Bavarian Nordic, an international biotechnology company, has announced that Health Canada has granted a notice of compliance approving IMVAMUNE for active immunization against smallpox in a public health emergency.
IMVAMUNE is indicated for persons 18 years of age and older who are contraindicated to replicating smallpox vaccines. This includes individuals with immune deficiencies and skin disorders.
Health Canada is the second regulatory body to approve the company's smallpox vaccine which earlier in 2013 was approved by the European Commission for use in the general adult population in all 28 EU countries and Iceland, Liechtenstein and Norway, where it is marketed under the trade name IMVANEX.
Since 2008, Bavarian Nordic has collaborated with the Canadian Government to address their biological preparedness requirements.
The company was initially awarded a contract to supply 20,000 doses of IMVAMUNE to the Canadian armed forces, followed by a replacement order in 2012. The original contract also provided funding for filing a New Drug Substance application for IMVAMUNE.
Bavarian Nordic president and CEO Anders Hedegaard noted the approval of IMVAMUNE in Canada continues the company's track record of successfully working with governments to address their biological preparedness requirements.
"We have partnered with the U.S. government for more than a decade on the development of our smallpox vaccine and we are delighted that Canada now leverages on this successful partnership. This approval provides further validation of our MVA-BN vaccine technology platform which we have successfully developed and commercialized," Hedegaard added.
