Naval Medical Center Portsmouth provides the COVID-19 pediatric vaccine to children ages 5 to 11, in Portsmouth, Virginia, Nov. 8, 2021. (U.S. Navy photo by Petty Officer 2nd Class Donald White)
Last fall, FDA safety officers began compiling a list of children possibly killed by COVID vaccines. Digging through thousands of reports of adverse effects and autopsy records of those who had died after receiving the mRNA vaccines manufactured by Moderna and Pfizer, the team eventually determined that several adolescents had apparently died from the COVID vaccines.
On Dec. 5, the team’s leader, Dr. Meghna Alimchandani, sent an email recommending changing the labels on all mRNA COVID-19 vaccines to notify patients of the risk for cardiac death (fatal myocarditis), adding that her safety team planned to present those results at an upcoming FDA meeting. Such warnings, even regarding rare outcomes, are standard procedure – as is well-known by everyone who has watched drug TV ads that run through long lists of known harms.
Ten months later, the FDA has still taken no action to warn parents.
A RealClearInvestigations inquiry found that a strange-bedfellows convergence of political interests appears to have blocked the dissemination of this scientific information. President Trump, whose Operation Warp Speed helped fast-track development of the vaccines in 2020, believes his efforts saved millions of lives, and several current and former health officials told RCI they are loath to complicate that narrative for him. RCI also found evidence that the Biden administration, a strong supporter of vaccine mandates, showed little interest in examining or publicizing mortality data that might undermine its policies. For its part, the pharmaceutical industry was intent on protecting its profits, and influential media outlets, especially the New York Times, have downplayed evidence of COVID vaccine deaths and attack those who’ve tried to bring them to light.
“In the end that’s the big story,” said Sen. Ron Johnson, who has sustained a years-long investigation into COVID vaccine safety, releasing hundreds of pages of internal FDA records that call into question the agency’s forthrightness and that the legacy media have largely ignored or dismissed. “Advertising allowed Big Pharma to not only capture our medical colleges, medical journals, and Congress, but now the media,” Johnson added. “They’ve run the table,” he said. “That’s why this isn’t covered.”
Denial of harm
As soon as the shots were approved, reports of harms from COVID-19 vaccines began surfacing through the Department of Health and Human Services’ Vaccine Adverse Event Reporting System (VAERS). Set up in 1990 to monitor possible vaccine side effects, VAERS allows anyone to submit a report of vaccine harms – not just doctors and nurses but even the crazy uncle you avoid sitting next to at Thanksgiving dinner.
After more than a million reports of injuries flooded the system, CDC Director Rochelle Walensky and FDA Commissioner Robert Califf released a joint statement in 2023 to bat down concerns about COVID-19 vaccine safety. “Reports of adverse events to VAERS following vaccination do not mean that a vaccine caused the event,” they wrote. “For signals identified in VAERS, physicians from FDA and CDC screen individual reports, inclusive of comprehensive medical record review.”
Some months later, Walensky gave a flippant response when asked about VAERS during a hearing before Congress. “If you got hit by a truck after you got your vaccine, that was reported to the Vaccine Adverse Event Reporting System,” she said.
But outside the VAERS system, physicians were publishing reports of children dying from the mRNA vaccines in the peer-reviewed literature. For example, U.S. pathologists published the autopsies of two teenage boys in 2022 who died mysteriously in their sleep, and concluded their unnatural deaths happened because of a bad reaction to a second dose of the Pfizer mRNA vaccine.
Later that year, pathologists at Heidelberg University in Germany published the autopsies of 35 people who died shortly after COVID vaccination. Five of those deaths were “likely or possible” from mRNA vaccines, in what the researchers described as “lethal vaccination-associated myocarditis.”
In 2023, patient safety advocate and former FDA advisor Kim Witczak and a handful of academics sent the FDA a citizen’s petition about the COVID mRNA vaccines, asking the agency to update the FDA label to notify patients of risks. The FDA denied almost every one of their requests in a letter signed by FDA official Dr. Peter Marks.
The Biden administration put Marks, a hematologist and oncologist, in charge of the COVID vaccines after it was announced in 2021 that the agency’s top vaccine safety researchers were leaving – some outlets wrote the two had been forced out. An industry newsletter reported that the two FDA researchers were upset that Marks had not defended the agency’s independence from outside influence, and they complained that the White House had pressured the FDA to approve COVID boosters without adequate data.
Witczak and others wrote an essay for The Hill newspaper noting that, by ignoring documented evidence of harm, Marks was violating federal law that requires FDA labels to report adverse events.
Republican investigators in the House released a 2024 report that concluded Marks and Acting FDA Commissioner Janet Woodcock had removed the two FDA safety researchers because they were slowing the Biden administration’s deadline for full COVID vaccine approval. “By late 2021, the FDA and Marks,” noted congressional investigators, “became advocates for the Pfizer vaccine – a role for the FDA that was unprecedented before the pandemic and outside the proper function of the FDA as authorized by Congress.”
Unearthing buried reports
Donald Trump’s return to office triggered renewed interest in the safety of COVID vaccines. Shortly after physician and epidemiologist Dr. Tracy Beth Høeg joined the FDA as an advisor in early 2025, she began digging into government records to see if there were cases of COVID vaccine deaths. Back in 2022, Høeg had published a widely discussed study that found boys were at an increased risk of deadly inflammation of the heart after a second dose of the mRNA vaccine. Regulatory agencies later began warning patients of these risks.
In a recent podcast, Høeg said she was surprised to learn that FDA staff had already completed investigations that found COVID deaths – compiling autopsy reports, clinical records, and medical histories of several kids who died after receiving COVID vaccines during the Biden years. “The fact that they didn’t disclose any of this earlier, it makes you think, ‘What is even the point of them doing these investigations?’” Høeg told RCI.
But when Høeg brought up the investigations at a September 2025 FDA meeting, these internal agency discussions were leaked to the New York Times. The paper portrayed Høeg’s discovery as a “political exercise” to cast doubt on“years of exhaustive work by government officials and academic researchers worldwide who have validated the safety of the vaccines.”
To buttress their narrative that the FDA was on a wild “antivaccine” goose chase, Times reporters also ran several quotes from Peter Marks, without noting that Marks had denied the citizen’s petition to inform the public of vaccine deaths and that House investigators had concluded he had ignored the risks of COVID vaccine injury and helped push out FDA safety researchers back in 2021.
“The media, they were vicious about this and didn’t understand at all what had happened,” Høeg says. “This had been covered up, and we were trying to expose it. But if you read the news, you’d think I went in by myself and ‘Oh, this report says a child died after a vaccine. Must be due to the vaccine.’”
‘A profound revelation’
After Høeg found the buried FDA investigations, emails provided to RCI show that vaccine safety officer Alimchandani told Marks’ replacement, Dr. Vinay Prasad, that her office had uncovered 97 credible COVID vaccine incidents in children, which they winnowed down to 10 “assessed by our team as probable (3 cases) or possible (7 cases).”
Prasad then sent an email alerting FDA staff about the findings from Alimchandani’s team. “I am writing to report that career staff have found that at least 10 children have died after and because of receiving COVID-19 vaccination,” Prasad wrote. “This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
As in the case of Høeg’s discussion of COVID deaths in September, Prasad’s email was promptly leaked to the New York Times, which once again inverted reality by implying the findings were proof politics was at play. “The memo represents another escalation of broadsides on vaccines by federal authorities under Mr. Kennedy,” the Times reported.
And once again, the Times quoted Peter Marks casting doubts on the FDA safety officers’ conclusions, without reporting that Marks had just joined Eli Lilly to head up their vaccine discovery work. The Times also quoted Dr. Paul Offit, a vaccine expert with the Children’s Hospital of Philadelphia, who called the leaked internal FDA email an example of science “by press release.”
The Times did not mention the extensive reporting on Offit’s ties to the pharmaceutical industry, such as a 2009 report from CBS News that Offit had made millions of dollars from a vaccine he developed with Merck. In 2011, the Orange County Register ran a 300-word correction after its editors caught Offit making “unsubstantiated and/or false” statements to one of their journalists, reporting that documents showed he had hidden millions of dollars he had received from the pharmaceutical industry, including royalties from Merck.
To further bury the FDA safety officers revelations that COVID vaccine deaths in children had been overlooked, the Times then ran two stories that cited an essay in the New England Journal of Medicine written by several former FDA leaders. “Previously, all the cases reported to the Centers for Disease Control and Prevention (CDC) and to the FDA had been carefully reviewed by FDA staff, who drew different conclusions,” reads the NEJM essay.
Two of the essay authors – Dr. Robert Califf and Dr. Janet Woodcock – ran the FDA during the Biden presidency, the period when the COVID deaths documented by FDA staff had been ignored. A third person who signed the essay, former FDA Commissioner Dr. Scott Gottlieb, sits on the board of Pfizer, which manufactures and sells the COVID vaccines that FDA safety officers found to have harmed children.
None of this information ended up in the Times reporting either.
RCI sent the NEJM a series of questions about the essay they published, noting that emails show safety officer Alimchandani found the evidence of vaccine harms, not FDA leadership, as the essay falsely claimed. RCI also asked whether NEJM believes the FDA should notify the public of product harms once safety officers uncover them. The NEJM did not respond directly to those questions. It did state that notification of errors is shared with authors, who are then asked to respond. “The New England Journal of Medicine publishes Perspective articles like ‘A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA’ to offer timely insights and encourage discussion of issues where medicine, policy, and public health intersect.”
RCI also sent Califf, now a professor at Duke, a series of the same questions, asking if he planned to make corrections to the essay. RCI also asked Califf if he agreed with FDA safety officers that the labels for mRNA COVID vaccines should be updated to notify parents of the risk for cardiac death. Califf did not respond.
Several former FDA officials told RCI that the Times’ flurry of reporting, hammering on the findings of pediatric deaths, appears to have unsettled the FDA’s safety office. In Alimchandani’s final email to Prasad, she wrote that her office had bit back the number of suspected child deaths from 10 to 7.
“This was a MONUMENTAL effort from all of us, to try to do a diligent thorough review while being bombarded with media articles on the subject,” she wrote.
Times health policy editor Hilary Stout did not respond to RCI questions asking why they did not disclose the industry ties of Marks and Offit.
Times turnaround
Witczak and others say they are especially disappointed by the New York Times’s reporting on COVID vaccine safety for children, given the paper’s long history of advocating for transparency regarding product safety on drugs such as the painkiller Vioxx, the diabetes drug Avandia, and the antipsychotic Risperdal. Witczak told RCI she became an advocate for patient safety thanks in part to the newspaper’s crusading reporting on risks of antidepressants, which coincided with her husband’s death by suicide while on Zoloft.
That scandal began in early 2004 when senior FDA officials suppressed findings by FDA medical officer and epidemiologist Dr. Andrew Mosholder, whose research found children on antidepressants were at increased risk of suicide. Reviewing leaked FDA documents, the Times reported that Mosholder had recommended FDA take steps to limit antidepressant prescriptions to children.
As is the case today with COVID vaccines – which FDA safety experts have found present risk of death while also offering protection from the COVID virus – prescribing antidepressants to children was a complicated matter. Suicide risk from antidepressant use had to be balanced with the dangers of untreated depression, the Times reported.
However, the Times reporting came down clearly in favor of making safety information public, writing approvingly when the FDA finally admitted during a public hearing that Mosholder was right and antidepressants were linked to suicide risk in children. Pressured by media scrutiny, the FDA was forced to give product risk and safety officers more attention, leading the Times to report that the “Daddy knows best” culture at the agency was ending as the FDA embraced a new era of “transparency.”
Witczak says the Times forced the FDA to acknowledge safety problems decades back, but the paper is failing the public today by covering up safety officers’ reports of COVID vaccine harms.
“There’s this assumption that patients don’t need to know or the safety information needs to be 100% confirmed,” she said. “If there’s a link or we’re seeing an association, you’ve got to let people know. It’s about transparency.”
Failure to inform
Many health experts fear the media’s politicization of the science regarding the small but real risks of COVID vaccines – which the CDC no longer recommends for healthy children – is keeping the parents in the dark.
MIT Professor Retsef Levi studies risk management and said that, no matter the evidence, the media regularly denigrates evidence of vaccine harms. Meanwhile, death and injury from the COVID virus itself are always reported, despite sometimes tenuous connections. “If you die three days after a vaccination in your sleep, for no apparent reason, they will still argue, ‘How do you know that it’s the vaccine?’” Levi said. “But if you die 30 days after a positive PCR test for COVID, you’re a COVID death.”
By failing to note vaccine risks, Levi said, the government isn’t providing patients with informed consent, something even prominent vaccine cheerleader Art Caplan of NYU admitted in a recent essay.
An HHS official who is not cleared to speak to the press said the U.S. media is experiencing a professional hangover after getting drunk on the hundreds of millions of dollars that the Biden administration paid in advertising during the pandemic to promote COVID jabs on TV and in newspapers. “When Vinay Prasad tried to shine a light on what FDA career employees found, the response from official Washington and the press should have been to take decisive action in regulating the COVID vaccine use in kids,” the official said.
“Instead, they took decisive action against Vinay. The media has served as cheerleaders for hiding the harms of the COVID vaccine.”
Sen. Johnson said he plans to continue investigating COVID vaccine harms that the FDA hid and still fails to disclose, even in the Trump administration. His investigators just received more than a million pages of documents on Peter Marks, and they interviewed him only a few weeks ago.
Johnson said Marks remained unrepentant about the handling of vaccine risks, sometimes even disputing what appeared in his own emails when shown them again during the interview. The experience of speaking to someone in such a state of denial left him flabbergasted, he said.
“It’s like telling a kid, ‘You can’t have a cookie.’ You then hear the cookie jar break,” Johnson said. “You run into the kitchen and the kid’s got a cookie. You go, ‘I told you you couldn’t have a cookie.’ The kid looks at you and says, ‘I don’t have a cookie.’”
Johnson, a Wisconsin Republican, added that the politics on vaccine safety are now completely upside down. When he first ran for the Senate in 2010, he campaigned on defending Big Pharma and Big Oil. At the time, Democrats and the media were in lockstep on haranguing both. Now they are in lockstep on defending the pharmaceutical industry, while only he and a couple of fellow Republicans ask hard questions and uncover malfeasance that legacy media ignores or ridicules.
“The politics has totally changed. I’m just racking my brain for how I can get the legacy media to cover this,” he said. “That’s our task.”
This article was originally published by RealClearInvestigations and made available via RealClearWire.
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[ H/T WorldNetDaily ]
