The Food and Drug Administration (FDA) is reportedly planning to implement stricter criteria for vaccine approvals, with top officials referencing concerns about the risks of COVID-19 vaccines for children.
Commissioner's Statements and Internal Communications
FDA Commissioner Marty Makary stated on Fox News that the agency would no longer "rubber-stamp new products that don't work," adding that such actions "made a mockery of science." This statement followed an internal email from Dr. Vinay Prasad, the FDA's lead vaccine regulator, to his team. The email, reviewed by NPR, PBS News Hour, and The Washington Post, outlined several planned changes:
- The agency will modify its annual flu vaccine framework.
- Vaccine labels will be updated.
- Vaccines for pregnant women will require stricter authorization requirements.
- Manufacturers of pneumonia vaccines will need to demonstrate disease reduction rather than solely antibody generation.
- The practice of co-administering multiple vaccines was questioned.
These changes could increase the difficulty and cost of vaccine approvals, potentially affecting vaccine availability. While vaccines are public health tools used to protect against infectious diseases, public health experts generally state that the current vetting process aims to ensure benefits outweigh risks. Post-approval studies and surveillance systems, such as the Vaccine Adverse Event Reporting System (VAERS), are designed to identify safety issues.
COVID-19 Vaccine Analysis and Expert Responses
Makary stated on Fox News that an FDA analysis linked 10 pediatric deaths to the COVID-19 vaccine during the current administration, without providing specific details on the methodology. Millions of children have received the vaccine. Officials from the Department of Health and Human Services and the FDA did not immediately respond to requests for comment regarding this analysis or the proposed changes to vaccine review standards.
Prasad's email detailed that the FDA's biostatistics and pharmacovigilance team analyzed 96 reported deaths from 2021 to 2024, concluding that 10 children died "after and because of" the COVID-19 vaccine. Prasad indicated that the true number might be higher. The email also noted that causality in case reports is typically assessed on a subjective scale, ranging from certain to unlikely.
Dr. Paul Offit, who directs the Vaccine Education Center at the Children's Hospital of Philadelphia, stated that Prasad has not shared the evidence for these deaths. Offit commented that without evidence, it asks for trust on an important issue and could cause unnecessary public concern. He recommended that all evidence be provided for expert review.
Dr. Jesse Goodman, a former FDA vaccine regulator, described the FDA's Center for Biologics Evaluation and Research as "globally recognized." Goodman defended the use of "immunologic endpoints like antibody levels" for accelerated approval of certain vaccines, stating that scientific evidence supports their use and subsequent confirmation studies. He added that these methods have facilitated timely access to vaccines, contributing to public health.
Epidemiologist Michael Osterholm challenged Prasad's statement that "COVID-19 was never highly lethal for children," noting 1,597 pediatric deaths from COVID-19 in 2020-2022. Osterholm also questioned the FDA's analysis of adverse event reports, stating that the 10 reported deaths have not been presented for review by the medical and public health communities or published in medical literature. He concluded that without third-party expert review, these cases cannot be accepted as vaccine-associated deaths.
Surveillance Systems and Policy Evolution
The FDA makes data from VAERS public, co-sponsored by the Centers for Disease Control and Prevention (CDC). The FDA cautions that for any event reported to VAERS, no cause and effect relationship is established.
Makary commented that in 2020, COVID vaccines reduced illness severity and saved lives, but argued that recommending annual COVID vaccinations for a 6-year-old is not scientifically supported. He affirmed the agency's stance against approving products without scientific evidence.
These developments follow the FDA's August restriction of eligibility for updated COVID vaccines, concurrent with the agency's stated plan to require more evidence regarding vaccine safety and effectiveness. Robert F. Kennedy Jr. has publicly questioned vaccines.
Upcoming CDC Committee Meeting
Prasad's email precedes a scheduled two-day meeting of the CDC's Advisory Committee on Immunization Practices (ACIP) on December 4-5. The ACIP is conducting a major review of the childhood vaccination schedule for diseases such as measles, mumps, rubella, polio, and hepatitis B. Public health experts have expressed concern that the committee's review could alter the childhood vaccination schedule. Potential outcomes include delaying inoculation timing, spacing out vaccinations, or reformulating some vaccines. These changes could potentially lead to reduced vaccination rates and the reemergence of eradicated diseases.
Manufacturer Responses
Moderna, whose COVID-19 vaccine is approved for children as young as 6 months, referenced a September statement. The company stated that multiple published, peer-reviewed studies indicate its shot is safe and that it is "not aware of any deaths in the last year or pertinent new information from prior years." Moderna also stated it monitors its vaccine's safety with regulators in over 90 countries, and these systems have not reported new or undisclosed safety concerns in children or pregnant women. Pfizer did not immediately respond to requests for comment.