Bharat Biotech today announced the phase 3 results of its Covaxin vaccine, which is one of the two COVID-19 vaccines—the other being Oxford-AstraZeneca's Covishield—currently approved for use in India by the national drugs regulator.
Bharat Biotech, which co-developed Covaxin with the Indian Council of Medical Research (ICMR), said that the vaccine demonstrated 81 per cent interim efficacy in preventing COVID-19 in those without prior infection after the second dose.
"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," Bharat Biotech chairman and managing director Krishna Ella said.
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The trials involved 25,800 subjects, and the data from these subects who received a vaccine or placebo in a 1:1 ratio, showed that the vaccine candidate was well tolerated.
It also said that the clinical trial will continue through to final analysis at 130 confirmed cases in order to gather further data.
“I want to thank every one of the participants, who volunteered to participate in this vital clinical trial, our partners, principal investigators across 25 study sites, and our team at Bharat Biotech who dedicated their time to this vaccine discovery,” said Suchitra Ella, joint managing director, Bharat Biotech. “We could not have achieved this public-private partnership milestone without the relentless commitment of those involved.”
The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains.
