FDA official threatens tougher standards for vaccines

A top Food and Drug Administration regulator called for tighter government vaccine oversight, including stricter guidelines for the annual flu shot and new vaccines, after an internal agency review linked COVID-19 vaccines to the deaths of 10 children.

Why it matters: The findings, which were announced in an internal FDA memo and haven't been published in a medical journal, signal another likely shake-up in vaccine policy.

• This one would extend beyond COVID shots and require more rigorous evidence to approve flu immunizations, inoculations for pregnant women and the practice of administering multiple vaccines.

The big picture: The memo from top vaccine regulator Vinay Prasad comes ahead of a key meeting of Health Secretary Robert F. Kennedy Jr.'s handpicked vaccine advisors next week that will take up a prospective overhaul of the childhood vaccine schedule.

• Kennedy's department has already dropped a broad recommendation that Americans get COVID shots, signaling an official lack of confidence in the safety and efficacy of the vaccines.

Driving the news: Prasad's emailed memo, a copy of which was reviewed by Axios, said no fewer than 10 children's deaths were linked to the vaccines, based on an intial review of 96 deaths between 2021 and 2024 reported to the federal Vaccine Adverse Event Reporting System.

• Prasad called the findings a "profound revelation" and called for swift action, including "pre-market randomized trials assessing clinical endpoints for most new products."

What's inside: The FDA will impose tougher standards for authorizing vaccines for pregnant women, and pneumonia vaccine makers will have to show their products reduce pneumonia (at least in the post-market setting) and don't merely generate antibodies, Prasad wrote.

• "For the first time, the U.S. F.D.A. will acknowledge that COVID-19 vaccines have killed American children," his memo stated.
• The email didn't cite the type of COVID vaccines involved or other key details, including how the agency established the link.
• The vaccine reporting system is a repository of reports of adverse reactions from a wide variety of sources. It isn't designed to assign a cause.

Prasad has long been critical of the vaccines and the federal pandemic response.

• Earlier this year, he abruptly left the agency amid rumored tensions with the White House but was reinstated less than two weeks later with the backing of Kennedy and FDA commissioner Marty Makary.
• In the memo, Prasad states he's "open to vigorous discussions and debate on vaccine policies ... until they are ready to be made public." He instructed staff members within the FDA's Center for Biologics Evaluation and Research who don't agree with these core principles to submit their resignations.
• The Department of Health and Human Services didn't immediately respond to a request for comment.

Between the lines: The memo's findings, first reported by the New York Times, suggests the children's deaths were connected to myocarditis, or inflammation of the heart muscle — a known, but rare, side effect linked to the vaccines since early in the pandemic.

• In 2021, the Centers for Disease Control and Prevention concluded there was a "likely association," especially in adolescents and young adults, but that there still was a benefit for the group to get the shot.
• Earlier this year, the FDA ordered Pfizer and Moderna to expand warnings on the labels of their COVID-19 vaccines for the risk of heart inflammation in adolescents and young men.
• The agency cited updated estimates of cases and a post-approval study showing the persistence of heart problems months after getting the mRNA shots.

Yes, but: Infectious disease doctors and health researchers insist that COVID vaccines remain safe and effective and have saved many lives, pointing to scores of peer-reviewed scientific articles and controlled trials.

• They've argued there is no scientific evidence to justify Kennedy's decisions to drop recommendations for the shots, and some accuse the administration of cherry-picking data to arrive at a pre-determined conclusion.
• Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, told the New York Times the memo was an example of science "by press release."