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2mo ago

FDA Restricts Moderna and Novavax COVID-19 Vaccines to Seniors and Vulnerable Groups

He argued falling COVID-19 severity means even rare side effects could outweigh benefits for younger, healthier people.

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 Dr. Vinay Prasad issued override memos diverging from career scientists to limit Novavax and Moderna shots to those 65 and older and people with underlying health conditions.
  • FDA reviewers had recommended broad approval for ages 12 and up after analyzing safety and efficacy data from trials involving tens of thousands of participants.
  • Prasad’s memos cited a reduced risk of severe COVID-19 and persistent myocarditis concerns as tipping the benefit-risk balance against mass vaccination of low-risk populations.
  • These interventions align with HHS Secretary Robert F. Kennedy Jr.’s policy to prioritize high-risk groups and mark a rare instance of political appointee override at the FDA.
  • The agency has also mandated updated myocarditis warnings on mRNA vaccine labels and required additional post-approval safety studies before expanding authorizations further.