MHLW (Japan) provides supplemental approval for Nuvaxovid to prevent COVID 19 in adolescents, caused by severe acute respiratory syndrome
Novavax, Inc. announced that Nuvaxovid (NVX-CoV2373) COVID-19 vaccine received expanded manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for primary immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17
Novavax has partnered with Takeda to develop, manufacture, and distribute Nuvaxovid in Japan.
The expanded approval was based on data from the ongoing pediatric expansion of PREVENT-19, a pivotal Phase III 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. In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical 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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