Full licence for Covaxin may take time

Full licence for Covaxin may take time

Bharat Biotech, the manufacturer of Covaxin, may have to wait till next year to get full approval from the Indian drug regulator for the indigenous vaccine, a senior government official told.

“The phase-3 trial has not ended yet,” said the official, adding that the company needs to carry out follow-up studies. “They have to establish data indicating how much protection the vaccine gives. The duration schedule is defined in their protocol. Till that is established, full licensure cannot be granted,” added the official.
Bharat Biotech on Tuesday submitted data from Covaxin’s phase-3 trials to the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO). However, the SEC did not accept the company’s proposal seeking full licensure for Covaxin, and recommended continuation of the vaccine’s use under the earlier emergency authorisation.

The data submitted showed that Covaxin had demonstrated 77.8% efficacy in its phase-3 trial, which was conducted on 25,800 subjects. Bharat Biotech has not yet published this data in an internationally recognised, peer-reviewed journal. Earlier this month, the company said it would publish only after the data were submitted to the regulator.

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