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FDA Review: Covid Vaccine Responsible for Deaths of at Least 10 Children

FDA Review: Covid Vaccine Responsible for Deaths of at Least 10 Children

FDA set to issue new and more stringent vaccine guidelines.

An intriguing memo from the Food and Drug Administration (FDA) Chief Medical and Scientific Officer Vinay Prasad was recently sent to various media outlets.

Dr Prasad also serves as the Director of the Center for Biologics Evaluation and Research (CBER). In the memo, Prasad asserts that an internal review conducted by FDA staff members concluded that at least 10 children died “after and because of receiving” a Covid‑19 vaccine.

The 3,000-word memo, obtained by NBC News, was written by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research. In it, Prasad claims that agency staff determined that “no fewer than 10” of 96 child deaths reported to the Vaccine Adverse Event Reporting System, or VAERS, between 2021 and 2024 were “related” to Covid vaccination. He said the true numbers could be higher, accusing the agency of ignoring the safety concerns for years.

The memo, sent Friday, did not include the children’s ages or medical histories, timelines or documentation for the deaths he references and does not identify the manufacturer of the vaccine. The FDA’s findings have not been published in a peer-reviewed journal.

While a direct link to the memo was not available via the media outlets at the time of the report, a copy appears to be available via X.com. The report is intended for members of the Center for Biologics Evaluation and Research (CBER). The full memo can also be found on the Brownstone Institute website.

Prasad states that the Office of Biostatistics and Pharmacovigilance (OBPV) career staff reviewed 96 VAERS reports of child deaths after COVID-19 vaccination (2021–2024) and concluded that “no fewer than 10” deaths were related to vaccination, with underreporting and conservative coding likely making the actual number higher.​ He notes that this will be the first time the FDA acknowledges that these vaccines killed American children and describes the finding as a profound revelation demanding introspection and reform.

The memo added: “Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”

It also reads: “It is horrifying to consider that the U.S. vaccine regulation, including our actions, may have harmed more children than we saved,” although it does state that the agency “does not have reliable data estimating the absolute benefit” regarding vaccine receipt.

I have often noted the troubling reports about post-vaccination myocarditis, especially in young men. In this analysis, Prasad disputes the claim that COVID-19 infection causes more myocarditis than vaccines, arguing existing studies are biased toward sicker patients, ignore age balance (e.g., young adults getting many doses), and use flawed denominators.​ He says no analysis has correctly compared myocarditis after infection versus vaccination in the key young-age cohorts and that the FDA has not adequately enforced post‑marketing safety commitments, including systematic myocarditis surveillance.

Prasad’s assessment on this subject is damning.

A perennial argument is that COVID 19, the virus, causes more myocarditis than COVID-19 vaccines. In fact, I heard this argument made inside CBER recently when one company submitted their PMC. Here is why that argument is wrong.

In order to study how often people have myocarditis after the virus, you would want to collect everyone who got covid, and see how many get myocarditis. Yet, studies on this topic don’t do this. They take people who presented to health care systems and had covid-19 and ask how many have myocarditis. But we all know most people who get covid simply recover at home. People who seek medical care are the sickest ones. These studies use a false denominator.

Second, the demographic matters. I have no doubt COVID vaccines were life saving for an 80 year old who never had COVID, but should a 20 year old get his 6th dose this fall? These studies often fail to look at the balance in younger people.

Of course, the elite media is quick to trot out their preferred “experts” to dispute the memo.

His predecessor, Dr. Peter Marks, who led the F.D.A. division during the pandemic, said he was taken aback by the “clearly political tone of the communication.” He agreed that the case reports of childhood deaths needed to be opened to further scrutiny to determine whether they were caused by the vaccines.

“I would not be surprised if the attributions turn out to be debatable, as these cases are often quite complex,” Dr. Marks said after reading the memo.

In a nutshell, Prasad argues that existing data on COVID-19 vaccination in children are too limited and methodologically biased (especially observational studies and myocarditis analyses) to reliably quantify benefits, compare risks with infection, or determine whether the vaccination program saved more children than it harmed. He also contends that VAERS underreporting, subjective causality judgments, and poor enforcement of post‑marketing studies mean current official conclusions understate vaccine‑related harms and overstate certainty about safety.

His memo is not the ranting of an “anti-vaxxer”, but a sound review by someone well credentialed to make a judgment on the information available. No wonder the elite media is making it challenging to find.

In the wake of the memo, the FDA is set to impose stricter guidelines.

The guidelines, obtained by The New York Times, could also impact vaccinations for other illnesses and viruses, including the FDA’s standards for annual flu shots and if Americans should receive multiple vaccines at a time. The memo also states that shots for pregnant women could be limited, and manufacturers will be required to conduct larger studies before seeking approval for vaccines.

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Comments

Every vaccine kills children. That’s why vaccine makers are immune from lawsuits, otherwise nobody would make vaccines.

How many lives saved is what it’s balanced against.

A public policy decision.

    mailman in reply to rhhardin. | December 2, 2025 at 10:11 am

    Firstly, the data has shown us that children are practically immune to the Chinese Death Kooties, we know this because the ONS data here in the UK and your data in ththe States was very VERY clear about this in the early stages of the covid scare until tha data was not helpful to Democrats.

    Secondly; the Covid data also showed us that people who were fit and healthy had very little to fear from Covid itself.

    Thirdly, the data very clearly showed us that if you had two or more serious health issues you were at risk and should have taken precautions to protect yourself from infection.

    Fourthly, if you were old and frail you were at risk as was demonstrated very clearly by New York and its care home policies.

    Fifth, very few people died BECAUSE of Covid.

    Basically, if you were a fat c8nt you needed to do things to protect yourself.

    If you were fit and healthy and had looked after your health you had very little to fear from Covid.

      The Gentle Grizzly in reply to mailman. | December 2, 2025 at 10:55 am

      I can’t help but suspect the two-shot Pfizer series led to a lot of my present issues. I stopped after those.

        There are a lot of people in the same boat as you G.

        Also a lot of young people suffering from sudden death onset from heart failure in age groups where prior to Covid deaths were very very low.

    sheepgirl in reply to rhhardin. | December 2, 2025 at 4:18 pm

    The public policy decision can’t be properly made when the policy makers refuse to gather the proper data and then assess what data they do have in a biased manner to achieve a predetermined conclusion.

The infertility numbers from the vax are going to haunt us.

Have not seen assertions of birth defects (yet). Knock on wood that we don’t.

Brownstone Institute. Good work.

No way! Is the FDA review here telling us the govt (run by Boomers and Silent Gen septuagenarians who were most at risk for a virus with less than a half a % lethality rate which was largely concentrated among the feeble elderly and others with preexisting chronic health problems) would have made decisions to protect themselves at the expense of the rest of the Nation?

    Ironclaw in reply to CommoChief. | December 2, 2025 at 2:22 pm

    Shameful, isn’t it, that the elderly who have had the opportunity to live their lives asked the young and healthy who haven’t yet had that chance to sacrifice for them. Even more shameful that they asked children to sacrifice for adults.

      CommoChief in reply to Ironclaw. | December 2, 2025 at 7:31 pm

      My Daughter was in her JR year of HS in Jan of ’20. The total overreach and the overreaction to the minimal danger posed by Covid with school shutdowns, basic fundamental liberties suspended and all.sorts of heavy handed coercion used by govt at multiple levels on anyone who raised questions has left her deeply PO at the geriatrics and cowards who ran this scam. She’d always had a far more empathetic side than I but now she’s unrelenting and intolerant of excuses made by the leadership class responsible for Covid Mania. Lots of younger folks agree with her stance that the older generations in leadership deserve no breaks when the younger generations are able to bring their own generation’s electoral power to bear if given the opportunity for retribution.

Fauci says everybody is missing the point. These 10 tykes didn’t catch COVID!

Since when have Democrats ever cared about children, other than for grooming purposes?

Another “conspiracy theory” ripens and beats fruit.
Hell, I should own Dole by now.

“the Office of Biostatistics and Pharmacovigilance”
And don’t try to tell me we don’t have German moles in our government.

THIS is why I no longer trust the FDA or the vaccine companies. They very clearly did NOT work in our interest and therefore they will never get any cooperation from me or my family again. Refusing that garbage for myself and my family was and still remains one of the best choices that I’ve made.

Dr Prasad correctly alludes to the huge uncertainty underlying the estimations of myocarditis incidences from COVID-19 infections in young men. We have a pretty solid understanding of the myocarditis incidences from the various vaccines which, it is my understanding, are up to 15 per 100,000 though the letter reports up to double that. Also, there may be a different level of severity of myocarditis depending on if it was due to the virus or the vaccine. So here we are, over 5 years after the initial onslaught of COVID-19, and we still don’t have a solid understanding of the benefits of the vaccine for young men. It is also disheartening to learn that the large, well staffed, and well equipped US medical establishment did not discover the “signal” of myocarditis incidences due to the vaccine but rather it was the Israelis, In fact Biden’s director of the CDC, Dr. Rochelle Walensky said they were still looking for the “signal” after administering over 200 million doses, Although Dr Prasad does not mention this, the US data on deaths related to COVID infections is based on dying “with” rather than dying “from”. In other words an infected individual could die from an auto accident and be a COVID statistic. Finally, I like how Dr Prasad frames the risk issue in light of the fact that the vaccine does not prevent one from getting the virus: vaccine + virus vs virus alone. I hope this memo causes a long over due cultural reform at the FDA and CDC.

And I was told to follow the science ; I guess science means cherry picked data that fits your preferred narrative and lines your pockets : Dr Fauci. I was called the pandemic of the unvaccinated; evil , selfish etc etc thank G-D I didn’t give this shit to my boys.

You know what experts don’t get trotted out by the media?

Actual European experts like Swissmedic that have reviewed the vaccines and have determined they are not cost effective in youth and do not cover them as a result.

These are detailed scientific studies by countries and government bodies that are sorely lacking in MAGA fans and Trump supporters ..,

.., and yet they questions it.

This is never mentioned by. American media.