A top FDA regulator has demanded stricter guidelines for annual flu shots and other vaccines after an internal memo claimed that the deaths of at least ten children have been linked to COVID-19 vaccines.
Dr Vinay Prasad, the director of the FDA's Center for Biologics Evaluation and Research conducted an initial review of 96 deaths between 2021 and 2024 that were reported to the Vaccine Adverse Event Reporting System (VAERS), The New York Times reported.
The findings have not been published in a peer-reviewed medical journal.
Prasad came to the conclusion that at least ten child deaths reported in the VAERS system could be directly attributed to the COVID-19 shots. No information about the children, such as their ages or any possible underlying health problems they had, was provided in the memo.
Since it was established in 1990, the VAERS database has compiled two million reports from Americans who say they had an adverse health reaction after taking a vaccine.
These reports are unverified and are used by the scientific community to see if there are symptom patterns with any particular vaccine. It is not designed to definitively determine if vaccines are causing adverse events.
'This is a profound revelation,' Dr Prasad wrote. 'For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.'
Based on this, Prasad wrote that he is recommending stricter standards for allowing vaccines for pregnant women, Axios reported.
The memo that claimed 10 children have died from COVID-19 vaccines came from Dr Vinay Prasad, the director of the FDA's Center for Biologics Evaluation and Research.
The memo found that the children's deaths were caused by myocarditis, or swelling of the heart muscle that can cause blood clots. This can lead to a heart attack if it isn't treated in time.
Prasad also wrote in the memo that he is 'open to vigorous discussions and debate on vaccine policies ... until they are ready to be made public.'
He said staff members should resign if they disagree with the direction he is taking the FDA's vaccine division.
The memo found that the children's deaths were caused by myocarditis, or swelling of the heart muscle that can cause blood clots. This can lead to a heart attack if it is not treated in time.
In December 2021, years before he became the health secretary, Robert F. Kennedy Jr said this risk is why COVID-19 vaccines are 'the deadliest' ever made.
mRNA COVID-19 vaccines have a small but increased risk of myocarditis and pericarditis, especially in adolescent and young adult males after the second dose.
However, multiple studies have shown that the risk for myocarditis is far higher for those who those who contract SARS-CoV-2, the virus that causes COVID-19, than for those who get vaccinated.
A 2022 meta-analysis that appeared in the Frontiers in Cardiovascular Medicine relative risk (RR) said the relative risk 'for myocarditis was more than seven times higher in the infection group than in the vaccination group.'
Another study published in January 2024 found that the risk was 20 times higher for those infected with COVID-19 than those who were vaccinated.
This latest recommendation by the FDA comes a week before key advisors to the Department of Health and Human Services (HHS) will meet to discuss potentially overhauling the childhood vaccine schedule.
Health Secretary Robert F. Kennedy Jr has fired and replaced all the members of the crucial Advisory Committee for Immunization Practices (ACIP). The committee has now stopped recommending COVID-19 vaccines for healthy people under the age of 65.
The CDC's vaccine advisory committee is also expected to talk about vaccine ingredients, the agency's vaccine risk monitoring protocols and whether the hepatitis B shot should be given to newborns shortly after birth.
The group, called the Advisory Committee for Immunization Practices (ACIP), was completely overhauled in June, with Kennedy announcing that he fired all 17 sitting members.
After new members were appointed, ACIP voted to stop recommending COVID vaccines to healthy Americans under 65 years old, instead urging them to rely on their own 'individual decision-making'.
HHS has said that federal insurance plans under the Affordable Care Act must still cover COVID vaccines, but clarified that the new guidance may make it more difficult for Americans with private insurance to get them covered.
In September, Kennedy was brought before the Senate Finance Committee to testify about this.
Senator Elizabeth Warren, a Democrat from Massachusetts, pointed out that Kennedy had said that he would 'take away anybody's vaccines' while he was being considered as a possible health secretary for the Trump administration.
'If you don't recommend, then the consequence of that is, in many states, that you can't walk into a pharmacy and get a [COVID-19 vaccine],' she said. 'It means that insurance companies don't have to cover the $200 or so cost.'
Senator Bill Cassidy, a Republican from Louisiana who is also a doctor, told Kennedy in the same hearing that his policy shift would 'effectively' deny people access to vaccines.
Kennedy responded by saying that most Americans would still be able to get COVID-19 vaccines and boosters for free.