New Delhi, India

Novavax announced on Tuesday (March 22) that the Drugs Controller General of India (DCGI) has granted its coronavirus (COVID-19) vaccine emergency-use authorisation for children aged 12 to 17 years. 

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In a statement published on its website, the company noted that DCGI has granted emergency use authorisation (EUA) for Novavax jabs for adolescents. 

"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 Covovax™ and is the first protein-based vaccine authorized for use in this age group in India," the statement read. 

DCGI has issued permission for restricted use in an emergency situation for Covovax for active immunisation to prevent Covid caused by SARS-CoV-2 in individuals 12 years of age and older.

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Novavax last month said its vaccine was 80 per cent effective against Covid in a late-stage trial testing the shot in 2,247 teens aged 12 to 17 years. 

The country's drug regulator in December authorised Novavax's COVID-19 vaccine for people aged 18 years and above.

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Covovax has also received Emergency Use Listing (EUL) from the World Health Organization. 

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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."  

Adar Poonawalla, Chief Executive Officer, Serum Institute of India, "The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunization efforts across India and LMICs." 

He added, "We are proud to deliver a protein-based COVID-19 vaccine with a favourable safety profile to the adolescents of our nation." 

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(With inputs from agencies)