The SEC approves Bharat Biotech’s Covaxin for the 2-18 age group, but there are conditions apply

Covaxin for kids aged between 2-18 years soon. Subject Expert Committee sends a recommendation to DCGI.

A Subject Expert Committee (SEC), an expert panel, granted emergency use approval (EUA) to Covaxin – Bharat Biotech’s COVID-19 vaccine for children aged two to 18. This is a huge relief for parents. On Monday, the SEC on COVID-19 examined the data and deliberated on the EUA application. Also read: WHO Experts Recommend Increasing COVID Vaccine Dose for People with Weak Immune Systems.

“After extensive deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to certain conditions,” the SEC recommended, according to a source.

The Drug Controller General of India will make the final decision (DGCI). “However, the emergency use authorization is subject to certain conditions.” “The developer of Covaxin will continue the study in accordance with the approved clinical trial protocol,” the drug regulator stated.

Covaxin will be the second vaccine cleared for use on children if it is approved.
Bharat Biotech, which completed phase 2/3 trials of Covid vaccine Covaxin in children aged 2 to 18 years, submitted the data to the Central Drugs Standard Control Organisation (CDSCO) earlier this month for verification and subsequent approval for emergency use authorisation (EUA) for the jab.
In August, DCGI granted Zycov-D, a COVID-19 vaccine developed by the Ahmedabad-based Zydus Cadillac group, emergency approval for use in adolescents aged 12 and up.

Zycov-D is the world’s first DNA-based coronavirus vaccine, and when injected, this three-dose vaccine produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which is critical for disease protection as well as viral clearance.
The vaccine was developed in collaboration with the DBT as part of Mission COVID Suraksha.
Until now, Covishield, Covaxin, and Sputnik V vaccines have been administered to only those over the age of 18, and, unlike ZyCoV-D, these are two-dose vaccines.

Meanwhile, chief medical officers in the United Kingdom have approved only one dose of a Covid vaccine for healthy children aged 12 to 15, citing concerns about the risk of myocarditis — inflammation of the heart muscle.
Pfizer and its German partner BioNTech had also urged the Food and Drug Administration (FDA) to approve the COVID-19 vaccine for children aged 5 to 11.
Moderna has also requested FDA approval to use its vaccine in 12- to 17-year-olds and is testing its shots in elementary school children.
Both Pfizer and Moderna are researching even younger children, down to 6-month-olds. The findings are expected later this year.