The findings appear to be based on information submitted to the federal Vaccine Adverse Event Reporting System, VAERS, that contains unverified reports of side effects or bad experiences with vaccines, the report added.
Until the vaccine safety data is shared publicly, this should be considered “pure speculation,“ the statement added.
Reuters has not independently verified the report.
Regulators in more than 90 countries have not identified any new or undisclosed concerns in children or pregnant women for Moderna's COVID shot, the company said in an email response.
Novavax told Reuters that clinical data and real-world evidence for its COVID vaccine is available to the FDA, the CDC, “along with dozens of regulatory bodies around the world and scientific and medical experts in public health.”
“We’re doing a proper investigation,“ he said in that interview, noting that the FDA plans to release a report in the coming weeks.
Moderna's updated Spikevax shot is authorized for people six months and older with at least one underlying condition, while Pfizer and BioNTech's updated version of Comirnaty was approved for individuals aged 5 through 64 years with at least one high-risk condition. The 2022 emergency use authorization for the COVID vaccine for children under age 5 had been rescinded.
President Donald Trump has backed Kennedy despite congressional pressure, public health concerns and the political risks of changing vaccine policies nationwide.
The revamped advisory committee is scheduled to meet on September 18 and 19 - REUTERS
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