India's drugs regulator on Sunday 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.
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 Harsh Vardhan, the health minister of India, which is the world's biggest vaccine producer and exporter.
"Urge all citizens to entrust the stringent protocols followed for ensuring safety, efficacy and immunogenicity of the approved vaccines."
Drugs Controller General of India V.G. Somani 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.
A lawmaker from Prime Minister Narendra Modi's nationalist party had earlier complained about the apparent preference for the foreign-made vaccine instead of the local one, whose approval has also raised questions about a lack of transparency in the process.
"Vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situations," Somani, the head of the Central Drugs Standards Control Organisation, said at a news conference, reading from a written statement.
Somani did not take questions.
Both vaccines will be administered in two doses and stored at 2-8° degrees Celsius, he said, without clarifying what intervals between shots were being recommended. Sources said on Saturday the doses would have to be given four weeks apart.
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, calling it a sign of a "self-reliant" country.
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.
"All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off," CEO Adar Poonawalla said on Twitter. "COVISHIELD, India's first COVID-19 vaccine, is approved, safe, effective and ready to roll-out in the coming weeks."