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Data on Myocarditis Risk from COVID-19 Shots Hidden

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 […]

FDA Official Leaves Agency Through the “Revolving Door” and Returns to Pfizer

FDA Official Leaves Agency Through the “Revolving Door” and Returns to Pfizer

On Feb. 24,2025, Pfizer, Inc. announced that FDA official Patrizia Cavazzoni, MD will rejoin the pharmaceutical company, which makes and sells federally recommended vaccines and drugs, as Pfizer’s Chief Medical Officer and Executive Vice President. Most recently, Dr. Cavazzoni served as Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food […]

Caught in Their Own Trap?

Caught in Their Own Trap?

On Jan. 5, 2024 the Journal of the American Medical Association (JAMA) published an article by Dr. Peter Marks and Dr. Robert Califf. Both authors are affiliated with the U.S. Food and Drug Administration (FDA). The article, “Is Vaccination Approaching a Dangerous Tipping Point?,” is a discussion about growing vaccine hesitancy in the U.S., and […]

FDA Removes Informed Consent Protections from Some Human Clinical Trials

FDA Removes Informed Consent Protections from Some Human Clinical Trials

The U.S. Food and Drug Administration (FDA) has issued a final rule that authorizes some experimental human clinical trials to operate without first obtaining informed consent from participants. The new rule, which took effect on Jan. 22, 2024, allows clinical investigations that pose no more than a “minimal risk” and have appropriate safeguards to protect […]

Evidence of DNA Contamination in mRNA Shots Prompts Call for Halting Their Use

Evidence of DNA Contamination in mRNA Shots Prompts Call for Halting Their Use

On Dec. 6, 2023, Florida’s Surgeon General, Joseph Ladapo, MD, PhD, wrote a letter to the commissioner of the U.S. Food and Drug Administration (FDA), Robert Califf, MD, requesting that an investigation be launched into the alleged DNA contamination in Pfizer/BioNTech’s Comirnaty and Moderna/NIAID’s Spikevax mRNA (messenger ribonucleic acid) COVID shots. Not satisfied with the […]

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