Appendix 37

Appendix 37

FMD vaccines: PFMD Vaccines Potency Testing in the Target Species

Lukas Bruckner, Christian Griot

Institute of Virology and Immunoprophylaxis (IVI), National Reference Laboratory for Exotic Diseases, Swiss Federal Veterinary Office, CH-3147 Mittelhäusern, Switzerland

A batch of FMD vaccine has been tested for potency in cattle. The sample was prepared from the Swiss antigen bank for emergency use. FMD serotype A Iran 96 antigen was emulgated in an oily adjuvant. Briefly, the potency test was performed as described in the monograph of the European Pharmacopoeia (Ph.Eur.) “Foot-and-Mouth-Disease Vaccine (inactivated) for Ruminants”. In contrast to the requirement of the Ph.Eur. the challenge was performed with a heterologous virus strain, A Iran 99.

All cattle vaccinated with either a double, a single or 1/3 of a recommended dose were protected from FMD. In contrast, non-vaccinated control animals showed typical FMD lesions on all 4 feet.

The experiment showed, that despite the antigenic difference, a vaccine prepared from FMD virus serotype A Iran 96 was capable to induce within 21 days after vaccination, protection from virulent challenge with FMD serotype A Iran 99.