India on Tuesday recommended emergency use of Bharat Biotech's Covid-19 shot in children below 12 years of age, making the vaccine maker the first in the country to get such an approval after a review of its trial data for the 2-18 age-group.
The decision comes as India shifts its focus to vaccinating children against the coronavirus, having already rolled out more than 950 million doses to adults among its population of nearly 1.4 billion.
Bharat Biotech's Covaxin, which uses an inactivated coronavirus with an immunity booster, is among the three shots that are being used in India as part of the vaccination drive for adults.
More than 110 million doses of Covaxin have been administered and the company is in the process of securing an emergency use listing from the World Health Organization, a decision that is expected later this month.
To be sure, without the WHO nod, the two-dose shot is unlikely to be accepted as a valid vaccine around the world.
"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."
Bharat Biotech began a trial of Covaxin in children in June following a devastating second wave of Covid-19 led by the Delta variant that brought country's healthcare system to its knees.
The data for the 2 to 18 age-group "has been thoroughly reviewed by the Central Drugs Standard Control Organisation and Subject Expert Committee and (they) have provided their positive recommendations," the company told Reuters.
Bharat Biotech has not publicly shared the efficacy and safety data for children.
So far, only drugmaker Zydus Cadila's DNA-based vaccine had been authorized for emergency use in children aged at least 12 years.