On Oct. 10, 2022, Novavax announced that partner, SK bioscience, had submitted a Post Approval Change Application to the Korean Ministry of Food and Drug Safety for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for use as a heterologous and homologous booster for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults aged 18 and older. In September 2022, the Korean Centers for Disease Control and Prevention advised that Nuvaxovid can be used off-label as a booster in adults aged 18 and older.

This request is based on data from Novavax’ Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a meaningful antibody response when used as a heterologous third booster dose.