The same corporate media and “expert” class that cheered censorship and did their best to “fact-check” dissent out of the discussion during the peak of Covid panic are on edge after a top U.S. Food and Drug Administration (FDA) official pledged to revamp the vaccine approval process. His commitment to reform comes on the heels of an unreleased report that found children died after receiving the Covid jab.
In a recent five-page memo to staff at the Center for Biologics Evaluation and Research (CBER), the center director and FDA Chief Medical Officer Vinay Prasad committed to acknowledging “for the first time” that Covid shots “have killed American children.”
The report outlining the deaths that Prasad repeatedly references is not yet public. His paragraph-by-paragraph analysis of the U.S. government’s response to Covid, the Covid jab, and the Biden administration’s shot mandates, however, reveals more in detail about the role the FDA played in ignoring the adverse events regulatory agencies and media repeatedly claimed did not happen.
At Least 10 Children Died After Covid Jab
In the first paragraph of the letter to his staff, Prasad declared that 10 children “have died after and because of receiving COVID-19 vaccination.”
These deaths, he continued, were not only classified by staff as “likely/probable/possible attribution” to the jab, but also “certainly an underestimate due to underreporting, and inherent bias in attribution.”
“This safety signal has far-reaching implications for Americans, the US pandemic response, and the agency itself, which I wish to discuss here,” he added.
CDC Overlooked Covid Shot Safety Signal
Speaking of safety signals, some of the first indicators that people experienced severe side effects linked to the Covid shot were “reports of vaccine-induced myocarditis.” Prasad noted that the heart inflammation appeared more in groups such as “young, healthy boys and men — those least likely to experience bad covid outcomes.”
“The risk was as high as ~200-330 per million doses given in the highest risk demographic groups,” he warned.
Despite the FDA’s alleged monitoring of these cases, Prasad said both the FDA and CDC “were not the first to recognize the safety signal.” In fact, in April 2021, CDC Director Rochelle Walensky claimed that her agency had not “seen a signal” even though “we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given.”
“Many felt this statement was dishonest and manipulative,” Prasad said, noting that the Israelis recognized the safety signal that same year.
FDA, CDC Ignored Evidence Of Booster Mandate Harm
In 2022, Prasad, now-FDA Commissioner Marty Makary, and senior advisor Tracy Beth Hoeg MD PhD authored a peer-reviewed paper outlining the “Risk-Benefit Assessment” for Covid booster shots for young adults. At the time, the researchers concluded that “booster mandates may cause a net expected harm.”
The FDA and CDC, however, ignored the research and “did not quickly attempt mitigation strategies such as spacing doses apart, lowering doses, omitting doses among those with prior COVID-19,” per the paper’s suggestion.
“Like many academic physicians, we felt the FDA and CDC abdicated their duty to the American people,” Prasad wrote.
FDA Ignored Safety Signal Until After Selling Young Boys On Jabs
Not only does Prasad allege the FDA fail to take action on the myocarditis concerns, but he also claims the regulatory agency “delayed acknowledgement of the safety signal until after it could extend marketing authorization to younger boys 12-15.”
“Had the acknowledgement come early, these younger boys, who likely did not require
COVID-19 vaccination, may have chosen to avoid the products,” Prasad added.
The FDA Has Never Admitted There Were Deaths After Covid Shots
Prasad said his colleague Dr. Hoeg determined earlier in 2025, based on Vaccine Adverse Event Reporting System (VAERS) reports, that children died after receiving the Covid jab. The FDA, however, has “never publicly admitted” that.
In fact, when Hoeg presented her investigative findings to “OVRR and OBPV stakeholders,” her material was leaked to corporate media, who were told Hoeg set out to “create a false fear regarding vaccines.”
The Real Number Of Covid Jab Deaths Is Higher Than Believed
After Hoeg’s presentation, Prasad commissioned a “detailed analysis of deaths voluntarily reported to the VAERS” from OBPV using a “subjective scale.” What they found based on an “initial analysis of 96 deaths between 2021 and 2024” was “no fewer than 10 are related” to the receipt of a Covid shot.
“If anything, this represents conservative coding, where vaccines are exculpated rather than indicted in cases of ambiguity. The real number is higher,” Prasad warned.
Biden’s Vax Mandates Bear Some Blame
Prasad wrote that children who were classified as “healthy” and “faced tremendously low risk of death” from Covid were “coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.”
“In many cases, such mandates were harmful,” Prasad wrote. “It is difficult to read cases where kids aged 7 to 16 may be dead as a result of covid vaccines. Did COVID-19 vaccine programs kill more healthy kids than it saved?”
There Are Still Many Unknowns
Since the FDA does not require manufacturers to prove their vaccines work on children, Prasad said data to determine the benefits for healthy children to receive shots is still lacking.
“Furthermore, COVID-19 was never highly lethal for children, and now MIS-c has decreased drastically, and the harms, to kids, are comparable to many respiratory viruses for which we do not provide annual immunization,” Prasad wrote.
Simply put, Prasad said it is still unknown “how many fewer kids would have died had they been vaccinated” and “how many more kids died from taking vaccines than has been voluntarily
reported.”
“Instead, the truth is we do not know if we saved lives on balance,” Prasad concluded.
Vaccine Reaction Reporting Suggests Adverse Events Fly Under The Radar
VAERS claims to be one of the “CDC’s and FDA’s multifaceted approach to monitoring safety after vaccines are licensed or authorized for use.” Prasad noted, however, that adverse events to shots are “passively reported.”
“It requires a motivated person, often a doctor, to submit the information. The submission process is tedious and most people who start the form give up along the way. Many more deaths may be unreported,” he added.
FDA Failed To Enforce Sponsors’ Commitment To Conduct Certain Studies
Additionally, Prasad alleged that the FDA failed to follow up with Covid jab sponsors who committed to studying the effect of the shot on “pregnant women and to document subclinical myocarditis” after their product hit the market.
“Putting these facts together, it is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved. This requires humility and introspection,” Prasad continued.
Covid Shot Investigation Only Possible Because Of Trump’s FDA Pick
“There is no doubt that without this FDA commissioner, we would not have performed this
investigation and identified this safety concern,” Prasad wrote, noting “this fact also demands serious introspection and reform.” He demanded to know why deaths were not “reviewed in realt time” and why it took four years after the Covid shot debuted to even “perform this analysis.”
Vaccines Are Not Universal
Prasad firmly believed that “many vaccines have saved millions of lives globally, and many have benefits that far exceed risks,” but warned they are never made to be perfectly effective for every member of the population.
“The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm. The same is true for vaccines. The US government’s coercive and unethical covid-19 vaccine mandates in young people may have been harmful,” he wrote.
Prasad acknowledged that “there is no doubt that an elderly, un-immune American benefitted from Doses 1 and 2 in 2020.”
“The people who might have benefit most from vaccination were those too old to be affected by workplace mandates — another Biden administration blunder.”
Anyone Claiming Covid Causes More Myocarditis Than The Jab Is Wrong
Prasad said claims that the Covid virus causes more heart inflammation than the shot are rooted in studies that used a “false denominator.”
Covid Shot Doesn’t Prevent Transmission
Americans who noticed that Covid shots did not prevent the virus from spreading were incessantly finger-wagged and censored. Prasad, however, confirmed yet again that even those who received the jab “still get Covid anyway.”
“No amount of covid vaccines stops a person from getting covid, so the risk is not virus vs vaccine. It is vaccine + virus vs virus alone. I am not aware of any analysis that does this right, and we have performed an empirical review of this fact,” he wrote.
Leaks Were ‘Unethical,’ ‘Illegal,’ and ‘Factually Inaccurate’
Prasad said that while he believes the leakers believed they were “doing the right thing,” their execution was wrong. He indicated that Hoeg’s determination that “COVID-19 vaccines did result in the death of children,” no matter the pushback that conclusion may have received from disgruntled staffers, was correct.
“[A]ny small differences in opinion about specific cases are due only to the fact that subjective attribution of death is inherently a topic where reasonable people may have subtle disagreements. But the overall order of magnitude and directionality show concordance between Dr. Hoeg and long-time CBER staff,” Prasad wrote.
Safety Won’t Be Sacrificed On The Altar of Vaccine Maker Incentives
The FDA’s role in the vaccine approval process, Prasad wrote, is “not our role to lower evidentiary standards or mask safety concerns to create artificial financial incentives to make vaccines.” Since there’s no such thing as a “generic” version of a shot, Prasad hinted that vaccine manufacturers can charge what they wan and still get market approval, essentially guaranteeing them “long tails of earnings.”
Evidence-Based Vaccines
CBER under Prasad, the director committed, “will be to direct vaccine regulation towards evidence based medicine.” In practice, Prasad wrote that includes acting quickly on safety concerns, withholding authorizations for vaccines on pregnant women “based on unproven surrogate endpoints,” and secure trials on new drugs before approving them.
“We will re-appraise safety and be honest in vaccine labels,” Prasad declared.
Flu Shot Framework Will Be Revised
The flu shot system that has dominated sick season for years, which Prasad called “an evidence-based catastrophe,” is also eligible for reform. Historically, Prasad warned that flu shots were marketed based on “low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.”
FDA’s Multiple Vaccine Studies Created ‘False Sense of Efficacy and Safety’
Additionally, Prasad warned that the FDA has ignored “the benefits and harms of
giving multiple vaccines at the same time.” Instead, the regulatory agency has relied on randomized studies that Prasad claims are “too small to draw any conclusions
from — creating a false sense of efficacy and safety.”
“OVRR and OBPV staff will be tasked with writing guidelines to reflect these changes, and the
mission of CBER will change to reflect this worldview,” Prasad wrote. “Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it. Vaccines will be treated like all other medication classes– no better or worse than AAV vectors, monoclonal antibodies, or anti-sense oligonucleotides.”
‘No Evidence’ That Covid Shots Benefit Third Parties
Prasad wrote that he has “seen no evidence that COVID-19 vaccines, which do not halt transmission, benefit third parties.” He did, however, claim that he also has “no doubt that MMR vaccines do provide third party benefits when administered to high enough fractions of society.”
Leakers And Close-Minded Staff Welcome To Resign
Moving forward, Prasad said he remains “open to vigorous discussions and debate on these topics, as I have always been.” Yet, he warned that any debates “should be private, internal to FDA, until they are ready to be made public.”
Employees who disagreed with “these core principles and operating principles” were encouraged to resign.
“For those who choose to remain in CBER, I look forward to working with you, learning from you, discussing with you, and interacting with you on our shared mission: to elevate vaccine science to 21st-century evidence-based medicine,” Prasad concluded.
