FDA Links COVID Vaccines to 10 Child Deaths, Announces Stricter Review Process
Atlanta, GA – December 4, 2025 – The Food and Drug Administration has acknowledged potential safety concerns with COVID-19 vaccines, linking the shots to the deaths of 10 children and announcing plans to require more rigorous evidence of safety and effectiveness for future vaccine approvals. The declaration comes ahead of a critical two-day meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), wich begins today, December 4th.
The FDA restricted eligibility for updated COVID vaccines in August, stating the agency planned to require more evidence regarding the shots’ safety and effectiveness. This decision follows long-standing questions about vaccines raised by Health Secretary Robert F. Kennedy Jr.
During the ACIP meeting, the committee will undertake a comprehensive review of childhood vaccination schedules for diseases including measles, mumps, rubella, polio, and hepatitis B. Public health experts express concern that the committee may delay vaccination timing, space out inoculations, and call for vaccine reformulation, perhaps leading to decreased childhood protection and a resurgence of preventable diseases.
claims made by Dr.Marty Makary and Dr. Prasad regarding COVID vaccine-related deaths among 10 children prompted a response from Moderna. The company cited a statement released in September, asserting that multiple peer-reviewed studies demonstrate the safety of its vaccine and that it is indeed “not aware of any deaths in the last year or pertinent new information from prior years.” Moderna emphasized its ongoing safety monitoring in collaboration with regulators in over 90 countries, stating that over one billion doses distributed globally have not revealed new safety concerns in children or pregnant women.
Pfizer has not yet responded to requests for comment.
The FDA’s email regarding vaccine policy arrives as the ACIP convenes its meeting, accessible at https://www.cdc.gov/acip/meetings/index.html. Further information on the FDA’s restrictions can be found at https://www.npr.org/sections/shots-health-news/2025/08/27/nx-s1-5515503/fda-covid-vaccines-restricted and the initial announcement of increased evidence requirements at https://www.npr.org/sections/shots-health-news/2025/05/20/nx-s1-5405013/fda-covid-vaccine-limits. Moderna’s safety statement is available at https://investors.modernatx.com/statement-on-the-safety-of-spikevax.
