CDSCO in India recommends emergency use approval for Covaxin
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India’s CDSCO recommends emergency use for Covaxin in children

13 Oct 2021 (Last Updated October 14th, 2021 16:58)

Recommendations based on clinical trial data have been sent to the Drugs Controller General of India (DCGI) for final approval.

An expert panel on India’s Central Drugs Standard Control Organisation (CDSCO) has recommended granting emergency use authorisation (EUA) to Bharat Biotech’s Covid-19 vaccine, Covaxin, for use in children aged two to 18 years.

Bharat Biotech recently submitted data from a Covid-19 vaccine clinical trial, which had been conducted in children of this age group, to the CDSCO.

The CDSCO and its Subject Expert Committee (SEC) have ‘thoroughly reviewed’ the paediatric clinical trial data and given positive recommendations to the Drugs Controller General of India (DCGI) for final approval.

In a statement, the SEC said: “After detailed deliberation, the committee recommended granting market authorisation to the vaccine for the age group of two to 18 years for restricted use in emergency situations subject to certain conditions.”

An event-driven, randomised, double-blind, placebo-controlled, multicentre Phase III study was conducted in volunteers aged 18 years or older to evaluate Covaxin’s efficacy, safety and immunogenicity.

The vaccine’s safety and efficacy in children of this age group were found to be similar to those in adults, with the vaccine showing 77.8% efficacy against Covid-19.

In a statement, Bharat Biotech said: “Covaxin is the first Covid-19 vaccine to be tested in the 2-6 years age group.

“This was feasible due to the safety of the manufacturing platform and empirical evidence from Phase I, II and III clinical trials in adults.”

Covaxin has been developed in alliance with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) in Pune.

The vaccine uses platform technology derived from whole-virion inactivated vero cells.

If approved by the DCGI, Covaxin will be the second Covid-19 vaccine authorised in India, after Zydus Cadila’s ZyCoV-D vaccine received EUA for children aged 18 years or younger.

Experts from the World Health Organisation plan to meet this week to take the final decision to provide emergency use listing for Covaxin.