Bharat Biotech’s indigenously developed coronavirus vaccine Covaxin has shown an interim vaccine efficacy of 81% in late-stage clinical trials, the Indian company said on Wednesday.
Covaxin 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.
The interim analysis was based on 43 recorded cases of Covid-19 in the trial of 25,800 participants, conducted in partnership with the Indian government’s medical research body.
According to the official statement by the company, 36 of the 43 cases were recorded in participants who received a placebo, compared with seven cases in people who were given the Bharat Biotech vaccine, pointing to an efficacy rate of 80.6%., the company said.
So far, the vaccine has been administered to healthcare and frontline workers “in clinical trial mode” as part of the government’s mass vaccination campaign against the coronavirus.
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.
India’s vaccination drive, currently underway, includes COVAXIN and a vaccine developed by Oxford University and AstraZeneca.