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2w ago

FDA Science Chief Overrides Vaccine Approvals, Launches Muscular Dystrophy Drug Review

Documents reveal Dr. Vinay Prasad countermanded about 30 FDA reviewers to narrow vaccine eligibility after deeming the COVID-19 threat diminished.

FILE - The U.S. Food and Drug Administration campus in Silver Spring, Md., is photographed, Oct. 14, 2015. (AP Photo/Andrew Harnik, File)
FILE - A nurse loads a syringe with a COVID-19 booster vaccine at an inoculation station in Jackson, Miss., Nov. 18, 2022. (AP Photo/Rogelio V. Solis, File)
WASHINGTON, DC - DECEMBER 06: Dr. Vinay Prasad is an Assistant Professor of Medicine at Oregon health and science university. His research is on health policy, cost of drugs, evidence based medicine. In his practice, he takes care of patients with cancer. He is one of the panelists attending the Chasing Cancer Summit in Washington, D.C. on December, 06, 2016. (Photo by Marvin Joseph/The Washington Post via Getty Images)
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Overview

  • In May, Prasad used override memos to block emergency use authorizations for Novavax and Moderna COVID-19 vaccines beyond high-risk populations.
  • He argued that rare or unknown vaccine harms could now outweigh benefits in non-high-risk groups due to reduced virus prevalence.
  • The FDA has limited annual boosters to adults 65 and older and individuals with qualifying health conditions.
  • Prasad initiated a safety review of a Duchenne muscular dystrophy therapy following reports of acute liver failure in at least two patients.
  • HHS spokesperson Andrew Nixon praised Prasad’s decisions as rooted in gold-standard science and comprehensive evidence evaluation.