The Food and Drug Administration (FDA) has announced a significant tightening of its vaccine approval process, citing concerns that COVID-19 vaccines may have contributed to the deaths of at least 10 children. This information stems from an internal email obtained by The Washington Post, which outlines a new, more rigorous approach to vaccine evaluations led by Vinay Prasad, an FDA official whose policies have garnered backing from Health Secretary Robert F. Kennedy Jr..
Prasad’s communication details several pivotal changes in the FDA’s vaccine approval framework. He proposed reevaluating the current guidelines for annual flu vaccinations, assessing the necessity of administering multiple vaccines simultaneously, and requiring pharmaceutical companies to present extensive data to validate the safety and efficacy of their products. For instance, he emphasized that manufacturers of pneumonia vaccines must demonstrate that their vaccines specifically reduce pneumonia occurrences, rather than merely generating antibodies.
In addition, Prasad indicated a shift in the requirements for authorizing new vaccines for pregnant women. His email concluded with an invitation for open discussions, stating, “I remain open to vigorous discussions and debate.” He further urged any staff who disagreed with his approach to consider resigning.
These proposed changes could lead to a substantial transformation of the FDA’s long-standing vaccine approval protocols. According to current and former FDA staff, as well as external public health experts, the new strategy is likely to necessitate larger clinical trials, which could delay the availability of new vaccines. Concerns have been raised about the potential hindrance to the development of innovative vaccines, particularly as manufacturers may need to conduct comprehensive studies for new approvals, including those aimed at expanding vaccination eligibility.
Prasad’s ongoing inquiry into the administration of multiple vaccines simultaneously marks a potential reversal of established federal guidance. His team’s findings may influence the vaccines listed on the Centers for Disease Control and Prevention (CDC) recommended schedule for childhood vaccinations, which typically includes administering several vaccines at critical developmental milestones. Health officials have historically advocated for the convenience of receiving multiple vaccines during the same visit, especially for respiratory illnesses such as flu, COVID-19, and RSV.
In response to these developments, Jesse Goodman, a former director of the FDA’s Center for Biologics Evaluation and Research, asserted that existing vaccine guidelines are already stringent. He noted that vaccines are not approved without robust scientific evidence, adding, “They’re being approved with strong scientific evidence.”
On a recent episode of “Fox & Friends Weekend,” FDA Commissioner Marty Makary stated that the agency would disclose information regarding the child deaths linked to the COVID-19 vaccine. He criticized the Biden administration for what he described as a “rubber-stamped” approval process, particularly concerning the recent authorization of an updated COVID-19 vaccine for healthy children.
The Department of Health and Human Services, which oversees the FDA, did not respond to inquiries regarding Prasad’s email. A correspondent from PBS NewsHour was the first to report on the email’s contents.
Prominent vaccine expert Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, stated that vaccine manufacturers must provide a range of evidence when a new vaccine is added to the childhood vaccination schedule. This includes demonstrating that the new vaccine does not compromise the safety profile or immune response of existing vaccinations. Offit criticized the vagueness of Prasad’s proposed changes, urging clarity for a constructive dialogue on the FDA’s direction.
Prasad’s new strategy reflects some of the long-standing demands from Kennedy and his supporters within the anti-vaccine movement for increased scrutiny regarding vaccine safety and efficacy. In his email, Prasad asserted that his team had uncovered significant evidence linking COVID-19 vaccines to child mortality, characterizing it as a “profound revelation.” He stated, “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
In contrast, past FDA leaders and public health experts have repeatedly emphasized that COVID-19 vaccines have undergone extensive research, particularly in pediatric populations, and that the benefits of vaccination notably outweigh the risks. They acknowledge that while there have been rare adverse events associated with these vaccines, the overall data supports their safety and effectiveness.
Former FDA vaccine chief Peter Marks commented on the rigorous safety checks conducted for COVID-19 vaccines, asserting that “every due care” was taken to ensure their safety. He pointed out that investigations into potential vaccine-related deaths had been carried out by both the FDA and the CDC, as well as international health organizations, concluding that none were definitively linked to the vaccines.
Peter Hotez, director of the Center for Vaccine Development at Texas Children’s Hospital, expressed a desire for Prasad’s claims regarding the link between COVID-19 vaccines and child deaths to be substantiated with additional data, particularly concerning any underlying health conditions. He remarked, “With almost one billion COVID immunizations administered to Americans during the pandemic, and perhaps close to 100 million for children and adolescents, it is conceivable that such a one in 10 million or 100 million event occurred,” referring to rare adverse outcomes.
Kennedy’s long-standing opposition to vaccines is well-documented, having previously referred to the COVID-19 vaccine as “the deadliest ever made.” His administration has faced scrutiny for revisiting discredited theories linking childhood vaccinations to autism, drawing criticism from medical groups and public health authorities.
Prasad’s email indicated that Tracy Beth Hoeg, a notable critic of widespread childhood COVID-19 vaccination, has begun investigating reports of child deaths following vaccination. These reports were submitted to the federal Vaccine Adverse Event Reporting System, which collects unverified reports of vaccine-related side effects. The CDC clarifies that this database is not intended to determine causality regarding vaccine-related deaths.
Prasad noted that an analysis of 96 deaths reported between 2021 and 2024 concluded that “no fewer” than 10 of these cases were associated with the COVID-19 vaccine. He emphasized that the FDA would take swift action in response to this emerging safety concern.
The FDA had previously intended to present data linking COVID-19 vaccines to the deaths of 25 children to federal vaccine advisers, which raised alarms among public health experts regarding the extensive body of research supporting vaccine safety. The planned presentation was ultimately not held. However, data presented by CDC staff over the summer revealed that at least 25 children had died following COVID-19-related hospitalizations since July 2023, with the actual number likely being an undercount. Of the 16 children eligible for vaccination, none were found to be up-to-date on their vaccinations.
