Biosecurity Advice 2013/05 - Review of published tests to detect pathogens in veterinary vaccines intended for importation into Australia, Second Edition
1 March 2013
This Biosecurity Advice informs stakeholders of the release of the second edition of the Review of Published Tests to Detect Pathogens in Veterinary Vaccines Intended for Importation into Australia. The second edition of this review has been revised to only contain test methods for pathogens of biosecurity concern (significant exotic animal pathogens and more virulent exotic strains of endemic animal pathogens). Test methods for pathogens not of biosecurity concern (i.e. endemic pathogens that do not have more virulent exotic strains) have been removed and these pathogens will be assessed and managed by the Australian Pesticides and Veterinary Medicines Authority (APVMA).
The Department of Agriculture, Fisheries and Forestry (DAFF) has issued the second edition of the review of the published test methods that are considered to be reliable and sensitive for detecting extraneous pathogens in veterinary vaccines and vaccine raw materials. It has been revised to only contain test methods for pathogens of biosecurity concern (significant exotic animal pathogens and more virulent exotic strains of endemic animal pathogens).
The first edition was issued on 26 July 2011 (Biosecurity Australia Advice 2011/12), which noted at the time that the review would be updated periodically to take into account stakeholder comments that are supported by relevant new scientific information.
DAFF and the APVMA agreed that contamination of veterinary vaccines with endemic pathogens that are not of biosecurity concern should be assessed by the APVMA under their requirements for ‘target animal safety’. Consultation with importers of veterinary vaccines and Australian veterinary vaccine manufacturers in 2012 achieved agreement that ‘target animal safety’ should be managed by APVMA under the Agriculture and Veterinary Chemicals Code Act 1994 (the Agvet Code) for all veterinary vaccines. The APVMA have agreed to assess the potential for contamination with endemic pathogens that are not of biosecurity concern for all veterinary vaccines in accordance with that organisation’s requirements.
Contamination with exotic pathogens, and with more virulent exotic strains of endemic pathogens, remains a biosecurity concern and continues to be managed by DAFF. This change does not compromise the rigour of the assessment for imported vaccines and Australia’s import requirements have not materially changed. The combination of measures applied by the APVMA (general testing combined with Australia’s high level veterinary services and a comprehensive adverse reaction reporting system) provides equivalence to the assessment of potential contamination with endemic pathogens that was undertaken by DAFF.
Prior to this agreement, DAFF assessed potential contamination of imported veterinary vaccines with significant exotic animal pathogens, more virulent exotic strains of endemic animal pathogens, and endemic animal pathogens and required specific testing. The APVMA assessed potential contamination with endemic pathogens of veterinary vaccines manufactured in Australia and required general testing.
The second edition of the review reflects the agreed change in responsibility for the assessment of the potential contamination with endemic pathogens and now only contains test methods for pathogens of biosecurity concern (significant exotic animal pathogens and more virulent exotic strains of endemic animal pathogens).
The potential gains from this agreement include:
- efficiencies for assessment for both DAFF and the APVMA through reduced data production requirements and reduced time to assess applications
- removal of duplication in the DAFF and the APVMA assessment process
- improved access by Australia’s animal industries and pet owners for vaccines with marginal commercial value through the removal of costs and time delays associated with specific testing for endemic pathogens.