Sources had told TOI on Friday that the subject expert committee (SEC) of the Indian drug regulator cleared the decks for Covishield — the Indian name of the Oxford vaccine — for its emergency use in the country.
Sources said the SEC’s recommendations come with certain conditions like every recipient of the vaccine will be given a factsheet about the vaccine prior to vaccination.
The manufacturer may also be asked to report adverse events every 15 days. The SEC has recommended EUA for two full doses of Covishield to be given with a gap of 4-6 weeks.
The Drugs Controller General of India is yet to formally announce the approval.
Covishield is the first coronavirus vaccine to be approved for emergency use by India, which has the highest number of infections after the United States.
Javadekar said at least three more vaccines were waiting to be approved — local company Bharat Biotch’s Covaxin, Zydus Cadila’s ZyCoV-D and Russia’s Sputnik-V.
“India is perhaps the only country where at least four vaccines are getting ready,” he said.
“One was approved yesterday for emergency use, Serum’s Covishield.” he said, referring to the fact that the AstraZeneca/Oxford shot is being made locally by the Serum Institute of India (SII).
SII, the world’s biggest producer of vaccines, has already stockpiled about 50 million doses of the AstraZeneca/Oxford shot.
The AstraZeneca/Oxford vaccine, which was granted its first approval by Britain on Tuesday, is cheaper and easier to use than some rival shots – major advantages in tackling a pandemic that has claimed more than 1.8 million lives worldwide.
However, it has been plagued with uncertainty about its most effective dosage ever since data published in November showed a half-dose followed by a full dose had a 90% success rate while two full shots were 62% effective.
India’s regulator has also received an emergency-use application for the Covid-19 vaccine made by Pfizer Inc with Germany’s BioNTech – the first shot to secure regulatory approval in the West.
Meanwhile, a nationwide dry run to assess the preparedness on field for the vaccination process was conduced on Saturday.
The exercise was conducted in all state capitals in at least three session sites.
Earlier today, Union health minister Harsh Vardhan said that Covid-19 vaccines will be provided free of cost to all Indians.
(With inputs from Reuters)