New Delhi: Serum Institute of India (SII) has sought emergency use authorisation (EUA) from DGCI for its Covid-19 vaccine ‘Covovax’ for the 12 to 17 year age group, official sources said Monday. The government has not yet decided on vaccinating those aged below 15. The Health Ministry had recently said the additional need for vaccination and inclusion of population for inoculation is examined constantly.
In the application for emergency use authorisation (EUA) for the 12-17 year age group, Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, is learnt to have stated that data from two studies on about 2,707 individuals aged 12 to 17 years show Covovax is highly efficacious, immunogenic, safe and well-tolerated in this age group.
“We are submitting our application along with documents for grant of permission for restricted use in emergency situation for ‘Covovax’ vaccine in children aged 12 to 17 years in addition to approved age of individuals 18 years and older,” an official source quoted Singh as having said in the application.
“This approval will not only be beneficial for the country but will also benefit the world, fulfilling Prime Minister Narendra Modi’s vision of ‘Making in India for the World’, Singh is learnt to have said.
“In line with the philosophy of our CEO Dr Adar C Poonawalla, we are sure that ‘Covovax’ will play an important role in protecting the children of India and the world against Covid-19 and will keep our national flag flying high globally,” Singh also said in the application.
The Drugs Controller General of India (DCGI) has already approved Covovax for restricted use in emergency situations in adults December 28.
‘Covovax’ is manufactured by technology transfer from ‘Novavax’ and is approved by the European Medicines Agency for conditional marketing authorisation. It has been granted emergency use listing by the World Health Organisation December 17, 2021. India has been using Bharat Biotech’s Covaxin to vaccinate adolescents between 15 and 18 years.