Covaxin gets emergency use approval in the 2-18 age group
Bharat Biotech’s Covaxin has been recommended for emergency use in the 2-18 years age group by an expert panel.
If it gets the final nod from the Drugs Controller General of India, it would be the second Covid-19 vaccine for children, the first being Zydus Cadila’s ZyCov-D. But it would be the first recommended for use in children as young as 2 years.
“The overall antibody response for the paediatric population is similar to that of the adult population per Phase-III efficacy study,” a government official told BusinessLine, explaining the Subject Expert Committee (SEC) recommendation.
Hyderabad-based Bharat Biotech had presented its proposal for an emergency use authorisation, based on the interim safety and immunogenicity data of Phase II/III clinical trials conducted in the 2-18 age group.
“The data has been thoroughly reviewed by the CDSCO (Central Drugs Standard Control Organisation) and the Subject Experts Committee (SEC) and they have provided positive recommendations. This represents one of the first approvals worldwide for a Covid-19 vaccine for the 2-18 age group. …. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for Children,” said Bharat Biotech.
The government had planned to roll out ZyCov-D for children on October 2, but it is yet to be made available in the market. VK Paul, NITI Aayog-Member, had recently said that people were being trained to administer the needle-less ZyCov-D vaccine and logistics issues were being resolved. Health Secretary Rajesh Bhushan also indicated, discussions were on with Zydus Cadila on the procurement price.
“This will be a major step as schools, coaching and sport centres are gradually opening,” said Akshay Budhraja, Senior Consultant, Pulmonology, Aakash Healthcare. Gauri Agarwal, Founder- Seeds of Innocence, added that “efforts must be made to establish the efficacy of the vaccine globally so that the children are not subject to restrictive measures when they travel abroad.”