NEW DELHI • India's drug regulator yesterday gave final approval for the emergency use of two coronavirus vaccines, one developed by AstraZeneca and Oxford University, and the other by local company Bharat Biotech and a state-run institute, paving the way for one of the world's biggest inoculation drives.
The decisions mark the first vaccine approvals for the world's second-most populous country, which, after the United States, has recorded the most infections of the coronavirus disease.
It is now expected to start a massive immunisation programme within about a week, a government official said, and hopes to inoculate 300 million of its 1.35 billion people free of charge in the first six to eight months of this year.
The AstraZeneca-Oxford shot, already approved in Britain, Argentina and El Salvador, will take the lead and Bharat Biotech's Covaxin will be administered under stricter conditions, given no efficacy data has been released for it.
"It's now time to reap the benefits of the robust supply chain infrastructure we've put in place for quick and equitable distribution of the vaccine," said Dr Harsh Vardhan, Health Minister of the country, which is the world's biggest vaccine producer and exporter.
He urged residents to trust the stringent protocols followed for ensuring safety, efficacy and immunogenicity of the approved vaccines.
The government has already held nationwide drills in the country ahead of the mass vaccination drive and some 96,000 health workers have been trained to administer the shots.
The World Health Organisation (WHO) welcomed the news.
"The use of vaccine(s) in prioritised populations, along with continued implementation of other public health measures and community participation, will be important in reducing the impact of Covid-19," WHO regional director Poonam Khetrapal Singh said in a statement.
Dr V.G. Somani, drugs controller-general of India, said the overall efficacy of the AstraZeneca-Oxford vaccine was 70.42 per cent, while Bharat Biotech's Covaxin was "safe and provides a robust immune response".
The British-developed AstraZeneca-Oxford shot is being made locally by the Serum Institute of India (SII)and will be branded Covishield, while Bharat Biotech has teamed up with the government-run Indian Council of Medical Research.
Both vaccines "are being approved for restricted use in emergency situations", Dr Somani, head of the Central Drugs Standards Control Organisation, said at a news conference, reading from a written statement. They will be administered in two doses and stored at 2 deg C to 8 deg C, he said, without clarifying what intervals between shots were being recommended.
Sources said on Saturday that the doses would have to be given four weeks apart.
Dr Somani said the Bharat Biotech vaccine had been approved "in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains".
Prime Minister Narendra Modi welcomed the approvals. "It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India!" he said on Twitter.
SII, the world's biggest vaccine producer, has already stockpiled more than 50 million doses of the AstraZeneca-Oxford vaccine even before securing a formal supply deal with the government.
But the British shot has been plagued by uncertainty over its most effective dosage ever since data published last November showed a half dose followed by a full dose had a 90 per cent success rate, while two full shots were 62 per cent effective.
The efficacy of the Indian vaccine could "go up much more" than 60 per cent after two doses are given, a source with knowledge of the matter told Reuters. Bharat Biotech earlier said it could produce up to 300 million doses a year.
India has had more than 10.3 million Covid-19 cases and around 150,000 deaths, though its infection rate has slowed significantly from a mid-September peak.
REUTERS, AGENCE FRANCE-PRESSE
