Monday, June 14, 2021
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Ocugen to file for full US approval of Covid-19 shot Covaxin instead of EUA – ET HealthWorld

Ocugen to file for full US approval of Covid-19 shot Covaxin instead of EUAOcugen Inc stated on Thursday it will not pursue an emergency use authorization for its Covid-19 vaccine candidate, Covaxin, and would instead purpose to file for a full U.S. approval of the shot.

Ocugen stated the choice was based mostly on a advice from the U.S. Food and Drug Administration (FDA), which additionally requested extra data and knowledge for full approval.

The firm stated it expects knowledge from an extra scientific trial shall be required to help the advertising utility 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 stated.

The firm is co-growing Covaxin with India-based Bharat Biotech for the U.S. market.

Ocugen just lately secured unique rights to market the vaccine in Canada and has began discussions with Health Canada for regulatory approval, it stated.

The firm’s shares have been down about 40% at $5.56 earlier than the bell.

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Monday, June 14, 2021
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