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Market
Will Novavax's vaccines receive FDA approval by the end of 2025?
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Resolution / Starting Odds
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FDA official announcements or press releases
Story
FDA Places Clinical Hold on Novavax's COVID-19 and Influenza Vaccines Due to Safety Concerns in Phase 3 Trial
Oct 16, 2024, 12:13 PM
The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's COVID-19 and influenza combination vaccine, as well as its standalone influenza vaccine candidates due to safety concerns. This decision comes after a spontaneous report of a serious adverse event (SAE) involving motor neuropathy. The clinical hold affects the Investigational New Drug (IND) applications for these vaccines, which were in Phase 3 Trial.
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