New Delhi: An expert panel of India’s Central Drug Authority has recommended granting emergency use authorisation (EUA) to Bharat Biotech’s Covaxin for children in the two to 18 years age group with certain conditions, sources said Tuesday. Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid-19 vaccine Covaxin for use in children aged between two and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month.
The Subject Expert Committee (SEC) on Covid-19 examined the data and deliberated on the EUA application Monday.
“After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of two to 18 years for restricted use in emergency situations subject to the certain conditions,” a source quoted SEC as having stated in its recommendations.
Also read: WHO to take final decision next week on approval to Bharat Biotech’s Covaxin
The recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval. When that approval does come, Covaxin will become only second vaccine cleared for use on kids. In August Zydus Cadila’s three-dose DNA jab was allowed to be used on adults and children over 12.
A third potential vaccine for kids is Serum Institute’s Novavax, for which the DCGI last month cleared trials for children between seven and 11 years.
India is now turning its focus towards vaccinating children against the coronavirus, having already administered nearly 96 crore doses to adults.
Dr Randeep Guleria, chief of Delhi’s AIIMS, has said children also have to get vaccinated ‘because that’s the only way to get rid of the pandemic’.
As schools re-open and students (and teaching and non-teaching staff) return to classrooms, concerns have been expressed over a spike in cases and the possibility of children being infected by the deadly virus, as well as the necessity to also fully inoculate adults working at all schools.