India on Sunday formally authorised the emergency use of two coronavirus vaccines developed by AstraZeneca and Oxford University, and by Hyderabad-based pharmaceutical firm Bharat Biotech. “The… vaccines of Serum Institute (AstraZeneca/Oxford vaccine) and Bharat Biotech are being approved for restricted use in emergency situations," the Drugs Controller General of India, VG Somani said at a virtual briefing.
The decisions mark the first Covid-19 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 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. Somani said the overall efficacy of the AstraZeneca/Oxford vaccine was 70.42%, 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.
Prime Minister Narendra Modi tweeted that the fast-track approvals were “a decisive turning point to strengthen a spirited fight" that “accelerates the road to a healthier and Covid-free nation". Serum Institutes chief executive Adar Poonawalla tweeted after the approvals that the vaccine would be “ready to roll-out in the coming weeks". 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 told 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".
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".
Both vaccines will be administered in two doses and stored at 2-8 degree Celsius (36 to 48°F), he said, without clarifying the intervals between the shots. A Reuters report quoted sources as saying that the doses would have to be given four weeks apart.
The AstraZeneca-Oxford vaccine, which was granted its first approval by Britain on Tuesday, is cheaper and easier to use than some rival shots, such as the one from Pfizer Inc — a major advantage in tackling a pandemic that has claimed more than 1.8 million lives worldwide The British shot, however, has been plagued by 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.
The efficacy of the Indian vaccine could “go up much more" than 60% after two doses are given, Reuters quoted another source as saying. Bharat Biotech earlier said they could produce up to 300 million doses a year. India’s regulator has also received an emergency-use application for the Covid-19 vaccine made by Pfizer with Germany’s BioNTech — the first shot to secure regulatory approval in the West.
India has 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 SII plans to sell the AstraZeneca/Oxford vaccine to the Indian government at about Rs 250 ($3.42) per dose and Rs 1,000 on the private market.
The regulator on Sunday also gave permission to Cadila Healthcare Ltd to conduct Phase-III clinical trials on 26,000 Indian participants for its DNA-platform vaccine candidate, whose interim trial data showed was “safe and immunogenic with three doses when administered intradermally".
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