Novavax and SII Announce First EUA of Novavax' COVID-19 Vaccine in Adolescents ≥12 to <18 in India

23 March 2022 | Wednesday | News

First authorization of Novavax' COVID-19 vaccine in adolescent population received
Image Source : Public Domain

Image Source : Public Domain

  • Covovax™ (SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine) is the first protein-based COVID-19 vaccine authorized for adolescents ≥12 to <18 in India
  • Authorization highlights immunogenicity and reassuring safety profile of Covovax in Phase 2/3 study of Indian adolescents aged ≥12 to <18 and data from an ongoing Phase 3 pediatric expansion trial of NVX-CoV2373 in adolescents aged ≥12 to <18 in the U.S.

 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, 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 vaccine, also known as NVX-CoV2373, is manufactured and marketed in India by SII under the brand name Covovax™ and is the first protein-based vaccine authorized for use in this age group in India.

"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 Chief Executive Officer, Novavax. "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."

A Phase 2/3, observer-blinded, randomized, controlled study in a total of 460 Indian adolescents aged ≥12 to <18 years was conducted to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well-tolerated with a reassuring safety profile. Furthermore, the data indicated that Covovax is immunogenic in adolescents aged ≥12 to <18 years. The authorization in India also references the ongoing PREVENT-19 pivotal Phase 3 pediatric expansion trial of NVX-CoV2373 in adolescents in the U.S. aged ≥12 to <18, results of which were shared in February.

"The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunization efforts across India and LMICs," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to deliver a protein-based COVID-19 vaccine with a favorable safety profile to the adolescents of our nation."

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.

DCGI initially granted EUA for Covovax for adults 18 years old and above in December. In addition, Covovax has received Emergency Use Listing (EUL) from the World Health Organization, as well as EUA in Indonesia, the Philippines, and Bangladesh. For additional information on Covovax, please visit the following websites:

Authorized Use of Novavax' COVID-19 Vaccine in India
The Drugs Controller General of India (DCGI) has issued a permission for restricted use in emergency situation for Covovax for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.

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