According to Sai D Prasad, President of Quality Operations at Bharat Biotech, 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 pharmaceutical firm aimed to achieve at least 60% efficacy - minimum criteria set it was now attempting to reach an even higher rate.
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“Chances of the vaccine being less than 50% effective are remote, as suggested by our trial results so far," the firm said.
According to WHO, “clear demonstration of efficacy (on a population basis) ideally with ∼a 50% point estimate” should be a minimum criterion for an acceptable candidate. The body also said that efficacy can be assessed against “disease, severe disease, and/or shedding."
Upon approvals from the regulators, the Pharma firm is set to roll-out vaccine which is aimed by mid-2021, Bharat Biotech said, "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 vaccine candidate “Covaxin”, which is India’s first indigenous vaccine Covid-19 had started Phase-III trials earlier this month. The trials, which will be involving 26,000 volunteers across 25 centers in India, are being conducted in partnership with the Indian Council of Medical Research (ICMR). It is the largest clinical trial being carried out for a coronavirus vaccine candidate in India.
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Other than Bharat Biotech’s Covaxin, in the vaccine race, India has three different vaccine candidate contenders. The indigenously developed Zydus Cadila’s ZycoV-D, Oxford University, and Astra Zeneca's developed Covishield and the Russian vaccine candidate Sputnik V which is going through clinical trials, in partnership with Dr Reddy’s lab.