Intervacc applies for a Permit for Sale and Distribution of Strangvac in the U.S.

Stockholm, February 16, 2022 - Intervacc AB (publ) announces that the Company’s application for a Permit for Sale and Distribution of Strangvac in the U.S. has been submitted to the U.S. Department of Agriculture (USDA).

Intervacc is seeking approval for Strangvac, a vaccine against the highly contagious equine disease strangles that affects horses worldwide. Strangvac has been approved for use in the European Union, the United Kingdom, Norway, and Iceland since the autumn of 2021.

“The number of horses in the United States is estimated to be around 10 million representing the largest market for equine vaccines in the world. The filing represents a significant milestone for Intervacc and is a major step towards preventing outbreaks and suffering in horses. Strangles is the most frequently diagnosed contagious equine disease in the world and in the case of an outbreak, stables must be quarantined and owners often face great difficulties and costs.” said Andreas Andersson, Chief Executive Officer of Intervacc.

“Authorization to sell and market animal vaccines in the United States is handled by the Center for Veterinary Biologics, CVB, which is part of the USDA. The data in the dossier is similar to what was required for the European approval, and we are well prepared for the process benefitting from the help of very experienced local experts. As in the European process, the authority will evaluate Strangvac on the basis of production, safety and efficacy. It is still too early for us to say how long the process will take, but we are very confident that Strangvac will be approved for use in the United States as well.” says Dr. Tim Wood, Head of Manufacturing and Regulatory Affairs at Intervacc.

"An extensive scientific study in which researchers from Sweden, the United Kingdom and the United States examined DNA from a total of 759 isolates of Streptococcus equi from 19 different countries was published in the 'Equine Veterinary Journal' in January this year. The study confirms that Strangvac is likely to be effective against all known strains of the bacteria that causes equine strangles, which is very relevant to our application for a marketing authorization in the USA.” says Dr. Andrew Waller, head of research at Intervacc.

The Strangvac vaccine has been developed with innovative technology and is based on recombinant fusion proteins. The research that forms the basis for the vaccine's technical platform has been carried out together with researchers at the Karolinska Institutet and the Swedish University of Agricultural Sciences, SLU.

For more information please contact:  

Andreas Andersson, CEO

Phone: +46-8-120 10 601, cell +46-73-335 99 70

E-mail: andreas.andersson@intervacc.com

The information was submitted for publication, through the agency of the contact person set out above on February 16, 2022, 08.30 CET.

About Intervacc

Intervacc AB is a Swedish company within animal health developing safe, effective vaccines for animals. The Company's vaccine candidates are based on several years of research at Karolinska Institutet and Swedish University of Agricultural Research where the foundation was laid for the Company´s research and development work. The Intervacc share has been listed on the Nasdaq First North Growth Market since April 2017 with Eminova Fondkommission AB, adviser@eminova.se, +46 (0)8–684 211 10 as Certified Adviser.

About equine strangles

Equine strangles, caused by Streptococcus equi, is the most frequently diagnosed infectious disease of horses, and affects horses all over the world with one exception Iceland where the import of horses is prohibited. Streptococcus equi invades the lymph nodes of head and neck, causing them to swell and form abscesses that can literally strangle, in around 2% of cases, the horse to death. Some of the horses that recover from strangles remain persistently infected. These apparently healthy animals shed bacteria into the environment and spread the disease to other horses with which they come into contact.

Contact information for Certified Adviser

Eminova Fondkommission AB

E-mail: adviser@eminova.se, Phone: +46 (0)8 – 684 211 10