FDA Official Ties Deaths of 10 Children to COVID-19 Shots
On Nov. 28, 2025, Vinay Prasad, MD, MPH, Chief Medical and Scientific Officer and Director of FDA’s Center for Biologics Evaluation and Research (CBER), issued an internal memorandum to FDA staff regarding an FDA investigation into child deaths associated with mRNA COVID-19 shots. The FDA concluded that federally recommended COVID shots have been related to […]
Former FDA Director Regulating Vaccines Joins Eli Lilly
The former director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), Peter Marks, MD, PhD, who was responsible for the agency’s regulation of the safety and effectiveness of vaccines, joined drug giant Eli Lilly and Company after resigning from the agency on Mar. 28, 2025.1 Dr. Marks alleged […]
FDA Questions Safety of Giving Multiple Vaccines at Once
The U.S. Food and Drug Administration (FDA) is re-evaluating the long-standing federal vaccine use policy that allows multiple vaccines to be given during the same visit—particularly COVID-19, influenza and RSV shots. In a memo last month, Vinay Prasad, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research (CBER), wrote that the agency […]
DHHS Investigating Risks of Getting COVID Shots During Pregnancy
The U.S. Department of Health and Human Services (DHHS) is compiling case examples of reported harm related to receiving COVID-19 shots during pregnancy, according to sources cited by The Wall Street Journal in early September.1 Health officials plan to eventually publicly release the information they are compiling on the potential relationship between COVID shots and […]
FDA Revokes EUA Status for COVID-19 Shots
The U.S. Department of Health and Human Services (DHHS) has revoked emergency use authorization (EUA) for the COVID-19 shots. The federal government had relied on the EUA status to justify release of the COVID-19 biologicals in December 2020 for public distribution without full licensure by the FDA.1 On Aug. 27, 2025, DHHS Secretary Robert F. […]
Clinical Trials Now Required for Annual COVID Shots Given to Healthy Adults
On May 20, 2025, the U.S. Food and Drug Administration (FDA) announced that new clinical trials will be required to approve annual COVID-19 booster shots for healthy adults under age 65. In a joint editorial published in the New England Journal of Medicine, FDA commissioner Marty Makary, MD and the director of the FDA’s Center […]