India’s drug regulator on Sunday announced that it had approved two COVID-19 vaccines for emergency use, one developed by Oxford University and AstraZeneca, and another developed locally.
Dr. V.G. Somani, the drugs controller general of India, said at a press briefing in New Delhi that the decision to approve both vaccines came after “careful examination” by Central Drugs Standard Control Organization, India’s pharmaceutical regulator.
A government minister said earlier that the AstraZeneca vaccine had been given the green light on Friday, paving the way for a huge immunization campaign in the world’s second most populous country.
The homegrown COVID-19 vaccine, known as COVAXIN, has been developed locally by Bharat Biotech and the government-run Indian Council of Medical Research.
The overall efficacy of AstraZeneca’s vaccine was 70.42 percent, according to the company, while Bharat Biotech’s vaccine was “safe and provides a robust immune response,” Somani, said, noting that both vaccines require two doses.
Experts meanwhile have raised questions about the decision to approve Bharat Biotech’s homegrown vaccine candidate before the completion of trials. Efficacy data for COVAXIN has not yet been revealed by the company nor India’s Central Drugs Standards Control Organization.
The All India Drug Action Network said it was “baffled to understand the scientific logic” to approve “an incompletely studied vaccine.”
Britain approved AstraZeneca’s vaccine on Dec. 30, the first country in the world to do so, saying it had accepted the recommendation from the Medicines and Healthcare Products Regulatory Agency to authorize the jab.
AstraZeneca’s COVID-19 vaccine is based on an adenoviral vector that requires only refrigeration and is therefore easier to store, meaning many low- and middle-income countries are relying on it.
In contrast, Pfizer and Moderna’s vaccines, which were created using messenger RNA and are currently being rolled out in the United States, need to be stored and distributed at cold temperatures to prevent them from degrading. They rely on segments of genetic material delivered into cells to help stimulate an immune response.
Several scientists have raised doubts about the robustness of results from AstraZeneca’s British and Brazilian trials, showing the shot was 90 percent effective in a sub-group of trial participants. That group, by error initially, received a half dose followed by a full dose. But the efficacy was 62 percent if the full dose was given twice, according to the company, which was the case for most participants.
India’s Prime Minister Narendra Modi welcomed the approvals in a statement on Twitter.
“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India!” he wrote, calling the move a sign of a “self-reliant” country.
Two other vaccine candidates—Zydus Cadila’s ZyCoV-D and Russia’s Sputnik V—are awaiting approval in India, Information and Broadcasting Minister Prakash Javadekar said earlier. Both are on trial in the country.
India hopes to vaccinate 300 million of its 1.35 billion people in the first six to eight months of this year.
Reuters contributed to this report.