English
New Delhi: Serum Institute of India’s CEO Adar Poonawala on Wednesday said his company-made Covovax vaccine has been granted Emergency Use Authorisation by the DCGI for adults and for children above the age of 12. He also said that the younger age groups will follow shortly and added that Novavax in global trials has demonstrated more than 90% efficacy.
Interestingly, Covovax is the fourth vaccine to receive the regulator’s nod for use among those below 18 years.
The approval from Drugs Controller General Of India’s (DCGI) 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.
Serum Institute of India's Covovax has been granted Emergency Use Authorisation by DCGI for adults & for children above the age of 12. Younger age groups will follow shortly. Novavax in global trials has demonstrated more than 90% efficacy: SII CEO Adar Poonawala pic.twitter.com/TU0ggaWRfK
— ANI (@ANI) March 9, 2022
Amid this development, the Centre has still 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, as reported by PTI.
On December 28 last year, the DCGI had approved Covovax for restricted use in emergency situations in adults. 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.
(With inputs from PTI)
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