The Central Drugs Standard Control Organisation (CDSCO) on Wednesday approved the extension of self life of Covaxin up to 12 months, from date of manufacture.
In a tweet, Covaxin producer Bharat Biotech informed that the approval is based on the availability of additional stability data, which was submitted to CDSCO.
Last month, a CDSCO expert panel had recommended granting emergency use authorisation (EUA) to Covaxin, for use in children aged two to 18 years.
The Hyderabad based company had submitted the data from a Covid-19 vaccine clinical trial, which had been conducted in children of this age group.
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 had 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.”
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.
SEC had reviewed the interim safety data of the phase 2/3 clinical trial on 26 August. The overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in phase-3 efficacy study, the recommendations said. GMT is a measure of neutralization of the virus by antibodies.
Covaxin has been developed in alliance with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) in Pune.
Meanwhile, the vaccine is expected to get an emergency nod from the World Health Organisation today.