India’s Central Drugs Standard Control Organisation (CDSCO) has approved today the coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, sources said. The decision would facilitate the vaccine’s rollout in the world’s second-most populous country which, after the United States, has the highest number of Covid-19 cases in the world.
The regulator, CDSCO, whose experts are meeting for the second time this week, may approve additionally a vaccine locally developed by Bharat Biotech, the sources said.
“Both AstraZeneca and Bharat Biotech will get approval today,” said a source. “All preparations are on with today’s date in mind.”
Britain and Argentina have already authorised the vaccine for urgent public use. Britain had on 30 December last year become the first nation to approve the Oxford University-AstraZeneca Covid-19 vaccine. The UK government had said that it has accepted a recommendation from the Medicines and Healthcare products Regulatory Agency “to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use”. The rollout is expected to begin as early as next week.
The CDSCO met a day ahead of a nationwide trial run here for vaccine delivery in the country with more than 10 million coronavirus infections.
AstraZeneca had said on 30 December 2020 that it was releasing the first doses of the vaccine so that vaccinations might begin early in the New Year. The company aims to supply millions of doses in the first quarter as part of its deal with the UK government to supply up to 100 million doses in total, it added.
The authorisation recommends two doses administered with an interval of between 4 and 12 weeks. Experts showed this regimen in clinical trials to be safe and effective at preventing symptomatic Covid-19, with no severe cases and no hospitalisations more than 14 days after the second dose, AstraZeneca said.
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 did not immediately respond to an email request seeking comment.
The 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.