Covovax is said to be the first protein-based recombinant Covid-19 vaccine authorised for adolescents in India, based on a Phase 2/3 study of NVX-CoV2373 in Indian adolescents
Novavax Scientist Conducting Vaccine Development Research. (Credit: Novavax, Inc.)
Novavax has received approval from the Drugs Controller General of India (DCGI) for emergency use of its protein-based Covid-19 vaccine, known as NVX-CoV2373, in adolescents aged 12 to 18 years.
NVX-CoV2373 is a protein-based vaccine developed from the genetic sequence of SARS-CoV-2, using the company’s recombinant nanoparticle technology.
Novavax is manufacturing and marketing its vaccine in India, through a partnership with Serum Institute of India (SII), under the brand name Covovax.
In December last year, Covovax has initially received EUA from DCGI for use in adults aged 18 years old and above.
It has also received Emergency Use Listing (EUL) from the World Health Organization, in addition to EUA in Indonesia, the Philippines, and Bangladesh.
Covovax is the first protein-based vaccine to receive DCGI authorisation for use in adolescents aged 12 to 18 years, said the company.
Novavax president and CEO Stanley Erck 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 authorisation 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.”
The DCGI approval was supported by Phase 2/3 trial that assessed the safety and immunogenicity of Covovax in 460 Indian adolescents aged between 12 and 18 years.
In the study, the vaccine was well-tolerated with a superior safety profile and showed immunogenicity in adolescents aged 12 to 18 years, according to the data.
The authorisation was also supported by the ongoing Phase 3 PREVENT-19 paediatric expansion trial in the US, which evaluated adolescents aged 12 to 18 years.
The Phase 3 PREVENT-19 trial recruited around 30,000 participants in the US and Mexico and has shown 90.4% overall efficacy for Covovax.
The vaccine is not advised for people who have a hypersensitivity to the active substance, or to any of its excipients.
SII CEO Adar Poonawalla said: “The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunisation 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.”