Intervacc seeks EMA approval for 12-month immunity claim for Strangvac

Intervacc has submitted a Type II variation application to the European Medicines Agency (EMA) seeking to extend the approved duration of immunity for its equine strangles vaccine, Strangvac, from two months to 12 months, supported by new long-term immunogenicity data.

Intervacc AB has submitted a Type II variation application to the European Medicines Agency (EMA) requesting an extension of the approved duration of immunity for its equine strangles vaccine, Strangvac, from the current two months to 12 months.

The application is supported by data indicating that protective antibody levels remain present for 12 months following completion of the primary vaccination course.
Strangles, caused by Streptococcus equi, is one of the most commonly diagnosed infectious diseases in horses worldwide and can lead to significant health and economic impacts. Strangvac, a recombinant protein-based vaccine, is currently approved for use across the European Union, the United Kingdom, Iceland, Norway and Liechtenstein, and has been launched in multiple European markets.

According to Intervacc, the original marketing authorization was based on data supporting a two-month duration of immunity. The new submission draws on a recently published peer-reviewed study that established a correlation between sustained antibody levels and protection against disease, providing evidence that protective immunity persists for up to one year after primary vaccination. The study forms the scientific basis for the regulatory application.

If the EMA approves the variation, annual revaccination against strangles could be aligned with routine influenza vaccination schedules for horses. Intervacc said this could simplify vaccination programmes and reduce the need for additional veterinary visits while maintaining protection against the disease.
The submission will now undergo the EMA’s scientific review process. Until a decision is reached, the approved product information for Strangvac continues to specify a two-month duration of immunity.

Image Source: Intervacc