THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE
Chapter 3: Clinical section – Use in target species 3.A General principles Note 1: Clinical studies in laboratory and field conditions are expected to have been designed and conducted to meet, respectively, international GLP and GCP principles. Note 2: For vaccines whose licence was originally obtained many years before the application for prequalification, it is possible that many, or all, of the clinical studies may not have been conducted or monitored to current international standards. For these vaccines, all sections should be completed using the data available and indicating the quality standards applied at the time in order to establish sufficiently a history of safe and effective use. Note 3: In some cases, where the information received regarding the sections detailed below is not sufficient, is not sufficiently clear or requires further scrutiny, the applicant may be requested to submit the raw data. 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.B Safety requirements The safety studies shall be carried out in each species for which an indication is sought using animals of the most sensitive category. This is usually taken to mean seronegative animals of the youngest age indicated and pregnant animals. The results of the safety test will be used to define the maximum number of antigens that may be incorporated into an FMD vaccine, the maximum permitted amount of each antigen, and the maximum permitted volume to be injected. The manufacturer should prepare a vaccine that contains the maximum number and the maximum permitted amount of each antigen (in terms of µg of 146S). The safety of this vaccine should be examined according to the tests described below. Satisfactory results should be considered as sufficient evidence of the safety of the FMD vaccine concerned when produced according to the details outlined under quality and formulated to contain any of the antigens permitted on the authorisation up to the maximum number, amount and volume examined in the safety test. 3.B.1. Laboratory studies The vaccine should be tested for local and systemic reactions by each recommended route of administration in an in-vivo test in at least eight animals of each target species of the minimum age to be recommended and with no antibodies against foot-and-mouth disease virus. In principle, according to OIE requirements, double dose and repeat single dose (after 14 days) tests shall be performed.
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