Bharat Biotech's Covaxin receives emergency use approval in children aged between 6 and 12

Bharat Biotech International announced that its Covaxin has received emergency use approval in children aged between 6 and 12 years. It had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity Covaxin in healthy children and adolescents in the 2-18 age group. The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity, it said.

The data readouts were submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received emergency use nod for children aged 12-18 from DCGI during December 2021. “We have established Covaxin as an universal vaccine for adults and children. Safety of the vaccine is critical for children and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children. We have achieved our goal of developing a safe and efficacious Covid-19 vaccine for adults and children,” said Bharat Biotech Chairman and Managing Director Dr Krishna Ella.

Clinical trials in children documented seroconversion at 95-98 per cent, four weeks after the second dose, indicating superior antibody responses in children when compared to adults, according to a press release.

Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike. It is a ready-to-use a liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi-dose vial policy. The same vaccine can also



be used for two-dose primary immunisation and for booster dose vaccinations.

Bharat Biotech has readily available more than 50 million doses of Covaxin in vials, and more than 200 million doses as drug substance. Additional production capacity is also available to meet product demand.

Biological E also announced that its Covid-19 vaccine Corbevax too has received a nod from the Drugs Controller General of India (DCGI) for emergency use authorisation for the 5-12-year age group. The approval comes after the Subject Expert Committee (SEC) recommendation based on the review of interim safety and immunogenicity data of Corbevax for this age bracket.

The company performed a multi-centric, Phase 2/3 clinical trial in 624 children aged between 5 and 18 in two age sub-sets. Children were administered two doses of 0.5 ml each of the vaccine or placebo in a gap of 28 days. BE submitted the interim safety data and immunogenicity data to regulatory agencies. For both the age sub-sets, the trial showed a significant increase in antibodies against ancestral strain and Delta variant.

“We are very happy to receive the formal approval from the DCGI making this an extremely safe and effective intervention available, particularly for the age groups 5 years onwards. This is a great opportunity to get back to some level of normalcy in our continuing fight against the prevalent pandemic,” said Mahima Datla, Managing Director, Biological E.