In a development that might silence the critics of the Union government for allowing the emergency use of the COVID-19 jab developed by Bharat Biotech sans the phase 3 trial, the company on Wednesday announced that the vaccine has been found to be 81 per cent effective in phase 3 clinical trials. The efficacy percentage is based on an interim analysis of the vaccine.
The third phase trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research. Interestingly, Prime Minister Narendra Modi too took Covaxin on March 1 as against Covishield that has lower efficacy than Covaxin.
Chairman of Bharat Biotech Dr Krishna Ella 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. Covaxin demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants.”
Covaxin effective against UK variant of virus
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. The primary endpoint of the phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
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%. Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains.
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