Novavax Resumes COVID-19 and Flu Vaccine Trials in 2025 After FDA Approval
Novavax has received FDA clearance to restart clinical trials for its combined COVID-19 and flu vaccine as well as its standalone flu vaccine, following a temporary hold due to safety concerns.
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Key Highlights
- FDA has lifted the clinical hold on Novavax's combined COVID-19 and flu vaccine and the standalone flu vaccine trials.
- The hold was initially imposed after a serious adverse event was reported during the Phase 2 trial.
- New data confirmed the adverse event was unrelated to the vaccine, allowing Novavax to resume Phase 3 trials promptly.
Shares of Novavax (NVAX) saw a modest increase following the announcement that the FDA has authorized the continuation of their vaccine trials. This decision enables the company to proceed with enrolling participants in the planned Phase 3 studies.
The FDA's previous pause came after a report of motor neuropathy in a participant, but further investigation clarified that the condition was not caused by the vaccine.
Dr. Robert Walker, Novavax's Chief Medical Officer, emphasized that the comprehensive data review supports the vaccine's safety and the company’s commitment to advancing the trials swiftly.
Novavax shares have surged nearly 90% year-to-date, reflecting strong investor confidence amid ongoing vaccine development.
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