New Delhi: India’s drug regulator has allowed Hyderabad-based Biological E to start phase-1 and 2 human trials in India for a vaccine against Covid-19. The subject expert committee that advisesthe Drug Controller Generalof India on applications seeking permissions for new drugs, clinical trials and vaccines forCovid-19gave its approval on October 26. “The firm presented its revised protocol to conduct phase-1/2 clinical trials of the SARS-CoV-2 vaccine along with non-clinical toxicity data before the committee. After detailed deliberations, the committee recommended grant of permission to conduct the clinical trials,” the minutes of the meeting showed.
Biological E has tied up with an unidentified company and will conduct the trials. An announcement about the partnership is likely to be made next week, people aware of the matter told ET. This will be the fourth vaccine to undergo clinical trials in India. The final phase of trials of the Oxford-AstraZeneca vaccine called Covishield and Bharat Biotech’s Covaxin will start soon while Zydus’s candidate is undergoing phase-2 trials. The Serum Institute of India is conducting the trials for Covishield. Health minister Harsh Vardhan said a few days ago that the government hopes to administer Covid-19 vaccines to 250 million people in the country by July next year.
Biological E has also tied up with Johnson & Johnson. The US drugmaker has transferred technology to Biological E and has given it manufacturing rights for its Covid-19 vaccine, which may become available in India by mid-2021. In an earlier interview to ET, Paul Stoffels, chief scientific officer of J&J, said that both companies will look at maximising output and hope to produce up to 400-500 million vaccine doses for India each year.
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