India approves vaccines from Bharat Biotech and Oxford/AstraZeneca
Two vaccines for coronavirus, Covishield of Oxford Institute and Bharat Biotech's covaxins, which are being developed by Pune-based serum company, received urgent approval from the country's drug regulator today.
Both vaccines should be administered in two doses and stored at a temperature of 2 to 8 C. Federal Health Minister Dr Harshvardhan said the government would give priority to 1 crore health workers and 2 crore leading workers when vaccinations start.
The Pune-based serum company conducted Phase 2 and Phase 3 trials on 1,600 participants in India. Recommended for prohibited use, tests will continue, he said. The vaccine, developed by Oxford University and pharmaceutical company AstraZeneca, is already in use abroad.
Bharat Biotech is conducting trials with the Medical Research Council of India. The results showed that the drug regulator conducted its Phase I and Phase II trials in about 800 people and that it "provides a safe and strong immune response." Of the 25,800 participants tested in the third phase, 22,500 were vaccinated.
India plans to vaccinate about 300 million people on this year's priority list.
The Drug Control General of India said that both the drug manufacturers had submitted data showing that it was safe to use their vaccines.
Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK
— Adar Poonawalla (@adarpoonawalla) January 3, 2021
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