By Independent News Roundup
In a leaked memo to staff, the U.S. Food and Drug Administration’s (FDA) top vaccine regulator said the agency will make changes to how it approves all vaccines, after an internal analysis revealed that “at least” 10 children died from the COVID-19 vaccine.
Dr. Vinay Prasad, who heads up the FDA Center for Biologics Evaluation and Research (CBER), said a recent review of 96 deaths among children ages 7 to 16 concluded that “no fewer than 10” were related to the shot. The deaths were reported to the Vaccine Adverse Events Reporting System (VAERS) between 2021 and 2024.
According to the memo — reported by The New York Times and other news outlets and obtained by The Washington Post — the estimated 10 deaths is “certainly an underestimate due to underreporting, and inherent bias in attribution.”
Prasad implied that the deaths were linked to myocarditis, an inflammation of the heart muscle.
“This is a profound revelation,” Prasad wrote. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
Mainstream media downplayed the memo and quoted noted vaccine promoters — Dr. Paul Offit, Dr. Peter Hotez, Dr. Peter Marks, who formerly held Prasad’s position, and others – who cast doubt on the child deaths, saying they wanted to see the data.
The Times cited “public health experts” who warned that such high-profile announcements raising concerns about vaccine safety will “erode confidence” in vaccines.
Some media accused Prasad of downplaying COVID-19’s risk to children. Others raised concerns that policy changes previewed in the memo will make vaccine approval more challenging and expensive for vaccine makers.
Response from COVID-19 vaccine critics was mixed. Many celebrated the memo’s release as the first official acknowledgement of what scientists and doctors have known for years.
Others said the memo exposed only a small number of child deaths from the COVID-19 vaccines, and criticized the agency for withholding the findings for far too long.
During a Nov. 29 interview with “Fox & Friends Weekend,” FDA Commissioner Marty Makary said the agency planned to make the data on the child deaths publicly available.
Makary also said the FDA would no longer endlessly rubber-stamp boosters for healthy kids. However, he reiterated Prasad’s claim that the vaccines had been essential for protecting older people.
The U.S. Department of Health and Human Services (HHS), which oversees the FDA, and Moderna and Pfizer did not respond to The Defender’s request for comment.
‘This is a major turning point’
Children’s Health Defense Chief Scientific Officer Brian Hooker said the memo to CBER staff was a “huge step in the right direction,” and that he thought it was “tip of the iceberg” in terms of expected future transparency.
He said it was “pathetic” that mainstream “experts” would condemn these efforts. “Unfortunately, when profits are at stake, given the corporatization of healthcare in the U.S., compassion and scientific curiosity are thrown out the window,” Hooker added.
In an email to The Defender, Jeffrey Tucker, founder of The Brownstone Institute and a long-time COVID-19 vaccine critic, praised Prasad and Makary. Tucker called the memo a “mighty breakthrough” because it’s the first time the agency has definitively admitted “the egregious deaths” among children from the shot.
“To be sure, critics have known this for years,” Tucker said. “What’s been missing is any official acknowledgment. This is what forces major media to cover it, and makes it impossible to continue to ignore not only this vaccine harm but possibly many more. This is a major turning point.”
Internist and long-term regulatory watchdog Dr. Meryl Nass also praised the memo. However, she questioned whether new policies were necessary. “What needs to be understood is that [Prasad] is only calling for what the FDA’ s rules and regs already call for: honest science.”
Prasad proposes more stringent guidelines for vaccine approval
According to Prasad’s memo, in the future, authorizations for vaccines in pregnant women and other subgroups would have to be based on studies that include pregnant women in the trials.
Vaccines for illnesses such as pneumonia will have to show the vaccine reduces pneumonia, rather than merely generate antibodies to the illness.
Also, the current process of updating flu vaccines is an “ evidence-based catastrophe of low-quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.” Prasad said the process will be revised.
He also also said guidelines will change to require research on understanding the benefits and harms of multiple vaccines administered at the same time.
These changes, he said, will bring the treatment of vaccines in line with all other medication classes.
Nass said that such changes are largely already agency policy, but the policies aren’t enforced. For example, antibody levels never were considered a valid surrogate for efficacy, she said, adding:
“When the FDA accepted them as such, it was, in my opinion, fraud—because everyone knew they were meaningless numbers. This has been discussed by FDA advisory committee members and FDA staff—but still it has been done over and over, using this meaningless number and calling it a measure of efficacy, which has been an FDA requirement since 1962.”
She said the real question is why the FDA has not previously acted like a serious regulator.
FDA ‘involved in a cover-up of COVID-19 deaths among children and adults’
Other COVID-19 vaccine critics were more critical of the FDA.
Cardiologist Dr. Peter McCullough, who raised concerns early on about the risks of myocarditis and pericarditis from the vaccines, said in an email to The Defender that Prasad’s memo “adds to the mounting evidence that the current FDA staffers, including Dr Makary and Dr Prasad have been involved in a cover-up of COVID-19 vaccine deaths among children and adults.”
He noted that in May, the U.S. Senate Permanent Subcommittee on Investigations concluded HHS and the White House colluded to conceal COVID-19 vaccine-related myocarditis, including fatal cases.
“Now 6 months after the Senate report both Makary and Prasad are implicated with a long list of predecessors,” McCullough wrote in his email. “The FDA Inspector General supervised by a Special Counsel should launch an investigation. Meanwhile all COVID-19 vaccines should be pulled off the market so more Americans can avoid death after vaccination.”
In a Substack post, former pharmaceutical industry executive Sasha Latypova asked why the FDA studied only cases of children between 7-18, as noted in the memo, when there were also deaths reported for younger children.
Latypova suggested the motivation was political. “They needed to ‘match’ what they ‘found’ to the myocarditis warning for ages 7-18 they put into the labels of mRNA shots earlier this year. They are not looking at the vaccine death reports. They are framing this all as myocarditis and cherry picking the mode of death,” she said — to bolster the credibility of Makary and Prasad, who pushed the label change.
A search of the VAERS database shows 174 child deaths related to the COVID-19 shot reported as of Oct. 31.
VAERS is a “passive reporting system,” which means it relies on people submitting reports, which doesn’t always happen. A 2011 Harvard report found that less than 1% of all adverse events are reported to VAERS.
According to analyst Albert Benavides, founder of VAERSAware.com, identifying children’s deaths in VAERS is especially challenging. The summaries that accompany the reports often contain the victim’s age. However, this information won’t appear when searching for reports by age in VAERS if the age field in the report is empty.
He said the summaries of reports with an “unknown” age show “three times the amount of dead children ‘hiding’ in VAERS” compared to the official figure.
VAERS researcher Jessica Rose told The Defender that she identified 230 deaths in children ages 0-16 in the VAERS database between 2021-2025, and 30 of those deaths were in children age 5 and under.
She also posted a graph of those findings on Twitter:
Just did a quick and dirty analysis of child (0-16) deaths in VAERS domestic and foreign data in the context of the COVID shots and in brief: 15% of the 230 children were reported to have died on the same day as the injection was administered. Since VAERS only reports the days… pic.twitter.com/lWLIPWFnVE
— Jessica Rose 🤙 (@JesslovesMJK) December 1, 2025
CDC vaccine advisers will meet this week to review vaccine policies
The memo was leaked less than a week before the Centers for Disease Control and Prevention convenes its next meeting of its Advisory Committee on Immunization Practices (ACIP) on Dec. 4-5.
The committee will discuss safety concerns related to the childhood/adolescent vaccine immunization schedule and the risks of adjuvants and contaminants in vaccines.
If the FDA investigates the safety of administering multiple vaccines and finds a safety issue, that finding could have implications for the childhood schedule set by ACIP.
This week, ACIP will also vote on whether to change the recommendation that all infants receive the hepatitis B vaccine at birth — a vote tabled at the last meeting so the committee could examine more data.
Brenda Baletti, Ph.D., is a senior reporter for The Defender. She wrote and taught about capitalism and politics for 10 years in the writing program at Duke University. She holds a Ph.D. in human geography from the University of North Carolina at Chapel Hill and a master's from the University of Texas at Austin.
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