SEC recommends DCGI to approve Bharat Biotech’s Covaxin for children between 2-18 years of age

If approved, the two-dose vaccine will be given to children within 20 days apart.

SEC recommends DCGI to approve Bharat Biotech's Covaxin for children between 2-18 years of age

An illustration of COVAXIN, the vaccine candidate for COVID-19 developed by Bharath Biotech. Image: Bharath Biotech

India may soon get its first COVID-19 vaccine for children.

A Subject Expert Committee (SEC) has recommended the use of Bharat Biotech’s Covaxin for children from the ages of 2-18 years. The recommendation has been given to the Drugs Controller General of India (DCGI) for final approval.

Usually, once an SEC gives their recommendation, the DCGI is quick to pass their approvals.

“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation,” the subject expert panel said in a statement.

The vaccine is the same product and presentation as the one being administered to adults. Bharat Biotech had submitted the data from Phase 2 – 3 clinical trials to the DCGI only last week.

While BB’s vaccine Covaxin has been approved for adults for over a year, separate trials were needed to be done to ensure the vaccine is also safe for children.

During Phase 2-3, two doses of the vaccine were administered to 525 children, 28 days apart. The trials were completed in September.

“This is feasible due to the safety of the manufacturing platform and empirical evidence from phase I, II, III clinical trials in adults,” the company had said on a previous occasion.

However, once ready to administer, the two-dose vaccine will be given within 20 days apart.

One distinct note that should be made is that the World Health Organisation has not yet given the vaccine an emergency use authorisation (EUA). They have delayed the process again as they have asked Bharat Biotech to provide them with more information. This has been making it difficult for Indians who want to travel abroad to get their travel documents.

While this could very well be the first vaccine for children in India, this won’t be the only vaccine available for them. Reuters reported The DCGI gave Serum Institute the approval to begin enrolling children between the ages of 7 to 11 years for a trial of US drugmaker Novavax’s COVID-19 vaccine.

Zydus Cadila’s new DNA-based vaccine was recently given emergency use approval and can be given to adults and children aged 12 years. It is yet to be made available in the market.

Currently, we have three approved vaccines that are in circulation – Covidshield, Sputnik V and Covaxin.