FDA Reviewing Deaths Potentially Linked to COVID Shots
Federal health authorities have begun a broad reassessment of whether any deaths may be connected to COVID-19 vaccinations, marking a major shift in the government’s handling of vaccine safety concerns. Officials revealed this week that the Food and Drug Administration has opened an expansive inquiry spanning multiple demographics.
According to Andrew Nixon, a spokesperson for the Department of Health and Human Services, the agency is “doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines.” Vaccine makers have also been notified that regulators are reexamining data on RSV immunizations as part of a larger review of post-market safety.
The COVID-19 vaccines were introduced at the end of 2020 under emergency-use authorization, and by the middle of the following year the Pfizer-BioNTech shot became the first to obtain full FDA approval. Public guidance has since tightened, with HHS Secretary Robert F. Kennedy Jr. openly criticizing the vaccines and significantly reducing federal recommendations for who should receive them.
Amid that backdrop, FDA Commissioner Marty Makary announced last month that 10 children had died following COVID-19 vaccination. He told NBC News last week that the Biden administration withheld information about the risk of myocarditis — a heart inflammation condition — from public release. “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. He added, “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.”
In response to the accumulating findings, FDA official Vinay Prasad circulated a memo to agency staff, saying the revelations would trigger a revision of how the FDA evaluates immunizations, including flu shots, placing heightened requirements on manufacturers to demonstrate safety and efficacy. “This is a profound revelation,” Prasad wrote in the memo, which The New York Times first disclosed. “For the first time, the U.S. F.D.A. will acknowledge that COVID-19 vaccines have killed American children.”
{Matzav.com}
