Novavax seeks UK nod for Nuvaxovid use in adolescents aged 12 through 17 years
NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
New Delhi: Novavax has announced the submission of a request to the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain to expand the authorization of Nuvaxovid (NVX-CoV2373) COVID-19 Vaccine (recombinant, adjuvanted), for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years.
The MHRA previously granted conditional marketing authorization (CMA) for Nuvaxovid in individuals 18 years of age and older in February 2022. The vaccine is given as a primary vaccination in two doses administered 21 days apart.
This request for CMA expansion is based on the totality of pre-clinical, clinical, and manufacturing-related (CMC) data provided to the agency. This submission includes clinical data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase 3 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. The vaccine achieved its primary effectiveness endpoint in the trial and demonstrated 80 percent efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S.
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Additionally, preliminary safety data from the pediatric expansion of PREVENT-19 showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine.
In the 12 through 17 year-old population, Novavax continues to submit regulatory filings worldwide, with emergency use authorization in this age range granted in India.
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NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
