Novavax Inc. (NASDAQ: NVAX) has filed for regulatory approval of its Covid-19 vaccine candidate in the U.K. — a major step toward seeking approval in more countries, including the U.S.
The Gaithersburg biotech said Wednesday it has completed all of the requirements for its submission to the U.K.’s regulatory agency, after kicking off a rolling review process earlier this year. It’s a big step for the company, which has faced numerous manufacturing challenges that have prolonged its ability to get its protein-based vaccine across the finish line in multiple markets.
The submission brings the business “significantly closer to delivering millions of doses” of its product, Novavax President and CEO Stanley Erck said in a statement. The company “will be prepared to deliver vaccine doses following what we anticipate will be a positive decision,” he said.
That’s doable because these doses are made through a partnership with the Serum Institute of India. And to that end, “in…
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