India’s First Indigenous Vaccine Against Covid-19 Will be ‘At Least 60% Effective’, Says Bharat Biotech

In a statement that has generated optimism and curiosity in the medical fraternity, Bharat Biotech said on Sunday that its Covid-19 vaccine ‘Covaxin’ will be at least 60% effective, according to trial data.

President 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% effective.

The firm said while it had aimed to achieve at least 60% efficacy, it could be more than predicted. “Chances of the vaccine being less than 50% effective are remote, as suggested by our trial results so far,” it said.

Bharat Biotech, which is manufacturing India’s first indigenous vaccine against Covid-19 had started Phase-III trials earlier this month. The trials, involving 26,000 volunteers across 25 centres in India, are being conducted in partnership with the Indian Council of Medical Research. It is the largest clinical trial being carried out for a coronavirus vaccine candidate in India.

However, the announcements raised eyebrows, as well. AIDAN co-convenor Malini Aisola said in a tweet – “Has not shared Phase 1 and 2 results. Doesn’t come clean on adverse events. Detailed protocols for Phases 1/2 and Phase 3 are not in the public domain(sic).”

But Dr VK Paul, member of the Centre’s expert group on vaccines, told News18 the data from trials would be available only after completion of Phase-III trials, dismissing the allegation that there was anything unusual about the data being kept from the public for now.

In their target product profile for Covid-19 vaccines, WHO suggested that a “clear demonstration of efficacy (on a population basis) ideally with ∼50% point estimate” should be a minimum criterion for any acceptable candidate. The body also said that efficacy can be assessed against “disease, severe disease, and/or shedding.”

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