[ad_1]
In a press release that has generated optimism and curiosity within the medical fraternity, Bharat Biotech mentioned on Sunday that its Covid-19 vaccine ‘Covaxin’ will be at the least 60% efficient, based on trial information.
President of Quality Operations at Bharat Biotech Sai D Prasad mentioned the World Health Organisation (WHO), United States Food and Drug Administration (USFDA), and India’s Central Drugs Standard Control Organisation (CDSCO) authorized a respiratory illness vaccine if it was at the least 50% efficient.
The agency mentioned whereas it had aimed to attain at the least 60% efficacy, it might be greater 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” ought to be a minimal criterion for any acceptable candidate. The physique additionally mentioned that efficacy can be assessed in opposition to “illness, extreme illness, and/or shedding.”
[ad_2]
Source hyperlink