FDA Plans Overhaul of Vaccine Testing Amid COVID-19 Safety Concerns

The Food and Drug Administration (FDA) is planning to overhaul its vaccine testing and approving methods radically. This alteration is said to be a result of a claim that at least 10 children have died due to mRNA-based COVID-19 vaccines, although no evidence is provided for this claim. Changes the agency is planning to make, as per a leaked memo, could have a very significant impact on vaccine regulation and public health.

The memo dated November 28, 2025, that was retrieved by several media outlets, among them The Washington Post, is signed by Dr. Vinay Prasad, FDA chief of vaccine regulation. It indicates a substantial change in methods for assessing the safety of ​‍​‌‍​‍‌​‍​‌‍​‍‌vaccines.

The FDA through the memo, is mulling over the idea of many more placebo-controlled trials to replace or supplement the present testing procedures not only for vaccines against COVID-19 but for other vaccines such as influenza and pneumonia as well. Confirming vaccine safety and efficacy through this method would lead to numerous new studies, especially as regards rare side effects, for example, myocarditis.

The​‍​‌‍​‍‌​‍​‌‍​‍‌ document covers a secret and unannounced review that links the death of about 10 children from myocarditis, i.e., the inflammation of the heart muscle, as a result of the COVID-19 vaccination. Unfortunately, no evidence has been made available to the public that demonstrates a direct cause-and-effect relationship between the vaccines and these deaths. The deaths were also reported to the Vaccine Adverse Event Reporting System (VAERS) which is a passive surveillance system that collects reports on the adverse events following immunization. Nevertheless, VAERS data alone cannot be the direct ​‍​‌‍​‍‌​‍​‌‍​‍‌cause.

Opponents of the idea consider that basing such serious accusations solely on VAERS is a mistake from the point of view of science. Reports found in VAERS can also be coincidental events that have nothing to do with vaccines, and they frequently necessitate further inquiry through the review of medical records, autopsies, and data from other sources such as the Vaccine Safety Datalink (VSD) and PRISM.

As​‍​‌‍​‍‌​‍​‌‍​‍‌ the pediatric cardiologist leading several studies on the incidence of vaccine-related myocarditis, assure you that such side effects occur at a very low level and, typically, their severity is lower than that of the COVID-19 complications. To date, research has pointed out that myocarditis due to vaccination is infrequent, and only very few cases are ​‍​‌‍​‍‌​‍​‌‍​‍‌severe.

I remain receptive to new proofs; however, any assertion of massive child death due to vaccines should be substantiated by in-depth, visibly conducted investigations. In the absence of such evidence, the limitation of approved vaccines and the change of testing procedures will most likely lead to a loss of public trust, vaccination rates will decline, and vaccine manufacturers will face unnecessary difficulties.

The FDA memo tightly associates the vaccination with the tragic deaths of the children. Yet, establishing causality from a clinical point of view needs more than VAERS entries. It requires linking the reports with full medical evaluations, lab results that confirm myocarditis, and determining the other possible causes of death.

The majority of the children's deaths recently vaccinated and reported in VAERS are only allegations and have frequently been mistakenly attributed. Proper causality determination relies on numerous sources of information, such as electronic medical records, autopsy findings, and active surveillance systems like VSD.

The intended change to a greater number of placebo-controlled trials discussed in the proposal brings up a number of practical and moral issues:

• Feasibility: For instance, a vaccine like influenza that has to be updated annually, performing new placebo trials every year would be impractical, very expensive, and the results might be outdated by the time the vaccine is approved.
• Ethics: The use of unvaccinated control groups when there are already effective vaccines could, therefore, expose the individuals to whom the control group belongs to unnecessary risk, thus making such trials ethically questionable.
• Cost and Time: Bigger, more complicated trials will postpone the vaccine rollout, thus potential lives will be lost during the time of epidemics.

In America, the present vaccine safety system that incorporates VAERS, VSD, and other active surveillance mechanisms, has been able to pinpoint real safety issues – e.g., blood clotting problems with viral vector COVID-19 vaccines, thus leading to temporary suspension and removal from the market.

For​‍​‌‍​‍‌​‍​‌‍​‍‌ myocarditis, the evidence indicates that the number of cases of the disease caused by vaccines is very limited, and most people are thoroughly recovered. Determining causation in each instance requires detailed medical examination, not just reports of adverse events.

It​‍​‌‍​‍‌​‍​‌‍​‍‌ is essential to scrutinize in detail the instances of side effects, nevertheless, extreme changes to the test methods based on unsubstantiated claims may lead to the public ceasing to trust health authorities and vaccines. There is an equilibrium that should be maintained between rigorous safety measures and the trust of the public; if the activities against vaccines are overly careful or without proper support, they may, by unintentional ways, bring about the reluctance to ​‍​‌‍​‍‌​‍​‌‍​‍‌vaccination.

In case the FDA reforms are implemented without solid scientific evidence, they may limit vaccine research, lead to the delay of necessary immunizations, and decrease the public's trust. It is very important that any safety concerns be addressed openly and with thorough scientific evidence, and that any changes in policy happen because they have the potential to improve health outcomes rather than being driven by unverified ​‍​‌‍​‍‌​‍​‌‍​‍‌​‍​‌‍​‍‌​‍​‌‍​‍‌claims.