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DCGI permits emergency use of SII`s Covovax vaccine for those aged 12-17

India’s drug regulator has granted Restricted Emergency Use Authorization to Serum Institute of India’s COVID-19 vaccine Kovovax for 12-17 years of age group, subject to certain conditions, official sources said on Wednesday.

It is the fourth vaccine to receive regulatory approval for use among people under the age of 18.

The Drugs Controller General of India’s (DCGI) approval comes after CDSCO’s subject expert committee on Covid-19 last week recommended granting emergency use authorization (EUA) to Kovovax for people aged 12 to 17 years.

The government has still not taken a decision on vaccinating people below 15 years of age. The Ministry of Health has consistently stated that the additional requirement of vaccination and the inclusion of the population for vaccination are constantly scrutinized.

In an EUA application to DCGI, on February 21, Prakash Kumar Singh, Director (Government and Regulatory Affairs) at SII, stated that two studies on approximately 2707 children aged 12 to 17 years show that Kovovax is highly efficacious, immunosuppressive, safe and effective. Is. And in this age group of children well tolerated.

“This approval will not only be beneficial for our country, but will benefit the entire world, fulfilling our Prime Minister’s vision of ‘Making in India for the World’. In line with the vision of our CEO, Dr. Adar C Poonawalla, we I am sure that Kovovax will play a vital role in saving the children of our country and the world from the Covid-19 disease and will keep our national flag high globally,” an official source quoted Singh as saying in the application.

DCGI has already approved Covovax on December 28 for restricted use in emergency situations in adults. It has not yet been included in the country’s vaccination campaign.

The DCGI on February 21 banned the European Union’s use of the biological E’s Covid-19 vaccine Corbevax for the age group below 12 to 18 years, subject to certain conditions.

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 list by WHO as of December 2017, 2020.

India is using Bharat Biotech’s Covaxin to vaccinate adolescents aged 15-18 years.

ZyCov-D is the first vaccine approved by India’s drug regulator in August last year to immunize people aged 12 years and above. Indigenously developed Covaxin was approved for emergency use in December 12 to 18 last year.

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