FDA Reviewing Deaths Potentially Linked to COVID Shots

The Food and Drug Administration is looking into whether COVID-19 vaccines were tied to any deaths, government officials announced this week.

The FDA is "doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines," Andrew Nixon. a spokesman for the Department of Health and Human Services, said in a statement.

Manufacturers report that the FDA is also reviewing the safety of RSV immunizations.

COVID-19 vaccines were deployed in late 2020 under emergency use authorization. Less than a year later, the Pfizer-BioNTech vaccine became the first to receive full FDA approval.

HHS Secretary Robert F. Kennedy Jr. has criticized COVID-19 vaccines and has narrowed recommendations for who should receive them.

Last month, FDA Commissioner Marty Makary announced that 10 children died as a result of COVID-19 vaccination.

Makary told NBC News last week that the Biden administration withheld data from the public regarding the risks of myocarditis from the COVID vaccine.

"We have done more to study myocarditis and to go back and look at deaths of people, of children from the COVID vaccine," Makary said.

"Internal data submitted on myocarditis, we found that the Biden administration was sitting on data on myocarditis in young people, and it was not made public," he added.

FDA official Vinay Prasad said in a memo to staff that, as a result of the findings, the agency would reexamine its framework for flu shots and place stricter emphasis on manufacturers proving their products are safe and effective.

"This is a profound revelation," Prasad said in the memo, which was first reported by The New York Times. "For the first time, the U.S. F.D.A. will acknowledge that COVID-19 vaccines have killed American children."

• FDA Comm Says Data Showed 10 Child Deaths Due to COVID Shots
• FDA Unveils New Rare Disease Treatment Approval Pathway