India's drug regulator and the government have been "proved right" in rolling out the home-grown Covaxin, sources in the government said today, a day after the company said the vaccine is 81 per cent effective in protecting against COVID-19. This is the interim analysis of the third phase of its trial.
The efficacy rate of Covaxin - co-developed by Bharat Biotech and the Indian Council of Medical Research (ICMR) - shows the decision to clear it in January for the vaccination drive was backed by "sound scientific process and logic", sources said. Covaxin was cleared amid concerns raised by experts over its safety due to the lack of its efficacy data at that time.
Reiterating that its decision was right, sources in the government said Covaxin being made available to the public means the country got an additional two months to vaccinate people.
Covaxin also has the world's highest efficacy based on the "whole inactivated virus" platform, government sources said. Covaxin's trial research data has not been peer-reviewed.
The vaccine's third phase of trials, which began last November, involved 25,800 participants aged between 18 and 98 across 25 sites.
Participants, who included 2,433 over 60 and 4,533 with illnesses, were randomly divided into two groups. One got the vaccine and the other a placebo. Bharat Biotech said an "initial interim analysis" of 43 participants who contracted the infection showed 36 had been given a placebo.
Hyderabad-based Bharat Biotech will conduct more tests and expand its trial. It will also release more information about a wider pool of people who tested positive for Covid.
Prime Minister Narendra Modi is among those who took a dose of Covaxin on Monday as the second phase of the vaccination drive in the country began.
Covaxin is one of two Covid vaccines to have been cleared for emergency use. The other is Covishield, which was developed by AstraZeneca and Oxford University and is produced by Pune-based Serum Institute of India. Covishield has 70 per cent efficacy after the second dose.