THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE
3.C Efficacy requirements Section 5.3. ‘Efficacy in Chapter 3.1.8. of the OIE Manual has to be taken into account. Vaccine efficacy is estimated in vaccinated animals directly, by evaluating their resistance to live virus challenge or indirectly through in-vitro testing using well-established correlations. The uncertainty of measurement in tests should be taken into account when interpreting its significance. Vaccine efficacy should be established for every strain to be authorised for use in the vaccine. The efficacy of each vaccine strain shall be demonstrated for each category of target animal species, by each recommended route of administration and using the proposed schedule of administration, unless scientific data can be provided demonstrating that extrapolation from one species to another species or from one category of species to another category of the same species is possible. The requirement for establishing onset of immunity, duration of immunity and the interference of maternally derived antibodies would depend on the claims and indications. If claimed, manufacturers should supply data to substantiate that the vaccine does not induce antibody to one or more non-structural proteins (NSPs) in line with section 3.C.1. (3), below. Claims included on the SPC should accurately reflect the testing performed to demonstrate lack of reactivity of sera from vaccinated animals against NSP. If DIVA properties are claimed, details should be provided on the serological test (or type of test) that may be applied to differentiate vaccinated from infected animals. Evidence in support of this claim should be included in the PSF. Where a range or minimum amount of antigen is specified, the tests should be carried out using a vaccine batch containing the minimum amount of antigen. The information submitted based on the PSF guidance may be the same package of data provided to national regulatory authorities in support of the product marketing authorisation. The information provided is expected to include the following elements 3.C.1. Laboratory studies 1. Challenge tests The in vivo efficacy studies should be controlled trials including vaccinated animals and unvaccinated control animals and using a challenge strain relevant to the epidemiological situation in the field. Exceptionally, in the case of FMD virus, the challenge strain may be the same as the vaccine strain provided that the strain is sufficiently virulent to induce disease in control animals and regulatory authorities are satisfied in terms of the epidemiological relevance of the immunity induced. Each test is carried out for each route and method of administration to be recommended for vaccination, using in each case cattle not less than 6 months old. If younger animals are used in the clinical studies, consideration should be made as to any potential impact on efficacy from the presence of maternally derived antibodies. The vaccine administered to each cattle is of minimum antigen content. 16
