NEW DELHI: An expert panel advising the Central Drugs Standard Control Organisation (CDSCO) has recommended granting emergency use authorisation to Serum Institute of India’s (SII) Covovax for use in children aged 7-11, official sources said Friday. Now, the Drugs Controller General of India (DCGI) will review the recommendation before granting final approval.
Officials said the Subject Expert Committee deliberated upon the matter and recommended EUA for use in younger children. The process of data review was on for past few months. The application for emergency use authorisation was submitted by Prakash Kumar Singh, Director (government and regulatory affairs) at SII, on March 16. The expert panel in its last meeting in April had sought more data from the Pune-based firm.
Covovax, the protein vaccine from US major Novovax, already has DCGI nod for use in adults as well as the 12-17 age group. Bharat Biotech’s Covaxin, too, has approval for use for 12-17-year olds. The government has procured Biological E’s Corbevax for adolescent vaccination but has not placed orders for Covovax, officials said.
The expert panel had recommended the use of Corbevax for children as young as five in April, while it had sought more data from Bharat Biotech for kids in 2-11 group. India started vaccinating adolescents in the age group of 15-18 years in January, and expanded the drive to include children as young as 12 years from March.