Expert panel of the Central Drug Authority has recommended granting emergency use authorisation to Bharat Biotech’s Covaxin for children in the 2 to 18 years age group with certain conditions.
With this, Covaxin becomes the first COVID-19 vaccine that can be administered to children in India. Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid vaccine Covaxin for use in children aged between 2 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 at the beginning of this month. The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday.
“After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” the SEC recommendations stated. The recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval.
The company had presented its proposal for grant of market authorisation of its Whole Virion, Inactivated coronavirus Vaccine (BBV152) in the 2 to 18 years age group for restricted use in the emergency situation along with the interim safety and immunogenicity data of phase 2/3 clinical trial conducted. The committee noted that the interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26.
The overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in the phase -3 efficacy study, the recommendations stated. After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the 2 to 18 years age group for restricted use in emergency situations subject to certain conditions, they stated.