Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that partner SK bioscience has received expanded manufacturing and marketing approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373) for use as a booster for active immunization to prevent COVID-19 in adults aged 18 and older. Prior to the approval, in September 2022, the Korean Centers for Disease Control and Prevention set out recommendations that advised that Nuvaxovid could be used as a booster in adults aged 18 and older.
“We are pleased to collaborate with SK bioscience to offer our protein-based vaccine, Nuvaxovid, for use as a booster in adults regardless of previous vaccine history,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “This is an important step in ensuring broad access to diversified vaccine options.”
This approval is based on data from Novavax’ Phase 2 trial conducted in the U.S. and Australia, from a separate Phase 2 trial conducted in South Africa, and from the United Kingdom-sponsored COV-BOOST trial. As part of the Novavax Phase 2 trials, a single booster dose of Nuvaxovid was administered to 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 significant antibody response when used as a booster dose following prior vaccination with other authorized COVID-19 vaccines.
In the Novavax-sponsored trials, following the booster, local and systemic reactions had a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, often seen with increased immunogenicity. Medically attended adverse events (AE), potentially immune-mediated medical conditions, and severe AEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.
Novavax’ COVID-19 vaccine is authorized for use as an adult booster in more than 35 countries, and a number of other countries have policy recommendations allowing use of the vaccine as a booster dose. The vaccine is actively under review in other markets and has ongoing trials to further explore its efficacy and safety as a booster.
KFMDS previously approved Nuvaxovid as a primary series in adults aged 18 and older in January 2022 and as a primary series in adolescents aged 12 through 17 in August 2022. In Korea, SK bioscience signed a licensing agreement with Novavax and is manufacturing drug substance and drug product of Nuvaxovid for domestic use.