Novavax's Nuvaxovid COVID-19 Vaccine Gets Expanded EUA In Taiwan For Use In Adolescents
(RTTNews) - Biotechnology company Novavax, Inc. (NVAX) announced Friday that the Taiwan Food and Drug Administration (TFDA) has granted expanded emergency use authorization (EUA) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active 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.
The EUA is based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 75 sites in the U.S., to evaluate the safety and effectiveness of Nuvaxovid.
In the pediatric expansion, Nuvaxovid achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95% CI: 37.55%, 92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S
The preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated.
The TFDA previously granted EUA for Nuvaxovid to prevent COVID-19 in adults aged 18 and older in June 2022.
In the 12 through 17-year-old population, the vaccine has been authorized in more than 10 markets including the U.S., the European Union, and the United Kingdom (U.K.).
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