I'm Stephanie Zaza, President of ACPM. I'm pleased to serve as your moderator for this session. In this two-part plenary on vaccine confidence, especially confidence for COVID vaccines, we will move now from the more consumer-facing education and outreach to some of the technical procedural information that can be helpful to answer questions and skepticism about the vaccines. First, though, I'm pleased to announce that ACPM was recently awarded a $2 million grant titled Engaging Preventive Medicine Providers for Effective COVID-19 Vaccine Conversations. In partnership with our strategic communications partner, BRG Communications, ACPM will amplify the reach and effectiveness of our Vaccine Confident Campaign, a package of materials we developed and released to our members earlier this year. We will use a coordinated, strategically integrated approach to engage preventive medicine physicians to empower their colleagues and patients to have effective COVID-19 vaccine conversations to boost vaccine confidence and uptake. The program will also activate ACPM physician members as trusted ambassadors to amplify vaccine confidence messages and increase the capacity of members to share credible COVID-19 vaccination information. And finally, we'll be creating a surround sound of vaccine positive visibility nationally, regionally, and locally through social and other media. Our session today provides additional information for you as ambassadors at large to increase vaccine confidence among your patients, organizations, and communities. The objectives for the session today are improve our knowledge of approved COVID-19 vaccines and therapeutics, understand FDA's Center for Biologic Evaluation and Research oversight of vaccines, and understand CDC's Advisory Committee on Immunization Practices' safety review process. We are fortunate to have with us today senior officials from FDA and CDC who have been instrumental in overseeing these procedures. This information has two audiences. First, those of us in the medical profession have to first address any concerns we might have about these processes. Second, we need to be able to translate this information to our patients and organizations. In this way, hopefully we can identify strategies and policies to continue to encourage vaccination and achieve higher levels of safety in our communities. I'll first introduce both of our panelists. They will each speak for about 10 minutes, and then we will continue with the Q&A that started in the first part of this plenary with Dr. Clinton. Dr. Peter Marks is the Director of the Center for Biologics Evaluation and Research at the U.S. FDA. He joined FDA as Deputy Director of the Center in 2012 and was subsequently appointed as Director in 2016. He received his graduate degree in cell and molecular biology and his medical degree at New York University. He completed internal medicine residency and HM-ONC fellowships at Brigham and Women's Hospital in Boston. He was a clinician scientist at Brigham and Women's Hospital and at Yale's Smilo Cancer Hospital. He also worked on clinical development of hematology and oncology products within the pharmaceutical industry for several years. Dr. Marks is board certified in internal medicine, hematology, and medical oncology and is a fellow of the American College of Physicians. I can also attest that he is warm, funny, somewhat irreverent, and unafraid to speak truth to power. Dr. Amanda Cohn is the Executive Secretary for the Advisory Committee on Immunization Practices and the Senior Advisor and Chief Medical Officer for Vaccine Policy, Preparedness, and Global Health within the office of the Director of CDC's National Center for Immunization and Respiratory Diseases, or NCIRD. Dr. Cohn is a decorated captain in the U.S. Public Health Service. During her medical training at Emory and the Boston Combined Residency in Pediatrics, Dr. Cohn came to CDC as an Epidemic Intelligence Service Officer. She had subsequent roles as a medical officer, team lead, and deputy division director within different organizational units of NCIRD. While she and I never worked directly together at CDC, our orbits crossed several times, and I know that she, too, exudes the warmth, intelligence, and grit to withstand the pressure cooker of the COVID-19 vaccine development, approval, and implementation process. Please join me in welcoming Dr. Marks and Dr. Cohn to our virtual stage. Dr. Marks, please take it away. Thanks very much. So I'll spend the next 10 minutes telling you a little bit about the development of COVID-19 vaccines, focusing on the most recent pediatric data. So traditionally, vaccine development is a very de-risked activity because vaccines are not a high-margin product for pharmaceutical companies. So they spend their research and development funds carefully. So things go from phase one to phase two to phase three, usually with a fair amount of time in between various stages. Now that's great for de-risking things when you don't have a pandemic around, but when you have a pandemic around, you need to move things along a little faster. And so what's been done is, as opposed to de-risking, one could call it risking, because instead of having separate phases, many of the development stages were collapsed, and in fact, the Pfizer-BioNTech vaccine was studied in a phase one, two, three trial in the United States while, at the same time, manufacturing scale-up was occurring so that millions of doses could be available when and if the vaccine was shown to be effective. So this was done this way. Corners were not cut in getting these things produced. It was just dead time was taken away from the process. One of the ways that we helped do that was by making very clear what the criteria would be for these vaccines to be successful. And we put out in guidance in June of 2020 that one needed a vaccine that would be at least 50% effective compared to placebo to be considered effective here, mainly because of the opportunity cost that it would take to start vaccinating people with one of these vaccines when we had multiple coming up through development. We also noted that we would need at least a median of two months of participant follow-up following the final vaccination of a series in order to feel comfortable that we would have adequate information on adverse events. Most serious adverse events with vaccines occur within the first six weeks of vaccination or completion of a vaccination series. So what's the difference here between these vaccines that are under emergency use authorization and a biologics license application? Well, a biologics license application or a licensed vaccine meets our standards in the Public Health Service Act. And the standard is really that there has to be substantial evidence of efficacy from adequate and well-controlled clinical trials. These are generally trials conducted in roughly on average about 20,000 people who received the vaccine in a clinical trial program. The emergency use authorization standard is much lower. And for treatments, it was put in place after 9-11 to allow medical products that were investigational that could potentially help someone with a life-threatening illness due to a chemical, biological, or radionuclear threat have access to these products without having to go through an investigational process like informed consent. However, just so that we understand, emergency use authorization, which might make sense for a treatment of somebody with a disease, it's a little bit of a low standard for healthy people who will be receiving a preventative vaccine. And because of that, in October, we put out additional guidance. That was October of 2020. We put out additional guidance, which basically said that if a COVID-19 vaccine was going to get emergency use authorization, it would have to look a lot like a licensed vaccine in that it would have to demonstrate clear and compelling efficacy in a large, well-designed phase three clinical trial. And you'll see the numbers that were in these trials in a moment, that there would have to be clear demonstration that it was safe and that it was made with quality, and that we would do this through a public advisory committee process where we would also post the memos that were used to make decisions about these products. And obviously, because the one thing that is obviously a little bit shorter on these vaccines than would normally be is the length of safety follow-up. And because of that, we've, in conjunction with, in collaboration with CDC, have had enhanced post-deployment surveillance, both passive and active. So what are the candidates? We have a total of six that are in development stages, but three which have emergency use authorization to this point, the two mRNA vaccines from Pfizer-BioNTech and Moderna, and the Janssen adenoviral 26 vaccine. All of these vaccines were studied in large trials ranging from 30,000 to 43,000, randomization was one-to-one in these trials. So roughly 15,000 to 21,000 people getting these vaccines that the cross-section of people getting the vaccines mirrors the cross-section of our country to a greater or lesser extent, but roughly 10% black African-American, 25% Hispanic, and about 20 to 25% over age 65. All of the vaccines were highly effective in preventing hospitalization or death from COVID-19. There were some small differences in the prevention of milder forms of COVID-19, and the mRNA vaccines were 94 to 95% effective in that regard. And the Janssen vaccine overall, including sites in South Africa, was about 66 to 67% effective. In the United States, it was 72 to 74% effective. In terms of the safety of these vaccines in phase three, they were really mostly short-term side effects seen, but there were some that were worthwhile mentioning because particularly after the second dose of these vaccines, in particular the Pfizer-BioNTech-Moderna vaccines, there's a fair amount of flu-like syndrome and injection site pain, and fatigue the day after to two days after getting the mRNA vaccine has become something that we tend to warn people about. Now, in the pediatric studies, these studies were done in about 22 to 2300 individuals ages 12 through 15, roughly half female, median age about 14. And the study was compared to age groups of 16 to 25 for immunogenicity purposes and for side effect purposes. The diversity was a little less than in the adults, but still there was diversity in the clinical trial. And there were about 20% of the 12 to 15-year-olds had some medical comorbidity. If one looks at, whoops, let's see what I did wrong here, whoops, there we go. Let's see, sorry. If one looks at the efficacy of this, first of all, I should say that the geometric mean titers were excellent in the 190 of the 12 to 15-year-olds compared to the 16 to 25-year-olds. They were actually 1.76 times the amount. So very, very well met in terms of that regard. We have the clinical data in 1005 vaccinated 12 to 15-year-olds compared to 978 placebo treated 12 to 15-year-olds. And there were no cases in those who were vaccinated versus the 16 and the placebo. So really in this case, 100% vaccine effectiveness in this particular trial. The safety looks extremely similar to the safety in older individuals. Here's the age 16 to 25 next to the age 12 to 15 safety data showing that you do get a fair amount of fatigue and local injection site pain. By the way, the 25 to, sorry, the 16 to 25-year-olds have a very similar safety profile to the 25 to 55-year-olds. So it's probably a fair statement to say that what the side effects that mom and dad have are probably the side effects that a 12 to 15-year-old are likely to see. And I will stop there and turn it over to Amanda. Mute. The product. Up. OK. Do we have the, do I, I'm pressing the clicker, but it's not moving. Great. Okay. So I'm going to take over where Dr. Marks left off. After FDA authorizes a product, in many ways, they hand the baton over to CDC and the Advisory Committee on Immunization Practices. And both of these processes, both the regulatory process and the recommendation process, they were using our normal typical functions, but we even elevated them even higher to make sure that these processes would help build trust and confidence in the vaccination program. So the role of ACIP is to provide advice and guidance to the CDC director on the most effective means to prevent vaccine-preventable diseases in the United States. So in essence, ACIP determines who should get a vaccine, when they should get the vaccine, which groups in a certain population, and looks at things beyond just the safety and effectiveness that FDA has reviewed so thoroughly. We do this by using an evidence-to-recommendations framework. So this is a very specific framework, which I'll take you through using the same pediatric example that Dr. Marks gave, which is meant to be very structured so that for every vaccine recommendation, we go through the same process. This also provides transparency around the impact of additional factors on deliberations when considering a recommendation. So the evidence-to- recommendations framework is reviewed at an open public meeting. And prior to that meeting, we have an ACIP COVID vaccines work group, which many liaison organizations participate in. So we get lots of input into what goes into the framework, and then it's discussed and deliberated by ACIP. So the policy question that ACIP considered after FDA authorized COVID vaccine, the Pfizer product for 12 to 15-year-olds, is should this be recommended for use in these persons under the EUA? The first thing that we do is we grade the evidence type. This is a very systematic way to look at outcomes data, primarily around safety and effectiveness, and to determine what level of certainty we have in the data that informs the safety and effectiveness of the vaccine. So are we very confident that the true effect lies close to that estimate of the effect, all the way down to do we have very low certainty, very little confidence in the effect? So the evidence type is not measuring the quality of individual studies, but it's how much certainty we have in the estimates in effect across each outcome. So it's bringing multiple studies together to determine the evidence type. These are the different criteria we review all of the data under. We, first of all, generate an initial evidence type based on whether or not it's a randomized controlled trial, which these were, versus observational studies. We then look at risk of bias, inconsistency, indirectness, imprecision, and other considerations. So this would include things like publication bias or indication of a dose response gradient. For the COVID vaccines, this was rather straightforward because there were several, there were a few large clinical trials, but there weren't multiple years of use of this vaccine for which we needed to grade. So this was the summary of grade for the pediatric vaccine. As you can see, we had one study that looked at symptomatic lab confirmed COVID-19. And this was the study that Dr. Marks just described. And so we gave that evidence type A-1. When looking at the harms, we looked at serious adverse events and then reactogenicity. And in terms of the evidence type of the serious adverse events, there were five SAAs among vaccinated and two among unvaccinated. So there was, the uncertainty around the estimate was very low and no SAAs were judged to be related to vaccination. After we do grade, we put it into the evidence to recommendations framework. And these are the various domains and the questions that are reviewed at ACIP meetings. We look at whether or not this is a public health problem, and we reevaluated this question. I think the question for whether or not this was a public health problem among adults had been clearly delineated already by ACIP, but this was looked at again from the pediatric perspective, looking at specific burden in children, deaths in children, and hospitalizations. We look at benefits and harms, that's taking the grade that I just described. And then we also look at values, acceptability, feasibility, resource use, and equity. And these additional factors have been really important, not only in COVID vaccine recommendations, but really in all of the ACIP recommendations. So looking at that pediatric question again, is the public health problem is, is COVID-19 disease among adolescents aged 12 to 15 years of public health importance? And you can see the work group considered it to be yes. The benefits and harms, the anticipated benefits were large and the potential undesirable effects were small. And so it definitely favored vaccination in this population. We also looked at values and acceptability. And in the ACIP presentations, which you can find online, there are slides that take you through each one of these evidence to recommendations domains. So values using surveys and other types of data were, showed that, that there's a lot of different values that are going into whether or not people believe that this group should be vaccinated. And there was important variability in how patients value the outcomes. There's, there's some parents don't want their child to get sick at all. And you go all the way to parents who don't feel like COVID is a serious disease and don't need to be vaccinated. But the acceptability of COVID-19 vaccine, especially among healthcare providers was, was very high. Additionally, the feasibility was, was, was high given that we're already vaccinating with COVID-19, the Pfizer product, and the resource use was considered reasonable. So the final question around equity is a new question on framework. And the question is, what would the impact of the Pfizer BioNTech COVID-19 vaccine given to adolescents due to health equity? And the, the discussion around the, around the increased harms that are done in vulnerable populations that happen in vulnerable. So in essence, the work group decided for this question that the desirable consequences clearly outweigh undesirable consequences in most settings. And for that reason, the ACIP recommended that 12 to 15-year-olds be vaccinated with the Pfizer vaccine. So one of the really important things as Peter already described is our, both the passive and active surveillance post-authorization for the COVID vaccines. There's, as many of you know, has existed for every vaccine and it is always the way in which we gather early warnings about potential issues with vaccine safety. But for COVID vaccine specifically, we added V-safe, which is a new smartphone-based monitoring program, which uses text messaging and web surveys to really solicit adverse events among patients who register. Additionally, we've been following women who are pregnant, who have also registered for the V-safe program. And this has given us an incredible insight into the vaccine safety of these vaccines. So we've now given over 272 million doses of COVID vaccine. And as you can see, over 157 million people have been vaccinated with at least one dose. This is 56% of the population that is 12 years of age and up. And so we're really doing well, but need to be doing much better when we look at the overall population. What I am really grateful and appreciative of seeing is that in adults over the age of 65, we have 84% covered with a single dose and 72% who are fully vaccinated. So while we do need to make sure that all of those adults in that age group do get fully vaccinated, we have incredible protection in our older population who is at most severe risk for disease. But as you can see, once we peaked at over 4 million doses, we have been steadily declining since then. And we did anticipate this. We have gotten vaccine available to almost everybody who wants it. And now we really have to work on that movable middle. So this is our vaccinate with confidence strategy, which is to reinforce trust, which is one of the most important things that we do. And so we're going to talk a little bit about trust, which is one of the critical things that both the FDA and the CDC ACIP process are meant to do. And then empower healthcare providers, which we rely on you and which is part of the reason why we're excited about providing ACPM with this grant. And then also engaging communities and individuals. We know that supply and demand is both really critical to reach high uptake. We have to make sure that there's vaccine available for those who want to get it and they can get it easily. And so as we have more doses available, we're making sure that we can get vaccine in every place so that vaccine is coming to people's workplace. Vaccine is coming to rural communities, is coming to inner city communities, either through pop-up clinics, mobile clinics, in the federally qualified health centers. We need to make sure that people have access to vaccine in the evenings and on the weekends so that anybody who wants it can easily get it. And this is just to remind everybody that with the new guidance last week, now fully vaccinated people can pretty much not mask and do not have to worry about socially distancing. And so this is a really big step in what vaccinated people can do. But this is also a really important reminder about all of the things that unvaccinated people still need to do to make sure they're protected. And this includes children less than 12 years of age and people who may be immunocompromised, even if they did get vaccinated, may not be fully protected. So looking ahead, both FDA and CDC will work closely to monitor the continued surveillance of variant viruses. We'll continue to look at vaccine effectiveness over time to determine what the next steps are. And if we do need additional doses of vaccine, we'll continue to hopefully reduce the age population that is eligible to receive vaccine over time. But the most important things we can do for now are combat vaccine hesitancy and continue to make sure that there's equitable access to vaccines. And I will end there. Thank you both so much. This is such important information. I know there are a lot of questions coming in and I want to move to those very quickly. You've both described some extraordinary ramping up of procedures and processes that go on all the time within the federal government. Did either of you expect us to be at these numbers five months and five days since the first EUA was authorized? Does this place that we're at today surprise you, please you, worry you? Where are you at? I'm happy to start. I think it pleases me. I don't think it shocks me because I think that we were hoping that if everyone put their mind to it, we would be able to have a mass vaccination campaign. If we found an effective vaccine, we're able to make it. And I think we're very lucky for a partnership between the federal government, academics, industry, public health agencies that, and actually for that matter, even the Department of Defense that has helped make this happen in a remarkable time. I think really the most important thing I can say, and I'll use this opportunity to say it, is we shouldn't rest on our laurels because we still have a long way to go before this thing can no longer do us harm. Because with an unvaccinated population around that's still pretty significant, there's plenty of room for variants to start to wreak havoc. Yeah, I completely agree. I was hopeful we would be where we are now. I remember we were vaccinated before the summer and we are there. But I am very concerned about this new phase which we're in, which is really a phase where we will not be vaccinating at the same rate and it's going to be much harder both to reach people and to encourage and support people to make the decision to get vaccinated. Which makes it all the more important for us to all be singing from the same hymnal on this and making sure we're getting the information out in clear ways. I want to start with a question that probably comes back to you, Dr. Marks. And I know it's been a question on a lot of people's minds. You've sort of explained the difference between an EOA and full license or full authorization and why it's necessary to do that. But what happens now? What is required to get to that place where we're like, this is a licensed vaccine like other licensed vaccines that we use routinely? What are the next things that have to happen? And how long does that take? So it's a matter of record now that, for instance, Pfizer has already started to submit its biologics license application. And it will probably complete doing so in the very near future. We'll then probably review it over the course of a few months to several months after. What happens in that license application is a lot of manufacturing information is put there. There are specific things that have to be done to show that a manufacturer can reproducibly manufacture high quality vaccine as part of a license that's there. There will also be data on enough individuals for at least six months for us to feel comfortable giving a full license to a vaccine. And so, although in some ways, some of that is administrative paperwork. In other ways, there are very important things that go to quality manufacturing and safety that will be incorporated. And obviously, in this case, we're going to do our best to review these biologics license applications as quickly as we can, though we can't exactly promise when a decision will be reached. Thank you. This one is for Dr. Cohn about the v-safe program. Many of us have been participating in the emails that come out and remind or the text messages reminding us to submit our information. You mentioned briefly that you've been getting some really good information from that. Could you talk a little bit about what information you have been seeing? And if there are sort of pieces of that that are useful to pull out to talk about some questions people might have about vaccine hesitancy? Yeah, so primarily what we're seeing is most people are doing really well after vaccination or having very self-limited mild to moderate side effects. And it really replicates what we saw in the clinical trials. And so it's very encouraging. It is a lot of data that's being collected and sifted through. Follow up calls are made for for individuals who who had a medically attended event or anything like that. And so those generate VAERS reports. So it's really in VAERS where we are looking for potential safety signals and where we ask that people who had an adverse event in, you know, after vaccination or are concerned about any medical event after vaccination send a report. And then once it's reported to VAERS, if all of these are followed up, the serious ones are there's a medical record review. And then we have a clinical safety team called CISA that will do consults on on some of these cases where we're trying to determine if this could be causally related to a vaccine. We have vaccinated over 200 million people, over 200 million doses, 250 million doses, probably with the Pfizer and Moderna products combined. We do see at rare adverse events and and we knew we would see rare adverse events. And and those the greatest news, from my perspective, is that these systems are working. We're picking up on these signals. The thrombosis with thrombocytopenia after Janssen vaccine is a really great example of how quickly we were able to pick those up. And that's because we have health care providers reporting things to us quickly and we have a large team that is able to rapidly review and determine next steps. This is really for both of you. So either one of you can jump in first. But the question is, what are the lessons we're learning about communicating this kind of regulatory information or confidence with the regulatory process to the general public? Like, do we have a sense that talking about these kind of things helps or are we looking at that in a systematic way? So I can start from the FDA perspective. I mean, it's clear that we've gotten a lot of feedback that having a process that has been accessible, transparent has been helpful. It's certainly been something that's been appreciated. We did some studies with our partner, the Reagan Udall Foundation, and they found that that providing the information was very helpful. But I think probably the most important thing that I've seen from the number of community engagements that I've done, and I do several a week, is just the willingness to answer questions. Because I think the difference between somebody who's on the fence about getting the vaccine, the difference between them not getting vaccinated and vaccinated is having someone that they feel comfortable with just answering questions and not judging. There's no question that's too silly. The microbots, you can ask me about them all you want. You'll get the same answer. They're not there. But I don't get mad. I don't get upset because it's what we have to do to make people feel comfortable getting vaccinated. And if it's a concern that's preventing them from taking that step over the threshold, we just have to be there and be the comforting ones to answer those questions. So I think having trusted people, health care providers, in some cases it's clergy, in some cases it's the tribal elder, being willing to answer questions, it's the right thing. Yeah, I agree. I think that, you know, we have had so many ACIP meetings, they've been open to the public. This meeting for the 12 to 15 year olds just set a record and over 41,000 people listened to that meeting, which is, you know, before COVID we probably had like a couple thousand people listening. So people are paying attention, which is really good. And I think we're getting, I think people want to understand the process. But like Peter said, like, we really need health care providers to be part of this, these trusted messengers that help explain questions, that listen to concerns. And so I think the most important thing that having these processes has done is made the health care system trust this process and these vaccines, which has been a big help in supporting the program. Thank you. So there's a question here about a very specific population within V-safe and the kinds of questions, but maybe it implies sort of a larger question. So the question is written that V-safe has a pregnancy question slash registry, but not a lactation one. Is there a reason breastfeeding women not in the trials either, or maybe not identified in the trials, but how do you select the kinds of subpopulations or potential risks that you're asking about? So that, you know, does that come from say the initial trials or how do you decide what things to include and not include? Yeah, so the V-safe pregnancy register was really an expansion. The intent is that everyone report or register to report into V-safe. And we didn't have that specific pregnancy thing in there at first. But we were looking for a way to identify pregnant women to follow through their pregnancy and through their delivery to have a larger group of pregnant women than were shown in the clinical trials. At the time, lactating women, I don't, we, I, the idea was that we would continue to follow these pregnant women through and their babies through the first several months of life. But I think that we, I think while pregnancy was one thing that we really felt was critical to set aside, I think once we started expanding, we didn't want to have, it was too complicated to have multiple different types of groups of people. And so what we do is when we get the report of an adverse event, then we ask questions like, are you immunocompromised? Are you lactating? Things like that. And so lactating women aren't sort of in this long-term follow-up registry, but we would gather that information if there was an adverse event that was reported. So we have time. I might, I might just add that, that, that if, if the, the, the, although we did not have a study in, in humans of, of, of lactating women, I think the, the, the going wisdom is that it is, it is reasonable to vaccinate a lactating woman and, and have her continue to breastfeed. Because these, there's no reason why we, one would expect there would be any adverse effect from these mRNA vaccines because of the nature of mRNA and, and for that matter, these non-replicating viral vaccines. They are not live virus vaccines that are shed, which is often, by the way, another myth that is circulating wildly, that there's some kind of weird shedding of these mRNA vaccines or the, I don't know, viral vaccines, they don't shed. So you don't need to wear a mask around people who have had vaccination. So I, I'm sorry to say, I want to come back for our last question to the issue of the new guidance regarding mask use simply because it's, it's something we're all being asked every day in every part of our lives. There are a lot of, a lot of questions about it. And I think that it's coming from this place of, of having become a bit more distrustful of the person who's not wearing a mask. Have they been vaccinated really or not? And so help us just think through the conversation with people when they ask. And usually the question is pretty general. Like, what do you think of this new mask guidance? So how do you respond to that? And how do you recommend that we do that either in professional conversations or in the more personal conversations we're having with family and friends? I'll start and let Dr. Marks pick up after. But so the mask guidance is a reflection of how effective these vaccines are and in gathering of additional data that individuals who get vaccinated are highly unlikely to transmit to other people. So if, even if, for example, you're walking into a place and you don't need to know if you've been vaccinated right now as an individual, you know, you are protected from COVID. I think the important thing, though, is nobody's saying you can't wear a mask or shouldn't wear a mask. And if it makes you feel more comfortable, I'm still sort of figuring out how I feel in every situation. I carry it with me everywhere and I've mostly been putting it on inside because I do, I'm not quite there yet personally. But I think that it is a reflection of how well the vaccines work. This doesn't mean that transmission has gone away. So it's, you know, unvaccinated people do still need to wear a mask for their own protection. But there is recognition that people who are vaccinated are highly unlikely to transmit to others and therefore do not need to wear a mask. I know it's really it's very early days. This is going to evolve as people get more comfortable with this. And we have to keep watching how disease evolves. There's still a lot of transmission in the United States right now. So I'll just add, I agree completely with Amanda. The only thing I'll say is, just like many other things in this pandemic, we may have to recalibrate as we see what happens over the next four to six weeks. And so we'll just have to see how it goes. But yes, thanks. Thank you both so much. This is incredibly helpful information. And we will be incorporating lots of this into our new advocacy and ambassadorship program to help people understand these issues and taking the message on the road. Thank you both again for being here with us. Thanks so much for having us. Thank you.

vaccine confidence

transparency

regulatory process

healthcare providers

post-vaccination surveillance

emergency use authorization

biologics license application

evidence-to-recommendations framework

equitable access