Bharat Biotech made an announcement on Sunday, 22 November, that the COVID-19 vaccine it has developed, Covaxin will be at least 60 percent effective based on earlier trial results. Covaxin is India’s first indigenous COVID-19 vaccine candidate.
Bharat Biotech had started the phase 3 trials earlier this month with 26,000 volunteers from across 22 sites in India, making it the largest COVID-19 clinical trial in the country.
India on Monday, 23 November, reported 44,059 new coronavirus cases, taking the tally in the country to 91,39,866. The death toll increased by 511 to 1,33,738.
Executive Director of Quality Operations at Bharat Biotech Sai D Prasad said the World Health Organisation (WHO), United States Food and Drug Administration (USFDA), and India's Central Drugs Standard Control Organisation (CDSCO) approved a respiratory disease vaccine if it was at least 50 percent effective, reported News18.
WHO said that any acceptable candidate for the COVID-19 vaccine should ideally have a 50% point estimate and a clear demonstration of efficacy. The efficacy can be assessed against “disease, severe disease, and/or shedding”, reported Scroll.
The vaccine has so far been evaluated in 1,000 subjects in Phase I and Phase II clinical trials, and ICMR scientist Rajni Kant expressed hope that Covaxin might be available as early as February, although Bharat Biotech told Reuters on Friday that results of the late-stage trials were expected only between March and April.
Malini Aisola, co-convenor of All India Drug Action Network (AIDAN) said the vaccine trial results of Phase 1 & 2 are not known and therefore has raised questions on the company’s claim on Twitter.
However, NITI Aayog member VK Paul, member of the Centre’s expert group on vaccines, told News18 that the data from the earlier trials would be available after completion of phase 3 trials.
Health Minister on India’s COVID Fight
India’s health minister. Harsh Vardhan, on Sunday addressed a global webinar organised by Boston Centre of Excellence For Human and Health Development on ‘Post-Covid Era: Future of Health and Humanity’ where he talked about India’s collective fight against COVID-19, the country now being the second-highest globally in terms of the number of infections. He reiterated the government plan of immunising 200-250 million people by July 2021
Vardhan, however, said in September the government could opt for emergency vaccine authorisation, particularly for the elderly and people in high-risk workplaces, reported Reuters.
Indian officials have said they expect to rely on Covaxin and four other locally-tested candidates to control COVID-19, as they do not expect early access to sufficient quantities of those developed by Pfizer and Moderna, reported Reuters.
Drug manufacturer Pfizer said that its vaccine showed 95 percent efficacy in phase three trials whereas Biotechnology company Moderna, too, found its vaccine candidate to be 94.5 percent effective in phase three trials, reported Reuters.
India is yet to sign a deal for a COVID-19 vaccine.
(With inputs from Scroll, Reuters and News18)
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