FDA Vaccine Regulator Vinay Prasad’s Claims Termed ‘Irresponsible Science at Best and Dangerous to the Public at the Very Least’

A top FDA 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.

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 that 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, according to Axios.

Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, said in an email to staff sent Friday that regulatory requirements for new vaccines would be heightened as a result of the deaths.

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

Proposed Policy Changes

The FDA will impose tougher standards for authorizing vaccines for pregnant women, and pneumonia vaccine makers will have to show their products reduce pneumonia and don’t merely generate antibodies, Prasad wrote, according to Axios.

Prasad’s emailed memo said no fewer than 10 children’s deaths were linked to the vaccines, based on an initial review of 96 deaths between 2021 and 2024 reported to the federal Vaccine Adverse Event Reporting System.

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 and isn’t designed to assign a cause.

Prasad also stated that the FDA may look at whether multiple shots should be given at once, a concern that could disrupt the childhood vaccine schedule.

Context and Timing

The memo from top vaccine regulator 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, according to Axios.

Earlier this year, Prasad 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.

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.

Expert Skepticism

Experts told STAT they are skeptical of the memo’s extraordinary claim because it was not presented with detailed data.

Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, called the claims irresponsible science at best and dangerous to the public at the very least, according to STAT News. Osterholm said the FDA should refer the question of whether there was a causal link between COVID vaccination and the deaths Prasad identified to the National Academies of Sciences, Engineering, and Medicine for independent review.

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.

Jesse Goodman, who led CBER during the George W. Bush administration, said the memo was destined to go externally given that it was emailed to the entire center. He noted that such an extraordinary claim would normally merit a very detailed scientific analysis.

Daniel Jernigan, the former director of CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said it is not clear what process was used for attributing deaths to the vaccine and that some greater transparency is needed, according to STAT News.

Myocarditis Connection

The memo’s findings suggest 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, according to Axios.

In 2021, the Centers for Disease Control 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, citing updated estimates of cases and a post-approval study showing the persistence of heart problems months after getting the mRNA shots.

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.

Some health experts have 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.

A Controversial Career

Vinay Prasad, a hematologist-oncologist known for at times scathing social media critiques of public health policy, succeeded Peter Marks, who abruptly resigned as director of FDA’s Center for Biologics Evaluation and Research in March, citing disagreements with Health Secretary Robert F. Kennedy Jr., according to Axios.

Prasad’s parents immigrated from India. He attended Michigan State University, where he took courses in health care ethics and physiology, graduating summa cum laude in 2005 with a double major in philosophy and physiology.

Prasad trained at the University of Chicago’s Pritzker School of Medicine, where he was recipient of the Chairman’s Award in Internal Medicine, according to his UCSF profile. He finished residency in Internal Medicine at Northwestern University, where he won the Gerald Grumet Award for best resident teacher, and completed fellowship at the National Cancer Institute and National Institutes of Health in Hematology and Medical Oncology, where he was Chief Fellow, according to his personal website.

Prasad has made a name for himself on social media platforms including X, his Substack called Sensible Medicine, and the podcast The Plenary Session, where he discusses medicine, policy, ethics and the pharmaceutical industry, according to Axios.

He’s courted controversy challenging industry influence in health policy and what he calls poor reasoning in clinical research. 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, according to Axios.

Top image: U.S. FDA photo by Matthew MacRoberts. The story, conceptualized and edited by American Kahani’s News Desk, was aggregated by AI from several news reports.