India’s drug regulator has granted restricted emergency use authorisation to Serum Institute of India’sfor the 12-17 years age group subject to certain conditions, official sources said on Wednesday.
It is the fourth vaccine to receive the regulator’s nod for use among those below 18 years.
The Drugs Controller General Of India’s (DCGI) approval comes after the Subject Expert Committee onof the CDSCO last week recommended granting emergency use authorisation (EUA) to Covovax for those aged 12 to 17.
The government has still not not taken a decision on vaccinating those aged below 15 years. The health ministry has consistently said that additional need for vaccination and inclusion of population for vaccination are examined constantly.
In the EUA application to DCGI, Prakash Kumar Singh, director (government and regulatory affairs) at SII on February 21 had stated that the data from two studies on about 2707 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, Dr 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.
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 vaccinefor the 12 to less than 18 years 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 WHO on December 2017, 2020.
India has been using Bharat Biotech’s
ZyCov-D is the first vaccine cleared by India’s drug regulator for inoculation of those aged 12 years and above in August last year. Indigenously-developed Covaxin received approval for emergency use in 12 to 18 in December last year.