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NEW DELHI: India’s drug regulator on Sunday (Jan 3) 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.
The second most populous country in the world is now expected to begin a mass immunization program in a few weeks, with AstraZeneca-Oxford injection taking the lead and COVAXIN from Bharat Biotech administered under stricter conditions, as no efficacy data has been published. .
The overall efficacy of the AstraZeneca / Oxford vaccine was 70.42 percent, while Bharat Biotech’s COVAXIN was “safe and provides a strong immune response,” said Indian Comptroller General of Drugs VG Somani.
The British-developed AstraZeneca-Oxford injection is being manufactured locally by the Serum Institute of India (SII) and will be branded COVISHIELD, while Bharat Biotech has partnered with the government-run Indian Council of Medical Research.
“The M / s Serum and M / s Bharat Biotech vaccines are being approved for restricted use in emergency situations,” Somani read in a written statement at a press conference. Somani did not answer questions.
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Both vaccines will be given in two doses and stored between 2 and 8 degrees Celsius, he said. Sources told Reuters on Saturday that the doses would have to be administered four weeks apart.
Somani explained that the Bharat Biotech vaccine had been approved “in the public interest as an abundant precaution, in clinical trial mode, to have more vaccination options, especially in case of infection by mutant strains.”
Prime Minister Narendra Modi welcomed the approvals.
“All Indians would be proud that the two vaccines that have received emergency use approval are made in India!” he said on Twitter, calling it a sign of a “self-sufficient” country.
SII, the world’s largest vaccine producer, has already stockpiled more than 50 million doses of the AstraZeneca-Oxford vaccine even without a formal supply agreement with the government.
“All the risks that @SerumInstIndia took with the vaccine storage 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.”
India is the second most infected country in the world with more than 10.3 million COVID-19 cases and nearly 150,000 deaths.
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