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.
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