Ocugen Inc (OCGN.O) said on Thursday it would no longer pursue an emergency use authorization for its COVID-19 vaccine candidate, Covaxin, and would instead aim to file for a full U.S. approval of the shot.
The word "COVID-19" is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration//File Photosaid on Thursday it would no longer pursue an emergency use authorization for its COVID-19 vaccine candidate, Covaxin, and would instead aim to file for a full U.S. approval of the shot.
Ocugen said the decision was based on a recommendation from the U.S. Food and Drug Administration , which also requested more information and data for the full approval. The company said it expects data from an additional clinical trial will be required to support the marketing application submission for Covaxin.
"While this will extend our timelines, we are committed to bringing COVAXIN to the U.S.," Ocugen Chief Executive Officer Dr Shankar Musunuri said.Ocugen recently secured exclusive rights to market the vaccine in Canada and has started discussions with Health Canada for regulatory approval, it said.More from ReutersSubscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.
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