India may approve Covid-19 vaccine in the next few weeks: Health Secretary

New Delhi: India’s drug regulator may grant emergency use licences to one or more Covid-19 vaccines of the three under review in the next few weeks, health secretary Rajesh Bhushan said on Tuesday. Pfizer, Serum Institute of India and Bharat Biotech have applied for market authorisation for their vaccines. A senior government official said the Subject Expert Committee (SEC) at the regulator, the Central Drugs Standard Control Organisation (CDSCO), will take up their applications for consideration on Wednesday. “The experts will give their recommendations to the regulator, based on which the final decision will be taken,” the official said. “The companies will give a presentation sharing their data before the SEC.” Once a vaccine gets green signal from scientists, India will launch a massive production drive, health secretary Bhushan said. “We’ve made preparations and drawn an outline to ramp up production and make it available to each and every person in the shortest possible time,” he said.‘Risk-benefit Ratio’Vinod Paul, a Niti Aayog member and part of the government’s Empowered Committee for Covid-19 Response, expressed the hope that at least one of the vaccines will get a licence soon. “Three vaccine candidates are under consideration for licensing,” he said. “There is hope that early licensure is possible in respect of all of them or any one of them. Please have faith in regulators.” Balram Bhargava, director general of the Indian Council of Medical Research (ICMR), said the SEC should consider Covaxin, although the interim analysis of Phase III clinical trials hasn’t been provided. Bharat Biotech has developed the indigenous Covid-19 vaccine in collaboration with ICMR. “In the emergency situation, the regulator may consider the risk-benefit ratio,” Bhargava said. “Numbers are there from Phase I and Phase II. That’s the reassuring point in terms of efficacy. I would emphasise that the risk-benefit is more important to look at in this situation of a pandemic.”

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