Emergency Use Authorization of Covovax for adolescents

Thursday March 24, 2022 at 1:54 pm

The Serum Institute of India Pvt. Ltd. (SII) is the largest vaccine manufacturer in the world by volume. It announced that the Drugs Controller General of India (DCGI) had granted emergency use authorization (EUA) for the Novavax’ protein-based Covid-19 vaccine for adolescents aged =12 to 18 years in India. The vaccine, also called NVX-CoV2373, is manufactured and marketed in India by Serum Institute of India Pvt. Ltd. (SII) under the brand name Covovax. It 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,” Stanley C. Erck, the president, and chief executive officer of Novava claimed, adding “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, randomized, controlled, and observer-blinded study of a total of 460 Indian adolescents aged 12 up to 18 years was conducted to evaluate the safety and immunogenicity of Covovax. The study proved that Covovax was well-tolerated with a reassuring safety profile, and it also indicated that Covovax is also immunogenic in adolescents. The authorization in the country also referenced the ongoing PREVENT-19 pivotal phase 3 of the pediatric expansion trial of NVX-CoV2373 in the adolescents in the United States that had results declared last month.

“The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunization efforts across India and LMICs,” reflected Adar Poonawalla, chief executive officer of Serum Institute of India. “We are proud to deliver a protein-based Covid-19 vaccine with a favorable safety profile to our nation’s adolescents.”

Covovax is the fourth such vaccine to receive EUA from the DCGI for use among adolescents 12 and older. The safety and efficacy of this vaccine in adolescents aged less than 12 years have not yet been established. Such studies, that is, those evaluating the safety and immunogenicity of the vaccine for the age groups of the two age groups 7 to 12 years and for the group 2 to 7 years in India, are underway.

DCGI had initially granted EUA for Covovax only for adults 18 years old and above last December. In addition, it has received Emergency Use Listing (EUL) from WHO and EUA in various countries like Indonesia, the Philippines, and Bangladesh.

It is a protein-based vaccine first engineered from the genetic sequence of the first strain of SARS-CoV-2, which is the virus that causes Covid-19 disease.

It is packaged as a ready-to-use liquid formulation in vials containing ten doses. The vaccination regimen needs two 0.5 ml doses given intramuscularly 21 days apart. The vaccine must be stored at 2°- 8° Celsius, which is easily possible in existing vaccine supply and cold chain channels.

Novavax, Inc., for the uninitiated, is a biotechnology company committed to developing and commercializing next-generation vaccines for different infectious diseases.

Novavax has already established partnerships for the manufacturing, commercialization, and distribution of the vaccine worldwide. Existing authorizations will leverage Novavax’s manufacturing partnership with the world’s largest vaccine manufacturer by volume, Serum Institute of India (SII). They will also later be supplemented with data from additional manufacturing sites throughout its global supply chain.

Serum Institute of India Pvt, Ltd. is the most prominent vaccine manufacturer by a total number of doses produced and sold globally, with more than 1.5 billion doses. It has supplied the world’s least expensive World Health Organisation accredited vaccines to 170 countries.