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What will be Novavax's strategic response to FDA's clinical hold by December 31, 2024?
2
Resolution / Starting Odds
Partnership with another company • 25%
Focus on different vaccine candidates • 25%
Continue with current strategy • 25%
Other strategic response • 25%
Novavax 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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Resume trials • 25%
Modify trial protocols • 25%
Abandon trials • 25%
Seek alternative partnerships • 25%
Clinical hold lifted with no changes • 25%
Clinical hold lifted with additional requirements • 25%
Clinical hold maintained • 25%
Clinical hold converted to full stop • 25%
Hold lifted with no conditions • 25%
Hold lifted with conditions • 25%
Hold extended • 25%
Hold converted to permanent suspension • 25%
Fast-tracked approval • 25%
Standard approval process • 25%
Request for more data • 25%
Rejection • 25%
Attributed to vaccine • 25%
Attributed to unrelated causes • 25%
Inconclusive • 25%
No further information released • 25%
Yes • 50%
No • 50%
