New Delhi: An expert panel of the country's central drug authority has recommended granting emergency use authorization (EUA) to Serum Institute of India's Covid-19 vaccine Covovax for the 12-17 age group, official sources said on Friday. The Drugs Controller General of India (DCGI) had approved Covovax for restricted use in an emergency situation in adults on December 28. It has not yet been included in the country's vaccination drive.

Prakash Kumar Singh, director-Government and Regulatory Affairs at Serum Institute of India (SII), had applied to the DCGI on February 21, seeking EUA for Covovax for the 12 to 17 years age group. The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Friday deliberated on SII's application and recommended granting EUA to Covovax.

The recommendation will be sent to the DCGI for approval, sources said. In the EUA application, Singh is learnt to have stated that data from two studies on about 2,700 children aged 12 to 17 years show that Covovax is highly efficacious, immunogenic, safe and well-tolerated in this age group of children.

Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorization and also granted emergency use listing by WHO on December 2017, 2020. India has been using Bharat Biotech's Covaxin to vaccinate adolescents between 15-18 years.

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