentioned the Pharmacy Partnership Program for long-term care facility vaccination Her — her capture is a little bit higher than mine, and maybe I’m working off older data, but pharmacy partners may vaccinate a substantial percentage of long-term — may vaccinate in a substantial percentage of long-term care facilities And this can provide early denominator information in long-term care facility residents, which can improve the accuracy of reporting rate estimates And we have outreach to pharmacy partners on VAERS reporting planned Next slide So, I want to run through a Rapid Cycle Analysis in older adults in the systems, which are going to do Rapid Cycle Analysis First, I’ll talk about FDA’s RCA in the CMS data Again, this is about 92% of the U.S. elderly, including 650,000 long-term care facility residents The data will be refreshed weekly with weekly sequential analyses I’ll just remind you that just because the data are refreshed and we do the analyses, that’s a separate issue from the data actually accumulating And for CMS Fee-for-Service, the average data lag is around 4 weeks, and the average data lag can be up to 5 to 6 weeks for hospitalizations Then, in the VA Electronic Health Record and Data Warehouse, historically, 60% of VA patients who get flu vaccination are 65 years and older, and that translates into about 1.56 million older adults vaccinated for flu annually in recent years

There are also 8000 long-term care facility residents per day in the VA captured the VA EHR and Data Warehouse The data will be refreshed weekly with weekly sequential analyses I will say, that is the — that is part of the sort of the standard methodology that we’ve developed with the federal partners as far as the refreshes and the weekly and sequential analyses And for the VA, there’s an approximate 1 week average data lag and up to about 4 weeks for hospitalization Next slide Then, for CDC Rapid Cycle Analysis in the Vaccine Safety Datalink, there are about 1.8 million older adults in nine integrated healthcare systems that comprise the Vaccine Safety Datalink Again, the data are refreshed weekly with weekly sequential analyses There’s an approximate 1 to 2 week average data lag and up to around 6 weeks for hospitalization We’ll say this — this — the data lag for hospitalization for these systems is mostly due to the hospital stay So, these are — these are average lags when we go back and look at large volumes of data Certainly, some hospitalizations are longer than others, some shorter than others The average is around 6 weeks, and that’s mostly due to the length of stay Once the patient is discharged, the processing of the data and that getting into the database for these systems is fairly rapid Again, that — that lag is mostly due to the to the length of hospital stay, which can vary Next slide So, we also plan to do case evaluations of adverse events and some of our planned activities are rapid processing and review of reports to VAERS classified as serious for adverse — and for adverse events of special interest FDA reviews all reports that are classified as serious, and CDC will be reviewing a selected — a selected list of adverse events of special interest where we’re going to review the reports and accompanying medical records The processing times for COVID-19 will be 1 day for death reports, 3 days for serious reports, and 5 days for non-serious reports We also plan to do investigation of clusters of clinically serious adverse events by a multi-disciplinary CDC team if necessary and clinical case reviews by the CDC’s Clinical Immunization Safety Assessment Project Next slide Moving on to coordination, communication, and implementation Next slide So, I want to mention the ACIP COVID-19 Vaccine Safety Technical Sub-Group, otherwise known as VaST The VaST was built off lessons learned from H1N1 The terms of reference and composition are finalized, and the VaST is ready to begin reviewing data once implementation commences It’s Co-Chaired by an ACIP member and an NVAC member It has ACIP and NVAC representation It includes independent expert consultants, federal agency ex officio members, and liaisons from VA and DoD Next slide The objectives — the post-implementation objectives of VaST are to review, evaluate, and interpret post-authorization or approval COVID-19 vaccine safety data, to serve as a central hub for technical subject matter experts from federal agencies conducting safety monitoring to share safety surveillance data, to advise on analyses, interpretation, and data presentation, into liaise with the ACIP COVID-19 Vaccines Work Group on issues of safety data presentation to the ACIP and application of safety data to policy decisions Next slide So, I want to mention that we are ramping up our communications efforts in anticipation of vaccine becoming available We will be stepping it up in the coming weeks — — as we anticipate that, you know, vaccine will be distributed and be available and be administered in priority groups And this includes distributing communication materials to state health officials, healthcare providers, and healthcare systems, providing up-to-date information on the website, and conducting ongoing partner outreach and engagement to — to raise awareness of v-safe and VAERS reporting requirements to include healthcare provider professional organizations, public health partners, healthcare organizations, and other private sector partners, long-term care partners, and pharmacy partners Next slide So, in summary, early data on COVID-19 vaccine safety

in healthcare workers will mainly be available through v-safe and VAERS and systems that report into VAERS Early data on safety and long-term care facility residents will mainly be available through VAERS and systems that report to VAERS VAERS is a long-standing established safety monitoring system that is critical to monitoring new vaccines during the early uptake period I will also mention, it’s critical to monitoring flu vaccine every season when 150 million or so doses are administered in a very compressed time window of several months Large-linked database monitoring systems will provide safety data when vaccines become more widely available in priority groups and in the general population, and efforts are ongoing to increase awareness and provide information needed to partners for safety monitoring Next slide So, I want to reassure the ACIP, our public health and healthcare providers, and the public that we have the systems in place to collect safety data We have validated methods to rapidly analyze the data We have processes in place to respond to safety signals when we detect them, and we have trusted partners that we will depend on when we implement the vaccination program Now, we have many important partners, but I want to specifically ask our public health and healthcare provider partners to help us over the coming weeks and months And for our public health partners, we ask that you promote participation in v-safe It is a manual enrollment process, and it will involve interaction with the patient to inform them of v-safe and inform them of the importance of v-safe, and we are asking your participation to help promote v-safe Also, promoting reporting to VAERS and communicating with your partners on vaccine safety And then, for healthcare providers, we’re asking you to encourage patient participation in v-safe, to report adverse events to VAERS, and to communicate with patients on safety Next slide And this is a reference slide with information on how to report to VAERS, how to contact CDC through CDC-INFO, and some other safety information resources Next slide Thanks, and I’ll be happy to address questions >> Thank you very much for that very detailed and in-depth discussion Before we move on to discussion and questions, I believe Dr. Messonnier has something to say >> Yeah. Thank you, Dr. Romero I just want to reiterate the importance that CDC places on the safety of vaccines I know that FDA will not authorize a vaccine, and ACIP will not recommend a vaccine unless you’re convinced based on the Phase 3 clinical trials that the vaccines are very safe, but we all also know that vaccine safety doesn’t stop there, and especially for these vaccines, we’re going to hold ourselves to an exceedingly high standard for safety monitoring after a vaccine is authorized and when it’s rolled out more broadly Tom Shimabukuro and his team and frankly a vast array of scientists across the U.S. government and among our partners have done an incredible job of enhancing our existing vaccine safety systems to really meet this challenge, and I think it’s — they’ve done a great job of trying to anticipate any gaps in the system and fill them But as Dr. Shimabukuro says, our vaccine safety systems are partly dependent on the stakeholders in the health systems, the public health departments, and frankly the public reporting adverse events So, we do need to ask, especially in this initial Phase, for everybody in the community to be rowing together It may mean extra work for some groups where they have to report through other systems as well as through these systems, but we really need to ask everybody to be mindful of this early Phase and the importance of this data And I think that we really need to call on the entire community to help us ensure the safety of these vaccines Thank you >> Thank you We’ll now open this up for a discussion So, Dr. Sánchez, you’re first on the list >> Sorry, that was from before >> Very good Thank you very much Dr. Ault >> I had a question kind of emphasizing the previous point there What can we do or what has been proposed to do

to encourage people to be involved in the v-safe program since that seems to be the quickest way that we’re going to get safety data? >> We are ramping up our communications efforts to get the message out to our public health partners and to the provider community and to, you know, other partners like pharmacy partners about the importance of v-safe in capturing early information on vaccine safety And I mean, we are — I think we’re — we’re reaching that time where we’re really going to be pushing out strongly and trying to get the message out as broadly as possible to those who are vaccinating or those who partner with those who vaccinate So, this mostly involves reaching out to partner organizations, professional societies, public health partners, pharmacy partners, and others who are going to be directly involved in vaccination >> And this is Amanda I just will add another plug This health — health system and healthcare provider toolkit, communications toolkit, will include information about how to enroll patients in v-safe and information about the program and tips for encouraging patients to enroll >> Our next speaker will be Dr. Poehling, please >> Yes, this is Kathy Poehling And so, first of all, Dr. Shimabukuro, thank you for a really important conversation and highlighting the importance of the initial assessment of safety, as well as following the safety of all vaccines that are being administered This is incredibly important I wanted to give you a chance to provide a little bit more information about v-safe and how that data will be monitored and the confidentiality of reporting through this system Thank you >> So, operationally, how v-safe works is that the — an information sheet, which will be available probably in different formats, includes a URL and a scannable QR code, and the individual patient enrolls themselves by either typing in the URL or scanning it, and it takes them to a registration site, and there’s a limited amount of information a person puts in to register Then, you have a confirmation step Then, you have to enter your vaccine And once you’re — once you’re registered, it kicks off this process of — of basically the CDC sending messages with a link, a web link And then, that link takes you to an electronic survey And for the first week of vaccination, we do daily check-ins where we ask about local and systemic reactogenicity and also a health — some health impact questions The local and systemic reactogenicity questions and some other questions, those are — those are fed into a database that has all the federal IT security and privacy protections That information is available to the — to the CDC folks who are doing the safety monitoring For those who have a health impact question, we are — we are going to actually use the cell phone numbers from the registration to reach out to them and take a VAERS report So, that report will actually get into VAERS, and the VAERS is our public health — our spontaneous reporting system, which basically is subject to, you know, all the security requirements and HIPAA as well So, I think patients should be — vaccinated individuals should be confident that private information will be protected and that it will be used for safety monitoring purposes only Do you have any other followup or any other additional information you want? And that will be reviewed — that will be reviewed and presented to this — to the Vaccine Safety Technical Sub-Group regularly and analyzed in the context of signal detection >> Thank you

That is incredibly helpful, and I appreciate that clarification >> Dr. Zahn >> Thank you Can you hear me? >> Yes, we can >> Yeah, okay Yeah, thank you, Dr. Shimabukuro, for that presentation So, you know, as a local public health person, I think we’ll be extremely enthusiastic to get out information about the need to report There’s a couple of comments I’d have One is that, you’d just like the general message to be, “If something happens to you or your patients, report it.” You know, “If you have an issue, report it.” I think the fact that you have to use a smartphone, it sounds like, in order to use v-safe complicates the message a bit You know, you — I know that, you know, there’s only so much you can do in a very short period of time, but that does complicate it a bit And I guess the other — one thing I — in terms of messaging that I think is going to be very important for us as providers, you know, they’re going to hear about v-safe, and they’re going to hear about VAERS, and which system do you use for which situations, and what do you tell your patients to report versus what, you know, we report through VAERS Clarifying that, it seems to me, is kind of really important And then, just one last question is — I think you mentioned that — and maybe I misunderstood this when — that you’re going to be conducting outreach to pharmacies and pharmacists regarding adverse events and their reporting in the context of vaccinating in long-term care facilities And I — maybe I misunderstood that, but in that scenario, I’d think of it as that they’re going to go out and they’re going to think the responsibility I have is to vaccinate, but over time, the people who are caring for them at their facility or their primary care provider are the ones who are really going to be identifying and reporting those issues And so, it seems to me it’s really, really important — I’m sure you’re going to do this — but to communicate also to skilled nursing facilities or long-term care facility staff, “This is how you are supposed to report, you know, these events.” Obviously, NHSN is one resource, but those are just comments Thank you >> Thanks Actually, you made — you brought up a good point that I — that I think needs clarification and probably better explanation in our communication material So, v-safe is really an interaction between the patient and CDC, and they’re reporting information to us For when you get beyond the first week where we’re looking at local and systemic reactogenicity, the patient is actually reporting to us a health impact They’re answering some health impact questions, and those questions — I don’t if the exact — this is the exact wording, but it’s three things, “Did you miss work?” “Were you unable to do certain daily activities?” Or, “Did you seek healthcare or get healthcare?” If any one of those is checked, then that triggers active telephone followup with that patient where we do an assessment And if the patient or the patient’s provider has not already submitted a VAERS report, we would take a VAERS report over the phone So — so, their reporting is not really to VAERS It’s more us doing an assessment of a health impact, then reaching out and getting a report, and I just wanted to make that clarification And then, I think you brought up a good point that our message to providers is, “We encourage — in addition to the EUA reporting requirements, we encourage reporting of any clinically significant adverse health event, even if you aren’t sure if the vaccine caused it,” and that would be irrespective of whether the person is enrolled in v-safe or not If it so happens that two reports get in there, we have ways of identifying those and consolidating the reports >> Thank you Dr. Foster >> Thank you This is — first of all, thank you for all the presentations and especially all the enormous effort that has gone into the planning for this Matt just brought up a very good point, which I want to kind of re-emphasize again is the fact that pharmacists will be, for the long-term care facility portion of it, will actually be going to the facilities and then will, in turn, be there for a day and separate it out by whatever length it is, and I think it’s going to be 3 to 4 weeks between visits and then back So, has there been a mechanism built into it for the reporting at these nursing homes in between or are they going to report back to the pharmacist? Are they going to actually take care of the reporting themselves? Because that’s — that may be a gap right there >> So, I mean based on your comments and Dr. Zahn’s comments, we probably need to revise that And maybe it’s awareness for our providers, but the — awareness for our pharmacy partners, but really the specific guidance on adverse event reporting needs to be targeted to the healthcare providers that are going to be interacting with these patients on a daily basis following immunization

>> Thank you Dr. Maldonado >> Yeah. Thank you very much Again, this is a great overview and really helps put a lot of the safety tracking into context, but I’m still struggling just a bit with all of the different systems Obviously, the old and current systems I think we’re pretty aware of, but I’m still struggling a bit with some of the workflow streams for some of the new systems For example, on slide nine specifically, I’m trying to figure out I don’t know if we can go back to slide nine, but if we can take a look at the different — on the right-hand side, there’s — there are a number of systems I think it’ll be helpful, as you heard before, to clarify how the signal detection systems will — will be — will be introduced to the general population, as well as to the healthcare workers who are already going to be struggling to try to understand who to vaccinate and how to do just the operations But I’m struggling in particular with the signal assessments and why I don’t see VaST there and — or where does VaST belong in all of this because it seemed to me that that was introduced as a signal assessment or maybe I’m misinterpreting that >> You’re — you’re referring to the Vaccine Safety Technical Sub-Group? >> Yeah. So, it’s not — I mean, is that an assessment platform as well? >> Well, I would consider that the VaST is more of a — that’s — that’s a group of external experts, which — and in that forum, that’s really the central hub for the — for the federal agencies that are doing the monitoring in these systems to go report — report to our — to our external experts and get feedback on data interpretation and analyses and maybe even further signal assessment This — this slide is really a systems-based slide So, for example, we do — we do Rapid Cycle Analysis in the Vaccine Safety Datalink If we detect an RCA signal, we would go into the Vaccine Safety Datalink and further assess that signal or possibly even engage with our FDA colleagues to see if they could do further signal assessment in the CMS data The VaST is the group where we would be in contact — we would be in contact with VaST and meeting regularly and presenting data from these systems on our signal detection and our signal assessment and getting feedback from them So, this is more of a systems-based slide where I think that is more of a process — maybe a signal assessment process Does that make — does that make sense? >> Yes. I guess I’m still struggling to understand where — so, let’s just say you find assessments, at what point are actions taken? Well, I guess they would be outside of the systems and the platforms then? There would be other — >> So, if — you’re saying if we detect a signal, and we verify it, and we establish that there is a risk? >> Right >> I mean, by that time, I think the VaST and the ACIP COVID-19 Work Group and the ACIP would be involved in the process and would be in receipt of this information, and there would be, you know, discussion and potentially some type of policy decision if — which might involve public health or regulatory action if necessary But that — that’s like a separate process from the — it’s intimately linked, what the VaST is going to do, but this is — this is more of a systems-based data analysis process that I’m describing on this — on this slide >> Yeah. Well, the reason I bring it up is not only is, you know, again, all of the stuff on the right-hand side of the slide is really important, but it — there’s — there’s a lot for people to digest there But also, if there needs — I’m thinking back to RotaShield back in 1999 How — how quickly — if you get — you know, that was rapid cycle — well, it was pre-rapid cycle, but essentially it was similar to a Rapid Cycle Analysis But if you’re trying to — if you detect a signal in vaccine x, how will it inform not only vaccine x but vaccine y, z, and beyond that are coming down the pike? I mean, I think those are — so, those go back to FDA? I mean, how are — how are those processes going to work? Because that’s really — I think it’s, you know, it’s helpful to track, but you want to know, how will actions be taken to address, you know — and how will — how will these signals be prioritized?

You know? So, what are — what are the different options? And I get that it’s vague and that we don’t know what we don’t know, but it would be helpful to see, you know, a separate maybe algorithm around how will actions taken based on signals that are detected, not only for this product, but for products coming down the line from the FDA, for example >> Dr. Maldonado, this is Amanda I think what you’re asking for is more of a what happens when a signal is detected, and the first step would be signal assessment And then, the role of VaST would be to interpret the data and to — and understand the data and provide advice to the ACIP on that What I can say is that, I think that during the next ACIP meeting in a couple of weeks, we can delineate more the step-by-step process of what we will do if there is a signal And we do anticipate that there will be signals that need to be assessed Because of the populations in particular, as all of you have discussed, you know, we anticipate that there will be signals among older adults that will need to be assessed, which may — which are unlikely — or may or may not be causal and related to the vaccine There will be many more signals than there will be — — actual adverse events that need to be assessed So, we can present that at the next meeting >> Great, thank you >> Dr. Lee >> Thank you And actually, I was just going to pick up where Amanda left off So — so, Bob Hopkins and I co-chair VaST And, you know, the goal is to review the data from all of these systems as it’s coming in, and I think Dr. Shimabukuro outlined nicely that the timing of the availability of the data will likely be staggered However, the plan is for that data to be reviewed on a regular basis, at least weekly at this point pending, again, the availability of data So, we anticipate that the work the Vaccine Safety Technical Sub-Group, which reports to the ACIP COVID Vaccines Work Group, will do so on a regular basis and that that information through the ACIP COVID Vaccines Work Group will be brought forth to ACIP And I agree very much that it would be helpful for us to present the processes that are in place for that — what we — the framework for evaluating signals, which is signal detection, signal refinement, and signal evaluation So, we can definitely bring that forward next time And following, you know, similar to what was done during H1N1 So, we anticipate a robust process I just did want to comment on the terrific comments that were brought up by the prior speakers So, the way I think about — and it is — there’s a lot of safety systems available, but the way I think about it, and I’m thinking about this right now from a healthcare provider perspective, is that v-safe really focuses on individual patients, and our role as healthcare providers are to, you know, support and facilitate vaccinees to enroll in v-safe so that they can self-report what is going on post-vaccination And I think Dr. Shimabukuro gave a lot of wonderful detail about, you know, what is included in that system, but that is really a patient-directed system In addition, the goal is to ensure that all healthcare providers are aware of how to report into VAERS any potential adverse events that may occur And so, that would be something that we would ask providers to engage in and report into And again, VAERS is co-managed by CDC and FDA, but that would be specific to providers and asking them to take action And then, I think the third layer that’s important to highlight is the National Healthcare Safety Network, and this is a national safety surveillance network that’s been in place for decades, and 4700 acute care facilities and 17,000 long-term care facilities in the U.S. are NHSN users And so, I do think that it’s going to be important for us to encourage also facility-level reporting So, different from patient-level reporting and different from provider-level reporting, but facility-level reporting that encourages acute care facilities and long-term care facilities to support efforts to report not only doses administered, which is in the COVID vaccine module that’s forthcoming, but also any clinically significant safety events that occur And that I think would address some of the questions and issues that were raised earlier regarding the connection between long-term care facilities and the — and pharmacies, recognizing again that those systems are coming online And we anticipate for the acute care facilities,

that will be sooner rather than — compared to the long-term care facilities But sharing this aggregate information with NHSN will be incredibly helpful And linking it to VAERS, which is what Tom presented, will be also incredibly helpful for the safety monitoring system But each of the systems is really targeted at a different level And hopefully, we can clarify, you know, those of us who are in healthcare systems, how we can use at the facility level NHSN for reporting, those of us who are practicing and seeing individual patients, how we can use VAERS to report, and then specifically v-safe, ensuring that we’re educating patients who are getting vaccinated and how they can also self-report So, hopefully, between those three levels, we will have many opportunities to continue to support vaccine safety monitoring in the U.S. Thank you >> Thank you very much Dr. Talbot >> Hello. Our pediatric colleagues are very well-versed with VAERS, but I don’t think our adult colleagues are quite as well I think our family practice positions are because they span the gap, but interns and geriatricians rarely have any knowledge about VAERS And what concerns me is that the people who work at long-term care facilities are not actually represented around the circle There is the American Geriatric Society, but there is not the American Medical Directors Association So, I have two questions One, what has been done to reach out to other groups that are not just liaisons And two, how many VAERS reports have actually been put in from long-term care facilities in the last year? >> I know that our communications folks are planning substantial outreach to partners including long-term care partners and geriatric care partners and also — also, OB/GYNs and other vaccinators So, I mean, we — we certainly recognize that we need to get the word out as rapidly and as broadly as possible on the importance of the availability of VAERS and on the importance of VAERS reporting As far as how many have come from long-term care facilities, I don’t have the answer to that That — that is captured on the VAERS form It’s more — I think the — I think the category is more combined, so it could be long-term care facility and these community living facilities for older adults, so you may not be able to split it out But — but that is something that we can look at, but I don’t have the — the numbers for that We’d also have to probably look at that by vaccine or vaccine type as well >> Hi. This is Dr. Dooling I just wanted to add that all of those important constituents who will need to be plugged into VAERS to ensure its success for this program, many of them are represented as liaisons on the COVID Work Group, and we will continue to inform them and have them inform their — their liaison constituents >> Thank you Dr. Bernstein >> Thank you An amazing presentation, Tom I don’t consider myself technologically savvy, but I was wondering if the CDC can work with cell phone carriers to have v-safe offered for download now sort of the way updates are made for software And then, practice teaching examples could be created so vaccine recipients in the future — in the near future can begin to learn about v-safe and hit the ground running for their own individual safety monitoring after being vaccinated >> I may be even less technically savvy than you, so I’m reluctant to — to give you a straight answer, but I will take that back to our technical experts at v-safe and see what they think about that >> Are there any other comments? I think I’ll — I don’t see any I’ll end this, I think, with this one comment that — which I think goes without saying, that in educating the public regarding these vaccine safety systems, it’s going to be very important that we provide culturally

and linguistically appropriate information to the general public so that they understand what this is all about and they enter data as appropriate And I really stress this going forward if we really want to capture all signals that could arise in the use of these vaccines So, if there are no — I see one more comment by Dr. Hayes And then, we’ll have to move to the next area Dr. Hayes >> Thank you Carol Hayes at the American College of Nurse Midwives So, I have two questions One is, is the working group — I would like to make suggestions for organizations that are not liaisons that I want to make sure that we communicate with, and I don’t know who should I send that contact information to And my second question had to do with the translating the app into multiple languages So, not just English And so, I just wanted to ask if there was plans to do that Also, with the consent forms, how many languages is the intent to translate them into? Thank you >> This is Tom I just want to — I just want to clarify that the v-safe program is not an app like an app on your phone It’s actually a text messaging program where you get a text message, and there’s a link to a survey in there, but the — the text messages and the surveys, there’s a plan to translate those into the — I don’t know how many it is, but the top so many languages that CDC does these translations for And so, there’s the plan to do that The first one that we’re going to work on is Spanish We want that one available quickly And for the other materials, I’ll have to defer to others on the — on the line >> This is — this is Dr. Cohn I — the — there are five languages that we will translate this, along with other CDC products, into I also want to assure everyone that we — you know, we have 30 liaison organizations to ACIP We have hundreds of partners that we need to engage and listen to and educate and talk to about all of this And so, we have very strong partnerships across the healthcare sector through the — that have really been solidified over the past year with the pandemic, and we will ensure that we do extensive outreach beyond the ACIP community And we will also ensure that we absolutely take the advice and understand the importance of ensuring that our outreach materials, both to healthcare providers who are being recommended to get vaccinated, as well as to individuals, to ensure that the materials — communication materials are culturally appropriate and at the — at a reading level that is accessible to — across the — the educational background of the — of the — of the healthcare community >> Thank you for that Dr. Zahn, your hand is up I’m not sure if it’s — if it’s a residual from earlier >> Yeah, no I — I just need to pull it down Thanks >> Thank you very much All right So, shall we move on then to discussion and a motion for vote? >> Dr. Romero — Dr. Romero — we — >> Yes, Dr. Cohn, do you want — yes, go ahead, please >> We are pulling up the language that we’d like for ACIP to consider making a motion on >> Yes >> So, it’ll be here in just a minute >> Thank you, Dr. Romero So, we’ve had — we’ve seen the evidence, we’ve had some very detailed discussions of clinical considerations and safety in the rollout of a future COVID vaccine, and now I’d like the members to take a step back and look once again at the policy question at hand, which is, “Should healthcare personnel and residents of long-term care facilities be offered COVID-19 vaccination in Phase 1?” And here —

>> Phase 1a? >> Phase 1a, yes And here is the interim recommendation language, “When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, healthcare personnel and residents of long-term care facilities should be offered vaccination in the initial Phase of the COVID-19 vaccination program, Phase 1a.” For your convenience, I’ve provided definitions of the groups that are contained within the recommendation language And Dr. Romero, I’ll turn it over to you >> Thank you very much So, this is open for discussion and further clarification Let me begin by asking this question, just to be certain that everyone understands that the listing of the order, that is healthcare personnel and residents of long-term care facilities, their listing implies no — no preferential order of vaccination, is that correct, Dr. Dooling? >> That’s correct That’s the intent of the Work Group >> Very good Dr. Poehling, please >> This is Kathy Poehling And so, I wanted to say thank you to all who’ve done great presentations to provide insight on this, and I’d like to take a moment to make a motion to approve this wording >> Does anybody else wish to offer comment before we move to the vote — to the approval of the motion? I believe Dr. Kimberlin’s hand is up Did you wish to make further comment, Dr. Kimberlin? >> Yes, David Kimberlin, AAP, Red Book I asked at the November 23rd ACIP meeting for confirmation that people who work in long-term care facilities are considered healthcare personnel? I don’t know that that needs to — and I was — I was told yes, that is the case I’d just like at least a verbal confirmation of that, if not actually putting them in one of the little sub — sub-bullets there to explain that more directly >> Dr. Dooling, do you want to comment? >> Yes, I can confirm that long-term care facility staff are included as healthcare personnel as under the definition that you see in front of you, and the details including that group will be included in a future MMWR And other groups such as EMS, community health, etc., will be detailed in — in greater detail >> Thank you, Dr. Ault >> Doctor — Dr Romero, I would just — can we get a second before we start the discussion? >> Okay >> Just to follow >> That’s fine >> That was actually why I had my hand raised >> Thank you, Dr. Ault >> I was going to second >> All right So, we have a second We have a first and second, okay? Shall we continue the discussion? Dr. Maldonado >> Yeah, you know, I’m sorry I forgot to ask this before, but it just seems so obvious now, but I assume you’re talking about medical long-term care facilities and not congregate living facilities such as prisons, detention centers, etc., or what happens if there are long-term care medical facilities that are detention centers, prisons, etc., those are not included here? >> The — the long-term care definition that we’re going by, which is listed, really refers to facilities that are providing medical and personal care Occasionally, those are provided within a corrections facility, and those would count >> Thank you Dr. Atmar >> Thank you, Dr. Romero So, I have no issue with the healthcare personnel I remain a bit concerned about including residents of long-term care facilities in the 1a group because of the lack of both safety and efficacy data in that patient population I am somewhat persuaded by the support of the AGA and others and the information provided about the ease of administration at the same time to the resident population as vaccinations being provided to the healthcare personnel working in that area I’m a little bit concerned about the issue that Dr. Talbot raised about the safety reporting

I know that, you know, plans are in place to do the monitoring, but there is a potential for a lag of information arriving, and it’ll be particularly important that, as is planned, the long-term care facility be asked to vigorously participate in the VAERS program Staffing to do that may be a bit of an issue, and I’m still worried about this group, although I’m leaning towards including it I still have concerns Over >> Sorry. Thank you Dr. Hunter >> I’m very strongly supportive of the interim recommendation as written here I wanted to just make a comment that I’m assuming that the sub-prioritization that we discussed earlier will be captured in guidance that’s written as part of the publication of this vote in the MMWR, and I’m just curious how soon that might be available to the — especially healthcare systems that are going to be needing that to do the prioritizations Thanks >> Thank you >> Dr. Hunter, this is Dr. Oliver I can clarify that So, several of the clinical considerations including sub-prioritization that were discussed earlier today will be summarized and posted on the CDC website, the ACIP website, under the recommendation including — including the healthcare personnel and long-term care facility information >> Thank you >> Thank you Dr. Howell >> Hi, Molly Howell with the Association of Immunization Managers A couple of comments One, I just wanted to let you know that we did survey our 64 members as to whether or not they would like to see long-term care residents included in Phase 1a with healthcare workers, and it was a short turnaround, so we only had 19 responses However, 14 responded yes, they would like long-term care residents included in Phase 1a, mostly for logistical reasons and then also concerns about uptake of vaccination among staff in long-term care The one question or clarification that would be helpful is regarding the definition of long-term care facilities You know, it was previously — I think a lot of us have been planning for skilled and assisted living And after today’s meeting, I’m getting the impression that it also may include group homes And then, it was just mentioned it might also include corrections And then now, I’m also wondering about homeless shelters And so, if additional clarification could be provided on the definition of long-term care, that would be helpful >> Hi, this is Dr. Dooling I can clarify So, long-term care facilities, we’re primarily focusing on skilled — skilled nursing facility and assisted living with an implied priority for skilled nursing facilities first and moving on to assisted living as vaccine supply dictates And it’s understood that, as we mentioned previously, that gating criteria will be needed to move from one Phase to the next And so, as shown previously, it’s possible that we may be working on assisted living as we move into other phases >> Thank you Dr. Sánchez >> Thanks, José Just a little bit of just the wording Technically, as stated, healthcare personnel and residents of long-term facilities, that as worded would say that it’s the healthcare personnel of the long-term facilities So, I think those two need to be separate just as a — it’s just a matter of wording I think one is healthcare facilities and two are residents of long-term — healthcare personnel and two are residents of long-term care facilities It’s a matter of wordsmithing I don’t want to get into specifics, but as you read it, it implies that it could be just healthcare personnel of long-term care facilities >> Thank you

We will clarify that >> Thank you Dr. Szilagyi >> Yes, I just want to express my strong support for this interim recommendation including both healthcare personnel and residents of long-term care facilities For me, the incredible high risk of the latter group, the residents of long-term care facilities, and the very careful safety monitoring, to me — and I know there’s some concern over some — there was comment that the modeling studies suggest that vaccinating healthcare personnel around them is more effective, I believe that’s — I’m sure that’s true, but if we could add more protection by vaccinating the residents, that kind of — that really swayed me, so it really has to do with an issue of safety, and I was very impressed with the safety monitoring systems that are being designed So — and I also wanted to emphasize that the transparency with consent and assent in the long-term care facilities will be really important, and that swayed it for me So, I express strong support for this recommendation >> Thank you Doctor — I’m sorry, Ms. Bahta >> Thank you I actually wanted to just echo my support of this interim recommendation and to thank the Work Group and the CDC leads for such a well-plotted-out process that you have taken us through to get us to this point Thank you >> Thank you Dr. Hahn >> Thank you Christine Hahn from CSTE I just have sort of a practical question as an implication of this My understanding is, as we’ve discussed, most long-term care facility residents and potentially workers would be vaccinated through that — through the pharmacy contract And my understanding from our immunization program is that it takes 2 weeks for the — for the state to sort of request that process to start and be sort of turned on And I know that vaccine isn’t in our doorstep today, but is there a possibility that we’ll be a little bit hamstrung by a delay in getting that vaccination started and that states will struggle to implement this recommendation when there’s some sort of a delay in getting that long-term care facility — I just wanted to — if somebody could just address that from just a practical standpoint of trying to be fair in getting this started so that healthcare workers and long-term care residents are being offered vaccination if the intent is about the same time, how that might look >> This is Dr. Cohn I can respond The intent of this vote today is to provide guidance and recommendations for health departments to go ahead and place their orders for COVID-19 vaccine and determine how they want to take this guidance and implement it at the state and local level So, we anticipate from — in terms of being able to turn on a pharmacy program for long-term care facility residents, that if a state chooses to do that in the first week or days of the program, that there would be enough time between the end of this week and vaccine availability We do not anticipate substantial delays in that program, but it will be determined at the jurisdiction level how they put in their orders >> Thank you Dr. Bernstein >> Thank you, Dr. Romero My decision to include the healthcare personnel in Phase 1a was straightforward In contrast, the decision to include long-term care facility residents was initially a challenging one for me, especially when vaccine supply is initially constrained Coupled with controlling resident direct contact with outside visitors and use of appropriate mitigation, I was thinking that only vaccinating staff was likely to notably minimize coronavirus exposure to long-term care facility residents However, reflecting further on the data that has been presented over the last several weeks and months actually has moved me to change my thinking on long-term care facility residents In particular, long care — long-term care facility residents and staff account for 6% of COVID cases and 40% of the deaths in the United States

A majority of the COVID-related hospitalizations in those 75 years and older have been from long-term care facilities The systemic reactogenicity of the vaccine in a relatively small number of older adults appeared lower among the older age population in Phase 1 and Phase 2 trials, although long-term care facility populations were not included And while vaccination should be strongly encouraged, it is likely that vaccine uptake among long-term care facility staff will vary considerably, which is not ideal for limiting resident exposure And lastly, there are federal pharmacy partners in place to help implement long-term care facility programs for residents So, for all these reasons, I am in support of this policy question >> Thank you Dr. Talbot >> So, I have really struggled with this, and you all have heard me struggle throughout these meetings I have spent my career studying vaccines in older adults, and we have traditionally tried a vaccine in a young healthy population and then hoped it worked in our frail older adults And so, we enter this realm of, we hope it works, and we hope it’s safe, and that concerns me on many levels Particularly for this vaccine, my concern is there is less reactogenicity, which also means there’s less immunogenicity Two, I do not feel like our safety network for long-term care facilities is strong enough yet I think there’s some work that needs to be done And — and three, if we’re going to spend the time to educate anyone, I think the workers are going to be incredibly important to vaccinate We know with flu that there’s little impact on vaccinating residents, but huge impact on vaccinating the healthcare workers So, I just — I’m still struggling, and I’m really struggling since we don’t have a good safety surveillance network in place Over >> Thank you, Dr. Talbot I see some hands are up, and I’m just going to run through to make sure that they’re — they’re either residual or I didn’t skip somebody So, Dr. Hunter, your hand is still up Do you wish to make another comment? >> Sorry, no >> Dr. Bahta — I’m sorry Ms. Bahta, your hand is up >> Sorry >> No, no need to apologize I’m simply making sure that everybody has an opportunity to have their say Dr. Hahn, your hand is still up >> Sorry, I’ll take it down >> No, no Again, no — no apology needed Dr. Frey, your hand is new So, please, go ahead >> I also just wanted to weigh in, but briefly I have to say that I am in favor of this group 1a as it is currently categorized with healthcare workers and people living in long-term care facilities I think it’s crucial to maintain our healthcare capacity and — but also to — for vaccinating healthcare workers, but it’s also important to prevent severe disease and death in the group that is at highest risk of those complications, and that includes the people in the long-term care facilities I have to say that I was less concerned about risk early on in the — in folks in the long-term care facilities because typically we see, you know, lesser immune responses in this group in general But this is an unknown platform that we obviously are testing in thousands and thousands of people, and we do have a lot of good safety data at this time post-second vaccination, but I still am a bit concerned about vaccinating this group, but I still think it’s the appropriate thing to move forward and vaccinate the healthcare workers and folks in the long-term care facilities simultaneously in order to, you know, get the job done more quickly But with the mind — keeping in mind safe — oversight of that safety at the same time Thank you >> Thank you very much, Dr. Frey I see no other hands up Right, there are no other hands

So, let me turn it over to Dr Amanda Cohn who has a comment or two before we take a break >> Thanks, everyone I just want to lay out what will happen when we come back from about a 10-minute break At about 5 PM, we will begin the public comment session We ask that the commenters respond to this recommendation for which ACIP will be voting on After the public comment session, which we anticipate will take about 30 to 40 minutes, we will have the ACIP members — the voting members only — turn their videos on, and we will vote on the motion After we go through the — the ACIP votes of the members, we will then allow each member the opportunity to indicate or make any comments related to their vote Some of you have — have expressed — have made comments already, but this will allow each ACIP member to make any — provide comment related to their vote We anticipate that the meeting will be done at about 6 PM We apologize for running late, but we appreciate the robust discussion >> Thank you, Dr. Cohn So, with — without more said, let us break until — for 10 minutes We will adjourn — sorry, we will reconvene at — — the hour — on the hour Excuse me Thank you very much