Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Health Canada has granted expanded authorization for Nuvaxovid™ (COVID-19 Vaccine (Recombinant protein, Adjuvanted)) (NVX-CoV2373) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous booster in adults aged 18 and older.
“Canadians now have access to our protein-based Nuvaxovid COVID-19 vaccine as an adult booster,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “With the winter months upon us, it’s important to have options for vaccination to help protect against COVID-19.”
The expanded authorization was based on data from a Phase 2 trial conducted in South Africa and from the Prevent-19 Phase 3 trial conducted in the U.S. and Mexico. As part of the trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six to 11 months after their primary series of two doses administered three weeks apart. The third (booster) dose produced increased immune responses to levels comparable to or exceeding those associated with protection against COVID-19 in Phase 3 clinical trials.
In the 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. The most frequent adverse reactions were injection site tenderness (68%), injection site pain (56%), fatigue (45%), myalgia (44%), headache (41%), malaise (35%), arthralgia (20%), and nausea or vomiting (11%). Following the booster vaccination in adults, frequencies and severity (all grades) of solicited adverse events generally increased, with most events being mild to moderate in severity.
Novavax’ vaccine has been authorized as a heterologous and homologous booster in the U.S., European Union, United Kingdom (U.K.), Japan, Australia, New Zealand, and Switzerland, and a number of other countries have policy recommendations allowing use of the vaccine as a heterologous or homologous booster dose. Novavax has ongoing trials to further explore the vaccine’s immunogenicity and safety as a heterologous booster.
Health Canada previously authorized Nuvaxovid as a primary series in adults aged 18 and older in February 2022. Novavax filed in Canada for the vaccine’s use as a primary series in adolescents aged 12 through 17 in June 2022.
Trade Name in the U.S.
The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration (FDA).