: Bharat Biotech submits phase 3 trial data of Covaxin, expert panel to meet today to discuss results #IndiaNEWS Bharat Biotech has submitted phase 3 trial data for coronavirus vaccine Covaxin to the

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Bharat Biotech submits phase 3 trial data of Covaxin, expert panel to meet today to discuss results #IndiaNEWS
Bharat Biotech has submitted phase 3 trial data for coronavirus vaccine Covaxin to the Drug Controller General of India over the weekend, NITI Aayog (Health) member VK Paul told The Economic Times on Monday.“Covaxin follow-up studies should be available, too, in peer-reviewed journals soon,� Paul said.The indigenously developed vaccine was granted emergency use authorisation in January though data of phase 3 trials were not available at that time. The company had then said it would submit efficacy results by March. On June 9, it said that the data will be made public in July.Phase 1 of a clinical trial is usually small and is used to determine its safety profile. Phase 2, on the other hand, employs a bigger sample size, and looks at the immune responses triggered by the vaccine. However, a vaccine is deemed safe to be commercially available only after Phase 3 – a much larger efficacy trial involving thousands of participants.In April, an interim analysis of Covaxin’s phase three data had shown that it was 78% effective against Covid-19. This was slightly lower than the 81% efficacy reported by the company in March.The drug regulator’s Subject Expert Committee will meet on Tuesday to review the results, a senior official told The Economic Times.The Hyderabad-based company is also expected to...Read more

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