Covaxin, India's first indigenously-developed vaccine candidate will be at least 60% effective, higher than the minimum criteria set by the World Health Organization (WHO), Bharat Biotech told News18 on Sunday.
Bharat Biotech's President of Quality Operations Sai D Prasad said the minimum criteria set by the WHO, United States Food and Drug Administration (USFDA), and India's Central Drugs Standard Control Organisation (CDSCO) is 50% efficacy. "Chances of the vaccine being less than 50% effective are remote, as suggested by our trial results so far," he said.
The Hyderabad-based company also said the process for rolling-out of 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," Bharat Biotech said.
Besides, Bharat Biotech and ICMR have already started the Phase-III trail of the indigenously developed Covaxin. The trials are being conducted across 25 centres in India, involving 26,000 volunteers.
Meanwhile, the government is exploring the modalities of emergency authorisation and usage of anti-coronavirus vaccines pending completion of Phase-III clinical trial and regular licensure.
The issue of advance purchase commitment for vaccines, including pricing, was also discussed in a recent meeting attended by NITI Aayog Member (Health) Vinod Paul, Principal Scientific Advisor to the government K VijayRaghavan and Union Health Secretary Rajesh Bhushan.
"It was decided that the PMO-constituted Vaccine Task Force (VTF) will lay down the principles for emergency use authorisation while the National Expert Group On Vaccine Administration for COVID-19 (NEGVAC) should take the lead in setting the principles for advance market commitment, including vaccine pricing," a source told PTI.
Moreover, five vaccines are under different phases of clinical trials in India.
(With PTI inputs)
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