India’s abrupt Covaxin approval draws questions over its efficacy

India’s approval of Bharat Biotech’s Covaxin, without proof of its efficacy, grew certain criticism on Wednesday after a regulatory panel approved the shot just one day after asking the vaccine maker for more evidence it would work.

The drugs regulator’s panel asked Bharat Biotech to present more efficacy data for its COVID-19 shot before it could consider approving the treatment. The very next day, the committee recommended approving Bharat Biotech’s vaccine for “restricted use in an emergency situation” in the public interest as an abundant precaution.

The SEC also separately recommended emergency use authorisation for the Oxford University’s AstraZeneca COVID-19 vaccine, being produced by Serum Institute of India.

Health experts questioned why the SEC abruptly recommended approval one day after asking Bharat Biotech for more analysis.

“The SEC appears to have been pressured overnight into reconsidering its decision and giving approval the next day, albeit hedged in by many conditions,” the All India People’s Science Network, a network of science advocacy groups, said in a statement.

Regulators also granted approval to Bharat Biotech’s vaccine only “in clinical trial mode”, an unusually cryptic language that left some experts baffled.

“They’ve introduced terminologies that are confusing. The phrase ‘in clinical trial mode’ is not generally a term you will see in approvals. Any confusion around vaccines could harm immunisation programmes by causing distrust. It takes decades of work to build confidence in vaccines,” said Giridhar Babu, a professor of epidemiology at the Public Health Foundation of India. “

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