Considerations for Vaccine Approval In A Pandemic

January 22, 2021

Information

In the session’s keynote address, Peter Marks, MD, PhD, director, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, described the steps and considerations involved in approving a vaccine during a pandemic, including the FDA’s role across the lifecycle of vaccine development and distribution.

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00:00What I would like to do,
00:02and probably the next half hour
00:04is talk to you about some of the
00:06considerations for vaccine approval
00:07in a pandemic and hopefully will
00:09have some time for questions at the
00:11end and still get everyone out of
00:13here at the end of the day on time.
00:16Having worked for a Swiss company,
00:17I also having learn think they the
00:19intersection of having worked for a
00:21Swiss company where things have to be
00:23on time and also having done enough
00:25adult education where knowing the
00:26end of something should end on time.
00:28If you want your ratings to not
00:30be in the toilet.
00:32Um at Intersection is is
00:34quite a good one to know.
00:38What I'd like to it was interesting,
00:39you know.
00:41At the this discussion about vaccine
00:44confidences is very relevant here,
00:47because ultimately everything we do
00:49at FDA across the vaccine lifecycle
00:53is ultimately targeted at helping
00:56to ensure public confidence.
00:58FDA has been in the business of
01:02regulating vaccines will actually
01:04FDA has only been in the business
01:08of regulating vaccines since 1972.
01:11When regulation of vaccines was
01:13transferred from NIH to FDA,
01:15and if you'd like to read more about
01:18that scandal during the Nixon administration,
01:21I'll be happy to point you in
01:24the right direction.
01:26It wasn't anything near
01:28like Watergate though,
01:29so nothing all that tasty.
01:31On the other hand,
01:32we have in regulating vaccines
01:34in the United States,
01:36since actually before the
01:38existence of the FDA,
01:39it originally was regulated
01:41through Department of Treasury.
01:43Because of the Biologics Control Act of 1902,
01:46which was enacted because of some
01:48manufacturing disasters in which
01:49contaminated vaccine was distributed,
01:51it was particularly bad because the first
01:54lot of vaccine that was distributed.
01:57And it killed several children.
01:59They knew was already contaminated
02:01and it was an accidental.
02:03Our release so that that that leads
02:06us to why our focus is very much a
02:10safety focus and one on efficacy.
02:13So what we do at FDA is really not
02:17just related to safety and efficacy.
02:20We deal with strange selection and
02:23referenced standard production.
02:24We have laboratories including BSL,
02:27three laboratories that currently
02:28have standards that are being
02:31generated for coronavirus.
02:32We deal with lot release that
02:34is once the vaccine is made,
02:35is it what it says it is?
02:38Through analysis,
02:39we obviously evaluate the safety
02:40and efficacy of vaccines and
02:43conduct postmarket surveillance,
02:44and more recently we've gotten more
02:47into advancing vaccine production
02:49technologies because it turns out
02:51that with pandemics and things
02:53like this are capacity to ramp up,
02:55vaccine production is limited,
02:57as we can see by the struggle
02:59to produce adequate amounts of
03:02vaccines right now,
03:03and ultimately all of that has to be
03:06done to help ensure public confidence,
03:09because if people don't.
03:10Wanna take vaccines in their arms?
03:12All of this other stuff is for not.
03:16And the past four years have shown
03:19us how we were probably borderline
03:23on vaccine confidence to begin with,
03:27and unfortunately. Conspiracy theories,
03:29anti science talk does not help
03:32public confidence in vaccines.
03:34I know you've heard about that earlier,
03:37but our big goal here is to make
03:40sure what we do as we roll out.
03:43These coronavirus vaccines is to
03:45make sure that we do whatever we can
03:48to help ensure public confidence.
03:50So at FDA, when we think about vaccines,
03:53we think about manufacturing
03:55quality because one of the things
03:57that's unique about biologics is.
03:59You can't, and probably true
04:01about many drug products.
04:03You can't put quality in if
04:05it if you don't start with it.
04:07So the the manufacturing process
04:09has to be a quality process that
04:12leads to a quality product.
04:14Obviously care very much about
04:16the safety of products that are
04:18going to be given to millions
04:20of otherwise healthy people.
04:22Products have to be efficacious.
04:23And then we also have to care
04:26about how we're going to make
04:28sure that nothing evolves overtime
04:30in terms of safety concerns,
04:32because even with a very large pre
04:35market safety program it's still
04:37possible to miss things that then can
04:40show up in the post market setting.
04:43So how we accelerate the process
04:45and I'll talk a little bit about
04:48what was done as part of warp speed.
04:52But if you look at the whole package here,
04:56we started by having very clear
04:58guidance on what our expectations
05:00were for the development process
05:03for these products.
05:05These vaccines we facilitated early
05:07conversations between manufacturers,
05:08academics who are developing vaccines,
05:10and the agencies.
05:13We also then did a variety of things
05:16that are the more typical things
05:18that are conceived of as warp speed,
05:22which was integrating different
05:23phases of clinical trials into one
05:26clinical program manufacturing large
05:28quantities of products at risk and
05:30then trying to choose optimal paths
05:33to facilitate product availability.
05:35It really did amount to in many cases,
05:38removing Dead Space from a process
05:41that has largely been done.
05:43To avoid risk and waste of money
05:46in the normal day when we don't
05:49have a pandemic 21,
05:51where to move as quickly as possible
05:54because we need a vaccine quickly.
05:58So just to take you through each of these,
06:01we realized that it would be important
06:04for manufacturers to understand
06:05what our expectations were upfront,
06:07and because of that we put
06:10out two guidance documents.
06:11The first of these came out in
06:14June of this year,
06:16at which point we wanted to make sure
06:18that we set some basic esentially
06:21floors for what we explored,
06:23except as an acceptable coronavirus vaccine,
06:25COVID-19 vaccine, and then later on in.
06:28October we came out with a second
06:30guidance document which really
06:32focused on how we would go about the
06:34Emergency use authorization process.
06:36I'm going to tell you a bunch more about
06:39the first in the next couple of minutes,
06:42but the second of these was really
06:44one that was very important for
06:47vaccine confidence because we wanted
06:49people to understand what we were
06:51going to do with emergency use
06:53authorization so that they understood it
06:55wasn't just putting out a half baked product,
06:58but really putting out.
06:59Something that was very close to a vaccine
07:02that would normally meet our standard
07:04for a substantial evidence of effectiveness,
07:07which is what we use to approve products.
07:11So as we put out these guidance documents,
07:15we wanted to make sure that it was pretty
07:19clear what we needed here and we we.
07:22We don't have statutory authority to
07:24mandate who you enroll in a clinical
07:27trial in terms of diverse populations,
07:30but we can encourage it.
07:32And so we used our our play pulpit,
07:35so to speak,
07:37to make sure that the vaccine
07:39manufacturers understood that when they.
07:41Enroll their clinical trials.
07:43They needed to enroll a diverse
07:46population reflective of those who
07:49were getting COVID-19 in this country,
07:52and in fact important because of the
07:55disproportionate amount of minority
07:57an underserved populations that
07:59have been affected by COVID-19.
08:02So we recommend it making sure that.
08:06There were the appropriate amounts
08:08of minority populations as well
08:11as older individuals,
08:12people with medical comorbidities,
08:14extent that women with
08:17childbearing potential could be.
08:19Enrolled who were not in voiding pregnancy.
08:21We encourage that and ultimately
08:23we realized that we have to get to
08:26pediatric populations if not in the first
08:29round in subsequent rounds of study.
08:32We also did something we had
08:34never done before,
08:35at least in anyone's memory.
08:37That's around.
08:38Which is we actually set a floor for what
08:42we expected vaccine effectiveness to be,
08:44and we we said that we wanted
08:47to see a vaccine efficacy of at
08:50least 50% above placebo,
08:52and the reason for doing that
08:54is in this particular pandemic,
08:57we realized that there was opportunity
08:59cost associated with any vaccine
09:01that was going to be manufactured.
09:04And to put a vaccine in peoples arms
09:06that was less than 50% effective could
09:08be counterproductive because we know
09:10from some of what you've already heard
09:13today that as soon as you put a vaccine.
09:15And somebody's arm.
09:16Their behavior may change if not.
09:19If not intentionally,
09:20it will change subconsciously,
09:22and so we wanted to have vaccines
09:24that at least had effectiveness.
09:27That was roughly about flu
09:29vaccine on an average year,
09:31like flu vaccine on an average year,
09:34or perhaps a little better.
09:36And we also wanted the trials to be
09:40sufficiently large that the lower
09:42bounds of a 95% confidence interval
09:44would say that they would be,
09:47there would be at least 30%
09:49effectiveness versus placebo.
09:50Again,
09:51just trying to again stop the deck
09:54here towards larger trials that would
09:56tend to show that they supported
09:58effective vaccines and we said that
10:01would that would apply to both an
10:03interim and final efficacy analysis.
10:05In practice,
10:06everyone in this house come in so
10:08far as has brought us final efficacy
10:11analysis to our advisory committee
10:13meetings because it turns out
10:15that at the rate we're starting,
10:18you know we've been having COVID-19 cases.
10:21From the time that you can
10:22start counting cases,
10:23it's only a matter of weeks till one
10:26gets to an interim analysis an it's
10:28been only a matter of a week or two
10:31more to one can get a sufficient
10:33number of cases for final analysis.
10:35So at the end of the day,
10:37there's been little distinction needed.
10:39And then one final thing here is
10:42we we said we wanted a two months
10:45of median follow up after the
10:47final vaccination of any series.
10:49And many people think that that
10:51was just for making sure that
10:54we had adequate safety data.
10:56But it wasn't just for safety.
10:58Obviously we wanted that amount
11:00of safety data,
11:01but we also wanted to make sure
11:04that vaccine effectiveness lasted
11:05for at least some period of time,
11:08particularly when one is deploying.
11:10Vaccine types that one had never
11:11deployed in large numbers of people,
11:13such as the M RNA vaccines.
11:16We then also realized that you can work.
11:19You can warp your speed and try to go fast,
11:23but we did not call this project
11:26warp time and that is we cannot
11:29speed up the amount of time it we
11:33we we we have to take time to get
11:36safety data and that takes time.
11:38We we want normally to have six months
11:41to a year or even two years of follow-up
11:44data to be able to license vaccines.
11:48We knew we could not get that and
11:50get something deployed reasonably,
11:52so we took the reasonable amount of
11:54knowing that most of the adverse events
11:57occur within the first 42 days after
11:59completion of vaccination series.
12:01So that's the two month follow up and
12:03then we realized that we would use
12:06postmarket safety surveillance is a
12:08systems to get additional safety follow up.
12:12In terms of making sure that there
12:15was confidence with the public,
12:17we realized that transparency
12:19would be very important,
12:21particularly when there was a
12:23push perhaps on the part of some.
12:26I don't know who,
12:27but I push on the part of some to get
12:31these vaccines there very quickly,
12:33particularly in the month
12:35of October to November,
12:37and because of that we we felt the
12:40transparency would be very important.
12:42By bringing these vaccines before our.
12:44Vaccine related biologics.
12:46Product's advisory committee.
12:47By having external experts,
12:49being able to discuss them by being
12:52able to post the materials so that
12:55those in the public who wanted
12:57to pull them down and read them,
13:00could we thought that would
13:02be very important here?
13:03And indeed there were really a thousands
13:06and thousands of people who tuned
13:09into these advisory committee meetings.
13:11Perhaps not a record,
13:13but among the most watched advisory
13:16committees that we've had.
13:18Now once one gets to a vaccine,
13:21one can potentially approve it via
13:24a biologics license application.
13:26The problem with biologics
13:28license applications is they are
13:30large submissions by our statue.
13:33Tori criteria.
13:34There are certain things that are
13:36required like conformance manufacturing lots,
13:39that often can take months to produce.
13:42The inspectional requirements
13:44are pretty significant and the
13:46amount of data in tables.
13:49That the companies need to produce
13:51for a biologics license application
13:53often mean that it can take
13:56several months for preparation.
13:58The good news is when we use a biologics
14:00license application or standard is
14:02that we have to have substantial
14:04evidence of efficacy from adequate
14:06and well controlled clinical trials.
14:08That's the part that gives people confidence.
14:11The downside,
14:12obviously,
14:12is the speed getting there at this point,
14:15slowing things down by a couple of months
14:17to get these prepared and then submit it
14:20and reviewed would have been a concern.
14:23So because of that we took advantage
14:25of another provision called
14:26Emergency use authorization,
14:28which was put in place after the
14:30terrorist attacks of 911 to allow.
14:32Chemical,
14:33biological,
14:34and radio nuclear addressing products to
14:38come to the aid of individuals without.
14:43Not the same standard of approval as
14:46substantial evidence of active effectiveness.
14:48Instead,
14:48the standard is the product may
14:50be effective in the known and
14:52potential benefits have to outweigh
14:54the known and potential risks.
14:56Now that standard is probably reasonable
14:58for a product that's being used.
15:01If you have a disease and you're
15:03looking to get a treatment for which
15:06there's nothing else out there,
15:08and actually the Statute requires
15:09that is some of the conditions.
15:12If you're going to use this.
15:14Provision but for vaccines
15:16for healthy individuals.
15:17This was a little bit.
15:19We felt a little bit light and
15:22because of that we articulated in
15:25our guidance the October guidance
15:27it for a COVID-19 vaccine.
15:30We want to see efficacy from a large,
15:34well designed phase three trial,
15:36much in the same way that we would for
15:39a biologics license application that
15:41we'd want careful evaluation of the
15:45quality and safety.
15:46That we take it to a public Advisory
15:49committee meeting and the the data
15:51would have to be clear and compelling,
15:54and that we'd also then want this to be.
15:58I have followed up with enhanced post
16:01deployment at surveillance by anyone of
16:04a number of safety surveillance systems,
16:06both active and passive,
16:07and although this isn't quite are
16:10normal standard for substantial
16:12evidence of effectiveness, it's close.
16:14Clearly, the piece that's a little
16:17bit on the life side here is our
16:20duration of safety follow up,
16:22but that's why we try have tried to
16:25make sure we have very robust posted.
16:28Ointment safety surveillance.
16:30And that safety monitoring that's in
16:33place right now is a is a collaboration
16:37between the Centers for Disease
16:39Control and Prevention and FDA on
16:42includes passive monitoring through our
16:44vaccine adverse Event Reporting system
16:46that's been in place for a long time.
16:49And that's just basically what
16:51one does with medwatch forms.
16:53In addition,
16:54the CDC has put together AV SAFE system,
16:58which is a text based monitoring system.
17:00That one. OPS into and gets text.
17:03It asks one if once had anyone of
17:06a number of adverse events and
17:08then gets active.
17:10Follow up if one reports certain adverse
17:13events like missing days of work.
17:15I do at sensibly to the vaccine.
17:18We also have active safety monitoring
17:20through a variety of methods,
17:22including CDC's vaccine safety Datalink
17:24that gives near real time surveillance
17:27at 12 sites around the country.
17:29When they have 7 sites with the clinical
17:32immunization safety assessment and
17:34then we had FDA have the Sentinel
17:36best system which covers well over
17:39100 million lives now actually
17:41well over 200 million lives.
17:43And that's a combination of claims data,
17:45an electronic health record,
17:47data which gives us access to high quality
17:50data for near real time surveillance,
17:52and we are monitoring about 20
17:55safety outcomes of interest.
17:56So how did we then take all of that,
18:00and how do we apply it?
18:02Well,
18:02for the manufacturing piece of this one,
18:05and for the clinical trials,
18:07one needed to condense things and
18:09just to show you how this works,
18:12this is actually taken from some of the
18:15original slides used for warp speed.
18:18This is kind of traditional
18:20vaccine manufacturing.
18:20It is a linear process with Dead
18:23Space and those in the audience
18:25who can hear my voice have ever
18:27dealt with academic contract ING
18:29between phases of clinical studies.
18:32Know that there can be 6 to 12
18:34months between phase one and phase
18:37two and phase two and phase three.
18:39That's just the nature of negotiations etc.
18:42That goes on and it leads to it also
18:44is the amount of time that often
18:48pharmaceutical companies take to go through.
18:50Essentially,
18:51stage gates making sure that they feel
18:53a product is actually efficacious
18:55enough to move forward and safe enough
18:57to move forward in development.
18:59Now that works reasonably when
19:00you're developing a new version of
19:02some established vaccine,
19:03and you're trying to make perhaps a safer,
19:06safer, or more convenient version of it.
19:09But when one is in the middle of pandemic,
19:12that isn't the best way to do this.
19:14In addition, waiting till the
19:16end of the process to scale up
19:18manufacturing is not the best thing.
19:21Because you don't want to find out
19:23that you have problems scaling up
19:25manufacturing at late on in the
19:27process when you might need to be
19:29able to have lots of doses and so.
19:32Accelerating vaccine development here
19:33involve having companies do Phase 1 two
19:36studies and then phase three studies.
19:39Some companies actually opted for
19:41doing Phase 123 studies where in
19:43one study they essentially studied
19:45all of these things together.
19:47They often did a pre prior even
19:50when they did a Phase 123 study,
19:53they often had a prior space.
19:55One study done,
19:56but the Phase 123 study allowed them
19:59to move seamlessly at the same time.
20:02Hi, the manufacturing scale up was
20:05started really as soon as Phase
20:08One was done and one thought one
20:11had a vaccine that could cause that
20:14could cause a good immune response.
20:17And obviously this could have in
20:19some cases resulted in needing
20:22to throw out vaccine,
20:23but when you have an economy that shut
20:27down and people dying very quickly.
20:30In terms of numbers of deaths,
20:33this was a very reasonable that to try.
20:37And an integrated into this plan
20:40was the concept of the use of
20:43emergency use authorization,
20:44as well as trying to make sure
20:47that there would be a distribution
20:50and administration infrastructure
20:51that was put in place an we can
20:55talk about this afterwards.
20:57I won't say more about this now.
21:00In retrospect,
21:00it's very clear that one of the things
21:03that we stressed at the beginning
21:05not to forget the distribution and
21:08administration infrastructure.
21:10Was not taken seriously enough,
21:12and that has actually hindered this response.
21:15Hopefully that will be remediated
21:17very shortly.
21:18Now, in terms of the targets here,
21:21just to take this through what we
21:24have out there and I you may have
21:28heard this earlier and I'm I'm
21:30sorry I wasn't present for this,
21:33but clearly most of the vaccines
21:35are against the spike protein.
21:37This is clearly a very large
21:40number of vaccines.
21:41Have targeted this,
21:43some have targeted some vaccines are
21:45using the whole whole killed virus,
21:48some are using.
21:49Both the spike protein and the
21:52nuclear protein to try to have
21:55a second target there.
21:56The advantage to the spike protein
21:59big immunogenic molecule,
22:00the disadvantages it's obviously
22:02undergoing mutation and so at some
22:05point we may end up having to double
22:07back and have new strains vaccine
22:09in order to address those much in
22:12the same way we do for influenza.
22:16And that same thing could actually
22:18though happen.
22:19We would be killed vaccines as
22:21well because I probably is that
22:24the spike protein is one of the
22:26major immunogens on those as well.
22:29So the candidates that are
22:31around right now include the
22:33two M RNA vaccines that are now available
22:36under emergency use authorization.
22:38Since December there are two non
22:40replicating viral vectored vaccines.
22:42The Chad the chimpanzee.
22:44At at the chimpanzee,
22:46adenoviral vectored vaccine from Oxford
22:48and Astra Zeneca on that has been
22:51deployed in some places around the globe.
22:54Now it does appear to
22:57be an effective vaccine,
22:59but there are some real concerns about
23:02exactly the administration schedule
23:04that one needs to get in order to get
23:08the same affectedness that has been
23:11claimed there is a human adenovirus
23:1326 vaccine from Hanson, which.
23:16Um will report out very soon and likely
23:19be at FDA in the not too distant future.
23:22Hopefully will be positive trial,
23:24but we'll just have to see.
23:27And then there are two protein
23:29subunit vaccines in development,
23:31one in phase three from Nova VAX and
23:34aggravated protein subunit vaccine,
23:36and one that is now coming back in
23:38through the process from Sanofi.
23:40That was a vaccine that was about
23:43to enter phase three,
23:45but they decided to go back to try
23:47to make a more immunogenic molecule
23:49because it was not immunogenicity
23:52enough in the older population,
23:54and so I just want to take you through.
23:57What we have for data here and I'll
23:59tell you at least what was I'll share
24:02with you what at least was surprising to me.
24:05Two COVID-19 vaccines that we have right now.
24:09the M RNA vaccines are very
24:12similar in many ways.
24:13One aside from the actual amount
24:16of M RNA in them,
24:19they are formulated similarly
24:21but not identically.
24:22Using polyethylene glycol 2000 derivatives.
24:25There are the usual buffers along
24:28with them difference between the
24:30two vaccines in terms of storage is
24:33significant because the Pfizer bio
24:35N tech vaccine has to be stored at
24:38ultra low temperatures minus 60 -- 80
24:41centigrade and has to be reconstituted.
24:43The Moderna vaccine is a conventional
24:46freezer storage and is not reconstituted
24:48we I would say here one observation
24:51we suspect but do not know that
24:54polyethylene glycol could be the offending.
24:56Agent here and there are studies
24:59ongoing now to try to get it that.
25:01It could be obviously something else in here.
25:05It could be some combined Modi.
25:07But we will learn soon enough.
25:09Both of these vaccines have been
25:12associated with allergic reactions an
25:14we do know that polyethylene glycols,
25:16particularly higher molecular weight ones.
25:18I can be associated with allergic reactions.
25:22These both of these vaccines went under
25:25went pretty large scale development
25:28programs which would have been
25:32respectable even in a non pandemic time.
25:35Pfizer Biogen tag 43,500 or so
25:38Moderna 30,400 or so individuals
25:41with a good distribution.
25:43Perhaps it could have been better,
25:46but about 10% people who characterize
25:49themselves as black or African
25:52American and 2025% people who were
25:55Latin acts as as as reported and then
25:59about 1/5 to 1/4 of the individuals
26:03that were age 65 or older.
26:06Actually is is pretty impressive,
26:08and the safety data set
26:10in the older population is
26:13a respectable safety data set on its own.
26:17In terms of efficacy,
26:19you're all probably aware that
26:21these are 94 to 95% efficacious.
26:23The number of severe COVID-19 cases that were
26:26observed in vaccinated individuals was small.
26:29Again, very impressive, but probably
26:31the most impressive part of this,
26:34an part that I am not sure that we're
26:37going to see with other vaccines.
26:40I may, I hope to be wrong,
26:43but will see is the very impressive efficacy
26:46in older individuals with these vaccines.
26:49Often times with vaccines,
26:51if you think about the influenza vaccine,
26:551 does not get outstanding efficacy.
26:58In older individuals.
26:59People in their 60s, seventies,
27:0280s with vaccines and.
27:04Are these did?
27:06Although the efficacy probably
27:07does drop off a little bit,
27:09it does not drop off anywhere near as much
27:12as one sees with some other vector vaccines.
27:15So we'll see how the other
27:18vaccines do with this.
27:19Safety of these vaccines is obviously
27:22something that's very important,
27:23and probably the most common things,
27:25and these are I I just put this slide
27:28up here because its reactivity after
27:31the second injection of the reactions
27:33after the first injection tend to be
27:36lower than after the second injection.
27:39You can see that the reactions also
27:41tend to be less in older individuals
27:44than in younger individuals.
27:46Most common things, injection site pain,
27:48very common and the other.
27:50I things like fatigue, headache,
27:52muscle pain, chills, joint pain,
27:54fever.
27:55Those are generally have been
27:57generally been mild to at most
27:59moderate and tend to go away within
28:02a day of receiving the vaccine.
28:04Probably the most significant thing
28:06we've dealt with so far I have
28:09been severe allergic reactions.
28:11Those were interesting in that they were
28:14not really seeing in the clinical trials,
28:16but very shortly after
28:18deployment in the United Kingdom.
28:20Were observed on there now as I
28:22mentioned thought to be possibly
28:24related to a vaccine component in
28:26common to both of the vaccines
28:28they appeared to be occurring in
28:30about 1 in 100,000 individuals who
28:32may have heard that there seems
28:35to have been a clustering.
28:37California, which were triggered a a concern.
28:40It's very challenging.
28:41I will tell you if you like a challenge
28:44you can go into vaccine safety
28:47surveillance of a new vaccine because
28:50it's very difficult to tell what's real.
28:53What's not real.
28:54In this in this area,
28:56but we take everything as
28:59real until proven otherwise.
29:01I'm So what what's been done with
29:04the COVID-19 vaccine developments.
29:06We've shortened vaccine
29:08development timelines,
29:08and I think we've done so without
29:12compromising vaccine safety and efficacy.
29:14We've tried to do so in his
29:18transparent manner as we could.
29:20And hopefully this will help enhance
29:23vaccine confidence in in what is out there,
29:27because we really will need a very large
29:30swaths of the population to get vaccinated.
29:34If we're going to put this behind us.
29:38And although I daresay this this may be
29:41one of those infectious diseases that
29:44we as a global health collaborative
29:47will want to try to eliminate.
29:50We We you know, unlike influenza,
29:54where it seems to be a seasonal
29:57distribution and where the death rate,
29:59although it can be terrible in a pandemic.
30:03Right? And given non pandemic year
30:05we do have the seasonality here
30:07we're not experiencing with this
30:10this with this particular virus and
30:12what we are experiencing is a virus.
30:15It's getting more and more as if it's
30:18going to burst out of control with
30:21this current current status vaccine.
30:23Thankfully not yet,
30:25and hopefully not in the near future,
30:27but we have to really think about
30:30how vigorously we want to pursue
30:32this particular virus towards
30:34potentially thinking about.
30:35Do we eliminate it?
30:37Do we try to go for eradication?
30:40I don't know what the right answer is there,
30:43but I do know that it will be very
30:45hard if we end up with a second
30:48influenza like illness that we have
30:51to deal with yearlong yearlong.
30:53So lots of things to think about.
30:56Lots of answers. We still don't know.
30:58But hopefully ones that by working
31:01together we will get on top of and not
31:05just through vaccines but also through
31:08a kind of a unified strategy of vaccines,
31:11therapeutics and testing contact tracing.
31:14So I'll stop there.