Bharat Biotech pursues COVAXIN approval in over forty countries

Bengaluru, Feb 18 (Reuters):
India’s Bharat Biotech is in the process of filing regulatory documents for approval of its COVID-19 vaccine, COVAXIN, in more than 40 countries, the company told Reuters.
“We have submitted our documentation in Brazil and other countries and await their approval. We plan to export several million doses to Brazil,” the company said in an emailed statement. “Pricing of COVAXIN for international markets will be based upon supply timelines, purchase commitments and procurement volumes,” it added.
Bharat Biotech, which last Tuesday had told Reuters it may export doses of COVAXIN to Brazil and the United Arab Emirates by the end of the week, did not name other countries and did not give exact figures on doses it expects to export.
The company has also entered into an agreement with U.S. drug developer Ocugen Inc for the commercialization of COVAXIN in the United States, which has seen the most number of infections in the world.
COVAXIN is one of the two vaccines approved for emergency use in India, though efficacy data from its late-stage trial is yet to be published.
Bharat Biotech expects results from an ongoing trial involving 25,800 participants in India only by March, though the country’s drug regulator has called the vaccine safe and effective amid criticism from some doctors and health experts.

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