Novavax has announced the first emergency use authorization of its COVID-19 vaccine for adolescents aged 12-18 years in India.
An official statement released by Novovax said 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.
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.
“Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, announced that the Drugs Controller General of India (DCGI) has 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™ and is the first protein-based vaccine authorized for use in this age group in India," the statement said. "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. "We are proud to deliver a protein-based COVID-19 vaccine with a favourable safety profile to the adolescents of our nation," he added. The statement further said that 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. 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.