FDA Enforces Stricter Vaccine Development, Linking COVID Vaccine to Pediatric Deaths

The FDA plans to revamp vaccine development in the US amid findings that the COVID-19 vaccine supposedly led to 10 youth deaths, according to an NPR article.¹ Agency leaders, however, failed to provide specific data highlighting the COVID-19 vaccine’s link to pediatric mortality.

“In an email sent to staff this afternoon, [Center for Biologics Evaluation and Research] CBER Chief Vinay Prasad says the [FDA] for the first time ‘will acknowledge that COVID-19 vaccines have killed American children,’ which he calls a ‘profound revelation,’” reported PBS News Hour contributor Ali Rogin on X.

The email was first circulated on Friday afternoon. Then, on Saturday, FDA Commissioner Marty Makary, MD, MPH, took to Fox News to add further details on the FDA memo.

FDA’s Findings Connecting Vaccines with Child Mortality

Vinay Prasad, MD, MPH, chief medical and scientific officer and director of the CBER, recently tasked the FDA’s biostatistics and pharmacovigilance team with analyzing data from 96 reported deaths spanning from 2021 to 2024. From the 96 cases, researchers determined that 10 of them occurred “after and because of” children receiving the COVID-19 vaccine. They also claimed that the statistics were most likely much higher than just 10 pediatric deaths as a result of immunization.¹

READ MORE: CDC Updates Webpage, Saying No Evidence Supports “Vaccines Do Not Cause Autism” Claims

However, Prasad and his team have yet to provide any additional information or data that actually proves these children died from the vaccine.

Despite the lack of evidence, Prasad and Makary are now vowing to reestablish vaccine development in the US through FDA oversight—blaming past presidential administrations for what current leaders think are crass missteps in health care. According to ABC News, Makary was criticizing the Biden Administration’s handling of the COVID-19 pandemic response and immunization approach.²

While he acknowledged the vaccine’s success among older adults and at-risk patients, Makary believes the US “makes a mockery of science if we’re just going to rubber-stamp things with no data,” according to the ABC News article.

A New Approach to Vaccine Development

Similar to the data connecting the COVID-19 vaccine with child mortality, Makary nor Prasad have shared details on what stricter vaccine developments look like. However, reports show that the FDA will re-examine flu shot policies, consider limits for and shy away from simultaneous vaccinations, and require significantly more robust data before vaccine approvals.³

With the agency’s recent findings about pediatric deaths from the COVID-19 vaccine, they provided further details on specific vaccines and populations they would be paying closer attention to.

First, Prasad told his colleagues the FDA would no longer authorize vaccines for pregnant adults unless stricter requirements are enforced.¹ Linked with the current administration’s worries regarding acetaminophen use and autism development,⁴ the agency is also looking to delink vaccines’ use among pregnant women due to claims of adverse effects.

Furthermore, Prasad, Makary, and the FDA focused on pneumonia, or pneumococcal vaccines—which are continuously being developed because of adapting disease serotypes.⁵ Going forward, pneumococcal vaccines must show they reduce disease rather than solely generating antibodies for the patient.¹

The Health Care Community’s Reaction

These claims have seemingly circulated since the COVID-19 pandemic and have continued with the current administration and its FDA leaders. While they continue to attempt a reshaping of various standards of US health care practice, other industry professionals and providers are voicing their concerns.

“[Prasad] says he has evidence that this vaccine killed 10 children, but that’s not the way it works,” Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said.³ “If you think you have an extraordinary claim, you should back it up with extraordinary evidence. He should have submitted it to an excellent journal where it can be reviewed by subject matter experts who can say, ‘Yes, this is clear evidence,’ then it can be published. That’s the way it works.”

According to Offit, the recent news from the FDA is a “dangerous and irresponsible thing to do.” Without clear evidence mapping out the COVID-19 vaccine’s link to the 10 specific childhood deaths, news about these data can only insight fear and uncertainty among the general public. It’s also creating further hurdles among the traditional medical community—a collection of millions of providers who have historically promoted the significant efficacy and safety of immunization.

Next Steps in Solidifying New Vaccine Requirements

Vaccine manufacturers are racing to defend their products and denounce some of the recent reports stemming from the FDA and CBER findings. While Pfizer has yet to comment on the evidence-based safety and efficacy of its product, Moderna is “not aware of any deaths in the last year or pertinent new information from prior years” regarding their COVID-19 vaccine formula.¹

“The FDA email on vaccine policy comes just before the CDC convenes a crucial 2-day meeting of that agency's influential Advisory Committee on Immunization Practices on December 4-5,” concluded authors of the NPR article. “The committee is in the process of conducting a major review of how children are inoculated against dangerous infectious diseases such as measles, mumps, rubella, polio, and hepatitis B.”

READ MORE: Immunization Resource Center

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REFERENCES

1. Stein R, Lupkin S. FDA to raise hurdles for vaccines, faulting COVID shots for 10 kids' deaths. NPR. November 29, 2025. Accessed December 1, 2025. https://www.npr.org/sections/shots-health-news/2025/11/29/nx-s1-5624998/fda-vaccines-covid-children-safety

2. FDA links 10 children’s deaths to COVID-19 vaccines. Doctors want proof. ABC News. November 30, 2025. Accessed December 1, 2025. https://abcnews.go.com/US/fda-links-10-childrens-deaths-covid-19-vaccines/story

3. Dunbar M. Experts say strict new FDA protocol for vaccine approval is ‘dangerous and irresponsible.’ The Guardian. November 29, 2025. Accessed December 1, 2025. https://www.theguardian.com/society/2025/nov/29/regulator-fda-stricter-protocols-vaccine-approvals

4. Nowosielski B, Garofoli M. Q&A: Pain medication expert on controversy surrounding acetaminophen-autism link. Drug Topics. September 25, 2025. Accessed December 1, 2025. https://www.drugtopics.com/view/pain-medication-expert-on-controversy-surrounding-acetaminophen-autism-link

5. Nowosielski B. Rise in IPD calls for development of more pneumococcal vaccines. Drug Topics. November 17, 2025. Accessed December 1, 2025. https://www.drugtopics.com/view/rise-in-ipd-calls-for-development-of-more-pneumococcal-vaccines