Vaccine maker Novavax announced on Tuesday (March 22) that the Drug Controller General of India (DCGI) has granted the company emergency use authorization for the Coronavirus (COVID-19) vaccine for children aged 12-17 years. In a statement published on its website, the company reported that DCGI had approved the use of Novavax for adolescents in an emergency situation.
The vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII [Serum Institute of India Pvt. Ltd.] under the brand name CovovaxTM. It is the first protein-based vaccine approved for use in this age group in India.
Novavax and Serum Institute of India Announce First Emergency Use Authorization of Novavax' COVID-19 Vaccine in Adolescents ?12 to <18 in India: https://t.co/rYDgw9jNM0
— Novavax (@Novavax) March 22, 2022
DCGI has granted permission for the restricted use of Covovax in an emergency situation for the active immunization of individuals 12 years and older in order to prevent disease caused by SARS-CoV-2. Novavax announced last month that its vaccine was 80 percent effective against Covid in a late-stage trial testing the shot on 2,247 teens aged 12 to 17. Novavax’s COVID-19 vaccine was approved by the country’s drug regulator in December for people aged 18 years or older.
The World Health Organization has also listed Covovax on its Emergency Use List (EUL). Stanley C Erck, President and Chief Executive Officer, Novavax 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.’
‘The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunization efforts across the nation and other LMICs,’ according to Darar Poonawalla, CEO of Serum Institute of India. ‘We are especially proud of our protein-based COVID-19 vaccine, which we believe has a favourable safety profile’.
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