Novovax Covid-19 vaccine gets emergency use nod for those aged between 12-18 years in India

New Delhi: Novavax has announced the first emergency use authorization for its Coovid-19 vaccine for adolescents falling in the age bracket of 12-18 years in India. According to an official statement released by Novovax, the vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by the Serum Institute of India (SII) under the brand name Covovax and is the first protein-based vaccine authorized for use in this age group in India.

The Drugs Controller General of India (DCGI) has issued permission for restricted use in an emergency situation for Covovax for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

"We`re proud of this first approval in adolescents given the efficacy and safety that our data show in this population and that our COVID-19 vaccine will provide an alternative protein-based vaccine option for individuals 12 years of age and older in India," said Stanley C Erck, President and Chief Executive Officer, Novavax.

"The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunization efforts across India and LMICs," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India.

Novavax in global trials has demonstrated more than 90% efficacy. @SerumInstIndia's brand Covovax has completed bridging studies in India & has been granted Emergency Use Authorisation by DCGI for adults & for children above the age of 12. Younger age groups will follow shortly. — Adar Poonawalla (@adarpoonawalla) March 9, 2022

"We are proud to deliver a protein-based COVID-19 vaccine with a favourable safety profile to the adolescents of our nation," he added. Notably, DCGI initially granted emergency use authorization for Covovax for adults of 18 years old and above in December. 

In addition, Covovax has also received Emergency Use Listing (EUL) from the World Health Organization.