An expert panel of the country’s central drug authority has recommended granting emergency use authorisation (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 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 submitted an application 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 Organisation (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.
"This approval will not only be beneficial for our country alone, but will benefit the entire world, fulfilling our Prime Minister’s vision of 'Making in india for the World'. In line with the philosophy of our CEO Adar C Poonawalla, we are sure that Covovax will play an important role to protect children of our country and world at large against COVID-19 disease and will keep our national flag flying high globally,” an official source had quoted Singh as having stated in the application earlier.
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 WHO on December 2017,2020.
India has been using Bharat Biotech’s Covaxin to vaccinate adolescents between 15-18 years.
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