September 23, 2020

Senator Hassan Secures Commitment from CDC and FDA to Conduct Key Oversight Measures in Vaccine Review Process

WASHINGTON – U.S. Senator Maggie Hassan, during a during a Health, Education, Labor and Pensions (HELP) Committee hearing today, secured commitments from Dr. Stephen Hahn, Commissioner of the Food and Drug Administration (FDA), and Dr. Robert Redfield, Director of the Centers for Disease Control and Prevention (CDC), that their agencies would conduct key oversight measures during the COVID-19 vaccine review process to help ensure that any potential COVID-19 vaccine is safe and effective and that the American public have confidence in the vaccine.

 

To watch Senator Hassan’s questioning, click here.

 

Senator Hassan expressed concerns about the lack of public confidence in a potential vaccine: “An ABC poll from this past weekend found that 69 percent of Americans will not have confidence in the President vouching for a vaccine…FDA and CDC have existing vaccine review processes that are considered the gold standard by public health experts all around the globe. We have to make sure that these proven review processes take place in a transparent way, free from political influence.”

 

In response, Dr. Hahn and Dr. Redfield committed to Senator Hassan that their agencies’ advisory committees – which meet and issue recommendations on the safety and efficacy of vaccines – will publicly release their findings and recommendations for each vaccine product that they review prior to its approval or authorization, and subsequent distribution to the public.

 

Following Senator’s Hassan’s questioning, Dr. Hahn said: “It will be a public process. The vote, the discussion, and the recommendations will be public. We will incorporate those and then make our decision.”

 

Dr. Redfield echoed Dr. Hahn’s assurances: “The [Advisory Committee on Immunization Practices] will make those recommendations after the FDA…then they will deliberate on how the vaccine should be used in the United States, and that will happen in public…before it’s recommend to be used for the American public.”

 

Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, agreed that the advisory committees’ process should be made public, and said that the “reason I have confidence in the process” is because the scientific community will be able to scrutinize the data reviewed by these advisory committees, as well as their public findings and recommendations, prior to any vaccine receiving approval or authorization and being distributed for public use.

 

Senator Hassan went on to discuss bipartisan legislation that she introduced that will enshrine into law the commitments made today. Specifically, it requires that the CDC Advisory Committee on Immunization Practices and the FDA Vaccine and Related Biological Products Advisory Committee each meet and issue recommendations on vaccine products, and alternatively, if such meetings do not take place, the Secretary of Health and Human Services is required to explain the justification for those decisions.

 

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