Expert Panel Clears Bharat Biotech Vaccine For Emergency Use, Drugs Controller General of India to Decide
A government-appointed panel for the study of various coronavirus vaccines has cleared Hyderabad-based Bharat Biotech’s Covaxin for “restricted use in emergency situation in public interest” and submitted its findings to the Drugs Controller General of India on Saturday. The national regulator will announce its decision when it addresses the media at 11 am on Sunday.
Covaxin has completed only two trial phases with the third and the final one currently going on to test the efficacy of the vaccine. in November when the third phase had started Bharat Biotech called it “the largest… ever conducted in India”.
The efficacy of the vaccine is based on the result of the combined analysis of all three phases.
Haryana’s PGIMS pharmacology professor Dr Savita Verma, who is working for Bharat Biotech, told NDTV that “good efficacy was shown” in the earlier trial phases of the vaccine.
“We have very robust Phase I and II results, in which good efficacy was shown. We are at present carrying out Phase III trials… have to recruit around 25,800 participants. As of now we have approximately 22,000 across India… we expect interim results by March,” she added.
According to Dr Verma, Bharat Biotech has already developed around 10 million doses of Covaxin.
The panel has also sent AstraZeneca and Oxford University’s Covishield for approval. The vaccine that is being manufactured by Pune’s Serum Institute claims to “protect 95 per cent of (its) patients”.
“A majority of the first 50 million doses will go to India,” Serum Institute CEO Adar Poonawalla was quoted as saying.
Another vaccine developed by American pharma giant Pfizer is currently being reviewed by the expert panel. Countries like the United States and the United Kingdom have started the vaccination drives with the Pfizer vaccine.
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