The expert panel of the central drug regulator has recommended that Bharat Biotech’s Covaxin be given marketing authorization with conditions for restricted emergency use (EUA) in children and adolescents aged two to eighteen years.
However, top government sources stated on Tuesday that ultimate approval of EUA from the drug authority and inclusion of the vaccine in the national Covid vaccination programme for the paediatric population will take a few more days since data supplied by the company will be further scrutinised.
The National Technical Advisory Group on Immunisation (NTAGI) for Covid-19 will assess the data after the Drugs Controller General of India gives final regulatory approval for Covaxin for restricted emergency use in the 2-18 age group.
Apart from Covaxin, Zydus Cadila’s ZyCov-D has received EUA for children aged 12 and up. Covovax is being tested in phase II and III trials by the Serum Institute of India in children aged seven to eleven. With Covaxin on the verge of receiving EUA, vaccine supply for children is expected to improve, raising hopes that vaccination would expand beyond the initial goal to include children with co-morbidities.
In the country, there are approximately 44 crore children. While Zydus Cadila’s ZyCoV-D has previously been approved for emergency use in children over the age of 12, final approval of Covaxin will assist in enhancing supplies to cover the paediatric population. The government has yet to begin administering anti-Covid vaccines to youngsters as part of the countrywide programme.
The continuation of clinical studies by Bharat Biotech is one of the requirements imposed by the Subject Expert Committee. Updated prescription information, package inserts, description of product characteristics, and a datasheet have also been requested from the company. It will also be required to submit adverse event and analytical data.
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