FDA Memo Links COVID-19 Vaccine to Child Deaths, Agency to Revise Approval Process

A Food and Drug Administration (FDA) memo has reported that the COVID-19 vaccine contributed to the deaths of at least 10 children.

Following the release of the memo on Friday, which was obtained by Reuters and other outlets, FDA chief medical and scientific officer Vinay Prasad told reporters that the agency would be changing its vaccine approval process.

Newsweek contacted the FDA via the Department of Health and Human Services (HHS) outside of regular working hours via email for comment.

Why It matters

The Trump administration, particularly Health Secretary Robert F. Kennedy Jr, has been vocal in its skepticism of the COVID vaccine.

Kennedy has previously made debunked claims about the vaccine, even falsely attributing it to the death of baseball player Hank Aaron, and has been clear on the sweeping changes he intends to make to child vaccination, which included overhauling the immunization schedule.

The memo also builds on previous concerns raised about the vaccines by the FDA.Earlier this year, the agency said that the main manufacturers of the vaccines, Pfizer and Moderna, would have to update their data about the chances of myocarditis and pericarditis, after cases of the two heart conditions were reported in young men who had taken the vaccine.

What To Know

The memo, which appears to have been shared on social media,states that it has been found “at least 10 children have died after and because of receiving the COVID-19 vaccination.” It added that the number is “certainly an underestimate due to underreporting, and inherent bias in attribution.”

The memo, which has not been peer-reviewed, does not appear to