Novavax and Serum Institute of India Announce Emergency Use Authorization of Novavax’ COVID-19 Vaccine in Adolescents Ages 12 to 18 in India

Novavax’ COVID-19 vaccine has been granted emergency use authorization for use in the adolescent population ages 12–18 in India.

Novavax, a vaccine development and commercialization company, and Serum Institute of India, the world’s largest vaccine manufacturer by volume, announced on March 22, 2022 that Novavax’ COVID-19 vaccine has been granted emergency use authorization (EUA) for adolescents aged 12–18 by the Drugs Controller General of India (DCGI). The protein-based vaccine is currently manufactured in India and marketed under the brand name Covovax.

The EUA for Covovax was initially granted for adults aged 18 years and over in India in December 2021. It is the first protein-based vaccine authorized for the age group of 12–18 in India.

"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 CEO of Novavax, in a press release. "We hope that this authorization of our COVID-19 vaccine in adolescents is the first of many worldwide so that families have an additional choice built on a well-understood platform used in other vaccines for decades."

"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, CEO of Serum Institute of India, in a press release. "We are proud to deliver a protein-based COVID-19 vaccine with a favorable safety profile to the adolescents of our nation."

Source: Novavax