Novovax's COVID-19 Vaccine Gets Emergency Use Nod From DCGI for Kids Aged 12-17

Serum Institute of India's Covovax has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12.

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American drugmaker Novavax's COVID-19 vaccine, manufactured in India by the Serum Institute of India (SII), has received emergency-use authorisation from the Drugs Controller General of India (DCGI) for children aged 12 to 17 years.

The vaccine, Covovax, is the first protein-based vaccine authorised for use in this age group in India. Novavax, in February, had said that its vaccine was 80 percent effective against COVID-19 in a late-stage trial testing the vaccine in 2,247 teens aged 12 to 17 years.

"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 CEO, Novavax.

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," as per a press release by Novavax.

The DCGI had granted EUA for Covovax for adults aged 18 and over in December 2021. In addition, Covovax has received Emergency Use Listing (EUL) from the World Health Organization.