The Food and Drug Administration’s (FDA) leading vaccine regulator has made a striking claim in a recent internal communication, raising serious discussions about vaccine safety and regulatory practices. In an email sent to staff, Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), asserted that the Covid-19 vaccine has been linked to at least ten deaths in children. This revelation calls for heightened regulatory scrutiny surrounding the approval and monitoring of new vaccines.
Prasad characterized this assertion as “profound,” stating, “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.” His memo also criticized vaccine mandates and expressed concern over the potential harm they may have caused, particularly in children aged 7 to 16.
Despite the severity of these allegations, experts in the field express skepticism regarding Prasad’s claims, primarily due to the absence of detailed supporting data and context. Many commentators noted that the remarkable assertion warrants extraordinary evidence, which was lacking in the memo distributed internally and subsequently leaked.
The FDA has yet to clarify its next steps regarding the allegations made in Prasad’s email. The memo lacks information on forthcoming detailed reports or plans to publish findings in recognized medical journals. Notably, Prasad indicated a shift in regulatory approaches, suggesting that new, stricter requirements would apply to Covid vaccines administered during pregnancy, as well as potential reforms to how annual influenza vaccines are regulated. He also mentioned evaluating whether multiple vaccines could be given concurrently, a concern that could significantly impact childhood vaccination schedules.
Expert opinions diverged on the implications of such changes. Jeff Morris, a public health and preventive medicine professor at the University of Pennsylvania, stressed the dangers of restricting combination vaccines based solely on fears without substantial evidence.
Additionally, there was uncertainty regarding which specific vaccines Prasad referred to, especially concerning those administered during pregnancy. Reactions from many experts indicated a pressing need for comprehensive evidence before establishing any causal link between Covid vaccine administration and the reported fatalities in children.
Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, emphasized the importance of an independent review of the claims by the National Academies of Sciences, Engineering, and Medicine. The memo’s implications regarding school vaccine mandates were also criticized as inaccurate, further highlighting the confusion surrounding the document.
Some staff members at CBER expressed discontent with Prasad’s message, characterizing it as misleading and politically charged. Concerns were raised about the potential impact on morale and the willingness of staff to engage in open discourse about vaccine safety.
The memo also mentioned that Prasad and FDA Commissioner Marty Makary had previously authored journal articles that scrutinized the regulatory response to reported side effects of mRNA Covid vaccines, particularly myocarditis. Prasad stated that a colleague had conducted an inquiry into the Vaccine Adverse Event Reporting System (VAERS) and concluded that a minimum of ten Covid vaccine-related deaths had occurred among children between 2021 and 2024.
This assertion, however, was met with skepticism from many vaccine experts. Critics pointed out that VAERS data, while useful as an early warning system, is often fraught with inconsistencies and should not be the sole basis for attributing cause. Calls for transparency regarding the process of linking deaths to vaccine administration echoed from experts, with many emphasizing the necessity for clear evidence and context.
While Prasad asserted that the numbers reported represent a conservative estimate, significant challenges remain in establishing a clear causal relationship between vaccine administration and reported fatalities. Experts are currently seeking comprehensive data to elucidate the complexities surrounding these claims.
Moreover, Prasad’s reference to the relatively low mortality risk from Covid among children raised additional concerns. Although it’s true that children generally face a lower risk than older populations, Covid-19 has led to notable fatalities in the under-19 demographic, indicating the necessity of a balanced perspective on the benefits versus risks of vaccination.
As discussions continue, the FDA’s Advisory Committee on Immunization Practices (ACIP) will convene soon to deliberate vaccine strategies. The reconstitution of the committee has already prompted concerns about the expertise on board, particularly given the high stakes surrounding vaccine policy changes.
Acknowledging the internal turbulence within the FDA, Prasad concluded his email by reiterating his willingness for open discussions on these contentious topics while maintaining a preference for keeping such debates confidential until they are adequately vetted for public consumption. The implications of this email and its reception within the FDA and broader medical community highlight the ongoing complexities of vaccine regulation and public health.
