10/21/20 – Dr. Jason Schwartz

Name: 10/21/20 – Dr. Jason Schwartz
Uploaded: 2020-10-23T13:20:15.697Z
Duration: 1 h 1 min 51 s
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October 23, 2020

For CME Credit, please read the CME announcement for this lecture.

For Community Practitioners, please read the following CME announcement

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00:09minute or two to let some more people join
00:16in as I'm sure people are just arriving.
01:20the Department of Pediatrics.
01:27Just a couple of announcements before
01:30we introduce today's great speaker.
01:32First next week we have John Hughes
01:35from the Department of Medicine who will
01:39be talking about rationing of care,
01:41an equity very timely topic.
01:44And then on November 4th will
01:47be hearing from Albert Co.
01:49Who is chair of the Department
01:52of Epidemiology and it's also
01:54professor of Medicine at the Yale
01:57School of Public Health.
01:59And he's going to be talking about
02:01reopening Connecticut as the
02:03COVID-19 epic evolves and Albert
02:05has played a major role in our state
02:08of Connecticut's plans for covid.
02:10So you want to be here to hear that?
02:15Wanna remind you?
02:16Also coming up is the monthly pediatric
02:19education learning community series.
02:22Doctor Brittany James will be
02:24speaking on anti racism in medicine
02:27and then in November we will be
02:30having Heather Dahlquist.
02:37And final announcement is where
02:39nearing the end of the window for all
02:43of our APS and positions to complete,
02:47the annual Wellness survey.
02:49It closes on October 27th,
02:51and so I urge you to participate.
02:55Our goal really is to be where
02:58other academic medical centers
03:00who participate in this survey,
03:03which is around a 60% participation rate.
03:07Typically at Yale,
03:09New Haven Hospital and Yale Medicine,
03:11we have a 30 to 35% so really some
03:15real opportunity on the upside
03:18to improve our response rate.
03:20Currently,
03:20the response for Pediatrics is
03:2331% for apes and 35% for MD's.
03:27Would really like to be at
03:2950% within the next week,
03:30so I really encourage you to
03:32take that survey.
03:33It was an email that came
03:35from Christine Olson.
03:36There's an email that's going
03:38out today about this.
03:39They'll have information so you can look.
03:42There's an individual link for each person,
03:44so you need the link that was
03:46sent to you in your email and
03:48in an announcement today that's
03:50coming out from Andy and I.
03:52You'll see when those emails were
03:54sent so you can look at the survey.
03:57Does take between 20 and 30
03:59minutes to complete.
04:00But I do encourage you to complete it,
04:04'cause really,
04:04those that information that we
04:07gather from that really guides
04:09our department's efforts and the
04:11hospital in the schools efforts and
04:14improving engagement and Wellness
04:16for all of our faculty and apes.
04:19So please participate.
04:20We need your voice.
04:22Now today's grand rounds.
04:24There are no disclosures,
04:26no commercial support,
04:27no conflicts of interest,
04:28and I want to remind you that it
04:31is available for see me as long
04:33as you signed in using your normal
04:35credentials that you use for grand rounds,
04:38which is your net ID.
04:40Please write questions in the Q&A
04:42section of the zoom meeting as you
04:45go along or at the end will have
04:47an open time for questions and
04:49you can indicate by raising your
04:51using the raise your hand function.
04:54So with that I will leave it to Mona
04:57Sharifi to introduce today's speaker.
05:00I everyone, it's my pleasure to
05:02introduce our Grand Round Speaker today.
05:04Doctor Jason Schwartz,
05:06an assistant professor in the Department
05:08of Health policy and management at
05:10the Yale School of Public Health.
05:12He holds a secondary appointment in
05:14the section of the history of Medicine
05:17in the Yale School of Medicine.
05:19Doctor Schwartz is a graduate
05:21of Princeton University and the
05:22University of Pennsylvania,
05:24where he got his PhD.
05:25Prior to arriving at Yale,
05:27he was the Harold T Shapiro Fellow
05:30at the Princeton University Center.
05:32Human values and earlier an associate
05:34fellow and lecturer in the Department
05:36of medical ethics and health policy
05:37at the University of Pennsylvania.
05:40Interesting Lee.
05:40He was also a staff member for President
05:43Barack Obama's presidential Commission
05:45for the study of bioethical issues.
05:47His research is focused on the ways
05:50in which evidence is interpreted,
05:52evaluated and translated into regulation,
05:54policy,
05:54and medicine and in public health.
05:57He's written by widely on vaccines
05:59and vaccination programmes,
06:00decision-making in public health policy,
06:02and the structure and function of scientific
06:05expert advice to government doctors.
06:07Which publications have appeared in
06:09the New England Journal of Medicine,
06:12the Journal of American Medical
06:14Association JAMA JAMA Pediatrics,
06:15the American Journal of Public Health,
06:18Health Affairs, and elsewhere.
06:19He's also responsible for authoring the
06:22chapter titled Ethics in Plotkin's vaccines.
06:24For those of you in the know,
06:27this is the leading textbook of
06:30vaccine scientists and policy,
06:31and he served as editor of
06:34vaccination ethics and policy.
06:35You know another textbook.
06:38He's also has upcoming.
06:41A book that he's writing.
06:43Additionally going over the role of
06:45expert committees in influencing policy.
06:47So be on the lookout for that.
06:49On a personal note,
06:50had Jason has the most extensive
06:52collection of conference ID's,
06:54ID badges on display in his office
06:56over at 60 college St and he teaches a
07:00very popular and well loved intro to
07:02health policy course at the school club,
07:05calpin is beginning a new course this
07:07spring on vaccination policy for
07:09Masters of public health students.
07:11We are so delighted to have Jason
07:14speak with us today about childhood
07:16vaccine policy during COVID-19.
07:18Thank you,
07:19thanks to everyone for for the invitation
07:22for the opportunity to be here.
07:23Let me pull up my slides while I
07:26get started here. Second there.
07:29It really is a pleasure to be here.
07:33I think I was going back through my emails
07:36and it was March 5th when the invitation
07:38first came to join you all here today.
07:40And obviously the world has
07:42changed considerably in the in
07:43the seven months since then,
07:45as we think about Kovid and how
07:47it's transformed our health care
07:48system and transformed our lives
07:50and for someone like myself,
07:51it's not a lot about vaccination policy.
07:53Obviously this is an important time
07:55in thinking about the development,
07:57the regulation of the implementation
07:58of vaccines,
07:59and how they can be a really
08:01important tool in our response.
08:02As we're also eagerly awaiting
08:04and hearing about.
08:05About the development of vaccines against
08:07COVID-19 in our broader vaccinations system.
08:09So that's my plan for today is to think
08:12about starting with an introduction.
08:14I know there's lots of expertise,
08:16lots of different specialties
08:18among among all of us here today,
08:20to provide a bit of a background about
08:22how US vaccination policy typically
08:24unfolds at the federal and state level,
08:27and then to transition to how the
08:30work ongoing around COVID-19 Vaccine
08:31Development and the plans for
08:33regulation and policy are overlaying.
08:35Are breaking the mold in many
08:37respects in that traditional model,
08:39yet still trying to find that
08:41sweet spot between speed and rigor,
08:43innovation,
08:44and consistency as I as I know here,
08:46both in the general level,
08:48and then certainly saying a bit
08:50about where we are with respect to
08:52vaccines in pediatric populations
08:53with respect to plans for testing
08:56and then downstream considerations
08:57regarding regulation and potential
08:59use of covid vaccines off in the
09:01horizon for children and adolescents.
09:03So will spend some time on that.
09:06And then I'll close with some
09:07thoughts on routine childhood
09:08and adolescent vaccination,
09:10which remains every bit as
09:11important as it always is,
09:13but has faced challenges as many of you,
09:15I'm sure,
09:16have known and seen and
09:17heard during COVID-19,
09:18and then the importance of
09:20sustaining routine vaccination
09:21both for early childhood vaccines,
09:22adolescent vaccines,
09:23an influenza vaccination,
09:24even while all of our vaccine
09:25attention seems to be focused on
09:27this race for COVID-19 vaccines.
09:29So that's my my focus for
09:31our time together today.
09:32I'll give you a spoiler alert here,
09:34and this is basically my last slide,
09:36which I'll show you early in the
09:39talk to show you where I'm go.
09:41Going in what messages I hope to
09:43convey to you in the next 3540
09:45minutes or so and there was follows.
09:48I think it's really been remarkable how
09:50much progress we've made so far with
09:53Covid Vaccine 19 research and development.
09:55You know where we are right now is amazing.
09:58Given how short in the history
10:00of the SARS Co V2 virus and the
10:02disease we are that we have such a
10:05promising landscape of potential
10:06vaccines in development,
10:08that's a great thing.
10:09But there is important
10:11and difficult work ahead.
10:12That will balance that innovation with
10:14making sure that the kinds of time tested,
10:17well established processes that we
10:19have for evaluating vaccine candidates
10:21for recommending their use and for
10:23deploying them are allowed to do the
10:25important and valuable work that they
10:27need to do to preserve public trust
10:29in vaccination and to ensure the
10:31vaccination programs proceed smoothly.
10:33Vaccine distribution will be
10:34tremendously complex, as I'll talk
10:36about just an enormous challenge.
10:38Every bit is difficult, I think.
10:40Is developing these vaccines,
10:41and will require resources,
10:43coordination, and collaboration that.
10:44We are just beginning to move forward
10:47on as a country in terms of thinking
10:49about what happens if and when we've
10:51got a good vaccine for children.
10:52There's a long Rd ahead as well
10:55as I'll say in a little bit here.
10:57If we're thinking about potential
10:58cobin 19 vaccination of children,
11:00especially young children,
11:01and I'll say a bit about what needs
11:03to happen to get us there and then,
11:06as I mentioned,
11:06there's this urgent need to reverse
11:08the declines we've seen nationally,
11:10at least in routine vaccination
11:11during COVID-19,
11:12as well as making that that
11:14strong case for the high.
11:15Influenza vaccination uptake.
11:16We want in all populations,
11:18including children,
11:18as we head into this fall and winter season,
11:21and we think about you know what
11:23may lie ahead with respect to Cobit
11:26and influenza and those issues,
11:28so that's where I'm specifically going to
11:30head over our time together in the next.
11:33Bit of time.
11:34So with respect to sort of
11:36vaccination policy.
11:37Overall in terms of sort of the fundamentals
11:39of how we think about vaccine policy,
11:42there are a number of issues that are
11:44always in the background of policy makers,
11:46regulators in public health officials,
11:48all of which point to the
11:50importance of safety,
11:51importance of confidence in vaccines,
11:52and how we use them,
11:54how we evaluate them and that
11:56there can be no compromise.
11:57Regarding the evidence we want to
11:59make sure that vaccines are safe.
12:01Some of these are Intuitive,
12:03but they're worth sort of spelling
12:05out because they do frame
12:06the conversation around.
12:07Around vaccine development,
12:08regulation and policy for giving
12:10vaccines to healthy individuals,
12:12at least with respect to the diseases,
12:14were preventing and our threshold
12:16for risk associated with prevention,
12:18I think is understandably less
12:20than we would think about.
12:22For therapeutic interventions
12:23were giving vaccines to large
12:25percentages of the population,
12:26sometimes nearly the entire birth
12:28cohort for childhood vaccines or
12:30large numbers of other age groups.
12:32So we're going to see rare adverse events,
12:35even very rare, adverse events will emerge.
12:38Giving vaccines to millions or 10s
12:40of millions of individuals again
12:42that shapes both evidence and
12:43perception about risk and safety.
12:45Children are typically the primary
12:47recipients of most routinely used vaccines.
12:49There's an important story to
12:51be told for adult vaccination,
12:53as I'll mention in adult vaccination
12:55is really at least
12:56where will be for the foreseeable
12:58future with respect to COVID-19.
13:00But the fact that children are so often
13:02our focal point of vaccination again
13:04puts a premium on safety and confidence
13:07both before and after licensure.
13:09That the risks of any vaccines
13:11are minimized and then some of the
13:14important issues for how vaccines
13:15fit into public health goals,
13:17both as as a communications challenge
13:19as well as a practical issue.
13:21The invisibility of benefits
13:23that we that we don't know,
13:25the individuals who benefit
13:26from receiving a vaccine.
13:28We don't have names and
13:29faces for those individuals,
13:31but given all the fears and
13:33uncertainties and allegations around
13:34around the safety of vaccines,
13:36individuals who allege a
13:37vaccine is caused harm in them.
13:39Do have names and faces and stories
13:41and that makes it very difficult to
13:44make sure that we're promoting and
13:46sustaining widespread public trust,
13:48both in vaccines, vaccination programs,
13:49and the individuals responsible
13:51for promoting them.
13:52And then,
13:52finally,
13:53the herd immunity herd protection
13:55story of vaccines that benefit we all
13:57receive from high rates of a vaccine
14:00and a community that protect all of us,
14:02including those who are unable to
14:04be vaccinated because age because
14:06of medical indications or because
14:08no vaccine is 100% effective.
14:09The way that it does shift how
14:11we think about vaccines,
14:12both as an individual intervention but
14:14as a public health intervention that
14:16benefits all members of the community.
14:17So those are issues.
14:18I just want to keep in the
14:20background and we'll see how they
14:22play out as we move forward.
14:24The path, don't worry,
14:26I'm not going to send to
14:28linger on this slide too long,
14:30but the path in which vaccines are
14:32developed and regulated at the federal
14:34level looks something like this.
14:35This is a paper from Larry Pickering
14:38and others here that begins with
14:39where we are right now with respect
14:41to COVID-19 vaccines with development
14:43and testing moves to evaluation by
14:46the Food and Drug Administration,
14:47which is advised by a group
14:49of expert advisors,
14:50I'll say more about in a moment,
14:53typically after a favorable
14:54licensure decision.
14:55There are recommendations generated by
14:56the Centers for Disease Control and
14:58its Advisory Committee on immunization
15:00practices that recommendations for
15:01their user published issues around
15:03financing and access are addressed,
15:04and then vaccines are made available
15:06either through public or private
15:08sector programs and then over here.
15:10This is a slide that specific
15:12over here on the right side.
15:14I'm not sure if you can see my cursor.
15:17We have parallel efforts that happened
15:19for medical professional societies.
15:20This figure of the specific
15:21to adult vaccination,
15:22but you can substitute the
15:24American Academy of Pediatrics.
15:26Redbook committee that also works
15:27to think about the most effective
15:29deployment of approved vaccines.
15:31An issues,
15:32recommendations and guidance to its
15:34members of its societies for adults,
15:36for children,
15:37for family practitioners and other groups.
15:39So I'll say more about each of
15:42these stages as we move through
15:44this this general introduction.
15:46The point to be made in the point that
15:48we've heard so much about in public
15:51discussion around coping 19 vaccines
15:52is typically the path to developing
15:55an approved vaccine is a long,
15:57torturous and a slow one with
15:58many failures along the way.
16:00This is a figure from Plotkin's
16:02vaccines that notes the many,
16:04many years that we typically move from
16:06just from the beginning of human trials.
16:08So not even the preclinical testing
16:10that happens in laboratories
16:12through just from the period in
16:14which human vaccine trials begin to
16:15when one finds a licensed vaccine.
16:17You see numbers here in the in the
16:20decades 28 years for varicella,
16:22and for Flumist, 15 years for human
16:24papilloma virus and rotavirus,
16:25and actually for rotavirus.
16:27The Rota Teq Vaccine,
16:28some of you may be familiar with,
16:30developed by Fred Clark and Stan Plotkin
16:33and Paul Offit at the Children's Hospital,
16:35Philadelphia, 15 years, was the
16:37clinical development the human trials.
16:39But there was another 10 years of the
16:41laboratory work that preceded that,
16:43so the rotavirus,
16:44the initial discovery was in 1981,
16:46that ultimately led to an
16:48approved vaccine in 2006.
16:49So a 25 year history,
16:51so put that in.
16:52Active when we think about where
16:54we are with COVID-19 vaccines and
16:56the talk that maybe in in the
16:59coming weeks are coming months,
17:01we may have one or more authorized
17:03or approved vaccines.
17:04It really is a remarkable compression
17:06of what is often a vastly longer
17:09timetable with respect to regulation
17:11we have at the federal level we
17:13have work from the Food and Drug
17:15Administration and the Centers for
17:17Disease Control and Prevention that work
17:19in parallel evaluating potential vaccines.
17:21the FDA through its.
17:22Center for biologics evaluation and research.
17:24That's the group led by Peter Marks are
17:27former colleague of ours here at Yale.
17:29For those of you who have
17:31been here for some time,
17:32is responsible for reviewing
17:34new vaccine candidates.
17:35It has a committee of Advisors
17:36whose name you see there,
17:38that I'll say a bit more about in
17:40a moment and their responsible as
17:42FDA does for drugs and devices for
17:44evaluating trial data and potentially
17:46approving the use of vaccines based on a
17:49favorable safety and effectiveness profiles.
17:51That's the FDA piece at CDC.
17:53It's advisors, the Advisory Committee
17:54on immunization practices issues,
17:56recommendations for the use
17:57of those approved vaccines,
17:58and they do other things.
18:00Track vaccination coverage,
18:01monitor safety jointly with FDA,
18:03work on promotion and education.
18:05It's worth saying a little bit about
18:07the AC IP as it's known familiar.
18:09I'm sure to some of you, but not to everyone.
18:12This is a recent meeting of the Advisory
18:15Committee on immigration practices.
18:17These federal advisory committees
18:18are open to the public meetings, or.
18:21Are in a pre kovid error.
18:23Things you could join in person
18:25but now everything is streamed
18:27and available for transparency.
18:28For open deliberation and the AC
18:31IP is most known for producing
18:33this recommended schedule that
18:35we see so often
18:36hanging up in our on the walls
18:39of our offices and your offices,
18:41in particular showing the
18:42recommended childhood and adolescent
18:44immunization schedule as well as
18:46schedules for adult vaccination.
18:47But the AC IP does other things in
18:50addition to developing that schedule.
18:52Policy making responsibilities that
18:54provide access to vaccines through the
18:56federal vaccines for children program,
18:58which makes vaccines available for
19:00nearly half of American children
19:02Medicaid eligible uninsured underinsured
19:04children at no cost once a vaccine
19:07is recommended by this group,
19:08it is purchased by the federal
19:11government and distributed through
19:12states to health care providers
19:14are really really important.
19:16Safety net for financial access to
19:19pediatric and adolescent vaccines
19:20and under the Affordable Care Act 4.
19:23Families with private insurance and
19:24a CI P recommendation transfers to a
19:27coverage requirement that insurance
19:28plans must cover vaccines recommended
19:30by this group without any cost sharing
19:32so the AC IP to put it short is
19:35incredibly influential in how we think
19:37about the shape of childhood adolescent.
19:39An adult vaccine policy in the United States,
19:42but this was a paper I wrote with my
19:45late colleague auto Mahmoud years ago.
19:47At the time of the 50th
19:49anniversary of the AC IP,
19:51which was created in 1964 and.
19:53And it's no exaggeration to say you
19:56can't tell the history of vaccination in
19:58post 1950 to 2020 and Counting America
20:01without thinking about the role of
20:03the AC IP and everything from the end
20:06of smallpox vaccination to the swine
20:08flu program to issues around vaccine
20:10safety and all chosen allegations and
20:13thigh marisol to H1N1 to where we
20:15are today so incredibly influential,
20:17will be hearing much more about
20:19their role in covid vaccines as
20:22the weeks and months proceed.
20:24That's in a nutshell,
20:25the Federale,
20:26the main players on the federal stage
20:29clearly States and municipalities have
20:31incredibly important roles as well.
20:33In a successful vaccination program,
20:36managing information systems about
20:37vaccine uptake, promotion and education,
20:39working with federal programs for
20:41vaccine purchase and distribution,
20:43and not really germane to our
20:46conversation today,
20:47but certainly relevant,
20:48and a usual topic of attention
20:50and vaccine policy circles,
20:52school entry requirements.
20:53Implementing and enforcing those
20:55those mandates for vaccination.
20:57When they are deemed appropriate,
20:59that's a state level function that
21:01cities can involve themselves in as well,
21:03so those are the main players in
21:05our vaccine policy landscape,
21:07not an exclusive list.
21:08As I note at the bottom of this slide,
21:11many other groups in the Department
21:13of Health and Human Services,
21:15the vaccine injury compensation program.
21:17There's a National Vaccine
21:18Advisory Committee,
21:19another advisory group,
21:20and there are medical professional groups
21:22like noting for this audience in particular,
21:25the American Academy of Pediatrics,
21:26Redbook Committee.
21:27Mention here which are issues,
21:29its recommendations on infectious diseases,
21:31including vaccine preventable diseases,
21:33and the use of vaccines which I
21:36should note for many years now
21:39have been harmonized with the
21:40work that the CDC does in terms of
21:43how vaccines should best be used
21:45in different pediatric and
21:46adolescent age groups,
21:48so that's the race through vaccine policy.
21:50101 a Federale, Rolla state role
21:53professional societies working together,
21:54each with different responsibilities,
21:56trying to promote confidence.
21:57And safe effective vaccines and to support
22:00through financing through education,
22:01high uptake in those vaccines.
22:03That's the landscape that we find
22:06ourselves in vaccination policy in 2020.
22:08That's the landscape upon which COVID-19
22:10vaccine development is building upon,
22:12and the most prominent difference
22:13to the story as it relates to
22:16COVID-19 vaccine development,
22:17you've no doubt,
22:18heard and seen is this operation warp speed,
22:21which I don't worry.
22:22I will not try to explain this
22:25organizational chart at the at
22:27the bottom left of this slide.
22:29But it is a reminder of what Operation Warp
22:32Speed is intended to be as we understand it,
22:36which is a government wide umbrella
22:38organization that is working with all
22:40of those entities I've just described,
22:42as well as others in the Department
22:44of Defense and some of the other
22:47special projects.
22:48Research groups to try and streamline,
22:50facilitate accelerate development,
22:51not just a vaccines,
22:52but prominently Cobin 19 vaccines
22:54as well as Therapeutics.
22:55So Operation Warp Speed is this
22:57umbrella organization led by the.
22:59The gentleman here at the podium on steps,
23:02lowy,
23:02a former pharmaceutical executive that is
23:05trying to break down the kinds of barriers,
23:08logistical or financial,
23:09that might otherwise delay the
23:11development arrival of vaccines
23:13and investing at the scale of
23:14about 11 billion dollars so far.
23:16Investing in prominent vaccine
23:18candidates to scale up both the
23:20research of those vaccines and
23:22the manufacture of those vaccines,
23:23if they are proven to be safe and effective.
23:27So Operation Warp Speed is trying to sit.
23:30Above and in dialogue with our traditional
23:32federal public health agencies,
23:34including the National Institutes of Health,
23:36which I haven't mentioned yet,
23:39but is heavily involved in
23:41research and development as well.
23:43That's where Operation Warp Speed fits
23:45in in terms of XLS an accelerator,
23:47and I think they've done a very good job.
23:50I think folks across the
23:52political spectrum recognized,
23:53and there's a story in the Washington Post.
23:55Just today,
23:56I saw that we have an incredibly
23:58deep pipeline of vaccine candidates.
24:00Over 300 of them at last
24:02count or around the world,
24:03most of which I should note her in early
24:06stage laboratory based development.
24:08But a deep bench using every vaccine
24:10technology that we've successfully used
24:11in the past and others that are being.
24:14Put forward is promising new
24:16vaccine technologies,
24:16and dozens of those candidates have
24:18advanced human clinical trials,
24:20including four as you,
24:21as you've heard and seen that are in
24:24phase three trials here in the United States,
24:262 from Maderna and Pfizer that are using
24:28a a Messenger RNA based vaccine platform,
24:31which is not one that has led to
24:33an approved vaccine but has been
24:36seen as very promising technology.
24:38Those trials underway for a few months there,
24:40approaching pretty close to their
24:42full enrollment that they've targeted
24:44there. Two dose vaccine series 28 days apart.
24:46And they are moving forward to collecting
24:48the kind of data as we talk about a minute.
24:51It might give the FDA the confidence
24:53it needs to act favorably on an
24:56authorization of those vaccines.
24:57In some populations.
24:58There's two other phase three clinical
25:00trials that are currently paused
25:01that use viral vector technologies.
25:03Johnson and Johnson, AstraZeneca.
25:04I saw just before I came on that one
25:07of those pauses the Astra Zeneca pause,
25:09both in paused because of potential
25:11adverse events while they were
25:13adverse events were not sure
25:14exactly whether they were linked to
25:16vaccines or whether they were among.
25:18Research subject that had
25:19received a vaccine or placebo.
25:21But in either case those trials
25:23had been are currently paused,
25:24but the Astra Zeneca vaccine trial
25:26looks like may restart in the US in
25:29the way that it's restarted in other
25:31countries over the past few weeks.
25:33So we have four vaccine trials
25:35and clinical development 1/5 from
25:37Nova vax that's likely to start.
25:39A phase three trial in the coming weeks,
25:42and there's again down the down the
25:44line are candidates from our other
25:45vaccine manufacturers that produce
25:47a lot of our recommended vaccines.
25:49Merck, GSK, Santa Fe.
25:50It also have vaccines that are
25:52moving through the pipeline.
25:53So while many vaccine candidates
25:55fail along the way,
25:56the thought is by having strength
25:58in numbers than at least one,
26:00if not more,
26:01of these vaccine candidates will show the
26:03kind of favorable safety and effectiveness,
26:05safety,
26:05and efficacy profiles that were
26:07hoping for in order to deploy them.
26:09On a large scale,
26:11now you've no doubt heard there's
26:13been plenty of concern about
26:15political interference in how the
26:17Food and Drug Administration going
26:19back to our sort of normal road
26:22map for how vaccine policy works,
26:24whether the Food and Drug Administration
26:26will have the independence to evaluate.
26:29Evidence that's put forward by these
26:31clinical trials by its career scientist
26:33the nonpartisan scientists at the FDA,
26:35or whether there will be pressure
26:37from the White House from the
26:39president in particular to accelerate
26:40an approval or authorization of a
26:42vaccine to meet political timetable.
26:44That obviously, as we approach the election,
26:47that window has all but closed,
26:48but there's been great concern
26:50about that and what that would mean
26:52for the confidence in any vaccine.
26:54If it appeared that the FDA's
26:56processes were not followed,
26:58that cyantific judgments were not driving.
27:00Decisions around vaccines.
27:01the FDA leadership.
27:02Peter Mark, Steven Hami,
27:04FDA commissioner and others for months,
27:07have tried to assure the public short
27:09policy makers that they will not be
27:12steamrolled that their decisions will
27:15only be made based on science and
27:18any political interference will be
27:20illuminated from the work that they do.
27:23When data is presented a regarding these
27:26particular vaccine candidates or others,
27:28so they made a very public commitments.
27:31Over the previous month,
27:33and one of those public
27:34commitments involved involved,
27:36I should say,
27:37convening it's Maxine
27:38Advisory committee that I
27:40noted a few minutes ago the
27:42vaccines and related biological
27:44products advisory committee,
27:45a group of non governmental
27:47expert advisors from medicine,
27:49from Pediatrics from Infectious Diseases
27:51that is typically consulted in open public
27:54sessions regarding new vaccines that are
27:56being considered for potential approval.
27:58the FDA has committed to bringing
28:01this committee together for.
28:03Each and every vaccine candidate that
28:05might be considered for approval in the
28:07coming months and justice tomorrow.
28:09You'll see a lot of attention to it
28:12tomorrow the committee is meeting for
28:14its first meeting to talk generally
28:16about about scientific standards for
28:18covid vaccines and what it will be
28:21looking for when the data becomes
28:23available in the coming weeks and months.
28:26Paul Offit,
28:26well known vaccine developer and
28:28vaccine advocate and scientist at
28:30Children's Hospital Philadelphia,
28:31is a member of that committee.
28:33You'll be you'll be seeing and hearing
28:35a lot from him and his colleagues
28:38again to use these open public meetings
28:40as a sign of transparency as a sign
28:43of scientific rigor as assigned to
28:45say that political interference
28:46or political considerations are
28:48not shaping how these vaccines are
28:50evaluated in which is viewed as a
28:52prerequisite for the kind of public
28:54support that will be needed for
28:56these vaccines to be effective.
28:58One of the concerns around Covid
29:01vaccine policy is this use of
29:03emergency use authorizations.
29:05EU AA, as they're called,
29:07the procedures,
29:08the provisions that allow the Food
29:11and Drug Administration too.
29:13Expedite the availability of interventions,
29:14not just vaccines in a health
29:16emergency on a based on of generally
29:18lower standard of evidence,
29:20and there have been controversies
29:22around the use of this.
29:23You a policy for hydroxychloroquine
29:25earlier this spring regarding convalescent
29:27plasma this summer and there have
29:28been concerns that this mechanism,
29:30which is a lower bar in general,
29:32will be used to bring forward Kobad 19
29:35vaccines to the public in the coming months.
29:37I think is the point of fact.
29:40It will be we're not going to
29:42have the kind of traditional.
29:44Approval anytime soon for COVID-19 vaccines.
29:46Given the time and and complexity that
29:48goes into that process in its review.
29:51But the FDA has tried very hard
29:53to signal in guidance documents
29:55like the one here on this slide,
29:58that there will still be very
30:00rigorous standards for the use of
30:02this regulatory mechanism to authorize
30:03vaccines for wide distribution.
30:05There still going to need to
30:07be several months of safety.
30:09Follow up that the clinical endpoints
30:12that show the vaccine works will
30:14still need to be met.
30:16They yeah has tried to signal that the
30:18UA is not going to be cutting corners
30:20in terms of evidence about the vaccines,
30:23but it's going to be trying to
30:25balancing speed and rigor in terms
30:27of the scientific requirements and
30:29the administrative requirements.
30:30That will help expedite the arrival
30:32of vaccines,
30:33so you'll hear more about that as well.
30:36I had a piece just a few weeks ago
30:38in the New England Journal that
30:41talked about this importance of
30:43transparency and scientific integrity.
30:45Meetings of advisory committees happening
30:47in public scientists, being able to.
30:49The Food and Drug Administration in
30:51CDC being able to go about their work
30:53free from political interference.
30:55How important those sorts of activities.
30:57Those process based activities will be
30:59to public trust in any vaccines that
31:01are made available in the coming months.
31:03And as I'll show in a little bit,
31:06as you may have seen,
31:08the survey data is not great by a long
31:10shot in terms of public enthusiasm
31:12for receiving these vaccines,
31:14if and when they become available,
31:16so there's going to be a really important
31:18educational and promotional strategy.
31:20To assure the public that safe and effective
31:22vaccines are in fact safe and effective,
31:25and that the scientific review has
31:27been preserved in order to have
31:29these vaccines reach to the kinds
31:31of populations and the number of
31:33populations that we want them too.
31:35So I so I reflected on that with
31:37respect to both the FDA's role in covid
31:40vaccines and I'll talk about now,
31:42the role of the CDC,
31:44who will we expect and have they've had,
31:46in practice,
31:47really be the lead federal agency for
31:49the distribution and deployment of vaccines?
31:51FDA says does this vaccine work?
31:53Is it safe? Is it effective?
31:55CDC says how do we use it?
31:58How do we get it to the places
32:00that needs to go?
32:02How do we maximize its benefits
32:04for individuals and populations?
32:05That's the role they play
32:07for routine vaccination.
32:08That's the role they played in
32:09the 2009 and 20 ten H1N1 influenza
32:11emergency vaccination program.
32:13And that's the role they will
32:15presumably play now.
32:16It's still not entirely clear as there's
32:18been so much controversy surrounding
32:19the CDC's role in autonomy in the.
32:22Federal government scope.
32:23In response.
32:24We know that the operation works
32:26Speedo WS and the Department of
32:28Defense will have some role in Covid
32:30vaccine distribution and delivery.
32:32How those lines of authority and
32:34responsibility work right now are
32:36frankly still not entirely transparent,
32:38but we expect the CDC will have
32:40a very high active role,
32:42particularly in the event that
32:44there's a presidential transition in
32:462021 when most of these vaccination
32:48programs will begin,
32:49so the CDC has gone about its planning,
32:52issuing a very detailed.
32:53Preliminary plan for what a kovid
32:55vaccine distribution program might
32:57look like that was released last month,
33:00and it noted a few things that
33:02particularly this figure that talks
33:04about really what the life cycle
33:06of a covid vaccination program,
33:09whenever it starts.
33:10Note that there's no time dates on
33:13this X axis here that we know there's
33:15going to be a period following
33:18the approval of the first or
33:20subsequent covin 19 vaccine,
33:21where there's going to be scarce supply.
33:24Windows are limited and difficult
33:26decisions will need to be made
33:28about how we prioritize the use of
33:30limited vaccine doses for some,
33:32not indefinite.
33:32But for some finite period of time,
33:35which will then transition to
33:36a period where supply will
33:38rapidly increase, the distribution
33:39will widen in terms of the locations
33:41where vaccines are distributed,
33:43who's who's delivering them
33:44and for whom they recommended,
33:46and then at some point in a happy point,
33:49hopefully not too far in the
33:51distant future about vaccination
33:52may continue in a limited way.
33:54It may continue as a routine vaccination,
33:56we don't know, but the.
33:58The surge of vaccination in the
34:00hundreds of millions of doses.
34:02We would presumably need in the next
34:04year or two would subside and we hit
34:07some sort of equilibrium with respect to
34:09how we think about kovid vaccination,
34:11but this period that circled is
34:13obviously the most imminent in the
34:15one that raises challenging questions.
34:17the CDC advisory committee and
34:19immunization practices that group I
34:21mentioned a bit has been thinking
34:23hard about how we evaluate,
34:24recommend,
34:25and deploy covid vaccines as a public
34:27health tool since this spring.
34:29Convening a workgroup subcommittee
34:31effectively that's reviewing the
34:32data in parallel with what the Food
34:35and Drug Administration is doing,
34:37thinking about prioritization.
34:38Thinking about the kind of data
34:41that will be needed,
34:42thinking about how it can shape
34:45recommendations as soon as we have
34:47an approved or authorized vaccine or
34:49vaccines to facilitate the rollout,
34:52a vaccination programs abroad
34:53group with interdisciplinary
34:55representation representation from
34:56the American Academy of Pediatrics,
34:58among them, Sean O'Leary.
34:59Meeting weekly and meeting publicly
35:02each month to discuss the planning
35:04in real time so that no time will
35:06be wasted if and when one of these
35:09phase three trials reaches a favorable
35:11outcome with one of the issues that
35:13CDC and others are very much concerned about.
35:16As I noted,
35:17are those points around allocation around,
35:19who to prioritize in the early
35:21stages of a vaccination program when
35:23we know supply will be increasing
35:26but will still be limited.
35:28CDC has not finalized its guidance.
35:30The AC IP in particular has not finalized
35:32its guidance for prioritization.
35:34They're going to wait until we
35:36have a particular vaccine where
35:38we know its particular profile,
35:40whether there's any risks or
35:42particular benefits and subgroups,
35:43but where they're headed is shown in
35:45this slide that they've been discussing
35:48at some of their recent meetings.
35:50An initial stage that focuses
35:52on health care providers,
35:53ascential workers, adults,
35:54adults with high risk medical conditions.
35:57That's that large circle there.
35:58As well as older Americans,
36:00and even if you note the
36:02overlap in the Venn diagram,
36:03we don't know exactly the degree
36:05in which those overlaps are.
36:07You can see there are 10s of millions
36:09well over 150 million Americans
36:11who will fall into one or more of
36:14these buckets in terms of the kinds
36:16of groups for whom vaccination
36:17will be recommended first.
36:19So there's going to be even more
36:21specific decisions that will need to
36:23be made within the phase one program.
36:25And of course,
36:26it's worth noting for this audience
36:28in this group that.
36:29Only after these 150 or more
36:31million Americans are vaccinated
36:33with what is all likelihood of
36:35two dose vaccination series
36:37for our first vaccine.
36:38So so double the number of doses would
36:41we potentially get to the point where
36:43vaccination of children would be in
36:46line with these recommendations?
36:47This guidance from the federal government
36:50that states will also then evaluate and
36:52try to implement in tandem with providers.
36:55So that's one prioritization framework.
36:57There's been another group
36:58that you may have seen.
37:00A group created by the national academies
37:03at the request of the CDC and National
37:05Institutes of Health Committee that
37:07worked very quickly to issue its own
37:10framework for vaccine allocation.
37:11Our colleague Saad Omer,
37:13was a member of this group that
37:15issued again its own sort of four
37:18phase vaccine distribution plan,
37:19which, in which looks broadly similar,
37:22but it's not worth parsing every detail,
37:24but focuses with high risk health workers,
37:27first responders,
37:27individuals with significant risks.
37:29Older adults broaden slightly.
37:30But you'll see that the children come
37:33in phase three after 10s of millions
37:36more than 100 million Americans who
37:38would fit into one of these buckets.
37:40Of of these populations,
37:41critical workers, individuals in prisons,
37:43and homeless shelters.
37:44So children are clearly in the
37:46plans but not imminently,
37:48which is sort of my theme as we
37:50think about the role of children
37:53in Covid vaccination planning
37:55and development at this point.
37:57States again to sort of parallel
37:59that how things normally look
38:01narrative with where we are now.
38:03States will have a very active,
38:05very important role in actually deploying,
38:07designing,
38:07implementing all of those
38:09federal regulations.
38:10Those federal guidelines.
38:11Those federal recommendations as they
38:12do for most vaccination programs.
38:14The state of Connecticut here has,
38:16as all states were required
38:18to do by the CDC last week,
38:21has drafted a plan and a long
38:23document sort of sorting through
38:25its own thinking for how it will
38:27carry out its responsibilities.
38:29It's created advisory group,
38:30which I'm a member of Rick martinello,
38:33yet another one of our colleagues is a
38:35member of as well as community leaders and.
38:37State officials,
38:38politicians,
38:38religious leaders as part of a
38:41group that will offer some guidance
38:43with respect to allocation,
38:44education,
38:44science of how Connecticut can
38:46best use whatever vaccines we
38:48get whenever we get them.
38:50Another states have taken a broader approach,
38:52frankly,
38:53out of concern about the political it
38:55isation of the FDA's review of covid
38:57vaccines and the potential fear that
39:00that process could be compromised.
39:02Some states, California,
39:03New York among them,
39:04have said that they're going to do
39:06their own parallel review of the
39:09science as the actual trial data.
39:11To ensure that eyes were dotted and
39:13T's are crossed with respect to vaccines.
39:15Not sure that's necessary right now.
39:17I'm not sure we not sure that can
39:20complicate some of the way in which we
39:22think about deploying these vaccines,
39:24but it's a signal of the fears and
39:27uncertainties around around these
39:28vaccines and how they are used.
39:30So states will be very actively
39:32involved as well.
39:33And as I mentioned along the way here,
39:36public confidence is a huge concern,
39:37which it will be a tragedy if we were
39:40able to spend these billions of dollars.
39:42All of this work to get safe,
39:44effective, valuable vaccines that
39:45could really make a difference in
39:47the trajectory of the pandemic.
39:48Only for large numbers of
39:49Americans to say no fakes.
39:51And that's the risk we're facing right now.
39:53Clearly, if we look at public
39:55opinion data and the trends,
39:56this is the most recent from seed from CNN.
39:59If a vaccine to prevent coronavirus
40:01infection were widely available at low cost,
40:02would you personally try to get that vaccine?
40:05And you can see the numbers who have
40:07responded no would not try has grown
40:09from 1/3 to 45% just in the past three
40:12months and parallel drop in terms of
40:14those who would try to get vaccinated.
40:17So that is obviously concerning that if half
40:19the population says right now will pass,
40:21it's a red alert.
40:22I think for the kind of work that
40:25will need to be happen to both assure
40:27the public that the process the
40:29science is proceeding as it should,
40:31that vaccines are being rigorously
40:33evaluated in any vaccine that
40:35will be offered to the public.
40:36Will have the strong endorsement of
40:38the scientific community that it is.
40:40It is safe and effective and will
40:42be a valuable tool or else it will
40:44have millions of vaccines that we
40:46won't be able to use and fail to
40:48reap the benefits of all this work.
40:49It's going forward.
40:51So pivoting to children,
40:52which, as we've talked about,
40:54have been in the conversation,
40:56but certainly not the front
40:58of the line right now.
41:00There's no doubt that any final
41:03prioritization or allocation recommendations
41:04will not have children in the Hyatt.
41:06Tears in the initial stages of a
41:09large scale vaccination program,
41:10and Moreover,
41:11we have had almost no clinical
41:12testing of these kovid vaccine
41:14candidates involving children.
41:15They've been excluded from all of the
41:18of the phase three trials to date.
41:20There's been some pediatric
41:21populations included in trials in
41:23the United Kingdom and elsewhere,
41:24so we're not going to have any data
41:27anytime soon as well on how these vaccines
41:29perform in children or adolescents,
41:31and we've got a development just in
41:33the last week that Pfizer Vaccine
41:35one of those two that's moving along.
41:38Has received approval and begun
41:40planning to expand the enrollment
41:42of its phase three trial to include
41:45adolescents and age deescalation
41:46manner starting with 17 year
41:48olds and working down to begin to
41:51collect some data of how its vaccine
41:54performs and children as young as 12.
41:57So at some point in the months ahead
42:00will have at least some data with
42:02respect to safety and effectiveness
42:05of vaccines in adolescents.
42:07American Academy Pediatrics is concerned.
42:09Understandably,
42:09that this these vaccination programs
42:11might be moving full speed ahead
42:13and might be launching with very
42:14little to no evidence in terms of
42:16the performance of these vaccines
42:18and children they issued,
42:19it sent a letter to federal
42:21health officials last month,
42:22saying as I put here in very delicate terms,
42:25as the letter quotes,
42:26it would be less than desirable to have
42:29one or more stars, vaccines, stars,
42:31Kobe 2 COVID-19 vaccines licensed are
42:33available at a time with no data have
42:35been collected on the safety, tolerability,
42:37dose and regimen for children. We.
42:39Urge the inclusion of children in
42:41vaccine trials as we move forward,
42:43so calling to try and get that
42:46data so that if and when we have
42:49the opportunity to vaccinate,
42:50children will have the data necessary
42:53to be sure that those vaccines
42:55perform as we would expect them to.
42:58This topic.
42:58This topic of testing COVID-19 vaccines
43:01in children was a focal point of a
43:03yet another federal advisory committee
43:05that works on vaccination policy.
43:07National Vaccine Advisory Committee and vac.
43:10There won't be a test on all of
43:11our federal advisory committees
43:13that work on vaccines acronyms,
43:14but this is a group that offers
43:16broader policy considerations and
43:17they discussed this issue about
43:19testing covid vaccines in children
43:20at their meeting just last week.
43:22So I pulled.
43:23This is not my slide here in the middle,
43:25but the slide from one of the
43:27presentations that made the case for
43:29why we need a vaccine in children,
43:31and we need to test it sooner than later,
43:33both in terms of the direct burden of
43:35the disease in children with respect
43:37to hospitalizations and mortality's.
43:38Which yes, they are less than adults.
43:40But they're not as less as we once thought,
43:43and they they compare favorably
43:45to the burden of disease.
43:46For other vaccine preventable diseases.
43:48Before we had vaccines to prevent them.
43:50So if that's what this slide tries to map
43:53here in terms of the scale of the bird,
43:55direct burden is certainly not
43:57trivial by any stretch.
43:58Add the indirect impact of COVID-19
43:59out the role in transmission
44:01and you're hearing arguments.
44:03I think we're probably arguments.
44:04A lot of us would agree with him
44:06saying that a vaccine in children
44:08vaccines that are tested and
44:09approved and available for children
44:11seems a very urgent priority.
44:13Even if it's not happening at this
44:15moment and move forward with the
44:17obviously the reasons we think about
44:19testing interventions in children,
44:21not just small adults as as
44:23as the Maxim goes,
44:24but the question this was not
44:26met with universal praise at
44:27during this committee of experts.
44:29The question was,
44:30should this clinical testing of Covid
44:32vaccine children in children begin
44:34when a only after we have favorable
44:36data from these adult trials?
44:38Or can they happen in parallel?
44:40Can we studied the vaccines in
44:42children at the same time as we're
44:44learning about their large scale?
44:46Performance in adults as an alternative
44:48and there was not a consensus.
44:50Frankly,
44:50among among the experts on the
44:52committee in terms of what would boast,
44:54be most prudent from an ethical
44:56perspective from a protection
44:58of human subjects perspective.
44:59But clearly there's a.
45:00There's a broad consensus that if
45:02this vaccine, any vaccine
45:04will be used in children,
45:05we need to have specific evidence
45:07for how it how it performs,
45:10dosing taler ability,
45:10all those sorts of things that we
45:13would think about for childhood,
45:15but vaccines in general.
45:16And these vaccines in particular.
45:17But we're a long way away.
45:20So with respect to that,
45:21that's what this slide tries to do.
45:23What will need to happen for us to have?
45:26A large scale vaccination program
45:28of children and adolescents against
45:30COVID-19 alot alot will have to happen.
45:32Will have to have trials launched
45:34and conducted an increasingly
45:35younger age groups and those results
45:37obviously will need to be positive
45:39for one or more vaccine candidates,
45:41which are then going to need to be analyzed,
45:44submitted,
45:44reviewed by the Food and Drug Administration.
45:46An favorably acted upon.
45:48I think there's an open question
45:50as to whether the Food and Drug
45:52Administration would be comfortable
45:53authorizing the use of vaccines
45:55for children under that emergency
45:57use authorization.
45:57Lower bar,
45:58shorter follow-up or weather
45:59for children at the FDA,
46:01would would would only make vaccines
46:03available for children under the
46:05it's traditional full licensure that
46:07we would think about for all the
46:09other vaccines that we use safety
46:11so important safety, so important.
46:13Vaccine safety is non negotiable for
46:15childhood vaccines in particular,
46:16so they're just there won't be any
46:19compromises with regard to that.
46:20But that means that will take more
46:22time in terms of collecting the data,
46:25the volume, the length of follow up.
46:27For the,
46:28I think the FDA and for the public
46:30health community to be comfortable
46:32with the use of vaccines in
46:34children and adolescents.
46:35After all that happens,
46:36then will need to think about the
46:39kinds of recommendations that might
46:40be developed for their use by the
46:43CDC and its expert advisors might
46:44apply to all pediatric age groups.
46:46Older adolescents only at first
46:48might be based on risk factors
46:50to the extent they exist.
46:51We don't know.
46:52I think it's probably more likely
46:54to see a vaccine made available
46:56for older adolescents sooner
46:58than later than you would for.
47:00A younger children just given all of the the.
47:03Safeguards and processes that
47:04I've outlined here and then,
47:05even after all that happens,
47:07of course we would need the adequate
47:09vaccine supply given all of the
47:10prioritization issues for other
47:11groups in the allocation plans,
47:13so you know,
47:14that's the bottom line for
47:15this is manage expectations.
47:16I think if we hear from colleagues,
47:18friends, family members who are thinking,
47:20I'm only going to do XY and Z
47:22until my kids are vaccinated.
47:24That's going to be a while.
47:26And you know,
47:27it's a reminder of how important
47:28all those other strategies are
47:30and will continue to be to respond
47:32to minimizing the spread of.
47:33The disease virus and the disease
47:35as we wait for a vaccine,
47:37but I think it wouldn't at
47:39all surprise me if even if we
47:41were talking a year from now,
47:42if My 7 year old, my one year old
47:45had not received a COVID-19 vaccine,
47:47I think I would be very surprised,
47:49maybe even shocked if we found ourselves
47:51in that place even within the next year.
47:53Maybe college students, older adolescents?
47:55That seems more plausible,
47:56but there's like there's a long
47:58Rd ahead with lots of potential
48:00potholes to get from where we
48:02are to where we would hope to be.
48:04At some point in the future,
48:06last few minutes last few slides.
48:08So what's the story in the
48:10meantime around around vaccination
48:12and children during COVID-19?
48:13It's has to be thinking about
48:15reversing the declines that we've
48:17seen in the most recent months around
48:20routine childhood vaccination,
48:21particularly in the early part
48:23of the spring when.
48:24Doctors offices and so much of
48:27our communities were closed.
48:28We have lots of data.
48:30This is M WR publication from Michigan,
48:32but it's certainly not in Michigan
48:35specific factor that showed just
48:37how much up-to-date vaccinations
48:38of early childhood kids in the
48:40first 2 years of life had declined
48:42from the those greyish dots.
48:44The 2016 2019 average of the percent
48:46up-to-date at various landmarks to where
48:49we found ourselves in Michigan in 2020,
48:51as much as a 20 percentage point drop in.
48:54Up-to-date vaccination status
48:55as of May gaps were even wider
48:58among children with Medicaid then
48:59they were children with private
49:01insurance and other national trend.
49:03This is a busy slide,
49:04forgive me,
49:05but it's it's national data from the CDC.
49:08Again,
49:08publishing M WR that shows this
49:10precipitous drop in the number of
49:12vaccine doses that were ordered
49:14through the vaccines for children
49:15program in March and April,
49:17as well as the number of the drop
49:19in the number of vaccine doses
49:21that were administered as measured
49:23by the vaccine safety datalink
49:25one of the federal databases for
49:27monitoring vaccine coverage and.
49:28Investigating potential adverse events.
49:30So there was a huge drop,
49:32perhaps not surprisingly in March and April.
49:35In May of this year.
49:37Since then,
49:38the story does seem to be one
49:40in which the trend is improving.
49:42This was published in New York
49:44Times from claims data from the
49:46health care cost Institute,
49:47at least through late June.
49:49We see that there was a rebound,
49:51particularly among these vaccines.
49:52HP V Meningococcal and Proquad
49:54Mbara Cela Vaccine,
49:55so there was a rebound happening.
49:57It looked like there maybe there
49:59was a steady state,
50:00though that was still less than the
50:02year to year average in vaccine
50:04administration that we would expect,
50:06and it looks like.
50:07There was a plateau at least
50:09through that point, I'm told,
50:10although I don't have the data to
50:12present to you that the early childhood,
50:15the first year or so of life
50:17vaccines numbers have gotten closer
50:18back to where you would normally
50:20expect them to be year to year.
50:22However,
50:22they haven't made up for all of those
50:24kids who have missed vaccination
50:26appointments during the spring and summer.
50:28They need to catch up.
50:29Immunization needs clearly have
50:30not been been been achieved,
50:32at least the national level so far,
50:34so that's a real concern.
50:35A real area for investment and attention,
50:37and everything else that
50:39health care providers.
50:40Are all dealing with during this time.
50:42Here is to try and prevent
50:43the under vaccination that can
50:45create cascading complications.
50:46For how for Children's Health from
50:48public health in the months ahead,
50:50so once also left his influenza vaccination,
50:52we've got, you know,
50:53the most recent data about flu vaccines.
50:56We've heard the push,
50:57I'm sure so many of you are making that
50:59that strong endorsement of influenza
51:01vaccination as something we can do this fall,
51:04at least medically,
51:05in addition to all the other things to
51:08try and get through this fall and winter.
51:10Nationwide CDC,
51:1164% of children six months of
51:1217 years were vaccinated.
51:14According to CDC data,
51:15Connecticut doesn't really well.
51:17As I noted in the bottom here,
51:19Connecticut was only a few percentage
51:21points behind Rhode Island,
51:22few fractions of a percentage
51:24point behind Rhode Island for the
51:26highest flu vaccine coverage among
51:28children under the age of 18,
51:30so that's clearly a priority, as we all know.
51:33And as you know,
51:34I certainly don't have to tell
51:36this group as something that can be
51:38done now to try and minimize them.
51:41Burden of disease and illness in our
51:43communities in the months ahead.
51:45So in closing here is that that
51:47key message point.
51:48It won't go through it in detail.
51:51Again, great progress,
51:52complicated challenges ahead.
51:53Logistical Cyantific Regulatory but
51:55but well established processes and
51:57scientists who can help us get there
51:59along path for children vaccination programs.
52:01I am uncertain one, but certainly one
52:03that we recognize will need to happen.
52:06And the sooner the better.
52:07And then lots of work with routine
52:10vaccination and influenza vaccination.
52:11In the mean time, so thanks so
52:13much for your time and attention.
52:15Here's my email and Twitter handle.
52:17Happy to talk.
52:18Happy to share slides.
52:19Individuals who are interested and I
52:20look forward to your questions and
52:22thoughts and our remaining time together.
52:24Thanks so much. Jason, thank you so much.
52:28I've been looking forward to
52:30this talk for two years and so
52:33really appreciate your taking
52:34time with us in Pediatrics and
52:37also tailoring it to obviously,
52:39you know, to be so timely.
52:41So I know we already have doctor Hemenway
52:44who in order to ask a question and then
52:48we've got other questions coming in.
52:51Also is another experiment.
52:52You may also put in X in the chat.
52:56And what we'll do is unmute you,
52:58and that saves you from having to
53:00write some of the questions out.
53:02So factor
53:02Hemenway. Oh, thank
53:04you Bonita doctor Schwartz.
53:06Due to the gravity of COVID-19
53:08and the emphasis on trying to
53:10get the vaccine out as soon
53:12as possible, is there any case
53:14for a single blinded study instead
53:17of the rigor of the double blinded
53:19study in order that if the ill
53:22patient that has been described was
53:24found to be in the placebo group,
53:26it wouldn't hold up the progress
53:29in continuing the study?
53:31Oh, it's an interesting question.
53:33I think the issues about right?
53:35How can we expedite getting meaningful,
53:37valid endpoints?
53:38Has been one that's really been
53:40dominating the conversation.
53:41I haven't heard talk about
53:43single blind studies.
53:44I think there's such, you know,
53:46we hear that gold standard maximum
53:49about the placebo controlled double
53:51blind study as the arbiter of what
53:53FDA expects is rigorous evidence and
53:56a signal very early on that that's
53:58what they would expect to see.
54:00For a vaccine to be favorably
54:02reviewed from it,
54:03so the conversation you know,
54:05I think it's an important.
54:07Ethical one important wanted
54:08to think about in terms of
54:10balancing urgency and speed,
54:11but it didn't really get out of
54:13the starting blocks because FDA,
54:14you know,
54:15signal that was one area where
54:16they weren't willing to buje
54:18where they are willing to look
54:19is at these interim results.
54:21That's really this question that
54:22we hear about in terms of why it's
54:24so uncertain when we might have the
54:26kind of data that might lead to an
54:28authorization or approval based on
54:29the kinds of stopping rules that
54:31can happen by that data safety
54:32and monitoring board that we've
54:34now become all become experts in.
54:35It feels like those groups that
54:37can get a peek at the data while
54:39a trial is still ongoing and
54:41figure out whether.
54:42Oh weather endpoints have been met
54:44that would signal that we could.
54:45We could move forward faster than what
54:47the trial might otherwise think about,
54:49but the single blind question I
54:51think I think you could have a
54:53very important conversation about
54:54about whether we could still get
54:56the kind of data we needed in ways
54:58that could could expedite the work.
55:00But the FDA chose that had early
55:01point to signal that was not on
55:03the table and in the same way that
55:05those issues around the intentional
55:07infection challenge studies that
55:09received a lot of attention as
55:10another way to get quick data.
55:12Which was sort of set aside from the
55:14regulatory process, but it's a great.
55:16It's a great topic to think with.
55:18OK, thank you very much.
55:19Thank
55:20you, great thank you doctor Bechtel.
55:22Hi doctor Schwartz,
55:23thank you so much for this
55:25really informative grand rounds.
55:27Practically speaking,
55:27when do you think the earliest it
55:30would be that children and adolescents
55:32could get back to me with the SARS
55:34groovy two vaccine? Oh, it's it's.
55:36It's hard. It's such.
55:38It's so hard to make forecast.
55:40I think if everything goes well and
55:42write these trials that are moving
55:44forward with pediatric populations,
55:46start enrolling patients.
55:47Start getting positive data vaccines.
55:48The broader trials get approved.
55:50I mean, I think we could talk.
55:53In the third and fourth quarter of next
55:55year might be the absolute earliest.
55:57If I had to.
55:58I had to make a prediction about that,
56:01and again in that sense I'd be more
56:04comfortable thinking about it in
56:05the context of older adolescents
56:07then younger adolescents,
56:08just in terms of how our public
56:10health officials will move forward.
56:12Being comfortable with these vaccines,
56:14but it's such a.
56:15It's so hard to think about any
56:16precise timetables other than to
56:18say that it can happen in the next
56:20handful or more months just because
56:22of all the work that will need to
56:24happen even to get us to that point.
56:26So I would,
56:27I would say late 2021 would be my prediction.
56:29As much as I hesitate to make
56:311 great thank you very much,
56:33thank you.
56:33Great doctor
56:34out these singer.
56:36Hi I was just wondering if
56:38you have information about any updates
56:41on human challenge trials and you
56:43know is that sort of accelerating
56:45the process around the world?
56:47If not domestically.
56:49Yeah, so the human challenge trial
56:51which they have a long history in
56:54medicine you know and continues to be
56:57used to actually expose a volunteer
56:59a fully consented adult volunteer to
57:01an agent to understand how the body
57:04responds to it has been discussed by.
57:07Ethicist by scientists since early
57:08spring as a way to get that kind of
57:11information that we might urgently
57:12need to know whether any vaccine works,
57:14there is a trial.
57:16I've only seen the media reports
57:17in the United Kingdom that looks
57:19like we'll move forward with a
57:21small human challenge study,
57:22which will again provide that
57:24immediate test to know whether a
57:26vaccine candidate and forgive me for
57:27not remembering which one it is.
57:29In that context, how the body responds to it.
57:32I think the concern there's obviously
57:33huge ethical concerns about about the
57:35intentionally exposing individuals to
57:36a disease that we were only still.
57:38Barely learning about and has
57:40widely variable affects,
57:41and we're not quite sure what causes
57:43more severe effects than others
57:45beyond broad high risk conditions.
57:47It was ethical.
57:48Issues aside,
57:48there was a regulatory question about.
57:50Ultimately,
57:50even if we move forward in a
57:52laboratory setting with these
57:54intentional infection studies,
57:55we wouldn't have the number of subjects.
57:57The number of research subjects,
57:59the volume of safety data,
58:01especially that we want to have to move
58:03comfortable with the vaccination program.
58:05That would involve millions 10s of millions,
58:07hundreds of millions of Americans.
58:09If we're talking about a challenge
58:11study that has 150 or 200 subjects.
58:14So while it might give us really
58:16interesting laboratory findings
58:18that we might be able to use
58:20to evaluate subsequent vaccines
58:21based on their immune responses,
58:23the kinds of protection that
58:25they generate down the road,
58:27I think it was from Doctor Fouchy and
58:30the American scientific and regulatory
58:31community was seen as not able to
58:34generate the kind of data we needed.
58:37An frankly not necessary
58:38given how widespread.
58:39Natural quote Unquote exposure
58:40to SARS Co V2 would be in our
58:42randomized control trial,
58:43so I think that's why it's been generally
58:45set aside and I don't think it will
58:48be a driving force in ultimate arrival.
58:50The initial arrival of any of
58:51these vaccine candidates were
58:52thinking about right now.
58:56Great thank you in last question,
58:59Doctor Vasquez can you unmute yourself?
59:04Oh yeah. Marietta,
59:08I think you're still muted. Go ahead.
59:12There, thank you for a great overview.
59:16I have a question regarding sort
59:19of more implementation and Upper
59:22Alization of this vaccination.
59:24What we have ahead of us,
59:27which is not only catching up with
59:30those immunizations that are delayed,
59:33but potentially immunizing an entire country.
59:36Can you comment on strategies or
59:39potential solutions for that?
59:41I mean, assuming that.
59:43The current traditional model of
59:46having patients come to offices
59:50and pharmacies is probably not
59:53going to be enough for the.
59:56For the work
59:57ahead, no, absolutely thank you.
59:58It's such an important question.
01:00:00I think. I think we're frankly,
01:00:02is a country really far behind
01:00:04on getting those processes in
01:00:06place and having the resources
01:00:08we need to deploy these vaccines.
01:00:10As you noted, right this,
01:00:11if we're thinking about the kinds of
01:00:14large scale rapid distribution we need,
01:00:16we're thinking about vaccines
01:00:17is I didn't mention,
01:00:19but require very specialized
01:00:20refrigeration and freezing hot load
01:00:22ultracold freezers logistics in terms
01:00:24of keeping track of doses and making
01:00:26sure people get the right vaccine.
01:00:28At the right time,
01:00:2928 days apart,
01:00:30I think we're seeing us a recognition
01:00:33that it's gonna be an all hands
01:00:35scenario that it won't just be in
01:00:37traditional providers offices where it
01:00:39vaccines will be administered initially
01:00:41thinking about community organizations,
01:00:42thinking about,
01:00:43working with commercial pharmacies,
01:00:44thinking about centralized distribution,
01:00:46which will really be needed.
01:00:47Logistics.
01:00:48Just you think about dig into
01:00:50these state level plans just
01:00:52become overwhelming to sort of.
01:00:53Think through how this will actually
01:00:55work and whether States and cities and
01:00:58communities have the resources they need.
01:01:00To to make this happen,
01:01:01I think there's been even the CDC is
01:01:04acknowledge that states municipalities
01:01:05really need billions dollars of more
01:01:07just to get these plans in place,
01:01:09and so much of our debates around funding
01:01:11for Covid and response that's not there yet.
01:01:14So I'm more concerned about the
01:01:16implementation frankly than I am about
01:01:18the scientific research and development,
01:01:19which seems like we're
01:01:21in a much better place,
01:01:22so I think that will be the issues for 2021,
01:01:25and I think there's a tremendous
01:01:27amount of work ahead so we can
01:01:30achieve the benefits that we hope
01:01:32these vaccines will achieve.
01:01:34Great, well thank you so much,
01:01:36doctor Schwartz,
01:01:37we
01:01:37really appreciate you coming.
01:01:39Mona, thank you for suggesting
01:01:41him and we really appreciated your
01:01:43grand rounds presentation. Thank
01:01:45you very much. Thank you all for joining.
01:01:48Take care bye.