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Coronavirus India LIVE updates
The Central Drugs Standard Control Organisation (CDSCO), which released a new set of guidelines for Covid-19 vaccines on Monday, also emphasized that the statistical range of efficacy (the ability to produce the desired outcome) in the human trials cannot be lower than 30 per cent.
The guidelines come several months after the World Health Organization (WHO) and the US Food and Drug Administration (US FDA) released their own guidelines for Covid-19 vaccine approvals and draw from both documents, according to experts that have been closely tracking and involved in Covid-19 vaccine developments.
“To ensure that a widely deployed Covid-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50 percent, and the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval around the primary efficacy endpoint point estimate is (greater than) 30 percent,” stated CDSCO.
“What this essentially translates to is that the trial size has to be sufficient so that if the investigators get exactly 50 percent efficacy, we should have confidence that it will not be less than 30 percent,” said vaccine scientist and Christian Medical College, Vellore professor Dr Gagandeep Kang.
Meanwhile, marking its first big staff lay-offs since the Covid outbreak, the BCCI has decided to not renew the annual contracts of 11 coaches at its premier National Cricket Academy (NCA), including five retired India players —Ramesh Powar, SS Das, Hrishikesh Kanitkar, Subroto Banerjee and Sujith Somsundar.
The Indian Express has learnt that former India captain Rahul Dravid, who had handpicked the team after taking over as Head of Cricket at NCA, informed the coaches last week about the termination of their services. Those who have been asked to leave include domestic stalwart Sitanshu Kotak.
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