SRINAGAR: Bharat Biotech, a major player in vaccine innovation Wednesday announced the first interim analysis of its indigenously developed coronavirus vaccine Covaxin and said that the vaccine has demonstrated an interim efficacy of 81 per cent in Phase 3 clinical trial. The first interim analysis, the company said is based on 43 cases, “of which 36 cases of Covid-19 were observed in the placebo group versus 7 cases observed in the BBV152 (COVAXIN) group, resulting in a point estimate of vaccine efficacy of 80.6%.”
Giving details, the company said the trials involved 25,800 subjects and was done in partnership with the Indian Council of Medical Research. “Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s result from our Phase three 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 the company in a press release.
According to the statement, the data revealed that from 25800 participants, who received a vaccine or placebo in a 1:1 ratio showed that the vaccine candidate was well tolerated.
While talking about the development, Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech said, “COVAXIN demonstrates high clinical efficacy trend against Covid-19 but also significant immunogenicity against the rapidly emerging variants.”
The clinical trials, the company said would 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 endpoints.
Besides, the Phase 3 trial results assume significance as the company had approached the Central Drugs Standard Control Organisation (CDSCO) for approval to conduct late-stage clinical trials of Covaxin in children aged 5-18.
Earlier it was approved for restricted use in an emergency situation by the Drug Controller General of India on January 3. However, since Bharat Biotech had not finished recruiting and vaccinating enough participants for Phase 3 trials, the approval was without efficacy data.
As the company reveals, more than 40 countries globally have expressed their interest in Covaxin. The company has delivered more than 4 billion doses of vaccines worldwide.