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Tech transfer unlikely to result in production soon: Bharat Biotech official – The Indian Express

Vaccine maker Bharat Biotech on Tuesday said it was in talks with at least four companies for transfer of technology for production of Covaxin, but only government-owned Indian Immunologicals was in a position to start manufacturing the vaccine anytime soon.

“Technology transfer to Indian Immunologicals is underway, and we expect that they will start manufacturing the vaccine very soon. The government of India has introduced three other companies to us for transfer of technology, and we are in discussions with them as well. But these are a little behind the curve, as none of them have manufacturing facilities yet,” a top official of the Hyderabad-based company told The Indian Express.

The official said the company was producing about 25 million doses of Covaxin every month at its Hyderabad-based facility, and manufacturing at other centres, including the newly-acquired one in Ankleshwar, Gujarat, was likely to begin in a “few months”.

In earlier statements, the company has said it was planning to ramp up its production to about 60 million doses a month.

The official said the company was actively pursuing the route of obtaining a biologics licence application (BLA) for Covaxin to enter the US market, after its application for an emergency use authorisation was turned down by the US Food and Drug Administration earlier this month.

“Once we are ready with the phase-3 efficacy data, we will go ahead with a biologics licence application in the US. There may be a requirement for a clinical trial or a small bridging study, which we are planning to carry out amongst children,” he said, adding that the firm had also started discussions with potential US partners for transfer of technology and manufacture of Covaxin in the United States.

“We have made applications to 50 other countries, and while some have said that our clinical trial data was adequate, a few others have conveyed to us about their slightly differing requirements,” he said.

An emergency use listing with the WHO was also pending, he said.