Letter to Steven Hahn, Director of the Food and Drug Administration - Lawmakers call on FDA to ensure science, not politics, guides COVID-19 vaccine approval process

Letter

Dear Dr. Hahn:
We write regarding the coronavirus disease of 2019 (COVID-19) vaccine development
efforts, seeking assurance and reiterating our expectations that science and the protection of
public health--not political expediency--will drive the U.S. Food and Drug Administration's
(FDA) decisions to authorize or approve a COVID-19 vaccine for use by the American people.
The trust of the American people and the health of the nation depend on FDA and the Trump
Administration abiding by this standard.
We all want a safe and effective COVID-19 vaccine as soon as possible. Since the
beginning of the pandemic alone, Congress has already provided over $8 billion for the pursuit
of COVID-19 vaccines, therapeutics, and diagnostics.1
This investment has enabled the
unprecedented timeline of COVID-19 vaccine research, development, and manufacturing
activities currently underway. Further, on May 15, 2020, the U.S. House of Representatives
passed an additional $4.75 billion for COVID-19 countermeasure efforts, including additional
support to expedite vaccine efforts as part of the Heroes Act.
2
These resources are crucial not
just for the speed of the endeavor, but also to ensure their safety and efficacy. As U.S.
Department of Health and Human Services (HHS) Secretary Alex Azar said earlier this month,
"The point is not to be first with a vaccine, the point is to have a vaccine that is safe and effective
for the American people and the people of the world."P2F
3
P We could not agree more. We appreciate the actions FDA has taken to provide leadership and expertise on the
required evidence and safety considerations for the future authorization or approval of a COVID19 vaccine. FDA's June guidance and recently published information confirming these
safeguards provided valuable insight into how FDA will uphold its responsibilities.P3F
4
P Further,
FDA convening the Vaccines and Related Biological Products Advisory Committee (VRBPAC)
may allow for public transparency into the safety and efficacy discussions and the decisionmaking process.P4F
5
You recently testified before the Committee that, when determining whether to approve a
potential COVID-19 vaccine, FDA "will use the science and data that come to us, and we will
use our high standards to assess the safety and efficacy of a vaccine."6 Industry experts agreed
in a subsequent hearing that the guidance published by FDA outlining the agency's expectations
for clinical development and licensure was sufficient to protect the health and safety of patients.P6F
7
According to FDA's guidance and your own statements, any authorized or approved
COVID-19 vaccine would need to show in a placebo-controlled randomized trial that it prevents
the disease, or decreases its severity, for at least 50 percent of people who are vaccinated.8 In
understanding this efficacy threshold was informed by our seasonal flu vaccine efforts, we
appreciate your explanation that a COVID-19 vaccine that could prevent "the majority of people
from becoming infected would be a tremendous step forward towards herd immunity and a
return to normal life."P8F
9
Given the time necessary to enroll and conduct phase III clinical trials as well as the
duration of minimum safety monitoring requirements laid out in FDA's guidance, licensure of a COVID-19 vaccine will be unlikely before spring 2021.10 As a result, any COVID-19 vaccine
made available for public use before then would only be possible through FDA issuance of an
emergency use authorization (EUA). Recently, you stated that, prior to issuing an EUA, FDA
"would have to be very secure about the safety and some level of clinical efficacy," and
furthermore you committed not to ""back away from the floor' of 50 percent efficacy."11 You
also acknowledged that most Americans are not familiar with the distinction between an
authorization and approval by FDA, and that FDA's "actions and communications can provide
clarity about product safety and insight into regulatory decision-making."31TPF
12
While we were encouraged by your past statements, we are gravely concerned about the
actions and the communications by the President, the White House, and HHS. Just this past
weekend, the President falsely accused FDA of making COVID-19 vaccine clinical trial
enrollment difficult as part of a "deep state" plot to delay a vaccine until after Election Day.13
Not only did White House Chief of Staff Mark Meadows defend the President's accusations
against FDA, he applauded them, stating, "sometimes you have to make them feel the heat if
they don't see the light."14 As FDA Commissioner, it is your responsibility to lead and defend
the agency, yet when the President and his Chief of Staff accused the FDA of being part of the
"deep state" you remained silent.
Unfortunately, this is merely the latest example of science being politicized throughout
the Trump Administration's COVID-19 response. Whether sidelining the Centers for Disease
Control and Prevention,15 undermining its public health guidance,16 or denigrating the
Administration's own experts such as Dr. Anthony Fauci, the Director of the National Institutes
of Health's National Institute of Allergy and Infectious Diseases,17 it is clear that there are many
reasons for us to remain vigilant about the increasingly pervasive role politics is playing in our scientific institutions.
We are increasingly concerned by the political pressure that is being exerted by this
Administration on FDA. FDA issuing and then rescinding an EUA for hydroxychloroquine,18
followed this weekend by the issuing of an EUA for blood plasma as a treatment for COVID19,
19 raise serious questions of scientific independence. In both of these instances, the President
exerted pressure on FDA to take action despite reports of conflicting evidence of the
effectiveness of the treatments.
20 As has been reported, the President's behavior feeds the
public's fear that "FDA will succumb to political pressure and approve a vaccine or drug that is
not yet ready for prime time."21 This makes it all the more imperative that FDA take the threat
to the public's vaccine confidence into account when conducting the benefit-risk assessment of a
potential COVID-19 vaccine. As you put it, FDA 's decisions should be grounded on the
"31T5scientific evidence and rooted in a benefit-risk calculation that always puts the safety of patients
first."31TP2F
22
We expect nothing less from FDA moving forward. It is essential that FDA maintain its
scientific independence, adhere to required standards and protocols, and as you have repeatedly
and recently promised, make decisions "based solely on good science and data."P2F
23P Should
political pressure arise, we believe it is your duty to the American people to notify Congress and
the American people. Any political involvement in a future vaccine or treatment threatens to
undermine the credibility of the agency, and public confidence in vaccines and
treatments approved for use by FDA.
1. What safeguards and practices are in place, to mitigate against any political pressure from
the President, the White House, and HHS, and also to prevent even the appearance of any
political interference or expediency?
2. What further actions will FDA take to ensure that the evidence of safety and efficacy of a
future vaccine will guide any and all decisions to issue an EUA prior to full licensure
approval of a COVID-19 vaccine?
3. What, if any, remaining discussions, infrastructure assessments and modifications, and
decisions must be made with regard to post market surveillance prior to vaccine
authorization or licensure? What is your timeline for completing these steps?
4. Will all meetings, materials, and recommendations made by VRBPAC related to a
COVID-19 vaccine or vaccine candidate be made public in real time? Please detail what
components will be publicly available and how they will be released to the public (i.e.,
via public website).
5. What steps will you take to communicate to FDA staff their obligation to raise any and
all concerns with regard to political interference undermining FDA's public health
mission and science-based authority, as well as options available to them, including
contacting Congress or the Committee?
Thank you for your timely attention to this matter. We look forward to the response and
further updates as the nation the COVID-19 pandemic. For any questions about this request,
please contact Jesseca Boyer and Stephen Holland of the Majority staff at (202) 225-2927.
Given the ongoing threats COVID-19 poses to Americans' public health, and with hopes
that an effective vaccine can be developed safely in record time, we request responses to the
following by September 4, 2020.

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