E&C Democrats Demand Answers on FDA’s COVID Vaccine Memo

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Ranking Member Diana DeGette (D-CO), and Oversight and Investigations Subcommittee Ranking Member Yvette D. Clarke (D-NY) wrote to Food and Drug Administration (FDA) Commissioner Martin Makary today voicing serious concerns with the Director of the Center for Biologics Evaluation and Research (CBER) and Chief Medical and Scientific Officer Dr. Vinay Prasad unilaterally ordering new guidelines for vaccine development in an email to career scientists. Prasad’s memo was littered with disinformation and failed to provide evidence for its shocking claims.

“There is no credible scientific basis for Dr. Prasad’s claims linking COVID-19 vaccines to children’s deaths, which you yourself parroted the following day in an interview. The ‘findings’ Dr. Prasad references in the letter were not published in a peer reviewed journal or otherwise made public,” Pallone, DeGette, and Clarke pressed in their letter to Makary. “It is appalling that your leadership would circulate misleading statements that are known to be scientifically overstated and yet they demand they be treated as truth.” 

In the memo, Prasad writes children died “after and because of receiving COVID-19 vaccination” – an unsupported accusation that is not grounded in meaningful scientific analysis. In fact, Dr. Prasad concedes as much by writing that the relation of these deaths to vaccination is only “possible.”

As the Advisory Committee on Immunization Practices’ (ACIP) meetings continue today with changes to the childhood vaccine schedule that were demanded by HHS Secretary Robert F. Kennedy, Jr., Pallone, DeGette, and Clarke also made clear that no scientific basis exists to make life-threatening changes to vaccine access for Americans.

“FDA has yet to provide meaningful data to prove these changes are necessary. It is clear that these changes will certainly make it more difficult to get approval of vaccines through the process that experts say has ‘helped provide children and adults with timely access to safe and effective vaccines, saving many lives,’” Pallone, DeGette, and Clarke continued in their letter.

The Democratic Committee leaders demanded the following information on FDA’s practices by December 19:

• Data upon which FDA drew the conclusion that “at least 10 children have died after and because of receiving COVID-19 vaccination”;
• FDA’s weighing of the COVID-19 vaccine’s proven effectiveness in preventing illness, hospitalization, long COVID, or death in children against its claims of COVID-19 vaccine related deaths;
• FDA’s source of legal authority in unilaterally releasing its “path forward” for vaccine regulation via email;
• Data supporting FDA’s determination that the existing regulatory requirements are insufficient to show safety and efficacy of vaccines; and
• Names and titles of all HHS personnel who were involved in proposing such policy changes.

“Dr. Prasad’s memo represents a dangerous trend in the agency’s politicization of science under your leadership. His email makes clear that Dr. Prasad has aligned himself with an extreme, anti-vaccine, partisan agenda that puts the lives of the American people at risk,” Pallone, DeGette, and Clarke concluded.

Full text of the letter is available HERE.

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