US FDA Denies Emergency Use Approval to Bharat Biotech's Covaxin
Without being approved by the WHO or the FDA, Covaxin is unlikely to be accepted as a legitimate vaccine by many countries.
Stay updated with breaking news from Master File. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
Without being approved by the WHO or the FDA, Covaxin is unlikely to be accepted as a legitimate vaccine by many countries.
Ocugen, the US partner of Bharat Biotech claimed the company will now be seeking full approval of Covaxin.
Ocugen, the US partner of Bharat Biotech claimed the company will now be seeking full approval of Covaxin.
The FDA has recommended that recommended Ocugen pursue a BLA submission instead of an EUA application for Covaxin.
USFDA last month came out with a revised guideline for covid vaccine approval that said it will no longer grant emergency authorization to new applications. In some countries, people vaccinated with both the doses of Covaxin have been treated as unvaccinated.