The U.S. Food and Drug Administration is investigating whether deaths “across multiple age groups” are related to the Covid-19 vaccine, a spokesperson said on Tuesday. Weeks ago, a senior official at the agency claimed without providing evidence that Covid-19 vaccinations caused the deaths of 10 children.
U.S. Department of Health and Human Services spokesman Andrew Nixon said the FDA was conducting a “thorough investigation” but declined to provide details about what data sources are being used and what, if any, potential changes it is considering for coronavirus vaccine approval or marketing.
Dr. Vinay Prasad, the FDA’s chief medical and scientific officer and director of the Center for Biologics Evaluation and Research, claimed in a memo late last month that “healthy young children at very low risk of death are being forced to receive potentially fatal vaccines at the behest of the Biden administration through school and work requirements.”
Prasad did not provide details about the 10 deaths or how the FDA came to that conclusion, but pointed to a “preliminary analysis” that examined 96 deaths and linked 10 to Covid-19 vaccinations. He also claimed that the coronavirus “has never been highly lethal to children” and that its impact was “comparable” to respiratory viruses for which there is no annual vaccine.
According to the World Health Organization, more than 700 million doses of Covid-19 vaccines have been administered in the United States since they became available in late 2020. These injections are extensively tested and continuously monitored for safety, and serious side effects such as allergic reactions or myocarditis are generally rare.
FDA regulations require health care providers to report deaths after vaccination to the Vaccine Adverse Event Reporting System (VAERS), even if it is not clear whether vaccination was the cause of the death. The public can also submit incidents to the database, which is used by federal agencies to conduct further research into vaccine safety.
Prasad said that based on the FDA’s analysis, the agency will adopt a new vaccine approval process and need more evidence to prove its safety and value before it can be put on the market. Among the changes are stricter requirements for the authorization of vaccines for use in pregnant women and for trials of pneumonia vaccines, which would require proof that the vaccine reduces disease rather than proof that it produces enough antibodies to fight the disease.
Prasad said the agency will also “revise the annual flu vaccine framework” and “will reassess safety and be honest about vaccine labeling.”
U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. has repeatedly questioned the effectiveness of vaccines and previously founded the anti-vaccination group Children’s Health Defense.
As secretary of state, Kennedy cut funding for mRNA vaccine development, replaced members of the Centers for Disease Control and Prevention’s Vaccine Advisory Committee, and directed the CDC to change its website to include false claims linking autism and vaccines.
CNN’s Kaanita Iyer, Adam Cancryn and Amanda Sealy contributed to this report.
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