On Mar. 22, 2022, Novavax and Serum Institute of India announced that the Drugs Controller General of India (DCGI) had granted emergency use authorization (EUA) for Novavax’ protein-based COVID-19 vaccine for adolescents aged =12 to <18 years in India.

The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name Covovaxﾙ and is the first protein-based vaccine authorized for use in this age group in India.

A Phase 2/3, observer-blinded, randomized, controlled study in a total of 460 Indian adolescents aged ≥12 to <18 years was conducted to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well-tolerated with a reassuring safety profile. Furthermore, the data indicated that Covovax is immunogenic in adolescents aged ≥12 to <18 years. The authorization in India also references the ongoing PREVENT-19 pivotal Phase 3 pediatric expansion trial of NVX-CoV2373 in adolescents in the U.S. aged ≥12 to <18, results of which were shared in February.

Covovax is the fourth vaccine to receive EUA from the DCGI for use among adolescents 12 and older. The safety and efficacy of Covovax in adolescents aged less than 12 years have not yet been established; however, studies evaluating the safety and immunogenicity of Covovax for the age groups of ≥7 to <12 and ≥2 to <7 years in India are underway.

DCGI initially granted EUA for Covovax for adults 18 years old and above in December. In addition, Covovax has received Emergency Use Listing (EUL) from the World Health Organization, as well as EUA in Indonesia, the Philippines, and Bangladesh.