India's drug regulator has granted restricted emergency use authorisation to Serum Institute of India's COVID-19 vaccine Covovax for 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 on COVID-19 of 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 vaccine Corbevax for 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 Covaxin to vaccinate adolescents between 15-18 years.
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.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
Dear Reader,
Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.
We, however, have a request.
As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.
Support quality journalism and subscribe to Business Standard.
Digital Editor
RECOMMENDED FOR YOU