FDA Investigation Into Child Deaths and COVID-19 Vaccination: What to Know

Federal officials acknowledged for the first time that COVID-19 vaccines resulted in deaths among children.

A vial of the children’s dose of the Pfizer-BioNTech COVID-19 vaccine sits in the foreground as children wait to be vaccinated at Hartford Hospital in Hartford, Conn., on Nov. 2, 2021. Joseph Prezioso/AFP

The Food and Drug Administration has concluded that at least 10 deaths of children were related to COVID-19 vaccination.

It’s the first time federal officials have determined that COVID-19 vaccines played a role in the deaths of minors.

“This is a profound revelation,” Dr. Vinay Prasad said in an internal memorandum sent on Nov. 28 and obtained by The Epoch Times.

Prasad, head of the FDA’s Center for Biologics Evaluation and Research, was one of the early opponents of keeping COVID-19 vaccines available for younger people. He has has supported COVID-19 vaccination for seniors and younger people with underlying conditions.

The FDA regulates vaccines and drugs, and the new finding means there will be changes moving forward, regulators said.

Here’s what to know.

Investigation Starts and Concludes

FDA official Dr. Tracy Beth Hoeg in the summer started looking into reports lodged with the Vaccine Adverse Event Reporting System (VAERS), which is co-managed by the FDA and the Centers for Disease Control and Prevention and accepts reports from health care practitioners, people who experience problems after vaccination, and contacts of those people.

The investigation was spurred by concerns that the previous administration misled the public about harms COVID-19 vaccines can cause, including myocarditis, or heart inflammation, Prasad indicated in the memo. Myocarditis symptoms include chest pain and irregular heartbeats and the condition can result in death.

Hoeg determined that some of the deaths among children following COVID-19 vaccination “were due to vaccine receipt,” Prasad wrote.

Prasad said he asked staff members with the agency’s Office of Biostatistics and Pharmacovigilance to perform an independent analysis of the deaths. The office concluded that at least 10 of the deaths were related to vaccination.

“If anything, this represents conservative coding,” Prasad wrote. “The real number is higher.”

Millions of children received a COVID-19 vaccine during the pandemic. They were first authorized for some teenagers in 2020, and later made available to children as young as 6 months of age.

Prasad said that causality is easy to assess in a randomized trial, but with case reports such as those in VAERS, causality is assessed on a scale ranging from certain to unlikely. In the scale, deaths ruled as “certainly,” “likely,” and “probably” linked to vaccination “are broadly considered as related to the product.”

VAERS reports can include documents such as autopsies, medical testing, and death certificates, which are written by medical examiners and include causes of death. The FDA has not released details of the assessed deaths, such as the ages of the children who died and how vaccines are believed to have played a role. Similar investigations in other countries have featured ruling out other possible causes.

First Acknowledgement

Federal officials previously found evidence that COVID-19 vaccines from Pfizer-BioNTech and Moderna caused deaths among multiple people, according to documents obtained by The Epoch Times and reported in 2024, and medical professionals have listed vaccination as a cause of death for some children.

The CDC said in its most recent statement to The Epoch Times that the only deaths related to vaccination were among people who received a vaccine that was removed from the market. In a presentation delivered in June, the director of the CDC’s Immunization Safety Office said that there was no increased risk of death following COVID-19 vaccination.

The FDA advised manufacturers to update their COVID-19 vaccine labels in July to say that side effects such as severe allergic reactions and myocarditis have been reported after receipt of the shots. The labels, which do not mention death as a possible outcome, say that for a more recent version of the vaccines, the risk of myocarditis was 27 cases per million in younger males. Prasad said in the new memo that the risk of myocarditis with the original vaccines was as high as 200 to 330 cases per million doses for young men and boys.

Prasad also said that following the determination from Hoeg and others, “for the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”

Pfizer did not return a request for comment by publication time.

A Novavax spokesperson declined to comment.

A Moderna spokesman in an email to The Epoch Times pointed to a company statement from September, in which it said it was “not aware of any deaths in the last year or pertinent new information from prior years” and that “global pediatric surveillance data continues to demonstrate the safety profile of Spikevax in pediatric populations.”

Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, said that she and other parents of children who have suffered injuries from vaccines have been calling for decades for health officials to investigate the safety of vaccines recommended for children.

“If we had not been marginalized and censored for ringing the warning bell and, instead, our calls for truth and transparency had been acted upon by FDA and CDC officials, the COVID shot debacle would not have happened,” Fisher told The Epoch Times in an email.

“It is tragic that cases of heart inflammation (myocarditis) and deaths in children and young adult men, who received the COVID shot, were covered up and it is tragic that politicians anchored their calls for COVID shot mandates based on disinformation produced by federal agencies. This is a hard lesson that the American people will long remember and government should never forget.”

Deaths ‘Ignored’

Prasad credited Dr. Marty Makary, the FDA’s commissioner, saying that without Makary, officials would not have performed the investigation and identified the deaths.

“This fact also demands serious introspection and reform,” Prasad wrote. “Why were these deaths not actively reviewed in real time? Why did it take until 2025 to perform this analysis, and take necessary further actions? Deaths were reported between 2021 and 2024, and ignored for years.”

Makary said on a podcast in November that “we’ve been looking into some of the vaccine injuries and we found that they were sitting on myocarditis data at the FDA.”

The FDA and CDC learned of post-vaccination myocarditis in February 2021, according to documents obtained by The Epoch Times. About two months later, the CDC director at the time said that no cases had been reported to the CDC, which was not true.

On May 10, 2021, the FDA expanded emergency authorization of Pfizer’s vaccine to children aged 12 to 15 without mentioning myocarditis. The CDC drafted an alert on myocarditis and COVID-19 vaccines but never sent it, over concerns it would cause panic. The CDC instead issued considerations for clinicians that discussed post-vaccination myocarditis cases and said that it was still recommending vaccination for people for whom the vaccines were authorized, or those 12 and older.

The FDA in June 2021 added a warning about the risk of myocarditis to labels for the Pfizer and Moderna shots, but they remained on the market. The shots were later made available and recommended for children as young as 6 months old.

“These agencies did not quickly attempt mitigation strategies such as spacing doses apart, lowering doses, omitting doses among those with prior COVID-19,” Prasad said on Nov. 28. “Worse, the FDA delayed acknowledgement of the safety signal until after it could extend marketing authorization to younger boys.”

He said that “had the acknowledgement come early, these younger boys, who likely did not require COVID-19 vaccination, may have chosen to avoid the products.”

Were Vaccines Beneficial for Children?

COVID-19 vaccine mandates were prevalent across society during the pandemic, including for minors. The FDA under previous leadership rushed approval of Pfizer’s vaccine to enable mandates, emails released in 2023 showed. Officials imposing mandates said they wanted to prevent more infections, hospitalizations, and deaths.

Prasad, in the new memo, described the mandates as harmful and said that officials do not have reliable data to answer the question of whether vaccine programs killed more healthy children than they saved, in part because the FDA never asked manufacturers to prove vaccines prevent severe disease and death in healthy kids.

Prasad and Hoeg co-authored a study in 2022 published by the Journal of Medical Ethics that said COVID-19 vaccine mandates at universities caused at least 18.5 serious adverse events per COVID-19 hospitalization prevented.

The CDC’s website says that through 2023, 1,216 child deaths had COVID-19 as the underlying cause on death certificates. A modeling paper published this year estimated that COVID-19 vaccination prevented deaths, primarily among the elderly.

The American Academy of Pediatrics says that COVID-19 vaccines are safe and effectively protect people against serious outcomes linked to COVID-19, citing research including a non-peer reviewed 2023 paper from the CDC that estimated the vaccines helped prevent emergency department and urgent care visits among young children.

Prasad said in his memo that older people benefited from COVID-19 vaccines, but younger people may not have. While COVID-19 can also cause myocarditis, according to studies, because the vaccines do not prevent infection, people who took them risked side effects from the shots in addition to problems from the virus, Prasad said.

“Comparing the number of kids who died from COVID against these deaths would be a flawed comparison,” Prasad wrote. “We do not know how many fewer kids would have died had they been vaccinated, and we do not know 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.”

Where’s the Data?

Some experts have called on the FDA to release the analyses that the agency said Hoeg and others performed.

“If there is a safety concern identified by the FDA for any medical product, the medical community would expect transparency in reporting the data. Someone saying there is a problem does not equal data, regardless of who they are,” Dr. David Boulware, a professor in the University of Minnesota’s Division of Infectious Diseases and International Medicine, told The Epoch Times in an email after reviewing the memo.

He said that he also wanted to know whether trained doctors were involved in adjudicating the VAERS reports.

The FDA and its parent agency, the Department of Health and Human Services (HHS), did not respond to requests for comment by publication time.

Prasad and Hoeg did not respond to requests for interviews.

The Epoch Times has filed Freedom of Information Act requests for the documents Prasad cited, including Hoeg’s analysis.

Dr. Robert Malone, who sits on the panel that advises the CDC on vaccines and regularly talks to Health Secretary Robert F. Kennedy Jr., told The Epoch Times that as part of his work, he has seen the data underlying the memo from Prasad.

“I can tell you that senior government officials within HHS are very aware of how explosive those findings are,” Malone said. He added later that “there is an active internal discussion about how to make these data … available to the public.”

What It Means Moving Forward

The FDA approved updated versions of four COVID-19 vaccines in the fall, but limited the approvals to seniors and younger people who have at least one underlying condition that officials say places them at higher risk of severe COVID-19 outcomes.

The CDC, which had for years promoted COVID-19 vaccination for nearly all Americans, then recommended that all people consult with health care professionals before receiving one of the shots, citing data on low effectiveness and risks of adverse events that advisers said were concerning.

Prasad said in the new memo that he’s focused on taking “swift action” in light of the findings of the VAERS review. He said that officials would be writing new guidelines to reflect a number of updates, including requiring randomized trials for most new products and mandating larger studies to support administering multiple vaccines at the same time.

“Vaccines will be treated like all other medication classes,” Prasad said.

Malone, vice chair of the CDC advisory panel, said that he will be helping panel members process the regulatory implications of Prasad’s memo. That will likely mean revisiting COVID-19 vaccine and influenza vaccine recommendations, he said.

“Influenza vaccination policy has to be brought up to date and aligned with the actual data,” Malone said.

(Visited 2 times, 1 visits today)