Novavax Inc. said Monday it will begin its delayed late-stage study for its coronavirus vaccine, and it may be put on the fast track, Reuters reports.
What’s going on?
Novavax said its vaccine — titled NVX-CoV2373 — received “fast-track” status from the Food and Drug Administration.
- The expected data could receive approval and authorization from the FDA for distribution if the company finishes its trial, according to Reuters.
- Novavax halted the trial back in September for about a month.
Key quote:
“While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally,” Gregory M. Glenn, president of R&D at Novavax, said in a statement, according to MarketWatch.
What’s next?
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Novavax said it will likely begin its Phase 3 clinical trial by the end of November.
- “Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021,” according to Yahoo! Finance.