Covid-19 Live Updates: India experiences 23,285 contemporary instances; Nagpur turns into 1st metropolis to impose 2nd lockdown amid rising instances
1 min read Health employees acquire swabs for Covid-19 testing in Thane, Maharashtra. (Express Photo: Deepak Joshi)
On Thursday, Drugs Controller General of India (DCGI) Dr V G Somani amended the authorisation initially granted to Bharat Biotech for “restricted use in emergency situation in public interest,” a senior authorities official advised The Indian Express. In doing so, he omitted the situation imposed on January 3 that the vaccine be administered “in clinical trial mode”.
However, holding consistent with suggestions of a topic knowledgeable committee on the matter, the DCGI has mandated that Bharat Biotech proceed its ongoing late-stage human trials of the vaccine. The firm had recruited round 25,800 contributors on this trial, of which half got Covaxin and the remainder had been administered a placebo.“The phase 3 (trial) will have to continue. Long-term follow up of the safety remains,” the official cited above stated.
Following Bharat Biotech’s announcement on March 3 that Covaxin had an interim efficacy of 80.6 per cent, the SEC on Wednesday determined to again the corporate’s request that the vaccine be taken out of medical trial mode.