Health Canada approves Emergent BioSolutions’ new anthrax vaccine

Health Canada, the federal drug approval arm for Canada, has approved a vaccine for anthrax developed by Emergent BioSolutions Inc., the global life sciences company announced on Monday.

The vaccine, BioThrax, is designed to immunize people from infectious disease caused by spores of the bacterium Bacillus anthracis.

BioThrax was approved under Health Canada’s Extraordinary Use New Drug Regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible.

“With the growing awareness of biological and chemical threats around the globe, Emergent is committed to partnering with allied governments and providing preparedness solutions to meet their national security needs,” said Abbey Jenkins, senior vice president and vaccines and anti-infectives business unit head at Emergent BioSolutions. “We are pleased to receive Health Canada licensure of BioThrax, fulfilling our commitment to the Canadian government, and enabling future procurement of this critical medical countermeasure.”

BioThrax is intended for individuals between the ages of 18 and 65 years old whose occupation or activities place them at risk of exposure to the disease, Emergent said.

The U.S. Centers for Disease Control and Prevention states that anthrax can be found naturally in soil and commonly affects domestic and wild animals around the world. While rare, people can get sick with anthrax if they come in contact with infected animals or contaminated animal products. If contracted, it can cause severe illness in both humans and animals.

Health Canada granted BioThrax market exclusivity for eight years. Earlier this year, Emergent conducted the necessary paperwork to expand licensure of BioThrax in five European countries – the U.K., Poland, France (marketed as BaciThrax), Italy, and the Netherlands. BioThrax received market authorization in Germany in 2013.

BioThrax is the only vaccine for the prevention of anthrax disease licensed by the U.S. Food and Drug Administration. The U.S. government stores the vaccine in the Strategic National Stockpile to be used as part of a post-exposure prophylaxis regimen with licensed antibiotics in the event of a biological terrorist attack with anthrax, according to the FDA.

BioThrax is administered in three doses with follow up doses at one and six months with boosters at three-year intervals thereafter. Individuals are not considered protected until they have completed the three-dose primary immunization series, the company said.

More than 14 million doses of BioThrax have been administered to more than 3 million individuals, Emergent said.