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5.3.1.2 What should be the requirements for oral rabies vaccines?

Basically, an oral rabies vaccine should meet the general requirements of live virus vaccines and rabies vaccines. These include: the capacity to successfully immunize the target species, no shedding in excretions and secretions, genetic stability, and no reversibility to higher pathogenicity.

It should include a genetic marker but no pathogenic contamination, and should have adequate shelf life and temperature stability under field conditions. It should also be able to be produced simply and inexpensively. However, due to the unique concept of ORV, additional data is required. It must be proven that foxes are protected against a relevant challenge infection after the uptake of a single vaccine bait. Moreover, a fox can encounter and consume multiple baits, thus overdose studies are required.

Pregnant and lactating vixens and young animals are of interest in this respect. Due to the fact that all animal species in an area where baits are distributed may have access to vaccine baits, including wildlife, livestock, pets and humans, safety studies must be conducted in the most important non-target species in terms of susceptibility to the virus strain used and potential bait contact.


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Version 1 - Last updated November 2012