PremiumThe government has not yet decided on vaccinating those aged below 15 against Covid. India has been using Bharat Biotech's Covaxin to vaccinate adolescents between 15 and 18 years.
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The Serum Institute of India (SII) has sought emergency use authorisation (EUA) from India's drug regulator for its Covid-19 vaccine Covovax for the 12 to 17 year age group, reported PTI, quoting sources, on Monday.
"We are submitting our application along with documents for grant of permission for restricted use in an 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 was quoted as saying by the news agency.
Further, as per the report, Prakash Kumar Singh, the director of government and regulatory affairs at SII, has stated in the company's application 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 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 our country and the world against Covid-19 and will keep our national flag flying high globally," Singh reportedly said.
The government has not yet decided on vaccinating those aged below 15. India has been using Bharat Biotech's Covaxin to vaccinate adolescents between 15 and 18 years.
The health ministry had recently said the additional need for vaccination and inclusion of population for inoculation is examined constantly.
The Drugs Controller General Of India had approved Covovax for restricted use in emergency situations in adults on 28 December last year. It was granted an emergency use listing by the World Health Organisation on 17 December 2021.
With this, India number of Covid vaccines that had received emergency use authorisation in the country has increased to eight – SII's Covishield, Bharat Biotech's Covaxin, Zydus Cadila's ZyCoV-D, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson, Corbevax and Covovax.
Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation.
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