Posted by Michael Wonder on 10 Jul 2022
Novavax files in Switzerland for expanded conditional marketing authorisation of Nuvaxovid COVID-19 vaccine for adolescents aged 12 through 17 and as a booster in individuals aged 18 and over
7 July 2022 - Novavax today announced the submission of a request to Swissmedic to expand the conditional marketing authorisation of Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in Switzerland for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adolescents aged 12 through 17 years and as a booster dose for individuals aged 18 and over.
The request for expanded conditional marketing authorisation for adolescents aged 12 through 17 is based on data from the on-going paediatric 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.
