India’s drug regulatory panel has approved Covaxin in children two years or older, making this home-grown Covid-19 vaccine the country’s first to be ready for use in children below 12, Hyderabad-based vaccine maker Bharat Biotech announced on Tuesday.

The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has reviewed data from a clinical trial of Covaxin in children aged 2 to 18 years and approved the vaccine for use in this age group, the company said.

It said it was now waiting for regulatory approval from the CDSCO to be able to market the vaccine for this age group. The SEC is a panel of medical experts that advises the CDSCO, the apex regulatory authority that has to grant the market authorisation.

Covaxin is one of the two main vaccines used by India’s Covid-19 vaccination campaign since its beginning in mid-January this year, but the vaccination policy makers will need to open the campaign for children before paediatric immunisation can begin.

The CDSCO had in August this year approved another home-grown Covid-19 vaccine from the Ahmedabad-based Zydus Cadila for people aged 12 years or older, or adolescents and adults.

For now, the vaccination campaign remains open only for people 18 years or older. A decision to vaccinate children between 2 and 18 years will add around 398 million potential recipients to the current estimated adult recipient population of 944 million.

Senior health officials have said that while vaccinating all adults — who are at greater risk of severe Covid-19 — will remain the current priority, paediatric immunisation may be introduced for select sets of vulnerable children.

Health officials have said that when paediatric immunisation opens, children with lung disease, kidney disease, malignancies or other chronic health disorders are likely to be prioritised for the vaccination.

Covaxin’s paediatric clinical trial involved 525 children aged 2-18 years. It was conducted in July this year at the All India Institutes of Medical Sciences in Delhi and Patna, and in one hospital each in Hyderabad, Kanpur, Nagpur, and Mysore.

The clinical trial was designed to evaluate the vaccine’s safety and capacity to generate immune responses, including antibodies that block SARS-CoV-2 — the virus that causes Covid-19 — in the paediatric population, experts familiar with the trial said.

An earlier clinical trial of Covaxin on 25,800 adults had found nearly 78 per cent efficacy against symptomatic Covid-19 and 93 per cent efficacy against severe disease. The vaccine uses inactivated (killed) virus to immunise people against Covid-19.

India had till Tuesday morning administered nearly 964 million doses of Covid-19 vaccines — 690 million

single doses and 274 million second doses. Only 29 per cent of the estimated 944 million adults have received the two doses required for full vaccination.

Limited vaccine supplies had constrained the pace of India’s Covid-19 vaccination campaign during its early months while the country waited for manufacturers to ramp up production.

Although vaccine supplies have increased over the months, Health experts say the campaign’s current pace is unlikely to achieve full vaccination of all adults by December 31 — the goal set by the Centre.

The immunisation campaign will need to administer 11.5 million doses daily over the next 80 days to meet that goal. But it crossed 10 million doses only on three days over the past one month.