Gaithersburg’s Novavax Inc. has submitted its long-awaited request for approval in the U.S. for its experimental Covid-19 vaccine, following several months of manufacturing delays and buildup, as well as a flurry of similar submissions and authorizations in other countries.
The biotech, which has faced a ticking clock on its domestic launch since it started developing its own Covid vaccine product, said Monday that it has submitted its application to the Food and Drug Administration for emergency use authorization of its protein-based coronavirus vaccine candidate, called NVX-CoV2373. That means the company has completed all of the required data — from preclinical studies to clinical trials to manufacturing data — for regulators to consider making it available to U.S. patients.
In a statement to the Washington Business Journal, Novavax said it couldn’t specify a timeline going forward. “While we can’t comment on how much time the FDA may take to review our request, we are confident…
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