Decision on Pre-Qualification

THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE

2.E.4. Identification and assay of adjuvants

The quantity and nature of the adjuvant and its components shall be verified on the finished product.

2.E.5. Identification and assay of excipients components

Insofar as is necessary, the excipient(s) shall be subject at least to identification tests. If a preservative has been added to the vaccine, the content of preservative should be determined. An upper and lower limit test shall be obligatory in respect of preserving agents. An upper limit test for any other excipient components liable to give rise to an adverse reaction shall be obligatory.

2.E.6. Safety tests

The safety of the final product should be proven batch to batch in order to detect any abnormal local or systemic adverse reactions. It would be acceptable to assess safety of the final product in animals used for the potency test. Animals should be inoculated by the recommended route of administration with the recommended dose of vaccine. When potency is assessed by PGP or EPP, all animals are observed for local and systemic reactions to vaccination for the 30 days duration of the potency test. When PD50 test is used, at least two healthy sero-negative target animals inoculated as above are observed for local and systemic reactions to vaccination for no fewer than 14 days. Any undue reaction attributable to the vaccine should be assessed and may prevent acceptance of the batch.

In line with VICH GL 50 ‘Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use’, in cases where consistent safety of the product is demonstrated and approved in the registration dossier and the production process is approved for consistency in accordance with the standard requirements referred to in chapter 1.1.8, a national regulatory authority may agree to omit the test in the final product. A statement to this effect should be included if such an agreement has been made.

2.E.7. Sterility test

Bacterial and fungal sterility plus viral testing and mycoplasma testing where performed.

2.E.8. Purity test

Purity relates to the level of FMD NSPs (non-structural proteins) in the final product, which should not induce antibodies that would interfere with serological tests used for sero-surveillance of virus circulation in vaccinated populations. Products claiming to be purified from NSPs have to demonstrate their level of purification. In cases where the production process is approved for consistency in accordance with the standard requirements referred to in Chapter 1.1.8 of the OIE Manual, the purity test in the final product on each batch of vaccine may be omitted.