The Food and Drug Administration’s chief medical and scientific officer, Dr. Vinay Prasad, rejected two COVID-19 vaccines in May due to unknown risks despite experts’ confidence that they were safe, documents revealed.
While both the Novavax vaccine and the newest generation of the mRNA Moderna vaccines had been signed off on by about 30 FDA vaccine officials, Prasad ended up writing overrides for each, restricting their use. Prasad argued that the threat of COVID-19 had decreased, changing the cost-benefit weight of receiving such a vaccine.
“Even rare vaccination-related harms, both known and unknown, now have a higher chance of outweighing potential benefits in non-high-risk populations,” Prasad said in the Novavax override memo.
The reversal is part of a larger effort at the FDA to limit vaccinations to people 65 and older. Vaccine eligibility was also reduced for people whose medical conditions would put them at risk if the vaccine were administered.
Records show the clinical trials involved 30,000 people, and another database containing 45,000 people was also reviewed. Andrew Nixon, spokesman for the Department of Health and Human Services, backed up Prasad, saying he did his job and did it in the best way.
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“He evaluated the totality of the evidence and made a judgment rooted in gold-standard science. That’s not political — it’s what principled leadership looks like,” Nixon said.
This is not the first time an FDA chief officer has overridden their own scientists. Many applauded Prasad’s predecessor, Dr. Peter Marks, for approving a treatment for the rare and sometimes terminal condition Duchenne muscular dystrophy despite opposition within the FDA. Prasad, however, recently announced a safety review of the drug approved by Marks, as it has been the possible cause of death by acute liver failure in at least two patients.
