The FDA noted that at least 10 children have died due to the COVID-19 vaccine.

The Food and Drug Administration's top vaccine officer, Vinay Prasad, released a memo stating that the COVID vaccine led to the deaths of 10 children, according to ABC NewsExperts believe the note is unsubstantiated and contains "a very disturbing mixture of distortions and untruths," he adds. NBC News.

Late on the evening of November 28, Dr. Vinay Prasad, director of the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER), sent a nearly 3000-word internal memo to all employees of his division. In it, he stated the following: after reanalyzing the VAERS (Vaccine Adverse Event Reporting System) database for the period from December 2021 to December 2024, FDA staff concluded that at least 10 deaths in children under 18 were caused by the coronavirus vaccine.

"These deaths are vaccine-related (staff consider attribution probable or possible)," Prasad wrote.

He added, "This is a major revelation. For the first time in its history, the US FDA has officially acknowledged that COVID-19 vaccines have caused the deaths of American children. The true number is likely higher because previous leadership ignored safety signals and hid data for years."

On the subject: You can order the flu vaccine online and have it delivered to your door.

The document doesn't provide a single specific detail: not the age of the deceased children, not their gender, not their state of residence, not any underlying medical conditions, not the exact time interval between the injection and death, not the specific vaccine (Pfizer, Moderna, or another). There are no autopsy reports, medical records, or even anonymized case reports attached. The findings were not submitted for external review and have not been published in a peer-reviewed scientific journal.

Prasad claims the children's deaths were linked to myocarditis, an inflammation of the heart muscle, but provides no evidence.

He used extremely harsh, almost ideological rhetoric: school and workplace vaccination mandates were called "coercive," and previous FDA decisions were called "dishonest and manipulative." He called former CDC Director Rochelle Walensky a "liar." General regulation of COVID vaccines "could have done more harm than good to children," Prasad believes.

At the end of the note, he openly addressed his colleagues: “If anyone is not ready to honestly admit the mistakes of the past and change policies for the sake of children, it’s time to resign.”

In the same document, Prasad included a list of radical changes that the FDA intends to implement as early as 2026. Among them are:

Tightening the approval process for all respiratory vaccines and reconsidering the need for annual flu vaccinations ("the current approach is a disaster of low-quality evidence"). Plans are also underway to require pneumococcal vaccine manufacturers to demonstrate a real reduction in pneumonia cases, not just antibody production in laboratory tests.

FDA Commissioner Dr. Marty Makary confirmed the memo's authenticity in an interview with Fox News on November 30. He stated, "We will release all the data on COVID vaccine deaths that the previous administration carefully concealed. This will be done in the coming weeks."

He added a caveat: “For older people and at-risk groups, this vaccine has been and remains amazing, especially when the vaccine strain matches the circulating virus well.”

Reaction of the scientific community

Paul Offit, director of the Vaccine Information Center at Children's Hospital of Philadelphia and one of America's most renowned pediatric vaccinologists, said, "This isn't science; it's science by way of a press release. The memo is irresponsible and dangerous. Without the publication of the primary data, it's just words."

Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, added: "The document is completely devoid of any medical details. To claim a causal link to death, you need to know at a minimum: the child's age, any underlying medical conditions, the specific vaccine, and what tests were performed to rule out other causes. None of that exists. Such statements only fuel anti-vaccine sentiment and politicize a topic that shouldn't be political."

Peter Marks, former director of the FDA's Center for Disease Control and Prevention (CBER) (removed in February 2025 by the new Secretary of Health and Human Services, Robert F. Kennedy Jr.), said the following: "This memo is a disturbing mixture of distortions and outright falsehoods. VAERS is an early warning system, not a tool for proving causality. It was thanks to VAERS that we promptly identified the blood clots after Johnson & Johnson. But you can't take old reports and retroactively declare them 'vaccine-related' without conducting a full investigation. COVID-19 itself causes myocarditis tens of times more frequently and more severely than mRNA vaccines."

Dorit Reis, a law professor at the University of California, San Francisco and an expert on FDA regulatory processes, believes Prasad is proposing a radical overhaul of the approval process for all vaccines based on a closed, unpublished, and opaque internal investigation. "This is not how the FDA has operated for the past 50 years," she says.

Context

Interestingly, the memo's publication occurred just days before a two-day meeting of the CDC's Advisory Committee on Immunization Practices (ACIP), scheduled for December 9, which will focus on the childhood immunization schedule, including hepatitis B vaccination for newborns and the possible exclusion or restriction of COVID vaccines for healthy children. Surgeon General Robert F. Kennedy Jr. has repeatedly called mRNA vaccines "the deadliest vaccine in history" and promised a "complete review of the entire vaccination program."

Meanwhile, dozens of large studies in 2023–2024 (including an analysis of 17 studies on more than 10 million children aged 5–11 in JAMA Pediatrics and a large study in Nature Communications) continue to confirm that the Pfizer and Moderna vaccines are safe for children and sharply reduce the risk of hospitalization and death from COVID-19.

You may be interested in: top New York news, stories of our immigrants and helpful tips about life in the Big Apple - read it all on ForumDaily New York

Rare cases of myocarditis after vaccination in adolescent boys are mild in 98–99% of cases and resolve completely within a few days. However, influenza can indeed cause severe inflammation of the heart muscle.

While independent experts are demanding that the FDA immediately release initial data on the 10 cases in question, the agency is referring all inquiries to the Department of Health and Human Services, which has so far remained silent.

Read also on ForumDaily:

420 bills have been introduced in state assemblies to defund vaccinations and introduce other unscientific ideas.

Trump has come up with a way to make American children healthier: 128 ideas - and no specifics

Hundreds of Health Professionals Call for Kennedy to Resign as Health Secretary

Do you want more important and interesting news about life in the USA and immigration to America? — support us donate! Also subscribe to our page Facebook. Select the “Priority in display” option and read us first. Also, don't forget to subscribe to our РєР ° РЅР ° Р »РІ Telegram  and Instagram- there is a lot of interesting things there. And join thousands of readers ForumDaily New York — there you will find a lot of interesting and positive information about life in the metropolis.