New Delhi: Pharma giant Bharat Biotech on Wednesday released the efficacy data of its Coronavirus vaccine, Covaxin, revealing that phase three of human trials has demonstrated an interim vaccine efficacy of 81 per cent in the clinical trials. In an official statement, the Hyderabad-based firm said that Phase 3 trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research (ICMR).Â
“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 and Managing Director Krishna Ella said.
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.Â
Ella further said that Covaxin not only demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants.Â
Covaxin vaccine’s phase 3 efficacy data could prove to be significant milestone for the Bharat Biotech as Serum Institute of India’s (SII) vaccine efficacy rate was pegged at 70 percent only in the phase 3 human trials.
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The company also stated that more than 40 countries globally have expressed their interest in Covaxin. These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity
Currently the Indian drug regulator Drug Controller General of India (DGCI) has authorised the emergency use of two Covid-19 vaccines in the country – SII’s Covishield and Bharat Biotech’s Covaxin. India on Monday started the second phase of Covid vaccination drive.
