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The COVID-19 pandemic sparked international concern about vulnerabilities in the global supply chain and disrupted the production of crucial pharmaceutical ingredients around the world. In a strained, but resilient market, two promising vaccine candidates boasting nearly 95% effectiveness rose to the top of various formulations. While their sponsors seek Emergency Use Authorization (EUA) from the Food and Drug Administration, the rest of the American health care system is preparing for vaccine deployment and mass immunization. This briefing explored how our supply chain must respond to manufacture millions of doses and then swiftly deliver them to administration sites. Panelists also illustrated the steps these stakeholders might take in the first 48 hours after an Emergency Use Authorization is approved.
- Esther Krofah, MPP, Executive Director, FasterCures, a Center of the Milken Institute
- Litjen (L.J.) Tan, M.S., Ph.D., Chief Strategy Officer, Immunization Action Coalition
- Hemi Tewarson, MPH, J.D., Visiting Senior Policy Fellow, Duke-Margolis Center for Health Policy
- Sarah J. Dash, MPH, President and CEO, Alliance for Health Policy (moderator)
The Alliance for Health Policy gratefully acknowledges the support of the National Institute of Health Care Management (NIHCM), The Commonwealth Fund, and Arnold Ventures for this event.
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“Covid-19: Getting Ready for the Vaccines.” Haislmaier, E. The Heritage Foundation. December 9, 2020. Available at http://allh.us/fnJD.
“COVID-19 Treatment and Vaccine Tracker.” Milken Institute FasterCures. December 8, 2020. Available at http://allh.us/c6wJ.
“The COVID-19 Vaccine Is Coming, but Will It Be Paid for? Federal and State Policies to Fill Gaps in Insurance Coverage.” Corlette, S., O’Brien, M. The Commonwealth Fund. December 4, 2020. Available at http://allh.us/gPGa.
“How Prepared Are States to Vaccinate the Public Against COVID-19? Learning From Influenza and H1N1 Vaccination Programs.” Baumgartner, J., Radley, D., Shah, A., et al. The Commonwealth Fund. December 3, 2020. Available at http://allh.us/akWe.
“Coronavirus Vaccine Hesitancy in Black and Latinx Communities.” COVID Collaborative. November 23, 2020. Available at http://allh.us/9HFb.
“From the Factory to the Frontlines: The Operation Warp Speed Strategy for Distributing a COVID-19 Vaccine.” U.S. Department of Health and Human Services. September 16, 2020. Available at http://allh.us/mYUu.
“Vaccinating Pregnant and Lactating Patients Against COVID-19.” Riley, L., Beigi, R., Jamieson, D., et al. The American College of Obstetricians and Gynecologists. December 13, 2020. Available at http://allh.us/6EqQ.
“Trump Team COVID Vaccine Plan Will Fail People of Color. Fast Does Not Mean Equitable.” Schneider, E. USA Today. December 9, 2020. Available at http://allh.us/v8jR.
“Some States Balk After C.D.C. Asks for Personal Data of Those Vaccinated.” Stolberg, S. The New York Times. December 8, 2020. Available at http://allh.us/CDFA.
“COVID-19 Vaccines: Dive Deep on Emergency Use Authorization.” Robeznieks, A. American Medical Association. December 7, 2020. Available at http://allh.us/yMDu.
“Coronavirus Vaccine: Addressing Challenges in Distribution and Uptake.” American Public Health Association. December 4, 2020. Available at http://allh.us/B6wY.
“Intent to Get a COVID-19 Vaccine Rises to 60% As Confidence in Research And Development Process Increases.” Funk, C., Tyson, A. Pew Research Center. December 3, 2020. Available at http://allh.us/VyUw.
“Vaccine Cards and Second-Dose Reminders Are Part of Warp Speed’s Immunization Plan.” Chappell, B. NPR. December 3, 2020. Available at http://allh.us/ACeP.
“Many Trial Volunteers Got Placebo Vaccines. Do They Now Deserve the Real Ones?” Zimmer, C., Weiland, N. The New York Times. December 2, 2020. Available at http://allh.us/6UYk.
“Framework for Equitable Allocation of COVID-19 Vaccine.” Gayle, H., Foege, W., Brown, L. et al. The National Academies of Sciences, Engineering, and Medicine. December 2020. Available at http://allh.us/eCWb.
“When and How You’ll Get a Vaccine.” Barbaro, M., Guillemette, D., Harper, S., et al. The New York Times. November 30, 2020. Available at http://allh.us/nqjT.
“Mass Vaccinations Against COVID-19 Will Be ‘Mind-Blowing’ Challenge for Alabama, Other Poor, Rural States.” Becker, I. The Washington Post. November 29, 2020. Available at http://allh.us/R4mU.
“Now Comes the Hardest Part: Getting a Coronavirus Vaccine From Loading Dock to Upper Arm.” Sun, L., Sellers, F. The Washington Post. November 23, 2020. Available at http://allh.us/n8JV.
“Fortifying the US Pharmaceutical Supply Chain.” Karas, L. Bill of Health. November 16, 2020. Available at http://allh.us/MRrU.
“Immunotherapeutics for COVID-19 and Post Vaccination Surveillance.” Kumar, S., Chintagunta, A., Kumar, J. et al. Biotech. November 11, 2020. Available at http://allh.us/AmFv.
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“Evaluating and Deploying COVID-19 Vaccines — The Importance of Transparency, Scientific Integrity, and Public Trust.” Schwartz, J. The New England Journal of Medicine. October 29, 2020. Available at http://allh.us/DQq8.
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“Developing a COVID-19 Vaccine May Not Be Enough: Three Challenges to Turning Vaccines Into Vaccinations.” PwC Health Research Institute. September 2020. Available at http://allh.us/ahG9.
“COVID-19 Vaccination Program Planning Assumptions For Jurisdictions.” Centers for Disease Control and Prevention. August 27, 2020. Available at http://allh.us/BbNn.
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FasterCures, Executive Director
Immunization Action Coalition, Chief Strategy Officer
Duke-Margolis Center for Health Policy, Visiting Senior Policy Fellow
Experts and Analysts
John Hopkins Bloomberg School of Public Health, John Hopkins Center for Health Security, Deputy Director
The University of Texas at Austin, Dell Medical School, Associate Dean for Health Equity
Healthcare Ready, Executive Director and President
South Capitol, Partner
May Elizabeth Daucher
National Institute of Health, National Institute of Allergy and Infectious Diseases, Vaccine Research Center, Associate Director for Management Operations, Acting Director, Vaccine Production Program
U.S. Food and Drug Administration, Deputy Commissioner for Medical and Scientific Affairs
Centers for Medicare and Medicaid Services, Center for Consumer Information and Insurance Oversight, Deputy Director
Pathway Policy Group, President, Coalition to Stop Flu, Senior Strategy and Policy Advisor
American Hospital Association, Senior Associate Director for Policy
Moderna, Vice President of Public Policy
R. Shawn Martin
American Academy of Family Physicians, Senior Vice President, Advocacy, Practice Advancement and Policy
U.S. Public Health Service, Captain (ret), Children’s Hospital of Philadelphia, Vaccine Education Center, Visiting Scientist
(This is an unedited transcript. For accurate quotes and presentations, please refer to the full-event video.)
0:05 Good afternoon and welcome. I’m Sarah Dash, President and CEO of the Alliance for Health Policy, and on behalf of our entire staff and Board of directors, welcome to today’s briefing From Bench to Body: How the U.S. Healthcare System Plans to Distribute COVID-19 Vaccines.
0:21 For those who are not familiar with the Alliance, we are a non partisan resource for the policy community, dedicated to advancing knowledge and understanding of health policy issues, and want to thank our new Ventures, the Commonwealth Fund, and the National Institute for Health Care Management Foundation, for supporting this event.
0:38 And remind everybody that you can use today’s conversation on. Join today’s conversation on Twitter, using the hashtag all, How five, and Following us at all Health Policy. Please get your questions ready. You have a speech bubble icon in your participant window. And if you send in your questions, they will get collected. And we will address as many as we possibly can throughout the broadcast.
1:00 Today, the Alliance has brought together three experts who can lay out, in detail, the science and the standards behind the safety and efficacy of the novel coronavirus vaccines, and how the US. Healthcare system will distribute them safely here with me today, to further discuss the Science safety and uptake of coven, 1009 vaccines.
1:17 And what we can expect in the coming days and weeks is a group of ext esteemed experts.
1:23 First, I’m thrilled to be joined by Ms. Esther Krofah, Executive Director of FasterCures, a center of the Milken Institute.
1:30 Ms. Krofah
1:30 has deep experience in the government, non-profit, and private sectors and in vaccine development. And we’re thrilled to have her here.
1:37 Next and pleased to be joined by doctor Litjen (L.J.) Tan, who is chief strategy officer at the Immunization Action Coalition and has years of experience in distributing vaccines to communities.
1:50 And in his work.
1:52 Finally, we have Hemi Tewarson visiting Senior Policy Fellow at the Duke Margolis Center for Health Policy, where she also has brings with her a wealth of state government experience as well. So, we’re thrilled to have you all with us and let me let me invite you all to just turn on your cameras and let’s start with you, Esther.
2:13 Hello, Hello, hello, fantastic. Glad. You are all here. I know it’s a very, very busy time, so, so, let me just start with you know, you’re, you’re such an expert on on the, the evidence of the safety and efficacy of vaccines and we know that the Pfizer vaccine received an Emergency Use Authorization from the FDA just last week. And that vaccine is starting to be deployed. We’re expecting a committee meeting tomorrow to advise on whether there should be an EUA for them return a vaccine.
2:48 Tell us just a little bit about like where we are in the process. What are the committees looking for with regard to safety and efficacy?
2:56 What do we know?
2:58 Yeah, Well, First of all, thank you so much, Sarah, for having me. It’s a delight to be with you again. You know, certainly regard, very highly the work of the Alliance.
3:07 So, thanks so much for making all of these sessions publicly available to answer these questions. So where are we? Well, first of all, I would just say that we’re in a really incredible place when we think about where we spend this year, what we wanted to accomplish in terms of vaccine development. Early on when we started tracking the development of vaccines and therapeutics.
3:29 In March, we had a handful of candidates now have well over 236 different vaccine candidates that are in either pre-clinical or clinical development.
3:39 38 of them that are in in human trials. Either phase one, phase two, phase 3, 8 that are in phase three. And if you’ve heard experts all over the last several months, there are predictions about 12 to 18 months, We’ll likely see some vaccine candidates. Being at this point in December, that we’re now seeing one over the finish line, at least from an authorization perspective and one, another one close to finish line, is just absolutely an incredible place to be from a science perspective. So first, I just have to start, by applauding all the scientists that have been working on this and the real heroes, which are the individuals who have enrolled in that in those clinical trials. So, where are we now? We have Pfizer and biotech, their partner that have successfully gotten through in the US. And Emergency Use Authorization. We should be clear that this is an Emergency Use Authorization, not licensure for the vaccine.
4:33 The authorization really allows the FDA the flexibility under the context of public health declaration for emergent needs to consider either biologics, therapeutics, and even devices their use, where there are no other news entities compounds, solutions for a particular pandemics. So, we’re in that kind of an emergency situation, and the FDA’s exercising their ability to be able to use that authority. So, we have Pfizer, again, who has their emergency use authorization eating right now doses of the vaccine to be made available. Madonna, similarly submitted to the FDA an application for an Emergency use Authorization for their vaccine. We have the advisory committee, the … Community Committee that FDA puts together. That meant for the Pfizer vaccines are meeting, again tomorrow to consider the data for the pejorative vaccine.
5:24 And this really is to look at the totality of the data that the companies are providing around what they have discovered in terms of safety and efficacy coming out of their phase three clinical trials. So, what we expect is a real careful application review by that committee, in terms of all of those elements. Which patients were enrolled, how do they do, coming out of their first dose, their second dose, And, what do we need to understand in terms of their use for the broader population? And, what we expect tomorrow is that, you know, we, there’s a lot of similarities between the Pfizer … vaccine. So, we might have questions as well as similar to the questions that came up in the prior application around should this be made available to those under age 18 at this point where there was a lot of debate.
6:15 But, otherwise, we may expect smooth sailing for the … review tomorrow during the committee meeting.
6:20 The FDA then comes back and reviews that input as well as an analysis and then comes forward with their recommendation for emergency use authorization, which we could expect by the end of end of the week. So, again, we’re in a really terrific spot for these two vaccines. There are a number of other vaccine candidates that we’re hoping to see data likely in the new year.
6:43 Great. Thank you so much. I started so many follow up questions, or I’ll hopefully get to some of these during the discussion.
6:48 So, LJ, I mean, you’ve been involved in kind of, you know, adult immunization, communication for a really long time. What are you hearing on the ground? Like, what are people believing perceiving about the vaccines? What are some of the challenges that you’re seeing? How are we going to know, and then how are we going to address some of those questions?
7:09 Yeah, that’s a great, great starting point, Sarah. And again, I want to echo what else to say. Thank you very much again for this opportunity to rejoin everybody here on another one of these great discussion. So, thanks for that. I appreciate that.
7:20 So, I just want to point out the fact that I think, you know, the challenges of vaccine acceptance has not been something that adults have generally had to deal with, for, you know, we hear about, you know, you know, children, pediatric vaccine hesitancy, we hear about, you know, does the vaccine cause autism so on and so forth. A lot of that concern has been predominantly focused in in the pediatric population. It is amazing what we’re now hearing and what and what we’ve opened up now, with regards to Coburn 19, I think part of it’s a little bit of our own doing. We’ve now added some some hesitancy around … vaccination.
7:57 So what we are hearing is exactly what I think everyone’s been hearing around on the panel, is this idea that there’s a lot of concern about, did we go too fast? You know, what are the things that have been put into place to assure that this, this process was transparent. And obviously, safe, Sorry, evidenced based, right? So those are the things that I think we’ve been hearing now. And I think what, what we’re trying to tell people, and what you’re trying to hopefully help people understand is that this process actually has been, you know, regardless of what you’ve been hearing about, the, you know, the outgoing administration’s efforts, and so on and so forth.
8:30 The, the process itself has had integrity, and has been guided by career scientist, independent scientists, at both the FDA and the CDC. And I think this is something that we’re trying very hard to help people understand the process.
8:44 And I think as Donna has already said, now for example in an EUA process the FDA does not have to call.
8:51 There comes the advisory committees to meet the, they can issue an EUA without a four pack meeting.
8:57 They chose to do overpack, meaning they chose to do two of them, and I got argued, they’ll do more.
9:02 And, the idea for that is to, again, to show that there is independence, India, in the evidence review, here, and I think that’s important for all of us to recognize that that’s there.
9:11 That being said, I think, then, the next step, obviously, now, the ACIP is an evidence based group that has done a lot of work and looking at the next step, which is, what are the side effects? What are the benefits risk, benefit analysis in terms of a recommendation of whether or not to give them give the vaccine to the public? And, as you all know, the ACIP voted that, the Pfizer Biotech vaccine is recommended for every 116 years of age and older, and, that is the difference between the Pfizer in the modern a vaccine, the modern a vaccine. The UA will be 18 years and older just to, just to put that out there.
9:43 So, I think, I think I think the ACIP’s work, again, a committee of independent scientists, physicians, clinicians, are looking at the evidence. Again.
9:55 So this is not this is over and beyond what we have these doing right. Again, and they’re coming out with the recommendations, saying that this vaccine is safe. 10:03 This vaccine is effective as efficacious.
10:06 We need to be giving it out there.
10:08 So now that that’s done, we now roll it over and we hope that our states can take that and run with it, right and say, We’ve got all this evidence now, let’s implement. And I think that’s where we are.
10:20 Great, Thank you. And before we move to hey, makes I want to ask you about like how this has been handled at the state and local level just I just want to ask you all day and Esther, feel free to chime in.
10:29 I mean, just, you know, we’ve heard efficacy rates of, you know, over 90%, 95% rate for both of these vaccines.
10:37 And, I think that was, um, above and beyond, what was being hooked for. Can you just briefly comment on that, like, how was that unexpected to you, was that a surprise to you? And, what does that tell you as well, about just the importance of getting the vaccine out there?
10:55 I’ll start with the evidence. And then, after, you can, you can jump in with, you know, what does that tell us? I think clearly, I think the 95% effectiveness rate took two, took even.
11:05 The smartest scientists A little bit by Surprise. I think, I think the reason it took people by surprises because we don’t actually know, while we have a lot of experience with m-r.n.a. vaccines as a platform we’ve never really lies with not licensed the Vaccine using MRD platform. So, we’ve not had the, you know, the huge sample population studies that generally, follow after vaccine falling, falling licensure. So, I think, most of us were anticipating, and we also know with adults, adults, don’t react. Don’t, don’t don’t respond to vaccination, as well as pediatric. So, you know, our immune system is actually a waning. I like to say, you know, after puberty my immune system downhill from there. You know, so, so, it’s one of those things where you have waiting immune systems.
11:44 And so, I think, I think it did take us, by surprise, especially since the data in both vaccines, as you’ve seen from the package that FDA has released, is that effective for 65 and older, as well, which is not where we used to sing high level of efficacy. So so that did take us by surprise.
12:01 Now, remember, these are clinical trials, clinical trials are conducted in the most positive for situations where people have compliance, their exact timing, in terms of when you get the second dose. All of that. And we know that in the real-world, there will be some variation. And sometimes, in the real, will we lose some of those numbers a little bit? The real-world effectiveness numbers may actually dropped a little bit. But, but, but 95% is amazing.
12:24 And if you think about what it takes to get us out of this in terms of community immunity, 95% effective vaccine gets us a lot, a lot further down the road than a 70% or 60% effective vaccine.
12:37 So I think this reflects on the m-r.n.a. platform is a very good science platform.
12:42 Yeah. Yeah, biology. And what were Terrific? The only thing I would add is that when FDA released their initial guidance document back in June, and then certainly updated that in October, they set the 50% efficacy bar, which was really meant to be, you know, an average of what we typically see for a flu vaccine. And I don’t think anyone anticipated or could predict that. We’re talking about 94.1 to 95% efficacy. And again, it speaks to the fact that, we have not had a commercially licensed m-r.n.a. vaccine. We haven’t seen this kind of data in 30,040, 4000 plus individuals, but even FDA was trying to set the bar in a relatively reasonable place and we have far exceeded even that relative standard.
13:28 Great. And we’re already getting some great questions in the chat about this and m-r.n.a. platforms, and I wanna get to this, but for someone to give me a chance to jump in and hear me just from, from your perspective. Obviously, there’s a lot of, you know, that there’s some unprecedented science here, Some better than expected results.
13:48 Still lots of concerns and questions on crafts from sound, on the public. And then there’s just like the plain and simple logistics of, like, getting the shots into the arms of people. We know, the Pfizer vaccine requires extremely cold storage. The modern, as I understand, does not require quite as. Cool. So can you just kind of put that together for us, like, from this the way, and like, we’ve already seen, some healthcare workers already beginning to be vaccinated, how is this process working? How is it playing out on the ground? And what’s the role of the private sector and then the state and local governments as well, and making this work?
14:30 Temi, you’re muted.
14:34 Happy to comment. Thank you for having me on this great panel.
14:36 So we here at Duke Margolis have been really talking to faith and looking at all of their vaccination plans that they all had to submit back in October and continue to try to really update that with, as, you know, if anyone’s falling, all of the state websites have started to release information to the public.
14:53 And in talking to the state leaders, you know, this is such an amazing development, but unless we can actually be successful in convincing people to get the vaccine, we will not be where we need to be on this pandemic.
15:05 And, I think, frankly, from my perspective, that is the biggest challenge we are facing right now, at the state and local level.
15:11 Um, I want to talk about that person. I want to talk about some of the other issues. So, you know, with respect to the public confidence, you know, we actually were just in the stakeholder meeting, and they were, you know, really concerned about, well, how is the rollout going to work?
15:25 How do I know that people that go first? Are they OK? I didn’t really have the information I need, and so, you know, all of us here on the panel, you know, read about all of this, all the time, and we’re excited, and we’re in the know, and that is not true for the average person.
15:40 So, you know, I think there really has to be a concerted effort across the country to talk about this in a way that reaches different types of population.
15:49 If you look at the polling, you’ll see, you know, women, for example, are more hesitant than men right now across families, and women tend to be the healthcare decision makers.
16:00 So, that’s, that’s a challenge in and of itself.
16:02 We’ve been hearing from health the health systems that, you know, they’ve been trying to back think their health care workers and, you know, they had everyone register or they’re rolling out the vaccines as they get them.
16:11 They’ve had 35% of their healthcare workers not wanting to get them back.
16:15 So, and that these are health care workers, right? So, who understand more about the health care system than others.
16:21 Communities of color, when you see some of the polling there, just as one example, you know, there’s up to 60% of the black community that really are are concerned about getting the vaccine.
16:33 And you know, these are some of the same folks that, you know, we saw earlier in the pandemic. There’s 5 to 1 ratio is the case rate. The mortality, some of that has gotten better, but not across the country in every place.
16:44 So that’s true with the latin X population than that Native Americans as well, so, So, I think there’s a lot of work to be done here. We are. We are partnering with an organization called The Collaborative, which is the, the big group of lots of really amazing folks across different disciplines, and, and, I think, you know, state know, had it, and local health departments know how to do vaccine. What unprecedented about this is the level at which they’re going to have to roll out the programs? And so, that’s why there needs to be partnerships, not just with the federal government, which is critically important, but also with, you know, healthcare providers, with health plan, with communities, and really thinking, you know, frankly, much more creatively about how you can have materials that we, all of those different populations.
17:27 So, one thing I did want to mention is the ad council, who we all know for their national campaign, is rolling out material. As we speak, I think, probably by the end of the week or early next week, we’re working closely with them as part of the Kogod Collaborative.
17:42 And they’re really trying to fill a gap of really getting information out to the public at different levels.
17:47 So that there can be more of a common understanding of, you know, what Esther and LJ really articulately talked about with respect to safety and efficacy. But also who’s gonna get it first?
17:58 And if I have one more minute, I just wanna talk about the polarization burst, you know, we hear all on the phone with healthcare worker, long-term care facility folks, but not everybody in the public understand that, and the bigger picture of how it’s going to roll out. Some states have started to put this information on their website, so people can start understanding and having, you know, community group, talk about this than, you know, Physicians and health plans and all these other folks. Who are still waiting for the final recommendations, which will come on Sunday. Which, that at least address, you know, Phase one, A, The first group of healthcare workers.
18:31 And people in long term care facilities, Phase one, B, and one C, are likely to be folks who are older than 65 and also have, you know, a serious medical condition.
18:41 And then there is also the essential workers who are not health care, who are the most at risk.
18:47 And I think those are the populations that I think are going to be challenging for different states to figure out how to prioritize depending on how many vaccines they have in their seat and who they’re going to decide should go for and how to make those determinations.
19:01 So, lots more to talk about. But I can just stop there for now.
19:05 Yeah, thank you. That’s great. A lot, lots to talk about here.
19:08 So, let’s, let’s just go to the, this just the trust question a little bit, because we’ve had some really good questions. And I think one of our chat questions as, you know, how can providers better engage patients and build vaccine confidence, particularly in the black community, which has been filled as having the highest rates of skepticism and reluctance?
19:28 And, of course, know, it’s just so important to acknowledge just the very, very specific. You know, historical traumas evidential, acted on black communities, you know, frankly by the medical system and the Tuskegee experiments, and others that have, you know, perhaps that gender, some of that mistrust. And so, so, you know, question one is like, what, you know, what is being done, what can be done? You can’t just flip a switch and turn on trust, right? What has been done, sort of, maybe you’re off the vaccine development process, why should people trust the process? And then, since the Chat question, actually asked specifically, about what providers can do, Amy, if you could maybe, maybe just help us get a little bit underneath.
20:10 Like, perhaps, you know, where some of the hesitancy may be coming from, just like from the provider community and and how that can also be overcome.
20:21 Yeah. So I’m happy to start to, with respect to, you know, how do we really address the equity issue and really getting trust in the communities? So there have been some states that are made, equities are front and center of how they’re rolling out their vaccination plans, but that isn’t apparent. And across all the states, I think all states will take some steps with them, that some states are taking more than others. And some of the way they’re doing that is they’re actually, some of them aren’t giving community grants, for example, two groups to actually help build messages.
20:49 A number of states have coven, Equity Task Forces, and they’re working with those task forces to make sure that, you know, the people that understand the logistics and like, you know, how you do sort of it from a health perspective, can understand.
20:59 How did then also work with communities and messaging, which is a different skill. And it’s sort of a different set of principles to think about.
21:07 With respect to the health care providers, you know, I think it differs in every state and locality.
21:11 But, just anecdotally, we certainly seem like some of the nurses actually have been hesitant to really take the vaccine and be first. You know, I think there’s that kind of wait, and see, they’d like to see how others do.
21:25 And then follow up and get the vaccine after there is some experience.
21:29 And so, I think part of that trust factor is having, you know, colleagues and people they work with and people they trust in the community, get the backing and see that those folks are OK. And a really kind of, you know, the heroes and really can feed back that information to make people feel like, it’s OK to get this. You know? Healthcare workers understand why they know their exposure to covert But they are still worried about their safety of themselves and their families.
21:55 So I think the other piece, too, is from a public perspective, transparency is going to be key. 22:01 And that’s where that’s where the data comes in for the data systems have to really be working well. And, you know, state there have been a lot of work.
22:07 They fan localities on an immunization system to make sure they’re ready, but you know this isn’t quite a big undertaking, and so safe the path to add enhancements to their systems. Make sure that you can connect to the federal government. There’s still more work to be done on that front. It’s not quite all done yet. 22:24 Essar will remember, you know, healthcare dot gov, there’s always challenges when you have IT systems that are, that are getting built as things get rolled out.
22:32 Um, but, you know, we need those to work well, because there has to be a B of information of, when there’s adverse event had gotten the vaccine. You know, what did those demographics look like? Are there adverse events?
22:46 And make sure there’s transparency around, all of that to the public and feel like they’re in the know, and they know how it’s going, and then who’s going to come in.
22:55 Yeah, thank you. Yes, sir, and and as you’re responding, Esther, I let’s say here because we have a couple of like pretty related questions in the chat, but I just want a name and maybe you can kind of incorporate them. I mean, they’re both basically about tracking, what are those longer term implications? And one of them, specifically, kind of notes and, you know, I don’t know if you could speak to the, the, the science of this a little bit. But since m-r.n.a. vaccines have never been licensed, they’re sort of two years required before autoimmune events could cruise on. You. Know, will there be an ability to track that, concern related concerns? And I’m going to save that. There was a part of that question around the placebo control that I’m gonna just kinda hold for a second, because we’ve already given you a mouthful here. Well, let me start with the trust question, and then we can get into some of the others. And Mimi brought up just really important points. I just wanna underscore a couple of things.
23:51 one is Pfizer. And Madonna did a great job of slowing down their enrollment, their clinical trial Phase III enrollment so that they can increase their enrollment for african american left latin X populations.
24:04 So, that, in and of itself, was just such a terrific effort, to show that we’re not testing this in populations that have not been disproportionately affected by this disease. And then, having the data to show the efficacy rates that we’re seeing across population is also applied to that population, And providing transparency around that, I think, is absolutely critical. And Hemi hit upon that point of transparency.
24:28 The other thing that I would say is, particularly for those communities, and there’s certainly a lot of attention around racial equity and racial injustice, is that what people are looking for is to be partners, provide information in a clear and transparent way. You know, don’t do medical research to us, You know, and don’t come into the community. To say, you must get this, but rather to say, here’s information, this is what’s occurring, here’s what we know to date, and making them a partner in, the decision making process, not coming in as the, you know, the only experts, and saying, here is what you need, which might not be successful. And of course, tied into that is having the appropriate messengers from communities and organizations that those communities trust. But, I do think that we have a tendency to kinda swoop into Communities, and have not really seen, you know, all of the range of medical experts. and then wondering, why are people not listening? Or why are they not taking things up? So, absolutely critical that we just needed to make sure that it’s all within context apart. Another part of the challenge is the question of speed.
25:35 So earlier, I was applauding how quickly we got here. But we need to explain, continually explain, over and over and over again. We went through the appropriate scientific process that their pre-clinical studies done, Animal modeling done a Phase one study done with small populations, increasingly bigger populations with Phase two and the larger population. With Phase three, FDA did extend the timeline for two months follow up following this: the initial data that came in their October guidance, and are putting steps in place to make sure that up to a year. Even after the initial vaccines rollout, there’s tracking that’s happening from a company side with respect to safety over time.
26:17 There are systems where individuals can opt in, being rolled out by the CDC to be able to share information in terms of any adverse reactions. And all of this real-time information will allow us to capture very quickly, as we’ve seen even some limited cases with some, you know, allergic responses, Here’s something to watch out for it and we really provide that updated guidance. But it’s going to have to be this continual process.
26:40 The third thing that I just mentioned, you talked about, the m-r.n.a. platform has not been rolled out for any commercially available vaccine. Though, as LJ mentioned, there are decades and decades of experience working with the platform. one of the key questions is, is it going to change my DNA CDC’s made it very clear, as well, as scientists, to say, no. It’s not altering your your DNA, it’s essentially creating instructions for your own body to produce an immune response. So that should help settle people’s questions in terms of what could the potential long term effects be, obviously, will gather more information over time. But FDA set the appropriate steps, and standards or requirements in place, that even the vast majority of adverse events that happened for vaccines typically happen in that 42 day to 60 day window, which is what led to that two month follow-up data requirement. So I do think we need to continue these messages, and they can’t be a one and done from here until we get up to that herd immunity.
27:40 Great. Thank you. And just to clarify, you said a two month, follow-up data requirement? Not a two year? Is that correct?
27:47 The two month follow-up data before requesting an emergency use authorization by the FDA. But following that, there is up to a two year follow-up period of time.
28:00 Got it. And LJ, could you address that too? I mean, you mentioned kind of the the real-world evidence and how that’s all going to work. And talk a little bit about that. And maybe, what is the adverse event tracking? I mean, I think we kind of got pretty quick notification of a couple of individuals in the UK. I mean, like, within, almost like 24 to 48 hours. So, how will people know?
28:24 I mean, there’s already lots of questions in the chat, you know, if somebody has allergies to antibiotics, can they take the vaccine? Like, how how are people going to know these kinds of things? And what works for them and what doesn’t?
28:36 I think that, I think that, remember, ma’am, you, can you hear me, OK, OK? I think the thing to keep in mind with those to you, to, actually, three UK cases is that they all three had come in with, with, with a previous history of severe allergies. And, hence, you saw the, the guidance from the ACIP that people with severe allergies, that means people who are caring, for example, Epi pens, should be currently deferred from the Pfizer Biotech vaccine.
29:00 But, that being said, I, you know, I think it is important to point out that in, in almost 45,000, patients pay for our volunteers. The, the allergic reactions were, were, were minimal, the, the adverse events actually been associated with the vaccination. That came out of the, the clinical trials has actually been quite.
29:22 I think actually have been, for me, surprisingly lower than I’d anticipated. I kinda put them at the same level of above flu but slightly below the current to dose sauce to vaccine, the shingles vaccine. I had expected they reacted in the city to be a little bit worse. So, I think actually, that’s a good thing to kind of remind people is that this is a reactor genetic vaccine, but it’s not any worse than some of the vaccines we currently have on the market. And just to remind people that it will hurt, you will get some. Some people, like, what, 35, 40%, actually had some systemic reactions, like a day or two a fever. We need to remind people of that. We need to remind people that this is something that we know happens then that shows the immune system is working. And then that being said, you know, the CDC and HHS have put in a remarkable amount of effort to supplement our existing vaccine safety surveillance systems. Right.
30:10 Just to remind everybody, again, the US has the best vaccine safety surveillance system in the world.
30:18 We have we have things like there’s which is like a passive monitoring system, which then feeds data into the Vaccine Safety Datalink under the vaccine safety that we have a whole bunch of things like Seesaw, which is a clinical investigation system to look at vaccine, to show causal reactions to show causality between a vaccination event, potential adverse event. We’ve got so many systems already in place, and on top of that, they’ve added additional surveillance systems for Covid 19. So, for example, the most recent one is the app based system called The Safe, where you’re going to be as a healthcare worker. And future vaccines of X will receive Covid 19. You’re going to be putting in, you know, if you get a severe reaction, you will put that in and that will go right into the monitoring database, so that people can kind of look and see, you know, what’s going on with regards to reactions after getting covered 1009 vaccine.
31:10 So I think, all right. I’m not worried about our surveillance.
31:14 I think, that is something that we are going to, We’re going to find If there is something, we will find it.
31:20 But, that being said, the data from the clinical trials have been remarkably re-assuring with regards to potential side effects from the vaccine.
31:32 Can I follow up with braille down that? Thank you for articulating all that. 31:37 I’ll just start from like a, a practical, on the ground perspective of what we’re hearing from some of the states. So, you know, I think the VC is really helpful.
31:46 I do think there are some consumers that are really concerned about using it, you have to put your information in, Your information is reported, and some of them are just not going to use that.
31:57 And, so, I think the question is, what is the backup to that? And, you know, the VR system for FDA, has never had to deal with the level of vaccinations that are going to happen so quickly. But I think there’s a concern about the, the data feed, then, you know, I think everyone would love to get access to the State Immunization Registry systems, and that’s just not going to be possible from a privacy perspective.
32:20 Health plans would like to get access to that, so they know, you, know, who, amongst their members, haven’t gotten a second dose, who have had adverse reactions based on the clinical record.
32:28 And I don’t know if that’s going to quite be able to happen. And so, I do think we need to be creative and practical about how to think about making sure these data systems are all going to flow in the way that we think they should lead.
32:42 Because I think there’s some, some limitations just at the moment right now of being able to get all of that, and in the real time that we need, especially for, like, Governors and their staff to feed it back out to the public and make sure their stream.
32:54 So, I mean, let me, let me just kind of follow up on that.
32:56 I mean, does is the sort of vaccine follow-up part of the messaging, or should it be, you know, as far as like, it’s important to not only get your vaccine, but also to report any adverse events? Should you have them, and like to kind of trust.
33:12 I mean, how, how does that get communicated?
33:17 Yeah, I think, at that, and, it’s going to be part of, you know, the material that, I think, you know, providers are going to be using, some of the health with, the Missouri, have already released the materials and training there, you know, workers to make sure they understand the process. I think we’re gonna get more challenging. That was when we get to those bath, maximum. 33:33 This math vaccination clinic, where you’re going to try to get lots and lots of people, you know, in per vaccines.
33:40 And it will be a less personalized. Like, it’s not your employer telling you.
33:43 It’s not your primary care physician telling you who you trust, and you’re going to a site. And so, I think, you know, we’re not there yet, obviously, because we’re still on phase one A And so I feel like this part is the easier part to keep track of. And in between getting it, who’s going to get a second dose at once? We get to the millions and millions of people that follow, that are gonna come in different, you know, places to really be able to get access to the vaccine. And as we talked about, you know, the communities of color and some of the essential workers that are at most at risk.
34:13 They may have, you know, multiple part-time jobs. They may be going to, you know, their community to get vaccinated. You know, states are going to and localities are going to try to have some different types of vaccinations like to encourage them to go and it could be at a local church.
34:25 It could be at, you know, different places where they feel like people can trust, where there’s not going to be necessarily the system built.
34:32 That’s going to be the traditional way we would track it back. 34:35 Yeah, And I want to get to that one dose, to dose question to.
34:39 I mean, so what experience do we have with that and let me ask you LJ first.
34:47 And then kind of Esther, and then hey, me, you know, just what systems will be in place to make sure that, you know, people do get the dose and not only get the second dose but get it.
35:00 On the day, they’re supposed to get it because, as I understand it, there are different intervals, even for the Pfizer versus the Maternal Vaccine. So, you know, like, how are we going to make sure people get it? You know, on that day, acts as opposed to day Z when it’s too, and is it too late to speak to some of that?
35:21 That’s the great news, I think, Sarah, this is that the CDC has actually issued a living document. It’s the kind of considerations document that accompanied their approval, their recommendation for Ufa Pfizer Vaccine, and that will continue to be updated. And some of these questions are actually addressed in that, I think. I think it’s kinda funny to think about the fact that, you know, we have 21 days for, for Pfizer and 28 days when we’re doing that.
35:42 We think that, know, as soon as the day 21, the vaccine, no good anymore. That’s not true. I mean, it’s it’s it’s never been true, right? I mean, that’s not the way vaccines work. And so, I think, I think, putting proving some reassurance around some of these clinical issues is important. And I think they’re out there, or CDC is doing a good job trying to get that out there. So, I’m not I’m not that concerned about that part. I think I think there are systems in place. Hemi has already touched on them from using the immunization information systems, or some of you might know them as registries. Right? To many of these systems have already been developed to be able to do Reminder, recall. To do provide a prompts to get patients backend for it. For multiple doses, the challenge.
36:20 And I think how we can talk to this is the fact that we’re not, we were, we were getting there. And then the pandemic hit and we are immunization information systems are not robust enough yet to do that for every state in each state is going to be different. So that’s one of the things. So there’s a little bit of nitty gritty there that needs to be considered. In terms of just getting, getting providers onboarded, right, so that they’re they’re actually in the system and can report and so on and so forth.
36:44 But that being said, it’s not that we don’t have experience with this. I mean, we’ve done multiple dose vaccines before, especially in the pediatric population. And now, thank goodness. We’ve actually about two years of experience now in the adult population with the shingles vaccine that was that was released in 20 18.
37:00 The data before the pandemic hit was that we were getting about 81% of people back for their second doses, which, for the shingles vaccine are granted, it’s not exactly at the same timeframe. The timeframe for the shingles vaccine is 2 to 6 months. And so, that’s a bit longer than the 2128 days we were talking about. But, I would actually argue that it’s probably going to be easier to get people back 20, 128 that actually 2 to 6 months. But, but, But that’s just me speculating, but the actual data is 81%.
37:29 And so, I think that’s actually, I thought that was actually pretty good, we need to do better, especially with the covert vaccine, but that tells me that some of the systems that we have in place, How are working?
37:39 We just need to make sure that with the immense nearness of the capacity that we are now asking them to do, we have the resources at the state level to get them doing what they do, we know they can do, and I think that’s the big thing.
37:52 Yeah. And I want to ask you, since you mentioned kind of older adults, and we had a couple of audience questions, So I want to try to keep getting to those audience questions now. And this kind of go somewhat backs of the communication, but by LJ, especially, you know, given you’ve, you’ve worked on the shingles vaccine for older adults, can area agencies on aging play a role like who are some trusted messengers and the older population? And, you know, are there special health equity considerations in the older population.
38:23 And and does Medicare, frankly, like this having Medicare make it easier or, like, how is that going to work for for those older adults who are, you know, at higher risk for complications from COPPA.
38:35 I’m just gonna, do, a quick on, and jump, because there’s so many, so much expertise here with Actor and Hemi, so I, you know, I will say, Medicare is actually a great equalizer I think it, especially since we’re, it’s going to be paid and I think that’s going to help a lot of providers, you know. 465 and 2 to the 65 and older population get engaged, so I think that’s, that’s huge. But that being said, I think we need to engage our our advocates for those over 65 better, I think we need to engage not just the provider side, which will groups like the American General Digital Society of America. But, we also think about AARP people, who, who have the ears of those over 65.
39:11 And then ultimately, I remind me, myself when we hear about long-term care facilities, that that also engages means engaging the families of residents, because families play a huge role in getting the residents in long-term care facilities. 39:24 Which is our phase one, a population that we need to do is to engage as well. So I think that’s, that’s where I’m will look. I would target initial efforts, but Medicare is a big deal.
39:33 I think the fact that they’re paying for this is going to really help and I’m going to just, you know, defer to the expertise that’s around me right now.
39:41 Thank you.
39:42 Esther, you are nodding.
39:44 Well, I just time into the earlier conversation around how do people know to come back for that second dose? And then part of the kits that are being distributed through Operation warp speed included vaccination card. So for those who probably grew up outside of the US for probably accustomed to these vaccination cards that you carry that shows, but your vaccination vaccination schedule has been. So, that will be helpful. Of course, it’s, it’s paper, it’s not digital. So, we’ll have to figure out how it can be integrated within electronic health records and the like.
40:15 What I actually worry about are the 29 million people who are uninsured, not part of a physician practice office or any kind of sort of formal, you know, healthcare system, in terms of them knowing where to go.
40:28 Getting their first shot and then coming back for their second shot, as well as a homeless and transient population.
40:33 So, when we talk about, know, the people who are suffering and bury, the worst brunt of the of the disease are actually the people who are the hardest to track. You know, formal systems. And, we can’t lose sight of that because what we can end up doing is really having an inverse response, that those who probably are lower risk outside of the one, a group, are getting access to the vaccine. And, those who really need that mean, we’re not working in a creative way to get access to the vaccine. So, we have to think about really carefully, you know, mobile units and having community health workers, and others deployed, which, I’m sure you will speak to the resources that states need to educate the whole company, you know, those, that workforce and getting them equipped.
41:13 All of this, you know, I think, to the question about, you know, the older adult population, there’s a lot of, you know, I think, platforms that already established vehicles to get to that older population, so I’m actually quite encouraged to think about how we can get there. The scale of this is enormous.
41:30 I mean, you know, LJ talked about, well, we have experienced zostavax, That’s, but the smaller population, we’re talking about trying to vaccinate a huge majority of the country, and we’ve never tackle of anything at this scale before. So I do think we need to be humble in terms of our approach and maybe add on an X factor of what we don’t know. So there is going to be a lot of learning and integrating that learning in real time. Coupled with the resources, appropriate resources for state and localities will be quite important.
42:02 Great. Thank you so much.
42:04 Well, speaking of the scale of the center, we have a few questions in the chat around kind of numbers of doses, distribution. So, I’d like to sort of turn to some of those series of questions, you know, first. and maybe this question was directed to Esther. So, we’ll put you on the spot at first and then others can chime in.
42:24 Can you shed a little bit more light or out some light on what is happening in terms of the Administration’s ongoing talks with Pfizer to purchase additional doses, like how, you know, is it going to slow down vaccine distribution? Do we have enough doses? You know, should Should there be an invocation of the Defense Production Act? Or are there other steps that need to be taken just to ensure that we have adequate numbers of vaccines? So puts you on the spot with that question, as far as the scale. And then I want to get to the timing of the distribution.
42:56 Yeah. I mean, those are fantastic questions. I think we’re seeing a lot of news reports related to that. Operation Warp Speeds goal was to have Contract a 300 million doses of a coven 19 Vaccine by the end of the year. They secured 100 million doses from a during a 100 million doses from Pfizer.
43:14 Have contracts in place for astra zeneca, novak’s. And, you know, the list goes on with the six vaccines that they had identified. The question, of course, right now, is, knowing that the Pfizer vaccine as as efficacious as it is, how can we scale the delivery? Even beyond that hundred billion doses operational, Warp speed did not contribute to pfizer’s development of the vaccine. I think that’s important to note, because they don’t have visibility into the manufacturing, the supply chain, the raw materials procurement and so forth. So, the discussions right now, or how can the government US. Government help Pfizer where there might be some challenges or roadblocks of securing some materials so that they can scale the ability, including the manufacturing, to scale their ability to to deliver more doses because operation works. We did not contribute to the development, and their contract was for 100 million doses plus an option for 500 million doses. Pfizer, have the option to contract out with other governments.
44:10 So they have contracts in place to deliver doses to the UK, to Brazil, other places in the world. And so there’s this question around or others a little bit ahead of where we could be. But again, it’s important to think about what Operation Warp Speeds plan was, which is a full portfolio approach, right? Not putting all the eggs in one basket. When these contracts for secure it back in June, July, we did not have insight that these are going to be 95% efficacious, you know, vaccines or the safety. So, you have to be able to spread that risk and so, is it appropriate for them to do that? Now is an appropriate time to try to make sure that we’re addressing any of the supply chain issues if they are issues to make sure that we’re getting additional doses coming out of Pfizer. Also important to note that we have Madonna.
44:53 As well, we’re operation where they did contribute to the clinical development and worked very closely with NIH In terms of even ongoing clinical trials starting at Phase one. So there is line of sight into all of the different manufacturing capacities to be able to scale the number of doses that are coming out. Of Maduro. No. Of course, there’s 100 million. And then the options for more additional doses as well, two point nine million doses have already been shipped out. That’s what’s being distributed now.
45:20 The news of it’s being used in different places. Another two million is expected black by next week. We’re just going to continue to see more doses available as we get through the end of December into January, February. But it will be ramping up over a period of time.
45:35 And I want to follow up on this, because I actually kind of want to know and asked if you agree. I mean, it seems to me pretty remarkable that we have this number of doses already. And, you know, I think in the, earlier, in the summer, in the spring when we were talking about vaccine development, you know, one of the key points that was made was that part of the way that the timeline was, was accelerated, was not by cutting corners on the science.
46:00 But, in fact, it was by sort of parallel processing some of the supply chain, you know, procurement, some of the manufacturing, and that in fact, that the companies actually manufactured a lot of these doses at risk.
46:13 Kind of knowing that if if the results weren’t so good, they would kind of throw those out. But if the results are good, they’d be like ready to go.
46:21 So I wonder if you can comment a little bit on that and you know I know earlier in the pandemic there were supply chain you know concerns as well like just you know maybe what has gone well from your perspective.
46:33 Yeah, I mean I do think that at risk strategy has gone well.
46:37 That’s why we are able to see within 24 hours have an EUA doses being shut down. And I would love to get LJ to comment on this as well, but that did work, which, never really is the strategy. If you’re a commercial product, sponsors, to put your business, you know, portfolio. And on the line, by Manufacturing, 100 million doses of vaccine, That has not made its way through phase. three clinical trials. That’s unheard of. And so what?
47:07 we determined as a country and many others around the world, including SEPI, for example, the Coalition for Epidemic Preparedness Innovation also committed to the strategy which is, we’re seeing the devastating impacts on human lives. We’re seeing the devastating impact in terms of the economy. When we weigh that, that cost benefit analysis and say, if we put $500 million for advanced manufacturing, what does that compare to? All of these are the ripple effects that we’re seeing. Losing $1000 billion a month in terms of the economic effect. That made sense. We never really have this kind of a government sponsored approach to vaccine development. That is why we’ve seen the process go much more quickly, and we’ll see that, in some cases, we do get some vaccines over the finish line. In other cases, we don’t. And we made that investment, and we decided that was the right approach. But it would not otherwise be commercially feasible.
47:58 And I know we could talk for hours about the business model of vaccines, and maybe, well, I’ll have a panel on that next year. I know maybe this will be an approach that’s used in the future, I don’t know.
48:09 Um, well, I mean, just really quickly that is, I mean, that’s a novel approach to think about. Particularly where they’re not incentives for infectious diseases. I mean, that was the challenge for a number of these companies which is right now we’re in the middle of a pandemic. There’s a lot of attention a lot of dollars.
48:24 We tend to forget and go back to life as normal and these companies don’t have a commercial incentive to continue developing platforms or potentially pandemic pathogens right? So we do need to think about that and make them another panel.
48:37 Yeah, absolutely. Hate me, I want to turn to you. And, you know, we’ve, we’ve, we’ve now talked about, you know, phase one and phase one B, and then, you know, and then there’s, there’s some, some issues around, like, who is an essential worker, And is it teachers? And, you know, well, will there be vaccine mandates? I just first, let me just kind of fuel level setting question, I mean, what, what is the timing? like, how, how far away are we from?
49:05 As we as it stands now, you know, from kind of the more more general public getting the shot, as opposed to, you know, the, obviously, the critical population that we’re talking about right now, and in the earlier phases.
49:19 Yeah. Maybe just breaking it down, but which could estimate the population? Numbers would help though. You know, after I think so eloquently talked about how we got to the 200 million back theme currently that the federal government purchase, which is fantastic.
49:31 But just to give you a sense, in Phase one A, there’s estimate that, you know, the healthcare personnel are 21 million and I should say of that 200 million. It’s really only 100 million people because they have to get two doses. 49:43 So, we’d like, we have 100 million covered right now and more, more to come, but just, that’s what we’re working with.
49:48 The healthcare personnel is around 21 million, long-term care facility residents is around three million.
49:54 When you get to the essential workers, if, like the bigger bucket that’s non healthcare that upwards of 87 million across the country, And then when you get to the adult with high risk medical conditions that are over 65 years of age combined, it’s potentially up to 150 million combined, 100 million with just the adult. And then the above 65 is another $50 million.
50:18 So you know just adding that up quickly you’re around 261 million or just phase one.
50:25 So you know I think it’s all there’s a lot of factors of, you know, how many more doses will you know the Pentagon to be able to procure. They’ve really done a fantastic job. I think of doing what they’ve done So quickly. How many more effective than how quickly are they going to be getting an EUA?
50:42 You know that will time will tell on that hopefully fairly soon but these are all factors to know like how quickly you’re gonna be able to get to the later B, the B two, B three and then the general population and feeds for.
50:54 I think you know anecdotally a number of experts that then I’d be curious about after an LD comment. 50:59 It’s really going to be like summer. Before we really the vast majority of the country being back, the needed.
51:07 The other piece to the vaccine hesitancy piece and how effective are we going to be on the messaging? I think the hope is that we’re gonna do all the things we need to do and get the message out and people will see that it’s OK and it’s important to get it.
51:17 And then, you know, we’ll be able to catch up on those that may not initially want to get the vaccine, but it’s all about the supply and the rollout had to know where we’re going to be.
51:28 The other thing, I just have to think, they feel like I need to comment on it on every one of the talk, that also educating the public that, you know, that the vaccine is an incredible development, but not going to solve everything in the next month. 51:40 We’re in the longer haul with our faith math and our physical distance thing.
51:47 And our, you know, avoiding crowd than all of these other measures that we’re, we’re still doing because, you know, I just did a whole thing on health care capacity, and California’s in the lead now, But I mean, they in some of their places, it’s another county there, It’s almost 0% ICU capacity.
52:03 I mean, we are really in the midst of the third surge, and so we can’t let our guard down with respect to all of the other things. We need to do, the back.
52:10 They need incredible development, but it’s going to take time, before we really can stop all of these other. 52:16 Yeah, we gotta get through it in order to get out of it.
52:19 Yeah, exactly, And Tired. You know, people are tired. You’re going in terms of that message.
52:30 I know, we’re all, you know, exhausted, and, and, you know, and I think, where some of, the lucky ones that get to work from home, and that kind of thing.
52:39 And I wonder, just, you know, again, in terms of public health messaging, like, let’s say, OK, the vaccine does start to get rolled out. What’s the threshold by, Which we can all kind of feel a little safer going out in public. You know, what is the are we going to start also still have to wear masks as a social distancing? I think everyone’s wondering that. Right? Like, how long is that going to last? And do we know the answer to that Yet?
53:04 The gold standard. How we measure that obviously as everyone neuron is, when do we achieve some kind of community immunity, Right?
53:09 I mean, And that’s so, that’s the million dollar question because if I think if we can have community immunity, we will stop transmission. But, but there are caveats with all of that. So, So, I think, if you may have heard doctor … has already said that he’s thinking that, maybe we’ll get there by name.
53:24 And the reason he’s thinking that is because of some of the numbers Hemi has just talked about. Because, if we get through phase one C with enough capacity for vaccines, and that’s another thing to do, we have enough vaccine.
53:33 We will have essentially vaccinated two thirds to three quarters of the US. population.
53:38 I mean, so, so, that’s pretty darn close, if you think you take into account already infected population. Let’s say, we have a 10%.
53:47 So, conversion rate, and I note, and deserve Sero conversion study that CDC is actually doing to see exactly how many people might have converted, right? So let’s say we have 10% zero converted.
53:57 And if you take a 95% effective vaccine and are not, which is how effective, the vaccines are infectious viruses of, let’s say three, you’re looking at having to get about 70 to 75% of the population vaccinated.
54:11 So, that’s in 65, if you think 10% already infected, So, I think so, I think we can get there.
54:16 I think we can really get there, though.
54:18 So, that’s why it’s so important to think about, how do we get people are sure to get vaccinated, because that is the way that we’re going to have to get out of this.
54:30 Yeah, there is no alternative there. 54:33 Thank you. And we’ve had a number of questions come in about vaccine mandates, and I know that’s kind of generally a very controversial topic. But, you know, maybe update us to follow on that, I mean.
54:44 Do you think that schools employers are going to mandate the vaccine? Is it going to be necessary, like, what are your thoughts for the others to be under some, because this is an evolving process, clearly. I think, I think, all of us would rather make no, especially since this is still an adult vaccine.
55:03 It’s not that I don’t see a pediatric indication for this for awhile. So, we’re looking at an adult vaccine, maybe down to 16 years of age, for the Pfizer vaccine, and and, and in the adult US population.
55:15 Other than the health care population, for flu, we have, we do not do well with mandates. It’s not something that, that it’s just something that will not used to using. For example, in all other employer settings, we do not use mandates.
55:28 And even with flu, where we have incredible track record of vaccine safety, there’s still a lot of resistance with regards to a mandate for influenza vaccination. I think one of the challenges and I know a lot of my colleagues for ethicists will disagree with me on this one, of the challenges obviously with with a coven 19 Vaccine is that were.
55:53 We’re not yet there, with a lot of the long term data with regards to this vaccine.
56:00 And so the question then is, can you ethically make a condition of employment for Coburn 19 vaccine in the absence of some long term data with regards to safety?
56:12 So, I think and efficacy? Absolutely. Right. So, I think that’s a starting point for conversation.
56:17 And I think so, the hope is, is that what we will understand as the whole world gets vaccinated is that, you know, we will continue to survey. We’ll see. We’ll see data on this.
56:27 Vaccine continue to come in and that people will get vaccinated because of its benefit to themselves and also to the community. And that, that mandates will not be something that we have to consider.
56:39 But, again, I would love to hear what estrin him, you have to say, I know we’re short on time, so I’ll just say really quickly. Which is that we’re talking about emergency use.
56:48 Authorized vaccines, not licensed vaccines, right?
56:52 So, flu vaccines are licensed. And another is that if you go through the pediatric schedule and some of the adult vaccine or licensed, we’re still in the middle of the emergency use context. So that we have to keep that in mind. I think it’s premature for us to talk about mandates under E waste, where additional data is coming in real time, as we’re seeing experience beyond the clinical trial population. So I think everyone just needs to take a breath and just slow down in terms of where we realistically are.
57:20 That being said, what we’ve seen even in the context of testing, for example, is that countries are creating whether their immunity passports or testing passports to say, You can travel from place A to place B.
57:34 If you can show a negative, you know, covered 19 test, we can imagine a scenario where you can show your vaccine card proof. And it allows you maybe to travel between jurisdictions nationally and internationally, in a different way. But I think that’s a little premature for vaccine mandates.
57:51 I also think the certificates maybe a little premature to, because we don’t have a lot of the science on the vaccines ability to stop carriage, So I think that’s something we, I would fully expect it’s going to based on the rigorous immune response it promotes, but I think carriage remains still something we need to validate and they’re working on it.
58:10 Hey, maybe we’ll give you the last word here given given that we are short on time.
58:17 Unfortunately, what are your thoughts on? The question? are more broadly. on the Let me let me ask you a fair question.
58:26 Yeah, and I do wanna, yeah, OK, great point that, like, even if you get the vaccine, in other words, what you’re saying is we still don’t know whether someone might be able to actually be, still be an asymptomatic carriers, but we won’t know that. Well, let me, let me ask you just sort of, as as a, as a, as a quick final question. I just want to go back to something that Esther said earlier, around the uninsured, the homeless, The very, very most vulnerable populations and how our states and localities preparing for that addressing what are what are some of the things on the horizon there.
58:59 Yeah. In a number of the states have been concerned about that population, there’s one day there could be more that actually have included prison populations and homeless populations in the Phase one, A priority group, which is Massachusetts.
59:12 So, you know, I think there’s a concern about that.
59:14 I do think that there, with an interest in trying to get to those populations first, with respect to homeless and people in prison, the uninsured, I think it’s more challenging. I think that’s where we really have to, I really would totally, in sync with … comment on this.
59:30 I think that’s where, you know, we’re going to leave people behind if we are not very focused on how we reach those populations. And that gets back to kind of what we talked about earlier, with respect to, like, where are you going to be able to give people access? There has to be, you know, free vaccination sites that are accessible to those folks that they feel like, are safe places to go. And you have to be really targeting your outreach to them, so they are hearing about this, and understand why that the place.
59:57 And, you know, those folks may or, may not want to, you know, register themselves, would be the, right, if they don’t have insurance, or, you know, perhaps, they’re undocumented. I mean, there could be other reasons why they may not want to disclose a lot of information from the government. And so, how do we reach those populations?
1:00:13 Is going to be, I think, the biggest challenge.
1:00:14 I also just wanna say that, in terms of all of us, you know, working together, you know, on this panel and beyond, if it’s a huge partnership.
1:00:22 And, I think, you know, from the national Federal government perspective, all the way down to like the people in barbershops, then, you know, hairdressers and churches, and, you know, they’re really, I think, have to be a concerted effort across the entire system to get people information.
1:00:39 Because some of the people that we want to reach, especially the uninsured, aren’t going to be reading what you and I read. In the news. Exactly. Well, I do, I do. I’m going to take moderator’s prerogative and then this kind of season of help ask each of you to kind of, and I’m very quickly unlike.
1:00:56 What is a note of hope for you and all of this process? And if you could articulate that, and kind of, just a sentence or two, that would be amazing. So all day, we’ll start with you, and then we’ll go to Temi and then Esther.
1:01:11 So, I think the Season of Hope, message I can give and I think I hopefully haven’t stolen nesters, fire, and this one is I think the research and development process that we show that we that we put through to get this vaccine into into arms, right?
1:01:28 Was remarkable and I think there’s a lot that we can learn from this in terms of getting pharmaceutical products, biologics for rare diseases And other other conditions out there, in the same way. I’m not saying, and I know this can be, can be like, really hard for some people, I’m not saying that we want to bypass clinical trials. But the clinical trial process as good as it is is a huge long process, especially when we’re leaving people behind because of their conditions being rare disease or otherwise, right. And I think we’ve learned something from this process with the R&D, with this vaccine that maybe we can adapt over post pandemic to a lot of future drug as well as biologics approval processes. So, so, that’s my, my hope that will happen and I hope the FDA is listening.
1:02:18 Thanks Amy, what do you think?
1:02:21 I think that in some ways a pandemic has brought a lot of groups together that never talk to one another. And, you know, my hope is we have the amazing development of vaccine and you just see so many different types of people donating their time and wanting to get involved and really being a part of really trying to be part of the solution. And so I hope with those many partnerships that have been, you know, slowly building over this code would respond can really help us get over the finish line with respect to getting vaccines into the arms of millions.
1:02:50 Thank you, Esther and I agree with the two and L J plus one for what you just articulated as well and partnerships. Hey, me.
1:03:00 I would just say, which is sort of an inverse, hope is the attention that span placed on systemic racism and racial inequality and social justice in this country. And, of course, it’s coming out of tragedy, right? It’s coming out of complete devastation for certain communities.
1:03:19 But I think we’ve captured everyone’s attention that this is a core area that we need to address in an ongoing way in a sustained effort over the next however many years it takes us to raise the level of the quality of care for all populations. So that gives me hope.
1:03:35 Yeah, absolutely. Thank you, Conversations that need to be had that have have been needed for a long, long time, or are finally happening. I think that’s that is really helpful.
1:03:48 Well, thank you. Thank you all very, very much for for your just this amazing conversation. I go back to my my sixth grade teacher: Who taught me the word scintillating. You know, because he liked to teach us words in this. There’s been a scintillating conversation and did, just just really enlightening. Thank you very much to our Alliance Audience, thank you for joining us, and what has been the final Alliance webinar for this year of 2020. We hope you will join us again in the new year. Keep, keep us posted on your thoughts on health policy dot org and fill out the evaluation that you’ll receive to Esther Profile LJ. Shannon … And thank you so much for the amazing work you’re doing and have a wonderful holiday and new year. Thank you.
1:04:37 Thank you, thank you. Thank you for that.
1:04:39 Sarah, Happy Holidays, Happy Holidays. Hi, everybody.