Letter to Alex Azar, Secretary of the Dept. of Health and Human Services, and Stephen Hahn, Commissioner of the Food and Drug Administration - Schweiker Joins Bipartisan Letter Urging Rapid Covid-19 Vaccine Development

Letter

Dear Secretary Azar and Commissioner Hahn,

We are writing to ask you to begin consideration of the conditions under which a COVID-19
vaccine might be approved and deployed more rapidly than under the usual approval process.
This consideration must rest on a rational analysis of the risk/benefit ratio, based on the best
available science, and be free of political interference.
For decades, the FDA and the public have been well served by a thoughtful drug approval
process that appropriately balances the risks and benefits of early drug deployment. We
recognize that there is an essential tradeoff between the benefits of having a new drug available
quickly, the risks to human health of deploying a drug with effectiveness and side effects that are
not fully known at the time of deployment, and the risks to test subjects in clinical trials. In the
case of vaccines for normal diseases, this appropriately results in a typical approval time for
vaccines of 18 months to several years.

However, the enormous human cost of the COVID-19 epidemic alters the optimization of the
risk/benefit analysis in favor of more rapid approval and deployment. Every week of delay in
the deployment of a vaccine to the seven billion humans on Earth will cost thousands of lives.
Human misery also results from the economic damage caused by COVID-19 pandemic, and by
the tragic psychological impact of social isolation on humans of all ages. Therefore, in addition
to proceeding along the normal route for developing an approved vaccine for COVID-19, we
urge you to consider adopting, in parallel, expedited procedures for testing, approval and use of
COVID-19 vaccines.

As you know, rapid vaccine development balances risks to human health of voluntary test
subjects in clinical trials, the risks of early deployment of a moderately tested vaccine to the
general population, and the certainty of human suffering and death from delayed vaccine
deployment. We write to assure you that Congress understands that a more risk-tolerant
development process is likely appropriate in the case of a COVID-19 vaccine. In the case of
accelerated human trials, justifiable risks may be taken by parallel testing of multiple dose levels,
advancing more rapidly from phase to phase and potentially by challenge trials that involve
deliberately infecting volunteers who have received candidate vaccines or placebos to confirm
the efficacy of those vaccines and are at very low risk of serious disease from the infection. This could accelerate the emergency use and eventual licensure of vaccines that have also
shown safety in larger groups by many months. We urge you to consider these and other options, provided they proceed with the principle of informed consent of truly voluntary subjects
and are backed by the best available science. Our situation in this pandemic is analogous to war,
in which there is a long tradition of volunteers risking their health and lives on dangerous
missions for which they understand the risks and are willing to do so in order to help save the
lives of others.

Once approved, vaccines must be deployed as rapidly as possible to the full population of the
world. Congress has given you clear direction and funding to invest in multiple routes to mass
production for multiple plausible vaccine candidates, in advance of their testing and approval,
with the acknowledgement that much of that capacity will likely go unused when the final set of
vaccines is chosen for mass deployment. We reemphasize that direction from Congress and ask
you to inform Congress immediately if it appears that mass production capabilities for
significantly promising vaccine candidates are being delayed for economic reasons.

Plans for domestic production and deployment should be robust against potential export
blockades by other countries, but equally we should not assume that US will go the route of
hoarding either vaccines or the intellectual property they depend upon. Intellectual property must
not be a roadblock, nor must the "not-invented-here" syndrome, nor should commercial
considerations delay the delivery of best available vaccines to Americans and people throughout
the world. We urge you to continue to stay current with international developments and to not
fear to rely on the best available scientific data from transparent and trusted scientific
collaborations from around the world. We urge you to continue to maintain close contact with
vaccine developers and their regulators around the world so that if a better vaccine is developed,
tested, and proven elsewhere in the world, we will be in a position to rapidly approve, procure,
produce and deploy it.

We expect you to react flexibility to the situation as it evolves, follow the science as it develops,
and adjust accordingly. We urge you to work closely with independent groups of experts such as
the National Academy of Sciences, Engineering and Medicine's Standing Committee on
Emerging Infectious Diseases and 21st Century Health Threats to transparently make these
decisions on the development, testing, and prioritization for deployment of potential vaccines
among subpopulations, and to inform Congress and the public as these decisions are made.
Finally, we reiterate that decisions about deployment of vaccines must be made by scientific and
ethical experts, following legal principles defined by Congress, and be free of political
interference.

If you believe that additional legislation, or a clearer statement of congressional intent, is
necessary or desirable for you to take the actions outlined above please let us know as soon as
possible.

Respectfully,