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4w ago

FDA Demands New Trials for Novavax COVID Vaccine, Raising Concerns Over Fall Booster Rollouts

The FDA's decision to require fresh clinical trials for updated COVID-19 vaccines marks a departure from prior practices and could delay timely booster availability for vulnerable populations.

The Food and Drug Administration campus in Silver Spring, Md., on Oct. 14, 2015.
FILE - A vial of the Phase 3 Novavax coronavirus vaccine prepared for use in a trial at St. George's University hospital in London, Oct. 7, 2020. (AP Photo/Alastair Grant, File)
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Overview

  • The FDA has formally required Novavax to conduct a new clinical trial for its updated protein-based COVID-19 vaccine before granting full approval.
  • This decision shifts away from the flu vaccine model, where annual strain updates do not require new large-scale trials.
  • FDA Commissioner Marty Makary characterized updated vaccines as 'new products,' necessitating stricter regulatory scrutiny under current agency policies.
  • Experts warn that the new trial requirements could impede the availability of updated COVID-19 boosters for high-risk groups this fall.
  • The move reflects broader political and regulatory changes under Health Secretary Robert F. Kennedy Jr., including increased vaccine scrutiny and revisiting debunked vaccine-autism claims.