Bharat Biotech's coronavirus vaccine 'Covaxin' demonstrated an interim efficacy of 81% against COVID-19, the company announced on Wednesday while releasing the results of Phase 3 clinical trials.
“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase 3 clinical trials, we have now reported data on our Covid-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants,” said Dr Kirishna Ella, Chairman and Managing Director of Bharat Biotech.
"Covaxin demonstrates a high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants, he further said.
"The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81 per cent in its phase III clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research (ICMR)," the Hyderabad based company said in a press release.
According to Bharat Biotech, the first interim analysis is based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus seven cases observed in the BBV152 (Covaxin) group, resulting in a point estimate of vaccine efficacy of 80.6 per cent.
The company further stated that an additional interim analysis is planned for 87 confirmed cases and a final analysis is planned for 130 confirmed cases in order to gather further data and to evaluate the efficacy of Covaxin in additional secondary study endpoints.
In the release, the company also stated that the analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv.
Covaxin is one of two Covid vaccines that was granted emergency use approval in the country in early January after the Drugs Controller General of India (DCGI) gave permission to Covaxin "for restricted use in an emergency situation." The announcement followed a huge backlash as the vaccine had yet not completed Phase III trials.
Prime Minister Narendra Modi on Monday was administered the first dose of Covaxin vaccine at the All India Institute Of Medical Science (AIIMS) Delhi.
(With inputs from ANI)
