FDA's statements on COVID-19 vaccine safety lack reliable data support and may impede vaccine accessibility

The U.S. Food and Drug Administration (FDA) is proposing major changes to the way vaccines are tested and approved, citing unverified claims that mRNA COVID-19 vaccines were linked to the deaths of at least 10 children. The agency outlined these plans in an internal memo released on November 28, 2025, obtained by multiple news organizations and reported by The Washington Post.

The memo, authored by FDA vaccine official Vinay Prasad, references an unpublished internal review and suggests the deaths were caused by myocarditis, a type of heart inflammation. It notes that these deaths were recorded in the Vaccine Adverse Event Reporting System (VAERS) but provides no direct evidence that the vaccines were the cause.

While any death connected to a vaccine is alarming, current research indicates such severe heart-related side effects from COVID-19 vaccines are extremely rare. Evidence so far shows myocarditis after vaccination occurs infrequently, and serious outcomes are even less common. Restricting access to approved vaccines without solid proof could impede patient care, hinder pharmaceutical efforts, and reduce public trust in vaccines.

Healthcare professionals emphasize that VAERS reports alone cannot establish causation. Confirming a vaccine-related death requires detailed clinical evaluation, medical records review, and corroborating safety data from systems such as PRISM and the Vaccine Safety Datalink. Historically, many deaths reported in VAERS after vaccination were later found unrelated to the vaccines.

Heart-Related Side Effects of COVID-19 Vaccines

Prasad has publicly suggested that cardiac side effects from COVID-19 vaccines are underestimated and that restrictions should be stricter. In a 2025 presentation, he cited a risk of 27 myocarditis cases per million in young men, slightly higher than previous estimates of about 20 per million. However, studies consistently show that unvaccinated individuals face a higher risk of heart complications from COVID-19 infection than vaccinated individuals, and vaccine-related myocarditis generally results in fewer complications than infection-induced myocarditis.

The U.S. vaccine safety system has historically detected genuine issues, such as rare blood clot risks from viral vector COVID-19 vaccines by Janssen and AstraZeneca, which led to a temporary pause and eventual withdrawal of those vaccines. Deaths from myocarditis linked to mRNA COVID-19 vaccines are exceedingly uncommon, and proving causation requires more than VAERS data alone.

Implications for Future Vaccine Approval

Currently, vaccines are evaluated based on their ability to prevent disease and generate antibodies. Annual influenza vaccines, for example, are updated seasonally based on new strains, with approval relying on antibody response comparisons rather than repeated placebo-controlled trials. The FDA memo proposes increasing the number of placebo-controlled studies for COVID-19, influenza, and pneumonia vaccines, but experts warn this is impractical. Conducting such trials annually would delay vaccine rollout, incur significant costs, and could be unethical if participants are denied effective vaccines.

Detecting rare vaccine side effects like myocarditis would require much larger clinical trials, adding millions in costs and further delaying vaccine availability. Suspected vaccine-related deaths should be thoroughly investigated, but stopping vaccines without strong evidence risks undermining public confidence and vaccination efforts.

Balancing Risks and Benefits

Accurate risk assessment must compare vaccine side effects with the health risks of the diseases they prevent. COVID-19 poses far greater danger to children than vaccination. Between August 2021 and July 2022, over 800 U.S. children died from COVID-19, while confirmed deaths linked to vaccines remain exceedingly rare. COVID-19 also causes more heart-related complications than the vaccines.

Vaccination significantly lowers hospitalization risk by over 70% and severe illness in adolescents by 79%, while reducing the likelihood of long COVID. Presenting only vaccine risks without context omits crucial benefits.

Thorough, transparent evaluation of vaccine safety is essential to protect public health and maintain confidence in immunization programs.

Analysis of FDA's Proposal on Vaccine Testing and Approval

The recent proposal by the U.S. Food and Drug Administration (FDA) to alter vaccine testing and approval procedures, as outlined in an internal memo dated November 28, 2025, has raised significant concerns within the medical and public health communities. The suggestion that the mRNA COVID-19 vaccines might be linked to the deaths of at least 10 children has not been substantiated by direct evidence but rather relies on unverified data from the Vaccine Adverse Event Reporting System (VAERS). Such claims, if not thoroughly investigated, could risk undermining public trust in vaccines and disrupt ongoing public health efforts.

While it is crucial to monitor potential vaccine side effects, healthcare experts have pointed out that VAERS data alone is insufficient to establish causality. Historically, many reported deaths were later found to be unrelated to the vaccine. Furthermore, current research overwhelmingly suggests that the risk of serious heart-related complications, such as myocarditis, remains exceedingly rare. In fact, unvaccinated individuals face a greater risk of heart complications from COVID-19 infection than from the vaccine itself.

The FDA's proposal to increase the number of placebo-controlled studies for COVID-19, influenza, and pneumonia vaccines may have unintended consequences. Experts warn that implementing such changes would result in significant delays in vaccine availability, incur substantial costs, and potentially deny participants access to effective vaccines. The recommendation to conduct larger clinical trials to detect rare side effects would also require millions in additional funding, a move that could slow down vaccine rollouts even further.

In the context of the ongoing COVID-19 pandemic, it is important to weigh the risks of vaccination against the risks of the diseases they prevent. COVID-19 remains a far greater danger to children, with over 800 deaths reported between August 2021 and July 2022 in the U.S. By comparison, vaccine-related deaths are exceedingly rare. Moreover, vaccination has been shown to significantly reduce the risk of severe illness, hospitalization, and long-term complications, such as long COVID.

In conclusion, while vaccine safety must be rigorously evaluated, it is essential that these evaluations are based on solid scientific evidence. Any proposals that may lead to a reduction in vaccination rates, without sufficient cause, could have devastating consequences for public health. The balance between risk and benefit is clear, and it is important for policymakers to focus on transparent, data-driven approaches to vaccine approval and safety monitoring.

Sources:

• FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access

Author: Grace Ellison
Grace Ellison is a journalist focusing on environmental issues and sustainability. She has experience publishing international reports and participating in documentary projects.