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.
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% effective.
The firm said while it had aimed to achieve at least 60% efficacy - a minimum criteria set - it was now attempting to reach an even higher rate. “Chances of the vaccine being less than 50% effective are remote, as suggested by our trial results so far," it said.
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."
With the vaccine’s efficacy passing the 50% mark, the news strikes an optimistic note in the country as it continues to reel under the effects of the ongoing pandemic.
Bharat Biotech has also said the rolling-out process for the vaccine is aimed by mid-2021 after receiving approvals. “If we get all the approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last stage of trials, we aim to launch the vaccine in Quarter 2 of 2021,” the company told News18.
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.