The country’s Subject Expert Committee (SEC) on Tuesday approved Bharat Biotech's COVID-19 vaccine, Covaxin, for emergency use in children between two and 18 years of age.
"Bharat Biotech had submitted data from clinical trials in the 2 to 18 age group for Covaxin to Central Drugs Standard Control Organisation. The data has been thoroughly reviewed by the Subject Expert Committee (SEC) which has provided positive recommendations," Bharat Biotech said in a statement.
This represents one of the first approvals worldwide for COVID-19 vaccines for the two - 18 age group. We now await further regulatory approvals prior to product launch and market availability of Covaxin for Children," the Hyderabad-based company said.
The final approval will be given by the Drug Controller General of India which is considered a mere formality after the positive recommendation of the SEC.
Once this approval comes through, Covaxin would be the first shot to be available for kids aged between 2 and 12, while those in the 12-18 years age-group can choose between Covaxin and Zydus Cadila's DNA-based vaccine.
Two other companies, Serum Institute of India and homegrown drugmaker Biological E., have also been allowed to test their shots on children.
Bharat Biotech began a trial of Covaxin in children in June following a devastating second wave led by the Delta variant that had overwhelmed the country's healthcare system.
Several countries have been working to authorise vaccines for children, with the United States clearing Pfizer's shot for children aged 12 and above.
The advisory panel to the U.S. regulator will meet later this month to discuss the shot for children between 5 and 11 years of age.
While COVID-19 is known to usually cause mild disease in children, there is a risk of rare post-disease complications.
"Children with comorbidities should be vaccinated as soon as possible now that a vaccine with immunogenicity in children and a large safety database in adults is available," said Dr Gagandeep Kang, professor at Christian Medical College, Vellore.
"For healthy children, given low risk and low virus circulation at the moment, it is safe to wait until more adults are covered," she added.
India has so far fully vaccinated around 29% of about 944 million eligible adults, as per government data, which includes administration of more than 110 million doses of Bharat Biotech's Covaxin.