Expert panel recommends Covaxin for 2-18 age group

The recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval

An Indian drug regulatory panel on Tuesday recommended emergency use of Bharat Biotech’s Covaxin on children and adolescents in the age group of 2-18 years, clearing the deck for large scale use of the home-grown Covid-19 vaccine on kids, who are not yet eligible for such shots as per the current norms.

“Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to the CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC), which provided its positive recommendations. This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group,” the Hyderabad-based company said in a brief statement.

Following the SEC approval, the Central Drug Standards and Control Organisation would have to accord the final clearance allowing commercial rollout of the indigenous vaccine for children.

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“We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” the company said.

The expert panel’s recommendation is on the basis of the trial results carried out on 525 children who were split into three groups of 175 each (18-12 years / 12-6 years and 6-2 years) and were given the two doses at a gap of 28 days. However, the results of the clinical trial are yet to be published in a peer reviewed journal.

Once approved by the CDSCO, it would be the second Covid-19 vaccine for kids in India after Zydus Cadila’s ZyCov-D, which is not only the world’s first DNA vaccine, but also the maiden Covid-19 shot approved for emergency use in 12-18 years old group in India. ZyCov-D, however, is yet to be available commercially in the market.

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“It is heartening to have vaccines that pass the test for use in children when needed. At present, adults and immunosuppressed children who are at higher risk of severe illness must have precedence for completing the full course of vaccination,” K Srinath Reddy, president of Public Health Foundation of India told DH.

“As evidence on the need for and benefit of universal child immunisation is not yet available, we may have to wait till 2022 to get evidence from global experience. Till then, it is good to know we have the vaccines if we need them,” he added.

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The Union Health Ministry is likely to come out with a policy guideline to identify the children who would get the vaccine first because of the chronic diseases they are carrying.

India has nearly 39 crore children in the age group of 2-17 years and prioritisation would be needed as Bharat Biotech’s current production is much below its capacity.

India has so far administered more than 96 crore doses of Covid-19 vaccines, of which nearly 85 crore are Covishield made by Serum Institute of India, whereas 11 crore are Covaxin.

Even though the company claims to have produced 4-5 crore doses of Covaxin since September, 2021, there are question marks on the production figures as it supplied much less to the Centre than what had been committed to.

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