EUA for Covid vaccine Covovax for 12-17 age group, recommended by Government panel

Official sources said on Friday that an expert panel of the country’s federal drug regulator recommended awarding emergency use authorisation (EUA) to Serum Institute of India’s COVID-19 vaccine Covovax for the 12-17 age range.

On December 28, the Drugs Controller General of India (DCGI) authorised Covovax for limited usage in emergency situations in adults.

It is yet to be incorporated into the country’s immunisation campaign.

On February 21, Prakash Kumar Singh, Director-Government and Regulatory Affairs at the Serum Institute of India (SII), applied to the DCGI for an EUA for Covovax for children aged 12 to 17.

On Friday, the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee on COVID-19 debated on SII’s application and recommended that Covovax be granted EUA.

According to sources, the recommendation will be given to the DCGI for approval.

Singh is said to have indicated in the EUA application that results from two trials involving around 2,700 children aged 12 to 17 years suggest that Covovax is highly effective, immunogenic, safe, and well tolerated in this age range.

“This permission will benefit not just our nation, but the whole globe, bringing our Prime Minister’s goal of “Making in India for the World” to fruition.

We are confident that, in keeping with our CEO Adar C Poonawalla’s philosophy, Covovax will play an important role in protecting children in our country and around the world from COVID-19 disease, and will keep our national flag flying high around the world “Singh had previously stated in the application, according to an official source.

Covovax is made through a technology transfer from Novavax and has been awarded conditional marketing authorisation by the European Medicines Agency, as well as emergency use listing by the World Health Organization (WHO) in December 2017 and 2020.

 

Medically Speaking

Recent Posts

WHY DO YOU EXPERIENCE RUNNY NOSE AFTER EATING SPICY FOOD?

Spicy food – whether it’s a dash of chili in your curry, a spoonful of…

9 mins ago

“4 Simple Tests to Spot Adulterated Wheat Flour: Protect Your Health with These Easy Checks”

How To Identify Adulterated Wheat Flour? Try These 4 Easy Tests Wheat flour is a…

15 mins ago

“Unlock the Power of Jaggery: 10 Surprising Health Benefits of Eating It After Every Meal”

Reasons That Will Make You Eat Jaggery After Every Meal (Potential Health Benefits Inside) Jaggery,…

38 mins ago

“Boost Your Bone Health: Top 9 Calcium-Rich Foods for Stronger, Healthier Bones”

Want Stronger Bones? Here Are Top 9 Calcium Sources Our bones are the framework that…

46 mins ago

“Protect Your Vision: Essential Tips to Prevent Diabetic Retinopathy and Safeguard Your Eyesight!”

Diabetic Retinopathy Disease: Diabetic patients are at high risk of losing their eyesight due to…

56 mins ago

“Watch: Unlock the Incredible Health Benefits of Papaya Leaves – A Natural Remedy for Lifelong Wellness!”

Benefits Of Papaya Leaves: Did you know that papaya leaves are incredibly beneficial for your…

1 hour ago