September 24, 2020 7:47:02 am
Bharat Biotech has been exploring the potential of tying up with international partners to scale up production of another Covid-19 vaccine candidate, ‘Covaxin’, to around a billion doses a year. The firm, currently conducting phase 2 human trials, also plans to move to late-stage testing for this candidate next month, said a senior executive at the firm.
“In the month of October, we plan to start our phase 3 clinical trials,” said Sai D Prasad, President-Quality Operations, Bharat Biotech, during the Virtual Expo on Pharma, Healthcare, Diagnostics and Hygiene on Wednesday.
While the sample size estimates and the countries where the trial will occur are still under discussion, the firm is targeting “about 25,000-30,000” subjects in the upcoming phase.
Bharat Biotech has already been manufacturing Covaxin “at risk” and can make anywhere between 100 million to 200 million doses as of now.
“We are actively trying to manufacture as much as we can right now, because we have the necessary permissions. And we’re also exploring strategies to expand the manufacturing footprint, not just in Hyderabad, but in other cities of India and also in other parts of the world,” said Prasad.
“We’re talking with our partners to see if they are able to receive tech transfer from us and scale up…those discussions are ongoing right now in about four or five different countries. Once those are established, I think we should be able to reach a manufacturing scale of about a billion doses a year, and those will all be what we call as distributive manufacturing–they’re going to be manufactured in local markets and supplied locally with the same quality and the quality control standards,” he said.
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