US declines emergency use clearance for Covaxin

Tribune News Service

New Delhi, June 11

The US drug regulator FDA today declined emergency use authorisation to Bharat Biotech-made Covaxin, asking the Hyderabad-based firm to pursue full approval pathway. Bharat Biotech said it would pursue the FDA’s advice for full approval, which, when granted to Covaxin, would be the first for any Indian vaccine manufacturer.

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The government said though it respected the FDA’s decision, it won’t impact Covaxin use in India. “We have ample safety data. The phase-3 trial figures will be available in a week,” said Niti Aayog Member (Health) VK Paul.

He said as sought, additional data had been submitted to the WHO to take a call on vaccine passports for Covaxin. So far, the vaccine had received green signal from 14 countries and approvals were in process in over 50 other nations, he said.

The development came on a day India’s national positivity rate fell to 4.49 per cent after two and a half months and new cases dropped to the peak of the first wave. The government, however, cautioned people against laxity saying it was no time to party or crowd. The government also launched preparations for the fourth round of national sero survey to be done this month to determine the scale of infection and asked states to conduct their own surveys to facilitate local policy decisions. Paul said the situation appeared to be stabilising but the moment people dropped their guard, the chain of transmission would form and cases would rise again. “If we want geographies to be protected, states have to do their own sero surveys to enable local policy decisions,” said Paul. The last sero survey had put Covid prevalence rate in adults at 25 per cent (25 per cent people had developed antibodies against Covid). “The recovery rate has surged from 81.8 per cent on May 3 to 94.9 per cent today and new recoveries have exceeded new cases for 29 days,” Health Ministry spokesperson Lav Agarwal said.