Vaccine maker Bharat Biotech on Wednesday said that Covaxin has demonstrated an interim vaccine efficacy of 81 per cent in Phase 3 clinical trials.
"Covaxin 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 biotech company said in a release.
The company said that “it enrolled participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities” for its phase 3 study.
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"The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the COVAXIN group, resulting in a point estimate of vaccine efficacy of 80.6 per cent," Bharat Biotech said.
"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 & Managing Director Krishna Ella said.
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"Covaxin demonstrates a high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants," he added.
Bharat Biotech said the interim analysis of its vaccine included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.
The company expects to share further details of the trial results as additional data becomes available.
India's drug regulator approved Bharat Biotech’s Covaxin for emergency use in India this year in January. However, it received a lot of flak as its third stage of trials, which measures the success, were not out, raising concerns over its safety and efficacy.
On Monday, Prime Minister Narendra Modi was administered Covaxin on the very first day of expansion of the inoculation drive to cover people aged 60 and above and those between 45-59 having co-morbidities.
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(With inputs from PTI)
