India’s drug regulator, Drugs Controller General of India, is set to approve on Friday a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, three sources with knowledge of the matter said.
The decision would pave the way for the vaccine’s rollout in the world’s second-most populous country which, after the United States, has the highest number of Covid-19 infections in the world.
Britain and Argentina have already authorised the vaccine for urgent public use.
AstraZeneca-Oxford University’s Covid-19 vaccine candidate has a better immune response when a two full-dose regime is used rather than a full-dose followed by a half-dose booster, the university said on Thursday, citing data from early trials.
The developers of the vaccine candidate, which has been licensed to pharmaceutical company AstraZeneca, have already published later stage trial results showing higher efficacy when a half dose is followed by a full dose, compared to a two full-dose regime. However, more work needs to be done to confirm that result.
India’s Central Drugs Standard Control Organisation (CDSCO), whose experts were meeting for the second time this week, could also approve a vaccine locally developed by Bharat Biotech, two of the sources said on condition of anonymity.
“Both AstraZeneca and Bharat Biotech will get approval today,” said one of the sources. “All preparations are on with today’s date in mind.”
The other sources were less certain about Bharat Biotech’s prospects.