Regulatory Uncertainty Surfaces as FDA Blames COVID Vaccines for 10 Child Deaths

A newly revealed internal memo from FDA reportedly links at least 10 child deaths to COVID-19 vaccination, marking a significant shift in how the agency assesses vaccine safety. According to reports by STAT News and Reuters, the memo concludes those deaths were “after and because of” receipt of a COVID-19 vaccine, with deaths tied to myocarditis or inflammation of the heart (1,2).

Sent by Vinay Prasad, MD, director of FDA’s Center for Biologics Evaluation and Research (CBER) and the agency’s chief medical and scientific officer, the memo triggered immediate questions within public health and biopharma circles about the strength of the evidence behind the claims (1–3). According to Reuters, certain details were not disclosed in the memo, such as the ages of the children—some reportedly between seven and 16, any underlying health conditions, and the vaccine manufacturers involved (2).

However, earlier in September 2025, the Centers for Disease Control and Prevention (CDC), through its Advisory Committee on Immunization Practices (ACIP), continued at that time to maintain a framework for COVID-19 vaccination that emphasizes shared clinical decision making—not blanket mandates (4).

Why is this news important for drug manufacturing and vaccine development?

Because FDA has historically set the regulatory standards that vaccine developers must meet, this internal reassessment of COVID-19 vaccine safety could lead to tighter approval requirements, larger required safety datasets, and slower regulatory timelines, all of which could reshape how biopharmaceutical companies design and conduct vaccine trials (1–2).

What evidence does FDA cite for potential vaccine-linked child deaths?

According to reports citing the internal memo, FDA reviewed 96 pediatric deaths reported between 2021 and 2024 and concluded that at least 10 are likely or possibly linked to COVID-19 vaccination, mostly involving myocarditis (2). Dr. Prasad was quoted as having written, “These deaths are related to vaccination (likely/probable/possible attribution made by staff). This is a profound revelation. For the first time, the FDA will acknowledge that COVID-19 vaccines have killed American children” (2).

Dr. Prasad was also quoted as having written, “I remain open to vigorous discussions and debate on these topics, as I have always been. I am open minded to modifications or alterations” (1).

Additional reporting noted that the memo did not include critical details like (as mentioned above) the specific ages of the children or their prior medical conditions, nor did it mention which vaccine products they received or autopsy findings (1,5). The absence of peer-reviewed publication and lack of public disclosure of underlying data have also drawn strong criticism from vaccine experts and former regulators, who argue that “extraordinary” claims require evidence (1).

How does this align with CDC’s vaccine safety monitoring and recommendations?

In its September 2025 meeting, the CDC’s ACIP met to review updated data on COVID-19 vaccine effectiveness, immunization schedules, and safety signals. The 2025–2026 COVID-19 vaccination guidance was issued at that meeting under a “shared clinical decision-making” framework, meaning that vaccination is recommended based on individual risk-benefit assessments rather than universally (4).

In the committee’s deliberations, one workgroup flagged “serious safety uncertainties,” including potential myocarditis risk after messenger RNA vaccination, concerns that the group said were not fully addressed under current pharmacovigilance systems (6). The group also indicated that reliable quantifications of vaccine benefit across subpopulations remain elusive, particularly in people at lower risk for severe COVID-19 (6).

That said, however, the CDC has noted that COVID-19 vaccination substantially reduces risk for severe disease, hospitalization, and death in both adults and younger populations, especially for those at higher risk (7).

What are the potential impacts on vaccine development and the broader industry?

Expected impacts include:

• Stricter regulatory requirements. If FDA formalizes new standards inspired by the memo, such as requiring larger safety datasets, longer follow-up periods, and more detailed adverse-event investigation, including autopsies, vaccine developers may face higher costs, longer development times, and greater complexity in trial design (1).
• Hesitancy and demand uncertainty. Given the lack of clarity and the public attention to death claims, demand for pediatric vaccination may decline, and companies may deprioritize pediatric or broad-market vaccines in favor of adult-only or high-risk group vaccines (8).
• Shifts in public-health strategy. Regulators and public health bodies may revisit the once-routine practice of concomitant vaccination (e.g., giving multiple shots in one visit). If simultaneous immunization becomes restricted, scheduling logistics and patient compliance may become more challenging (9).
• Regulatory precedent. This episode may set a precedent for how safety signals, even when not fully confirmed, can be used to reshape regulatory frameworks, which may then influence the broader future of biologics and vaccine approvals (10).

FDA’s internal memo, coupled with CDC’s review of data, points to the biopharma industry and public health experts grappling with the issue of whether, ultimately, this move is a necessary tightening of safeguards or a politicized overreaction that could hinder vaccine innovation and public trust (11).

References

1. Herper, M.; Branswell, H. Experts Say Top FDA Official’s Claim that Covid Vaccines Caused Kids’ Deaths Requires More Evidence. STATNews.com. Nov. 29, 2025.
2. Reuters. US FDA Memo Links 10 Child Deaths to COVID Vaccines. Reuters.com. Nov. Nov. 29, 2025.
3. Lovelace Jr., B. FDA Claims Covid Shots Killed 10 Children and Vows New Vaccine Rules. NBCNews.com. Nov. 29, 2025.
4. US Department of Health and Human Services. ACIP Recommends COVID-19 Immunization Based on Individual Decision-making. Press Release. Sept. 19, 2025.
5. Breen, K.; Brennan, M.; Gounder, C. FDA Official, Without Providing Data, Claims Link Between COVID-19 Vaccines and Pediatric Deaths. CBSNews. Nov. 29, 2025.
6. Levi, R. COVID-19 Vaccine Discussion Framing, 2025-2026. CDC.gov. Sept. 19, 2025.
7. CDC. Benefits of Getting Vaccinated. CDC.gov. Updated June 11, 2025 (accessed Dec. 1, 2025).
8. El-Deiry, W.; Kuperwasser, C. Workgroup Safety Uncertainties of mRNA COVID Vaccines. CDC.gov. Sept. 19, 2025.
9. CDC. COVID-19 Vaccination Implementation. CDC.gov. Sept. 19, 2025.
10. Su, J. Vaccine Safety Signal Detection and Evaluation. CDC.gov. Sept. 19, 2025.
11. Nahum, A.; Drekonja, D. M.; Alpern, J. D. The Erosion of Public Trust and SARS-CoV-2 Vaccines—More Action Is Needed. Open Forum Infect. Dis. 2021, 8 (2), ofaa657. DOI: 10.1093/ofid/ofaa657