India's drug regulator has granted restricted emergency use authorisation to the Serum Institute's COVID-19 vaccine Covovax for the 12-17 age-group subject to certain conditions.
Confirming the Drugs Controller General of India's (DCGI) approval, Serum Institute of India Chief Executive Officer Adar Poonawalla on Tuesday tweeted: "@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly."
It is the fourth vaccine to receive the regulator's nod for use among those below 18 years. However, only one vaccine — Bharat Biotech's Covaxin — is used for the 15-18 age-group in the vaccination drive in the country after the government approval.
The DCGI approval comes after the Subject Expert Committee on COVID-19 of the CDSCO last week recommended granting emergency use authorisation (EUA) to Covovax for those aged 12 to 17.
The government has still not taken a decision on vaccinating those aged below 15 and the Health Ministry has consistently said additional need for vaccination and inclusion of population for vaccination were examined constantly.
‘Highly efficacious’
In the EUA application to the DCGI on February 21, Prakash Kumar Singh, Director (government and regulatory affairs) at the SII had stated that the data from two studies on about 2,707 children aged 12 to 17 showed that Covovax was highly efficacious, immunogenic, safe and well-tolerated.
Mr. Singh, in his application, had said, "this approval will not only be beneficial for our country, but will benefit the entire world, fulfilling our Prime Minister's vision of 'making in India for the world'.
The DCGI has already approved Covovax for restricted use in emergency situations in adults on December 28. It has not yet been included in the country's vaccination drive.
The DCGI on February 21 granted restricted EUA to Biological E's COVID-19 vaccine Corbevax for the 12-18 age-group subject to certain conditions.
Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by the WHO in December 2020. ZyCov-D is the first vaccine cleared by India's drug regulator for inoculation of those aged 12 and above in August last year. Indigenously developed Covaxin received approval for emergency use in 12 to 18 age-group in December last year.
