Records show that a top U.S. regulator rejected the recommendations of agency experts and limited the use of Covid vaccines.
The Food and Drug Administration’s top vaccine official rejected broad uses of two Covid vaccines, citing unknown risks or injuries despite assurances of safety from dozens of staff experts, newly released documents show.
The decisions by the official, Dr. Vinay Prasad, the agency’s new chief medical and scientific officer, stunned agency veterans. Records show that the F.D.A.’s vaccine staff members had signed off on approving the Novavax vaccine, an alternative to mRNA shots and weeks later on the next-generation of the mRNA Covid shot by Moderna for anyone 12 and older.
Dr. Prasad overruled those recommendations by the end of May and instead advised restricting the use of both Covid vaccines. He wrote in two memos that the threat from the virus had fallen and changed the risk-benefit balance of vaccinating healthy, younger people.
The changes for the two vaccines aligned with the agency’s broader plan that limited the use of all Covid vaccines to people 65 and older. For those younger than 65, the F.D.A. rolled back eligibility for Covid vaccines to those with a medical condition that would put them at high risk.
The new documents offer a window into Dr. Prasad’s vision for the agency and his thinking on vaccine policy. The records reveal that F.D.A. staff members concluded that the vaccines were safe and effective based on clinical trials of the shots tested in thousands of people. But Dr. Prasad wrote that there could still be vaccine-related injuries that have yet to be discovered.
