Article Summary
Dr. Vinay Prasad, a critic of the FDA’s COVID-19 vaccine booster approvals, has been appointed as the new head of the center responsible for vaccine approvals and other biologics products at the FDA. Prasad takes over from Dr. Peter Marks, who served a key role in launching Operation Warp Speed. This change comes at a time when the FDA is considering whether to approve annual updates to COVID-19 vaccines this fall.
Original Post
The Food and Drug Administration (FDA) announced Tuesday that it has selected Dr. Vinay Prasad, a vocal critic of the agency’s COVID-19 vaccine booster approvals, as the new head of its center responsible for vaccine approvals and other biologics products. Prasad will replace Dr. Peter Marks, who served as the director of the Center for Biologics Evaluation and Research (CBER) and played a significant role in launching Operation Warp Speed.
Prasad has been a professor in the Department of Epidemiology and Biostatistics at the University of California at San Francisco. He has been a vocal critic of the FDA, often criticizing the agency for granting emergency use authorization for COVID-19 vaccine boosters without clinical, randomized data. Prasad has called Marks “one of the most dangerous, pro-pharma regulators of the 21st century” and a “mediocre academic” before joining the government.
Prasad’s appointment comes at a time when the FDA is considering whether to approve annual updates to COVID-19 vaccines this fall, as part of a routine process that had been due to start next month. Officials have floated the possibility of requiring new randomized trials before approving future updates to COVID shots.
Prasad has said he backs the idea of new randomized clinical trials before approving COVID shot updates, calling it “absurd” that the U.S. was still offering COVID vaccinations to young children. He warned that strain changes could result in changes to efficacy and safety.
Prasad’s following grew during the COVID-19 pandemic as he criticized measures like vaccine mandates and called for Moderna’s vaccine to be banned in men under 40. He was accused alongside Makary and Dr. Tracy Høeg of being a prominent purveyor of misinformation about COVID-19 vaccines.
Høeg now works for the FDA as a special assistant to Makary, and replaced the agency’s representative on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
What This Means for You
- Be prepared for potential changes to COVID-19 vaccine recommendations as the FDA considers new randomized trials before approving updates to the vaccines.
- Stay informed about the latest developments and recommendations from the FDA and CDC regarding COVID-19 vaccines.
- Consider the source and credibility of information regarding COVID-19 vaccines, as misinformation can spread quickly and be harmful.
- Be open to future updates and adjustments to COVID-19 vaccine recommendations as new data and information become available.
Key Terms
- Food and Drug Administration (FDA): The U.S. agency responsible for protecting public health by ensuring the safety and efficacy of human and veterinary drugs, biological products, and medical devices.
- COVID-19: A virus that causes respiratory illness and can spread from person to person.
- Vaccine: A product that stimulates a person’s immune system to produce immunity to a specific disease.
- Emergency Use Authorization (EUA): A mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies.
- Operation Warp Speed: A Trump administration effort to speed up the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
- Center for Biologics Evaluation and Research (CBER): An FDA center responsible for regulating biological and related products, including vaccines, blood and blood products, and gene therapy.
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