Letter to The Honorable Stephen Hahn, M.D., Commissioner of Food and Drugs - Senator Murray Demands FDA Address Political Interference By Promising Thorough COVID-19 Vaccine Review, Outlining Standards for Emergency Authorization

Letter

I am alarmed by your statement to the Financial Times that the Food and Drug Administration
(FDA) is prepared to authorize a COVID-19 vaccine for emergency use before the completion of
Phase III clinical trials.
1 It is essential that FDA engage in a transparent and rigorous process for
review of all COVID-19 vaccine candidates. The agency must adhere to clear standards and
guidelines for vaccine authorization and approval, not rely on ad hoc "podium policy." I urge
you to issue official FDA guidance clarifying your remarks on the criteria for emergency
authorization of COVID-19 vaccines and making clear the agency will uphold its commitments
to scientific integrity and regulatory independence. The nation cannot afford for FDA to
jeopardize the fight against COVID-19 by cutting corners and undermining public confidence
when it comes to the safety and efficacy of vaccines.
Last month, almost 400 leading public health experts wrote to you urging that FDA authorize or
approve COVID-19 vaccines only after the agency has been able to evaluate safety and efficacy
data from completed Phase III clinical trials.2 Days later, you assured the public in an editorial
that a "safe and effective COVID-19 vaccine that meets or exceeds the FDA regulatory standards
will provide important momentum for pandemic recovery" and underscored the importance of a
"clear public understanding of the evidence supporting vaccine safety and efficacy." In addition,
you emphasized that "[i]ssuance of an EUA for a COVID-19 vaccine may be appropriate once
studies have demonstrated the safety and effectiveness of the vaccine."3
Notwithstanding these assurances, in a Financial Times article published on August 30, you
stated that FDA may find it "appropriate" to authorize a COVID-19 vaccine "before the end of
Phase Three" clinical trials.4 In response, your predecessor, Dr. Scott Gottlieb, questioned the
approach of "fast tracking" a vaccine before Phase III clinical trials are complete, saying FDA
must wait for certain pre-specified benchmarks to occur before the agency "can make a decision
around the efficacy of these vaccines."5
1 https://www.ft.com/content/f8ecf7b5-f8d2-4726-ba3f-233b8497b91a 2 https://www.nytimes.com/2020/08/05/health/covid-19-vaccine-fda.html 3 https://jamanetwork.com/journals/jama/fullarticle/2769421
4 https://www.ft.com/content/f8ecf7b5-f8d2-4726-ba3f-233b8497b91a 5 https://thehill.com/policy/healthcare/514336-gottlieb-questions-fda-chiefs-vaccine-fast-track-comments-fullapproval-a; https://www.cbsnews.com/news/transcript-scott-gottlieb-discusses-coronavirus-on-face-the-nationaugust-30-2020/
Your assertion that FDA may authorize vaccines for emergency use prior to completion of Phase
III trials risks creating uncertainty and distrust in FDA's process for the review of COVID-19
vaccines during a critical time in this public health emergency. I am especially concerned about
these statements given reports of political interference in FDA decisions to authorize COVID-19
therapies, including hydroxychloroquine and convalescent plasma, and baseless allegations from
President Trump that FDA's career public servants are trying to stop treatments and vaccines for
COVID-19 from reaching the public. It is your responsibility to push back against any attempted
political interference in FDA scientific decision-making and ensure the COVID-19 vaccine
review process meets the highest standards and is beyond reproach.
6
In June, FDA issued guidance that provided the agency's current thinking on standards for
approval of a COVID-19 vaccine.
7 I urge you to issue similar guidance on standards for
emergency authorization of a COVID-19 vaccine to address uncertainty raised by your recent
comments. In addition, I request you provide me a briefing within seven days to discuss this
matter. To further discuss compliance with this request, please contact Katlin McKelvie
Backfield with my Health, Education, Labor, and Pensions Committee Staff at (202) 224-7675.

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