FDA Halts Novavax's COVID-Flu Combo Vaccine Trial Over Safety Concerns
The FDA imposed a clinical hold on Novavax's vaccine trials following a reported case of nerve damage in a participant.
- The clinical hold affects Novavax's COVID-19 and influenza combination vaccine and a standalone flu vaccine.
- The hold was triggered by a report of motor neuropathy in a participant from a phase 2 trial completed in July 2023.
- Novavax's stock fell nearly 20% following the announcement of the FDA's decision.
- Novavax is collaborating with the FDA to address the safety concerns and aims to resume phase 3 trials swiftly.
- Previous trials of Novavax's vaccines have shown no similar safety issues, and the standalone COVID-19 vaccine remains unaffected.
Investopedia 
CNBC 
Benzinga 
