After claiming that Covid shots killed children, FDA says it is also looking at other age groups

By Katherine Dillinger, CNN

(CNN) — The US Food and Drug Administration is looking into whether deaths “across multiple age groups” have been related to Covid-19 vaccines, a spokesperson said Tuesday, weeks after a senior agency official claimed — without offering evidence – that Covid-19 vaccinations resulted in the deaths of 10 children.

Andrew Nixon, a spokesperson for the US Department of Health and Human Services, said the FDA is conducting “a thorough investigation” but declined to offer details on what data sources are being used and what potential changes, if any, are being considered to Covid vaccine approval or marketing.

Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of its Center for Biologics Evaluation and Research, claimed in a memo late last month that “Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”

Prasad did not provide details about the 10 deaths or how the FDA came to that conclusion but pointed to “an initial analysis” that examined 96 deaths and linked 10 to the Covid-19 vaccination. He also claimed that Covid “was never highly lethal for children” and that the effects of it “are comparable” to respiratory viruses for which there aren’t annual vaccines.

More than 700 million doses of Covid-19 vaccines have been administered in the US since they became available in late 2020, according to the World Health Organization. The shots have been extensively tested and continually monitored for safety, and serious side effects such as anaphylaxis or myocarditis have been generally rare.

FDA regulations require health care providers to report deaths after vaccination to the Vaccine Adverse Event Reporting System (VAERS), even if it’s not clear that vaccination was the cause of death. Members of the general public can also submit events to the database, which federal agencies use to generate further study on vaccine safety.

Prasad said that as a result of the FDA analysis, the agency will adopt a new approval process for vaccines that will require more evidence of their safety and value before they can be marketed. Among the changes would be stricter requirements for authorization of vaccines used for pregnant women and trials for pneumonia vaccines that will need to prove the shots reduce disease, instead of showing that the vaccine produces enough antibodies to fight the illness.

The agency will also “revise the annual flu vaccine framework,” Prasad said, and “will re-appraise safety and be honest in vaccine labels.”

HHS Secretary Robert F. Kennedy Jr. has repeatedly raised doubts about the effectiveness of vaccines and previously founded the anti-vaccine group Children’s Health Defense.

As secretary, Kennedy has slashed funding for mRNA vaccine development, replaced the members of the vaccine advisory committee at the US Centers for Disease Control and Prevention, and directed the CDC to change its website to include false claims that link autism and vaccines.

CNN’s Kaanita Iyer, Adam Cancryn and Amanda Sealy contributed to this report.

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