In the memo, Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), asserted without evidence that at least 10 pediatric deaths were “related” to COVID-19 vaccines. He cited a review of data reported to the federal Vaccine Adverse Event Reporting System, a catchall early warning database that isn’t designed to show causality.
“The truth is we do not know if we saved lives on balance,” Prasad wrote.
Prasad said that as a result, the agency will be rethinking the framework for annual flu shots and will examine whether people should be receiving multiple vaccines at once. He also said vaccine makers will be required to provide more data on the safety and value of their products.
The memo did not detail any specific next steps, and it was unclear what, if any, new official policies Prasad was proposing. But he said that “FDA will acknowledge that COVID-19 vaccines have killed American children.”
More concrete changes could come later this week, when the Advisory Committee on Immunization Practices (ACIP) is set to discuss the entire childhood, adolescent and adult vaccine schedule. It is also scheduled to vote on changing the hepatitis B vaccine schedule for newborns.
The panel seemed poised to vote on eliminating the 34-year-old recommendation to provide hepatitis B vaccination to babies upon birth during its September meeting, but then tabled the discussion at the last minute.
CDC did not list on the agenda who will be making the presentations to the panel, a common practice during previous meetings.
The influential panel, which is largely comprised of vaccine skeptics appointed by Kennedy, is slated to discuss “adjuvants and contaminants” in vaccines— likely aluminum. The ingredient has been used in vaccines for several decades and has been repeatedly proven to be safe, but vaccine skeptics like Kennedy have long focused on its inclusion.
Removing aluminum, or even issuing a warning about its use, would affect some of the most important childhood shots including DTaP; hepatitis A and B; HPV; pneumococcal; and meningitis vaccines.
