India approves AstraZeneca and native COVID vaccines rolling out in weeks

By Aftab Ahmed and Nigam Prusty

NEW DELHI (Reuters) – India's Medicines Agency on Sunday issued final approval for the emergency use of two coronavirus vaccines, one developed by AstraZeneca (NASDAQ 🙂 and Oxford University and the other by local company Bharat Biotech.

The world's second most populous country is expected to launch a massive vaccination program within a few weeks, with the AstraZeneca / Oxford shot taking the lead and the Bharat Biotech's COVAXIN being administered under stricter conditions as no efficacy data has been released.

The overall effectiveness of the AstraZeneca / Oxford vaccine was 70.42%, while Bharat Biotech's COVAXIN was "safe and provides a robust immune response," Drugs Controller General of India V.G. Somani said.

The UK-developed AstraZeneca / Oxford shot is made locally by the Serum Institute of India (SII) and is branded COVISHIELD, while Bharat Biotech has partnered with the government-led Indian Council of Medical Research.

"Vaccines against M / s Serum and M / s Bharat Biotech are approved for restricted use in emergency situations," said a written statement at a press conference. Somani took no questions.

Both vaccines are given in two doses and stored at 2-8 ° Celsius (36 to 48 ° F), he said. Sources told Reuters on Saturday the doses would need to be given every four weeks.

Somani stated that the Bharat Biotech vaccine was "approved in the public interest as a common precaution in clinical trials mode to provide more opportunities for vaccination, especially in the event of infection by mutant strains."

Prime Minister Narendra Modi welcomed the approvals.

"It would make any Indian proud that the two vaccines approved for emergency use are made in India!" he said on Twitter, calling it a sign of a "separate" country.

SII, the world's largest vaccine maker, has already stocked more than 50 million doses of the AstraZeneca / Oxford vaccine, even without a formal supply agreement with the government.

"All the risks @SerumInstIndia took in stocking up 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 use in the coming weeks."

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