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Copied from the New Zealand Journal "Bio-Security" 15 March 2004

International Vaccine Bank to be terminated

The IVB will terminate on 30 June 2004 since it is no longer able to deliver FMD vaccine of the quality that members now require. Manufacturing facilities meet neither European nor New Zealand standards for licensing of veterinary pharmaceuticals. With the changing international perspective on the disposition of FMD vaccinates, it is essential that any emergency vaccine is registered in New Zealand.

Although antigens from the current IVB will probably be incorporated into a new IVB model, the nature of that potential model is currently unknown as member countries have not agreed about a future vaccine bank arrangement with a commercial supplier.

New Zealand’s likely requirements could be met by a contingency supply arrangement for 500,000 doses – the minimum volume generally available commercially.

Access to vaccine bank vital

International experts have advised that if the option to vaccinate for FMD is included in national contingency plans for FMD, the only guarantee that supplies of vaccine will be available when required is to be a member of an antigen or vaccine bank. Most FMD-free countries store only vaccine antigen concentrate (antigen), as formulated vaccine has a limited shelf life. The North American FMD Vaccine Bank (Canada, United States and Mexico) has existed since 1982 and the European Union FMD Vaccine Bank since 1993.

Individual EU countries including Belgium, Denmark, France, Germany and the Netherlands hold additional independent FMD vaccine reserves.

Outside the EU, Bulgaria, Croatia, the Czech Republic, Poland, Hungary, Israel, Romania, Russia and Slovenia hold vaccine banks.

Multiple strains required for full protection

There are seven serotypes of FMD virus (O, A, C, ASIA1, SAT1, SAT2 and SAT3), with little or no cross protection. Some, such as serotype A which is prevalent in South America, have several antigenically unique strains requiring multiple type A vaccine strains to ensure protection. Currently vaccine for nine strains is considered the minimum to ensure adequate protection for New Zealand.

New Zealand investigating own arrangements

Australia weighed the alternatives and decided to enter a commercial contract independently in April 2003. New Zealand is also investigating private arrangements with a commercial vaccine manufacturer to ensure an initial supply of emergency FMD vaccine from 1 July 2004. New Zealand would purchase antigen for important strains of FMD virus currently circulating in the world, focusing on those in South East Asia. The commercial manufacturer would agree to hold vaccine antigen frozen in liquid nitrogen, guarantee quality and break routine commercial production to formulate emergency vaccine for New Zealand for immediate delivery.

There is no ready off-the-shelf supply of FMD vaccine and the establishment of a contract with a commercial FMD manufacturer will ensure that New Zealand has immediate access to an FMD vaccine that reflects the current circulating strains representing the greatest threat to New Zealand.

Constant threat

FMD is a low probability but high consequence risk for New Zealand. Recent experiences in Taiwan 1997 (free since 1929), South Africa 2000 (free since 1956 in domestic livestock), South Korea 2000 (free since 1934), Japan 2000 (free since 1908) and the UK 2001 (free since 1967) are reminders that the threat from FMD is constant.

Dorothy Geale DVM PhD Bsc (Hons), Exotic Disease Response Programme Coordinator, Surveillance and Response, Animal Biosecurity, dorothy.geale@maf.govt.nz