FDA says COVID-19 vaccine caused at least 10 deaths in children

In a memo sent to FDA staff on Friday, Vinay Prasad, director of FDA's Center for Biologics Evaluation and Research (CBER) said COVID-19 vaccines caused at least 10 deaths in children and added that regulatory requirements for new vaccines would be heightened as a result.

Prasad said that this past summer, Tracy Beth Høeg — a senior adviser for clinical sciences at CBER who previously co-authored a journal article with Prasad and FDA Commissioner Marty Makary criticizing the way FDA and CDC handled early evidence that the COVID-19 vaccine increased risk of myocarditis in adolescents and young men — started investigating reports to the Vaccine Adverse Event Reporting System (VAERS) of children who died after receiving a COVID-19 vaccine. By late summer, Prasad said Høeg had concluded "that there were in fact deaths — a fact this agency had never publicly admitted."

Prasad said he then asked FDA's Office of Biostatistics and Pharmacovigilance to review 96 deaths that occurred between 2021 and 2024 that were reported to VAERS. Of those deaths, Prasad wrote that "no fewer than 10 are related" to receiving a COVID-19 vaccine. He added that the team's estimates were conservative and that "the real number is higher."

"This is a profound revelation," Prasad wrote. "For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children."

It's unclear which COVID-19 vaccines Prasad was referring to in his memo.

In an interview on Fox News, Makary also referenced the deaths but didn't provide specifics on how FDA came to its conclusion. He said that when COVID-19 shots were first rolled out, they were "amazing" for people at high risk of developing severe disease but said that things have changed.

"Back in 2020, we saw a reduction in the severity of illness and lives saved, but now recommending that a 6-year-old girl get another 70 million COVID shots — one each year for the rest of her life — is not based on science," Makary said. "And so we're not going to just rubber stamp approvals without seeing some scientific evidence."

"It's irresponsible science at best and it's dangerous to the public at the very least," said Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy. Osterholm added that FDA should refer the question of whether there was a causal link between COVID-19 vaccination and the deaths Prasad found to the National Academies of Sciences, Engineering, and Medicine for an independent review.

"Because [Prasad] doesn't provide any evidence, he is asking us to trust him on an important issue," said Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia. "All this will do is scare people unnecessarily. At the very least, he should provide all the evidence he has so that experts in the field can review it and decide whether he has enough data to prove his point."

CDC walks back claim that vaccines don't cause autism

Meanwhile, CDC last month updated its website to say that the statement "vaccines do not cause autism" is not "evidence-based" and that "studies supporting a link have been ignored by health authorities."

A previous version of the webpage said that studies had shown "no link between receiving vaccines and developing autism spectrum disorder," citing a 2012 review from the National Academy of Medicine and a CDC study from 2013.

There have been dozens of studies over the past 30 years in various countries across millions of people in a variety of age groups that have consistently found no connection between vaccines and autism, including one study from 2019 in Denmark that examined the entire child population of the country over a decade.

The page does still include the statement "vaccines do not cause autism," but it now has an asterisk that states the phrase was only kept on the site "due to an agreement" with Sen. Bill Cassidy (R-La.), who cast the deciding vote for HHS Secretary Robert F. Kennedy Jr.'s nomination after receiving a pledge that "CDC will not remove statements on their website pointing out that vaccines do not cause autism."

Kennedy said he specifically directed CDC to make the changes to the website. In an interview with the New York Times, Kennedy acknowledged that large-scale epidemiological studies of the measles, mumps, and rubella vaccine have found no link to autism and that studies of the mercury-based preservative thimerosal have shown the same.

However, Kennedy cited gaps in vaccine safety science and said he ordered the change in guidance in part because high-quality, large studies hadn't been done to examine a potential link between autism and other shots given within the first year of life.

"The whole thing about 'vaccines have been tested and there's been this determination made,' is just a lie," Kennedy said, adding, "The phrase 'Vaccines do not cause autism' is not supported by science."

Health experts and former CDC officials were concerned about the change, saying Kennedy's argument doesn't make sense as it's scientifically impossible to prove a negative.

"It's doublespeak, bottom line. There's also no evidence that umbrellas don't cause kittens," said Demetre Daskalakis, a former top official at CDC who resigned in August. "This is why I left the CDC. You're seeing the ideology of RFK Jr. elevated into the space of legitimate science by being branded as a CDC document."

"There is overwhelming evidence that vaccines do not cause autism but do save lives," said Mandy Cohen, who led CDC during the Biden administration. Cohen added the website change damages CDC's credibility and "risks endangering children by driving down vaccination rates and leaving kids vulnerable to preventable diseases like measles and whooping cough."

In a post on X, Sen. Cassidy said that as a doctor, he has "seen people die from vaccine-preventable diseases. What parents need to hear right now is vaccines for measles, polio, hepatitis B and other childhood diseases are safe and effective and will not cause autism. Any statement to the contrary is wrong, irresponsible, and actively makes Americans sicker."