Hyderabad-based Bharat Biotech on 3 March announced the phase III clinical trial results for its COVID-19 vaccine Covaxin. The company said the efficacy of Covaxin is 81 per cent.
The company said the drug shows 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose. The clinical trial will continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of Covaxin in additional secondary study endpoints, it further added.
The data, collected from 25,800 participants who received a vaccine or placebo in a 1:1 ratio, showed that the vaccine candidate was well tolerated, the company stated. The trials were conducted in partnership with the Central government's medical research body ICMR.
The vaccine was granted emergency use authorization along with Serum Institute of India's Covishield ahead of India's countrywide vaccination programme that started on 16 January. However, the use of Covaxin had raised concerns among experts as the Central Drugs and Standards Committee had approved it for use before the completion of the third phase of human trials.
In January, preliminary data of its phase I trials published in 'The Lancet' journal showed that the vaccine was well tolerated and induced enhanced immune response with neutralizing antibodies among participants.
Covaxin had completed only two of the three required trial phases; the third - which tests for efficacy - began in November. The two earlier phases only ensured that the drug is safe.
Meanwhile, Bharat Biotech has been supplying its vaccine to other countries apart from India. Recently, the vaccine maker confirmed that the company has signed an agreement with Brazil to supply 20 million doses of Covaxin.