Covaxin, a vaccine against Covid-19 which has been developed by Indian Council of Medical Research (ICMR) in partnership with Bharat Biotech International Limited (BBIL), is 81 per cent effective in preventing Covid and can work against the UK variant of the virus, Bharat Biotech said Wednesday while explaining Phase 3 results of the vaccine.
“The bench-to-bedside journey of completely indigenous Covid-19 vaccine in less than eight months’ time showcases the immense strength of Aatmanirbhar Bharat to fight the odds and stand tall in the global public health community. It is also a testament to India’s emergence as a global vaccine superpower,” said Dr Balram Bhargava, Director General, ICMR.
Trials for the third phase were jointly initiated by ICMR and BBIL in November last year. Trials were conducted on a total of 25,800 individuals across 21 sites.
“The interim efficacy trend of 81 per cent, analysed as per the protocol approved by the rugs Controller General of India (DCGI), puts it at par with other global front-runner vaccines,” read a statement by ICMR.
“Covaxin demonstrates high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants,” Bharat Biotech Chairman Krishna Ella said in a statement, referring to its vaccine.
It said the analysis is based on 43 cases of Covid-19 patients who showed symptoms ranging from mild to moderate and severe, and of the total cases, 36 were from a placebo group, while seven were from those who received the vaccine.
The positive result also brightens prospects for sales overseas, with the vaccine, India’s first successful homemade Covid-19 shot, already attracting interest from more than 40 countries, according to the firm.
The company, which signed a deal with Brazil to supply 20 million doses of the shot, said the next interim analysis will target 87 cases and the final analysis will be based on 130 cases.
Its first interim analysis was based on a Phase III clinical trial involving 25,800 participants which was conducted with the Indian Council for Medical Research (ICMR), a federal government body. The trial included 2,433 participants who were older than 60, and 4,500 participants with co-morbidities.
The trial results were evaluated by an independent data safety and monitoring board, the ICMR said in a separate statement. Covaxin is one of two Covid-19 vaccines that was granted emergency use approval in the country early January.
The DCGI in early January gave permission to Covaxin “for restricted use in an emergency situation.” However, a huge backlash followed the announcement as the vaccine had yet not completed phase three trails.
On Monday, Prime Minister Narendra Modi received the first dose of Covaxin at AIIMS in Delhi as the second phase of the vaccination drive in the country began.