Item 8 – Regulatory issues affecting FMD vacine selection and use

induced higher immune response in pigs than saponin- DOE vaccine. No adverse side effects were associated with the addition of saponin to vaccine oil formulations.

Recommendations

1. Laboratories and producers are encouraged to make their data and sera available to groups working on correlations between serology and protection. 2. Buyers should check quality of vaccines by audit or testing. 3. Vaccine performance should be monitored by serological screening of different age groups on selected farms at different locations in the country on an annual basis. 4. Laboratories using serology for evaluation of herd protection should validate the test in their own laboratory. 80 % of the animals should reach titres considered indicative of protection. 5. Evaluation and reporting of results should be carried out annually as well in order to inform and involve stakeholders. 6. Further studies are encouraged to investigate the protective capacity of the addition of saponin to the vaccine formulation and to characterize the specific immune response associated to the adjuvant effect of saponin.

Item 8 – Regulatory issues affecting FMD vaccine selection and use

Dr David Mackay summarised the current regulatory requirements for FMD vaccines within the EU (Appendix 54). The Committee for Veterinary Medicinal Products has recently adopted a Position Paper on Requirements for Vaccine against FMD (EMEA/CVMP/775/02). This paper proposes practical means whereby manufacturers can overcome the regulatory ‘hurdles’ that currently act as deterrents to authorisation in the EU. Following the recent review of EU pharmaceutical legislation, there is currently an opportunity to amend the annexes to directive 2001/82/EC to make specific provision for the unique requirements of FMD vaccines. The Commission was encouraged to make use of this opportunity to promote the authorisation of FMD vaccines in the interests of animal health and consumer protection.

Dr Tim Doel reviewed how virus strains are selected for use in FMD vaccines (Appendix 55). Well established vaccine strains are suitable in the great majority of cases. New vaccine strains are required when outbreaks occur due to field strains against which existing vaccine strains do not provide adequate protection. Existing vaccine strains of serotypes O, C and Asia 1 generally provide a sufficient spectrum of antigenic coverage that the possible development of new vaccine strains is rarely necessary, although some strains may be developed as a result of a specific customer request. In contrast, new variants of type A repeatedly emerge requiring constant surveillance and the possible development of appropriate, new vaccine strains. The wide genetic and antigenic diversity of the SAT serotypes makes vaccine strain selection more difficult and further work to characterise the antigenic coverage of existing, and newly developed, SAT vaccine strains was encouraged.

In the discussion that followed an aspiration was expressed that a system of surveillance, and selection and distribution of vaccine strains, would be set up for FMD that would operate in a similar way to the network of WHO human influenza reference laboratories.

Conclusions

1. That authorisation of FMD vaccines is strongly desirable in the interests of animal health and consumer protection. 2. That sufficient general guidance on the requirements for authorisation already exists in the

European Pharmacopoeia, the OIE Manual and in EU legislation and guidelines. 3. That the recently adopted Position Paper EMEA/CVMP/775/02 on ‘Requirements for Vaccines against Foot-and-Mouth Disease’ provides additional, specific guidance on the requirements for authorisation of FMD vaccines within the EU. 4. That the position paper may serve as a useful model for regulatory agencies in other regions. 5. That surveillance and the development of new vaccine strains continues to be essential, particularly for serotypes A and the SAT serotypes. 6. That submission of samples from countries worldwide is essential for this surveillance to be worthwhile.