India’s drugs regulator has given final emergency-use approval for two coronavirus vaccines — Serum Institute of India’s Covishield, developed by Oxford University and pharma major AstraZeneca, and Bharat Biotech’s Covaxin.
The country is now expected to start a massive immunisation programme within weeks.
Drug Controller General of India (DGCI) chief VG Somani said both firms submitted data on their trial runs and both have been granted permission for “restricted use”.
“Safety immunogenicity data submitted by SII found efficacy was 70.42 per cent. Restricted use in emergency conditions allowed. The clinical trials will continue. Covaxin has been developed in collaboration with ICMR and NIV,” he said in a press briefing on Sunday.
Indian Prime Minister Narendra Modi called the approval a decisive turning point to strengthen a spirited fight, and congratulated scientists and innovators.
He said, “The DCGI granting approval to vaccines of Serum Institute of India and Bharat Biotech accelerates the road to COVID-free nation.”
Invoking ‘Aatmanirbhar Bharat’, PM Modi said it would make every Indian proud that two vaccines given emergency use approval are made in India.
The approval is expected to kick off one of the world’s biggest vaccination drives in coming days in the country of 1.3 billion people.
The CDSCO is expected to announce the dosage and other details about the shot later. SII had applied for a two full-dose regime about 28 days apart.
The government has already been holding nationwide drills ahead of the mass inoculation drive and 96,000 health workers have been trained to administer the shots.
Somani added to reporters after the briefing that the drug regulator would “never approve anything if there is the slightest safety concern”.
“The vaccines are 100 percent safe,” he said, adding that side effects such as “mild fever, pain and allergy are common for every vaccine”.
India has so far reported more than 10.3 million COVID-19 cases and around 150,000 deaths, though its rate of infection has come down significantly from a mid-September peak.
The country hopes to inoculate 300 million of its 1.35 billion people in the first six to eight months of this year.
SII, the world’s biggest producer of vaccines, has already stockpiled about 50 million doses of the AstraZeneca/Oxford shot, which will be sold to the government at about 250 rupees ($3.42) per dose and 1,000 rupees on the private market.
A government minister said earlier the AstraZeneca/Oxford vaccine had been given the green light on Friday, paving the way for a huge immunisation campaign in the world’s second most populous country.
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