FDA, COVID-19 and vaccine
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The FDA’s top vaccine regulator asserted in a staff email that the Covid vaccine caused at least 10 kids' deaths, but experts told STAT they are skeptical of the “extraordinary” claim because it was not presented with detailed data.
In the wake of the memo, several vaccine experts responded that the CBER director's claim about the deaths requires more scrutiny. In a disclaimer on the Vaccine Adverse Event Reporting System (VAERS) website, the HHS notes that the data alone "cannot be used to determine if a vaccine caused or contributed to an adverse event or illness."
The FDA expands COVID vaccine death review to include adults amid ongoing vaccine safety evaluations and political scrutiny.
WASHINGTON, DC – Dr Vinay Prasad, the Food and Drug Administration’s vaccine chief, ignited a political and scientific firestorm after circulating an internal memo that claimed at least ten children had died “after and because of” receiving the COVID-19 vaccine.
Vaccine experts said the memo was irresponsible and omits key details about how officials arrived at the conclusion.
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FDA official, without providing data, claims link between COVID-19 vaccines and pediatric deaths
Dr. Vinay Prasad, the director of the FDA's vaccine division, did not provide data to back the claim in a memo sent to staff.
The agency claimed that 10 children’s deaths were linked to the shots, although it did not release evidence to support the assertions.