Posted by Michael Wonder on 18 Dec 2018
Emergent BioSolutions receives Health Canada approval of BioThrax (anthrax vaccine adsorbed)
17 December 2018 - Emergent BioSolutions today announced that Health Canada has approved the company’s new drug submission for its anthrax vaccine, BioThrax (Anthrax Vaccine Adsorbed).
BioThrax is indicated for active immunisation for the prevention of disease caused by Bacillus anthracis, in individuals 18 through 65 years of age, whose occupation or other activities place them at risk of exposure, regardless of the route of exposure. BioThrax is administered in a three-dose primary schedule (0, 1 and 6 months) with boosters at three-year intervals recommended thereafter.
BioThrax was approved under the 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.
