India's first covid vaccine, Covaxin, in final phase trial
'Despite vaccines in phase 3 we need global cooperation, healthcare diplomacy to combat the Covid pandemic,' says Dr. Krishna Ella, CMD, Bharat Biotech
India's much-touted indigenous Covid-19 vaccine, Covaxin, being developed by Bharat Biotech is now undergoing phase-3 trials, Krishna Ella, Chairman and Managing Director, Bharat Biotech said on Monday.
Covaxin is being developed by BharatBiotech, in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
The Hyderabad-based vaccine maker had on 2 October sought the Drug Controller General of India's (DCGI) permission to conduct phase 3 randomised double-blind placebo-controlled multicentre trial of its COVID-19 vaccine, sources said.
"We are working on another vaccine through nasal drops my feeling is by next year it will reach the population," Ella said.
BharatBiotech in September said it entered into a licensing agreement with Washington University School of Medicine in St. Louis for a novel "chimp-adenovirus" (chimpanzee adenovirus), single dose intranasal vaccine for COVID-19.
Meanwhile a press release from Bharat Biotech said the Phase-III trials of Covaxin would involve 26,000 volunteers across 25 centres in India and it is being conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India. This is Indias first phase-3 efficacy study for a COVID-19 vaccine, and the largest phase-III efficacy trial ever conducted in the country. Participating volunteers, who undergo vaccination in the phase-II trials, would be monitored over the next year to detect occurrence of COVID-19. The trial volunteers would receive two intramuscular injections approximately 28 days apart, it said.
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