Novavax, a biotechnology company dedicated to developing and commercialising next-generation vaccines for serious infectious diseases, announced on Tuesday the first emergency use authorization of its COVID-19 vaccine for adolescents aged 12 to 18 years in India.
According to a Novovax official statement, the vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by the Serum Institute of India (SII) under the brand name Covavax, is the first protein-based vaccine approved for use in this age group in India.
The Drugs Controller General of India (DCGI) has approved Covovax for limited use in an emergency situation for active immunisation against COVID-19 caused by SARS-CoV-2 in people aged 12 and up.
Stanley C Erck, President and CEO of Novavax said that “We are proud of this first approval in adolescents given the efficacy and safety that our data show in this population and our COVID-19 vaccine will provide an alternative protein-based vaccine option for individuals 12 years of age and older in India”.
He further added, “We are proud to offer a protein-based COVID-19 vaccine with a favourable safety profile to our country's adolescents”.
Notably, in December, DCGI (Drugs Controller General Of India) granted emergency use authorization for Covovax for adults aged 18 and up. Furthermore, Covovax has been granted an Emergency Use Listing (EUL) by the World Health Organization, as well as EUA in Indonesia, the Philippines and Bangladesh.
The DCGI has approved Covovax as the fourth vaccine for use in adolescents aged 12 and up. The safety and efficacy of Covovax in adolescents under the age of 12 years have not yet been established; however, studies in India are currently underway to assess the safety and immunogenicity of Covovax in the age groups of 7 to 12 years and 2 to 7 years.
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