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.
“We are hopeful,” another source said about the vaccine developed with the government-run Indian Council of Medical Research.
A CDSCO representative declined to comment. The group is meeting a day ahead of a nationwide trial run for vaccine delivery in the country with more than 10 million coronavirus infections.
More than 50 million doses of the AstraZeneca vaccine have already been stockpiled by its local manufacturer, Serum Institute of India (SII), and one of the sources said the shots could start to be transported from cold storage to Indian states as early as Saturday.
SII said in an email it would “wait for the final approval to come” before commenting.
India’s government said on Wednesday that Pfizer Inc had sought more time to present data for emergency authorisation of a vaccine it has developed with Germany’s BioNTech.