PharmaLytica 2021 Hyderabad review.

Bharat Biotech seeks approval in over 40 countries for Covaxin

19 February, 2021 Mumbai; As per reports, Bharat Biotech’s the indigineous developer of coronavirus vaccine is in the process of filing regulatory documents for approval of its vaccine, Covaxin, in more than 40 countries. The Hyderabad-based biotech on Wednesday said that the process for filing the documents is underway.

"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."

The company had earlier said that it may export doses of Covaxin to Brazil and the United Arab Emirates by the end of the week, however, it did not name other countries and did not give exact figures on doses it expects to export.

India approved Covaxin along with Serum Institute manufactured Covishield for emergency use earlier this year. Although efficacy data from its late-stage trial is yet to be published.

The company has also entered into an agreement with US drug developer Ocugen for the commercialisation of Covaxin in the United States.

Bharat Biotech expects results from an ongoing trial involving 25,800 participants in India only by March.

Covaxin is currently being used in India's vaccination campaign which has already covered over 9 million health workers, and aims to cover 300 million people by August.

Bharat Biotech has supplied 5.5 million doses to the government and will sell an additional 4.5 million doses.

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