Bavarian Nordic A/S announced today that Health Canada has expanded the approval of the Company’s non-replicating smallpox vaccine, IMVAMUNE® to include additional indications – specifically, monkeypox and related orthopoxvirus infections and disease in adults 18 years of age and older determined to be at high risk for exposure.
The extended approval was granted following assessment of additional clinical and non-clinical data, generated since IMVAMUNE received approval as a smallpox vaccine by Health Canada in 2013. These data include among others a Phase 3 study which demonstrated that, in terms of efficacy, IMVAMUNE was non-inferior to replicating smallpox vaccines, while also confirming its favorable benefit/risk profile. IMVAMUNE is approved in Canada under the Extraordinary Use New Drugs (EUNDS) Pathway.
Paul Chaplin, President and CEO of Bavarian Nordic said. “The extended approval of IMVAMUNE in Canada confirms its potential to prevent infections from a wider range of orthopoxviruses, many of which are naturally occurring. While monkeypox is endemic to certain parts of Africa, orthopoxvirus infections may occur from animals to humans all over the world. Although cases are rare, no vaccine has previously been approved for these indications, and we are pleased to receive this extended approval of IMVAMUNE.”
Bavarian Nordic has collaborated with the Canadian authorities since 2008 on supplying IMVAMUNE, initially for the Canadian Department of National Defence. Subsequent to the initial Canadian EUNDS approval in 2013, Bavarian Nordic has also collaborated with the Public Health Agency of Canada for stockpiling of the vaccine for the general population.