FDA Won’t Add “Black Box” Warning to COVID-19 Shots
News outlets have recently reported that the U.S. Food and Drug Administration (FDA) was considering adding a box warning (known for many years as a “Black Box” warning) to COVID-19 shots. A boxed warning appears prominently at the top of a drug’s prescribing information and represents the FDA’s strongest safety alert. The agency uses it […]
Data on Myocarditis Risk from COVID-19 Shots Hidden
The U.S. Food and Drug Administration’s (FDA) commissioner Marty Makary, MD, MPH recently said in a prepared statement that the Biden administration withheld data on heart inflammation risks from the mRNA COVID-19 vaccines. The statement was made less than a week after the FDA’s top vaccine regulator, Vinay Prasad, MD, MPH confirmed that at least […]
Tens of Millions of Americans Experienced COVID-19 Shot Side Effects
It has been nearly five years since the U.S. Food and Drug Administration (FDA) fast-tracked the COVID-19 mRNA biologic and distributed it under an Emergency Use Authorization (EUA), with the U.S. Centers for Disease Control and Prevention (CDC) recommending the COVID shot for every American. This was followed by many workplaces and universities across the […]
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 […]
Louisiana Surgeon General Named to No. 2 Post at CDC
The U.S. Department of Health and Human Services (DHHS) last week confirmed the appointment of Louisiana surgeon general Ralph Abraham, MD to be principal deputy director of the Centers for Disease Control and Prevention (CDC). Dr. Abraham, who served in the U.S. House of Representatives from 2015 to 2021 representing Louisiana’s 5th congressional district, will […]
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 […]