The US Food and Drug Administration is looking into whether deaths “across various age groups” were related to Covid-19 vaccines, a spokesman 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 spokesman 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 for the approval or marketing of the Covid vaccine.
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 an extremely low risk of death were forced, at the request of the Biden administration, through 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 reached that conclusion but pointed to an “initial analysis” that looked at 96 deaths and linked 10 to the Covid-19 vaccine. He also claimed that Covid “has never been very lethal for children” and that its effects “are comparable” to respiratory viruses for which there are no annual vaccines.
More than 700 million doses of Covid-19 vaccines have been administered in the United States since they became available in late 2020, according to the World Health Organization. The shots were extensively tested and constantly monitored for safety, and serious side effects such as anaphylaxis or myocarditis were 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 that the 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’s 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 placed on the market. Among the changes will be stricter requirements for the authorization of vaccines used for pregnant women and trials for pneumonia vaccines that will need to show that the vaccines reduce disease, instead of showing that the vaccine produces enough antibodies to fight the disease.
The agency will also “review the annual flu vaccine framework,” Prasad said, and “will reevaluate safety and be honest in vaccine labeling.”
HHS Secretary Robert F. Kennedy Jr. has repeatedly questioned the effectiveness of vaccines and previously founded the anti-vaccination group Children’s Health Defense.
As secretary, Kennedy cut funding for mRNA vaccine development, replaced vaccine advisory committee members at the US Centers for Disease Control and Prevention, and ordered the CDC to change its website to include false claims linking autism and vaccines.
CNN’s Cananita Iyer, Adam Cancryn and Amanda Sealy Contributed to This Report.
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