Novavax applies to the EU to expand the scope of the new crown vaccine authorization for adolescents aged 12-17

Novavax has announced that it has submitted a Conditional Marketing Authorization Application (CMA) in the European Union for its COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for adolescents aged 12-17
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If finally approved, the vaccine would be the first protein-based Covid-19 vaccine for 12-17-year-olds in the European market

The documents submitted for this expansion application consist primarily of clinical data from the ongoing PREVENT-19 pediatric expansion study
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This is a pivotal Phase 3 trial evaluating the safety, efficacy (immunogenicity) and efficacy of the vaccine in 2,247 adolescents aged 12-17 years across 73 U.

Preliminary safety data from the PREVENT-19 pediatric extension study showed that the NVX-CoV2373 vaccine was well tolerated
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There were also fewer cases of serious adverse events related to vaccination, were relatively evenly distributed between the vaccine and placebo groups, and side effects were generally not vaccine-related

NVX-CoV2373 is a protein-based vaccine designed from the genetic sequence of SARS-CoV-2, the first virus that causes COVID-19 disease
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NVX-CoV2373 uses Novavax recombinant nanoparticle technology to create antigens derived from the coronavirus spike (S) protein and is formulated with a patented saponin-based Matrix-M adjuvant, which enhances immune responses and stimulates high levels of production in patients of neutralizing antibodies

The NVX-CoV2373 vaccine contains purified protein antigens that neither replicate nor cause COVID-19 disease
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In December 2021, the European Commission granted conditional marketing authorization for the Nuvaxovid vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older

It is worth noting that the Directorate General of Drug Control of India has also recently approved NVX-CoV2373 for restricted use in emergency situations for adolescents aged 12-17
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SKbioscience, Novavax's South Korean licensing company, also recently submitted a regulatory application to the South Korean Ministry of Food and Drug Safety to authorize injections for juveniles

Original source: https:// -to-adolescents-ages-12-17--829585389.

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