Vaccination Policy and Politics During the Covid-19 Pandemic
January 22, 2021Information
Jason L. Schwartz, PhD, assistant professor of public health (health policy) and in the history of medicine, discussed how he and colleagues have contributed to the discussion of vaccine policy and politics, including “Operation Warp Speed” and political pressures to accelerate approval of vaccines as evidence of safety and efficacy was being reviewed.
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- 00:00And everyone I'm going to talk
- 00:02a bit about policy and politics
- 00:04around vaccines during COVID-19.
- 00:05And like so many of us during this pandemic,
- 00:08our work and what we're doing has
- 00:10expanded to meet the moment for me.
- 00:13That has meant expanding from my work,
- 00:15which is typically looked at analyzing,
- 00:17studying the policy process,
- 00:18studying the use of evidence and
- 00:20policy making in public health,
- 00:21particularly around vaccines and
- 00:23thinking about ways in which those
- 00:25processes can be strengthened.
- 00:26I'm still doing that,
- 00:27but also have been contributing
- 00:29in some ways to the.
- 00:31The policy making process contributing
- 00:32to the generation of evidence that can
- 00:34inform how we think about these vaccines,
- 00:36both in terms of regulation and rollout.
- 00:38So in our time today,
- 00:40I'll briefly walk through a
- 00:41variety of those ways.
- 00:43Colleagues and I have been contributing,
- 00:44studying the work and also
- 00:46contributing to this work around
- 00:47COVID-19 vaccine policy and politics.
- 00:49I think just by way of context,
- 00:51we know some of the many challenges
- 00:53before us in terms of a public
- 00:55health and health policy community
- 00:57with respect to vaccines,
- 00:58it's a balancing act as I try
- 01:00to articulate here between.
- 01:01Recognizing the urgency of the crisis,
- 01:03the need to rapidly innovate,
- 01:05including innovate,
- 01:06not just scientifically,
- 01:07but with our regulatory and policy
- 01:09making activities while also still
- 01:10figuring out how we can make most use
- 01:13of our mechanisms or processes that
- 01:15are in place for evaluating evidence
- 01:17and putting that evidence into work.
- 01:18And at the same time generating and
- 01:21gathering and rapidly incorporating
- 01:22the evidence that can help us do
- 01:24that more efficiently and more
- 01:26effectively with respect to COVID-19
- 01:27vaccines in the United States.
- 01:29As you heard earlier today,
- 01:31and are no doubt well aware.
- 01:33Operation Warp Speed is perhaps the
- 01:35most visible representation of those
- 01:37efforts to innovate in to accelerate
- 01:38the research and development process,
- 01:40and you've heard about it.
- 01:42There's months of slowie the scientific
- 01:44head of the operation warp speed effort,
- 01:47and then you've heard about that their work.
- 01:50I don't need to repeat the way
- 01:52in which they were intended to
- 01:54facilitate and accelerate some of the
- 01:56research and development programs,
- 01:58as well as the manufacturing of vaccines
- 02:01where that balancing act in in terms of of.
- 02:04How we think about that first
- 02:06sort of tension?
- 02:06I articulated where the questions around
- 02:08the review and evaluation of vaccine
- 02:10candidates and persisting concerns
- 02:12throughout the summer into the fall,
- 02:14and actually just recently affirmed
- 02:15just in the past few hours by
- 02:18by Doctor Stephen Hahn.
- 02:19The current FDA commissioner
- 02:20regarding concerns about pressure
- 02:22to two on the part of the White
- 02:24House on the part of the outgoing
- 02:26president to accelerate to interfere.
- 02:28Perhaps with the review of vaccine
- 02:30candidates by the Food and Drug
- 02:32Administration over over this past fall.
- 02:34And we heard repeatedly into
- 02:35great credit of Doctor Marx,
- 02:37who will hear from in a little bit,
- 02:39and his colleagues at the FDA
- 02:41loud and clear in
- 02:42this paper in JAMA is a
- 02:44representative example of it.
- 02:45From September, the degree to which
- 02:47they were committed to preserving,
- 02:49to strengthening to defending the
- 02:50scientific review process of these
- 02:52vaccine candidates to allow there not to
- 02:54be compromises with respect to the to
- 02:56the speed and quality of the evidence.
- 02:58Review, even as we were moving quickly,
- 03:00still still in a rigorous way,
- 03:02but quickly through the vaccine
- 03:04development process that balancing act.
- 03:05And that that work to preserve the
- 03:07integrity of the FDA review process,
- 03:09I think, was a was a great asset
- 03:12and remains a great asset,
- 03:13taking one one of the challenges off
- 03:15the table that we now encounter with
- 03:17respect to these vaccines in September,
- 03:19the New England Journal.
- 03:21Drawing upon my prior work studying the
- 03:23Vaccine Expert Advisory Committee process,
- 03:24the role of expert advisors and public
- 03:26health policy making more generally
- 03:28in the important role they can play
- 03:30in transparency and in promoting
- 03:32public confidence in vaccines.
- 03:33I wrote a piece that supported this measure,
- 03:36relying on our government scientists.
- 03:37Those expert advisors such as.
- 03:39Burp active vaccines Advisory committee
- 03:40that met so prominently with our
- 03:43initial vaccine candidates in December.
- 03:44The value that those mechanisms those
- 03:46processes those time tested review
- 03:48entities serve even in this time
- 03:50of great urgency and innovation.
- 03:52And I think the review process that we
- 03:54found ourselves with left us with not
- 03:57just highly efficacious ANAN vaccines
- 03:59with a very favorable safety profile,
- 04:01but real confidence in the quality of the
- 04:03work by which that evidence was collected
- 04:06and by which that evidence was analyzing.
- 04:09At the state level,
- 04:10we're seeing lots of of attention
- 04:12to the role that states are playing
- 04:14in the vaccine rollout,
- 04:15including not just the issues
- 04:17around allocation that are getting
- 04:18a lot of attention recently.
- 04:19Of course, for understandable reasons,
- 04:21but also the question about how
- 04:23the science can inform the way in
- 04:25which the state of Connecticut and
- 04:26other states are supporting the
- 04:28rollout and distribution of these
- 04:30vaccines here in Connecticut.
- 04:31As, as you heard,
- 04:32were one of those states that has a
- 04:34vaccine advisory committee on which
- 04:36I serve along with aryel colleagues
- 04:37Brick Martinello and Albert Cohen.
- 04:39Jim hadler.
- 04:40On our main advisory group and the
- 04:42Science subcommittee and one of
- 04:43the responsibilities of our group
- 04:45is not to replace or usurp,
- 04:47or to duplicate the work that the FDA did.
- 04:50Reviewing the vaccine candidates.
- 04:51But,
- 04:51as these vaccines were being made available,
- 04:53and as they had been authorized
- 04:55by the FDA to affirm the integrity
- 04:57of those review processes to look
- 04:59carefully at the data,
- 05:00the way in which the data was collected,
- 05:03the way in which it was reviewed,
- 05:05and to provide one more set of eyes,
- 05:07one more vote of confidence that
- 05:09we could have.
- 05:10We could we could trust the mechanisms
- 05:13that were used to help us get the
- 05:15vaccines that we're now rolling out,
- 05:17and you can see the summary
- 05:18statement here affirming the
- 05:19integrity of the processor recommendation
- 05:21that our science subcommittee,
- 05:23major Governor Lamont first for
- 05:24the Pfizer by Ontech vaccine,
- 05:26and again for the Moderna vaccine
- 05:28in a process, will continue for
- 05:29subsequent vaccine candidates.
- 05:30As part of this broader effort to
- 05:33build confidence in the vaccines and
- 05:35to help support and evidenced way
- 05:37their rollout and their distribution.
- 05:39As we turn to the issues around rollout and.
- 05:44Next slide here is not advancing,
- 05:46which is a bit problematic.
- 05:47Excuse me here as we turn to the
- 05:50issues around roll out and hopefully
- 05:52you can still see that slide.
- 05:54Here colleagues and I picking up on
- 05:56some of the work that Jenny Pitts
- 05:58and her colleagues in the public
- 06:00Health Modeling Unit are doing.
- 06:02Another of their colleagues in mind,
- 06:04David Pal teal from the School
- 06:06of Public Health,
- 06:07along with Doctor Rochelle Lenski,
- 06:09the incoming director of the CDC,
- 06:11and the new administration.
- 06:12We looked using mathematical
- 06:13modeling techniques at how
- 06:15different vaccine candidates.
- 06:16Having different profiles,
- 06:17hypothetical profiles with respect
- 06:18to their efficacy as defined in
- 06:20different ways against infection
- 06:21or transmission or severity.
- 06:22Looking at different ways in which
- 06:24vaccines are implemented in terms
- 06:26of the pace of their roll out,
- 06:28the number of individuals in terms of
- 06:30the fraction of the population reached,
- 06:32as well as what the state of the
- 06:34pandemic is at the circumstances
- 06:36which in which a vaccine is
- 06:38introduced as measured through
- 06:39through our party and what we did in
- 06:42collapsing a lot of work and into
- 06:44a single slide that that could be.
- 06:46Full paper was to look at,
- 06:48see what factors could help drive
- 06:51a vaccine rollout that could be
- 06:53most effective at reducing cases
- 06:55of COVID-19 and reducing deaths
- 06:57and what we found summarizing
- 06:58a lot of information into a key
- 07:01point was looking at the effects
- 07:03that implementation really has.
- 07:04As the title suggests,
- 07:06here that even if we have very
- 07:08highly efficacious vaccines,
- 07:10this slide only went up to 75% efficacy,
- 07:12but the pattern holds that even 95%
- 07:15efficacy that what will be matter critically.
- 07:18Or it is the pace in which we
- 07:20can implement these vaccines,
- 07:21the speed at which we can roll them out,
- 07:24the number of the percentage of the
- 07:26population we can reach and how
- 07:28effectively we are holding down
- 07:30the pandemic at the time in which
- 07:32the vaccines are being introduced
- 07:33as measured through RT that we can
- 07:35accrue much greater vaccine related
- 07:36benefits around those circumstances
- 07:38of implementation almost as much
- 07:40so as some incremental advantages
- 07:41in vaccine efficacy itself,
- 07:42we summarize some of these key findings
- 07:45in a companion Op Ed and USA TODAY.
- 07:47Back in November,
- 07:48when we wrote this paper.
- 07:49Really emphasizing things that we're all
- 07:52living through and seeing right now,
- 07:54and the public health community has
- 07:56been thinking about for sometime
- 07:58about the importance of distribution,
- 08:00the importance of continuing our
- 08:02public health strategies to keep the
- 08:04virus manageable, all things considered,
- 08:06an the importance in investment.
- 08:08The investment in implementation of
- 08:09vaccine distribution and delivery.
- 08:11As we wrote in in November,
- 08:13challenges that we're continuing to see now,
- 08:16and hopefully efforts that will
- 08:18improve as the weeks and months ago.
- 08:20Along with respect to the to the
- 08:23investments in vaccine rollout
- 08:24that we're now encountering.
- 08:26My colleagues and I have continued this
- 08:28work looking using that model as well
- 08:30to think about questions that have
- 08:32also come up earlier today thinking
- 08:34about particular one dose vaccines,
- 08:36windows vaccines or Windows vaccine regimens.
- 08:37If there are studied and confirmed,
- 08:39what would we look at in terms
- 08:41of the of the trade offs in over
- 08:43a six month time horizon?
- 08:45Is this paper looks at in terms of the
- 08:48advantages of a one dose formulation
- 08:49in terms of of providing efficacy
- 08:51more quickly than two doses in terms
- 08:53of what level of efficacy might?
- 08:56Below that 95% threshold we now have
- 08:59result in as many infections or deaths
- 09:01averted and what we found using our model,
- 09:04which again no model is perfect.
- 09:07But they help frame and
- 09:08hopefully inform the debate.
- 09:10We found that a single dose vaccine that
- 09:13provides protection over an indefinite
- 09:15period could have an efficacy of 55%
- 09:17and invert as many infections over a
- 09:20six month period as that 95% two dose
- 09:23vaccine series and if efficacy wanes,
- 09:25obviously that's an important consideration.
- 09:27Well then, even uh.
- 09:28Duration, mean,
- 09:29duration of efficacy of 75%,
- 09:31mean duration of efficacy of six months,
- 09:33rather even a 75% efficacy could
- 09:35avert the same number of infections
- 09:37as a two dose series.
- 09:38Just looking at the advantages
- 09:40of getting immunity more quickly.
- 09:41Not to mention the issues around pacing
- 09:43and speed of vaccine distribution.
- 09:45So one data point again a full
- 09:47paper that's hard to do justice
- 09:49to in a single slide.
- 09:51That helps us to try and think
- 09:53about some of these considerations
- 09:54that might emerge in the weeks and
- 09:57months ahead as we begin thinking
- 09:59about collecting more data.
- 10:00Out windows alternatives.
- 10:01Very briefly and then to try to help
- 10:05us return a closer to schedule,
- 10:07I want to turn to the global context here.
- 10:10Such an important consideration.
- 10:12Lots of our colleagues here at Yale
- 10:14and elsewhere have been thinking much
- 10:16more deeply around the global vaccine story,
- 10:18including my colleagues at over,
- 10:20who's up next year.
- 10:21But it's such an important part of
- 10:23this broader policy and politics
- 10:25conversation around around covid vaccines.
- 10:27BMJ published two very nice papers
- 10:29earlier this year last month.
- 10:31Actually in December. Looking at.
- 10:33The marketplace of vaccine reservations
- 10:35that exist for cobin 19 vaccines.
- 10:37The countries that are procured
- 10:39vaccines how many have been procured.
- 10:42The the vaccine supply anticipated
- 10:44for a vaccination.
- 10:45Programs in low and middle income countries,
- 10:48particularly through international
- 10:49collaborations.
- 10:50In one paper and the other looked
- 10:52at the demand, you know,
- 10:54tried to measure what the actual need,
- 10:56the demand for these vaccines will be
- 10:58a globally depending on how we think
- 10:59about high priority groups or how
- 11:01we cast broader Nets.
- 11:02And they asked me to write a
- 11:04companion tutorial that I'll close
- 11:05with here just to return us to the
- 11:07issue of of politics and policy in
- 11:09those intersections that I study.
- 11:10In most of my work,
- 11:12and as as we know here at this,
- 11:14at this moment of transition,
- 11:15and at this important inflection
- 11:17point in our vaccination effort
- 11:18here in the United States and
- 11:19around the world, you know.
- 11:21We know that how important
- 11:22this spirit of solidarity,
- 11:24global collaboration,
- 11:25but particularly leadership,
- 11:26from from high income wealthy
- 11:27countries will be to the success
- 11:29of global vaccination efforts,
- 11:31both in the financial, logistical,
- 11:32technical way as important partners.
- 11:34If we're going to have an equitable
- 11:36global vaccine rollout,
- 11:37and as I know here,
- 11:39I think we're at a point where the
- 11:41re engagement of the United States
- 11:43in that global health community
- 11:45beginning tomorrow with the return
- 11:47to the World Health Organization,
- 11:49and hopefully what that signals for
- 11:51COVID-19 vaccine efforts globally as well.
- 11:53It is a very favorable signal that will
- 11:55certainly not solve their problems ahead,
- 11:57but will be really valuable in getting us
- 11:59in the right direction on the global front.
- 12:01So with that I will conclude I'm happy
- 12:03to follow up individually by email.
- 12:05There's my Twitter handle as well,
- 12:07and thanks again for the opportunity to
- 12:09be part of this group this afternoon.
- 12:12Thank you.