Novavax Covid vaccine gets emergency use authorisation for teens in India

Novavax Inc has confirmed that its Covid-19 vaccine NVX-CoV2373 has got emergency use authorization from the Drugs Controller General of India for teens.

The biotechnology company Novavax Inc and Serum Institute of India Pvt. Ltd. have 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 Novavax Covid vaccine is manufactured and marketed in India by 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.

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." 

"We hope that this authorization of our COVID-19 vaccine in adolescents is the first of many worldwide so that families have an additional choice built on a well-understood platform used in other vaccines for decades."

Covovax is fourth Covid vaccine to receive EUA from the DCGI for teens

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, said the official statement.

A Phase 2/3, observer-blinded, randomized, controlled study was conducted to evaluate the safety and immunogenicity of Covovax in a total of 460 Indian adolescents aged ≥12 to <18 years. The study demonstrated that the vaccine was well-tolerated with a reassuring safety profile and is immunogenic in teenagers.

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

"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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