12.08.2022 15:40:40
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South Korea Approves Novavax's Nuvaxovid COVID-19 Vaccine For Use In Adolescents
(RTTNews) - Novavax Inc. (NVAX) said Friday that partner, SK bioscience, has received a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent COVID-19 caused by the SARS-CoV-2 in adolescents aged 12 through 17.
In the 12 through 17 year-old population, Nuvaxovid has been granted authorization in India, the European Union, Australia, Thailand, and Japan, and is actively under review in other markets.
The South Korea approved Nuvaxovid for use in adults aged 18 and older in January 2022. In Korea, SK bioscience signed a licensing agreement with Novavax and is manufacturing drug substance and drug product of Nuvaxovid for domestic use.
The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.
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