FDA official restricted approvals against advice of government scientists

WASHINGTON>> The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government scientists, according to federal documents released Wednesday.

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally intervened to place restrictions on COVID-19 shots from vaccine makers Novavax and Moderna.

Both vaccines were approved by the FDA in May after months of analysis by rank-and-file FDA reviewers.

But internal correspondence shows Prasad disagreed with staffers who planned to approve the shots for everyone 12 and older, similar to previous COVID vaccines. The scientists had concluded the benefit from the vaccines and the risk of COVID-19 outweighed the risk of possible side effects, which are rare.

Instead, Prasad decided the shots should be limited to those who face special risks from the virus — seniors or children and adults with underlying medical issues.

Prasad explained that the COVID vaccine benefits must be reconsidered in light of falling rates of death and hospitalization and the possibility for vaccine side effects. It’s the latest in a series of vaccine restrictions imposed by officials working under Kennedy, who has long questioned the benefits of vaccines.

“Even rare vaccination-related harms both known and unknown now have higher chance of outweighing potential benefits” Prasad wrote in a five-page memo explaining his decision.

COVID-19 remains a pandemic, resulting in 32,000 to 51,000 U.S. deaths and more than 250,000 hospitalizations since last fall, according to the Centers for Disease Control and Prevention.

Most at risk for hospitalization are seniors and children under 2 — especially infants under 6 months.

Top FDA leaders typically are not involved in the review of individual products. Officials such as Prasad can overrule staffers, but such cases are rare and often controversial.

News of the FDA documents was first reported by The New York Times.

Prasad was hired to lead the FDA’s vaccine center in May, after the previous director, Dr. Peter Marks, was forced to resign over disagreements with Kennedy.

An academic researcher specializing in cancer therapies, Prasad came to prominence during the height of the pandemic for criticizing public health measures, including the FDA’s approval of COVID boosters for healthy adults and children.

— The Associated Press