Apex®-IHN is a plasmid DNA-based vaccine for use by salmon farms in the prevention of infectious hematopoietic necrosis virus (IHNV) disease. It was developed by Novartis based on technology licensed from Vical. Apex®-IHN received licensure from the Canadian Food Inspection Agency (CFIA) in 2005, the first commercial DNA vaccine to achieve approval for sale and use in Canada, where it is currently marketed by Novartis Aqua Health. A detailed information package was submitted by Novartis to the CFIA as part of this licensure process, including data supporting the safety of the vaccine not only for treated fish but also for humans and the environment. The successful licensure, marketing and use of this product represent an important validation of the potential for Vical’s technology, both for the prevention of infectious diseases and for the development of commercially successful products.
IHNV is endemic in the Pacific Northwest, an important area for salmon aquaculture. IHNV infection can produce a fatal disease, and an epidemic has the potential to devastate fish hatcheries, with mortality rates rising up to 90%. Apex®-IHN, delivered as a one-time intramuscular injection to young fish at the hatchery, is effective in generating a robust immune response to prevent such outbreaks.