In a substantial first step towards vaccination for kids — those in the sub-12-year-old category — the Drugs Controller General of India (DCGI) has recommended emergency-use authorisation (EUA) for Bharat Biotech’s Covaxin for 6-12-year-olds.

The DCGI has also recommended EUA for Corbevax (made by Biological E) for those aged 5-12 years, and Zydus Cadila’s plasmid DNA Covid vaccine, ZyCoV-D, for those above 12 years of age.

India is still not vaccinating children below the age of 12.

Confirming the development, Union Health Minister, Mansukh Mandaviya, in a tweet, said: “The approvals will help strengthen India’s fight against Covid.”

The subject expert committee (SEC) had suggested amendments to the protocols for Covaxin,which is among the India-made vaccines and the second most-predominant vaccine in India after Covishield.

Covaxin is already administered to children in the age group of 15-18 years. The vaccine is administered in two doses, with a gap of 28 days between the first and second dose.

The DCGI has directed the vaccine-maker to submit safety data, including data on adverse events, with due analysis every 15 days for the first two months, and thereafter monthly data for up to 5 months.

Superior antibody response

Bharat Biotech, in a statement, said clinical trials in children documented sero-conversion at 95–98 per cent four weeks after the second dose, indicating superior antibody responses when compared to adults, and has also displayed Th1 bias.

The company has over 50 million doses of Covaxin vials readily available and over 200 million doses as drug substance.

In the 12–14 age group, India currently administers Corbevax. Close to 2.71 crore were inoculated with the first jab, and over 37 lakh received the second dose till Tuesday morning.

According to Mahima Datla, Managing Director, Biological E, the SEC had already given a positive recommendation for the vaccine. “This [is] an extremely safe and effective intervention, particularly for the age groups 5 years onwards,” she said.

Zydus Cadila’s vaccine is to be administered in intervals of 0–28–56 days with a total dosage of 6 mg (three doses of 2 mg each).

“In October 2021, the SEC had granted Zydus a go-ahead for Phase-III trials for the two-dose regimen of its ZyCov-D. The two dose regimen comes in 3 mg strengths of each,” the company said.

Meanwhile, India reported 2,483 fresh Covid cases, while deaths shot up to 1,399, which included a backlog of 1,347 from Assam and 47 from Kerala. Delhi reported one death and Punjab had 4 deaths in the last 24 hours.

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