India's Bharat Biotech said in a statement that its Covid-19 vaccine 'Covaxin' will be at least 60 per cent effective, according to a report by CNN-News18.
"World Health Organization (WHO), United States Food and Drug Administration (USFDA), and Central Drugs Standard Control Organisation (CDSCO) only approve a respiratory disease vaccine if it is at least 50 per cent effective," Executive Director of Quality Operations at Bharat Biotech Sai D Prasad told the publication.
“Chances of the vaccine being less than 50 per cent effective are remote, as suggested by our trial results so far," the firm said indicating positive news for the largest clinical Covid-19 vaccine trial in India.
According to the WHO guidelines, a “clear demonstration of efficacy (on a population basis) ideally with ∼50 per cent 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," the report said.
The indigenous vaccine, which is being developed by Bharat Biotech and ICMR, has received the approval of the CDSCO for initiating the third phase trial.
Indian Council of Medical Research (ICMR) and privately-held Hyderabad-based Bharat Biotech this month started third-stage trials of Covaxin, in a process that would involve 26,000 volunteers. It is the most advanced Indian experimental vaccine.
Earlier, reports had suggested that Covaxin could be licensed by the second quarter of 2021.
"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 the publication confirming the same.
Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95 per cent effective in preventing Covid-19.
Five vaccine candidates are currently undergoing clinical trials in India. Among them, three that are in advanced stages of trials -- the Oxford-AstraZeneca candidate for which the Pune-based Serum Institute is conducting Phase 3 clinical trials, Bharat Biotech’s Covaxin which is also in Phase 3, and Russia’s Sputnik V which is expected to start Phase 2/3 trials next week.
(With agency inputs)