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 […]
European Medicines Agency Issues Support for New Recombinant Pertussis Vaccine
A new pertussis vaccine, which has been designed to be used as a booster and for vaccinating pregnant women, has received “positive regulatory support” from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Marketed under the name VacPertagen, the recombinant pertussis vaccine—formulated with genetically engineered proteins rather than inactivated whole […]
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 […]
Study Finds COVID Shots Harm Kidneys
A new retrospective cohort study of nearly 2.9 million adults using the TriNetX global health database—a large, privacy-compliant network of real-world clinical data from major health care organizations across multiple countries—found that individuals who received an mRNA COVID-19 shot experienced significantly higher rates of acute kidney injury and need for dialysis over a 12-month period […]