Changes to European rules on Bluetongue vaccination

Recent amendments to the EU Bluetongue Directive will make the rules on vaccination, particularly for the use of inactivated vaccines, more flexible in the near future.

When the EU Directive (2000/75/EU) was originally drafted, only ‘live’ vaccines, which have an associated risk of reversion to virulence, and subsequent disease spread, and in some serotypes, of foetal damage, were available. Consequently vaccination was only permitted in a disease outbreak situation within a bluetongue protection zone.

Stable ‘inactivated’ vaccines (with Marketing Authorisation at the EU level) against serotypes 1, 2, 4, and 8 are now widely available and their use (particularly against serotype 8) has played a significant role in the control of Bluetongue across northern Europe in recent years. Consequently the EU have introduced changes to the Directive to allow the use of inactivated vaccine within a Bluetongue free area, should a Member State authorise its use, however amended UK legislation to implement these changes has not yet come into force.

EU Member States are required to produce a risk assessment before deciding whether to permit use of inactivated vaccines in disease-free areas or either type of vaccine during an outbreak (and no live attenuated vaccines have Marketing Authorisation for use in the UK).

In principle the three GB administrations support the use of authorised inactivated vaccine for any serotype within a bluetongue-free area, as it is considered that livestock producers should have the opportunity to protect the health of their animals against the risk of a new disease incursion. In England, Defra expect that the necessary legislative changes will be made during summer 2012. Until the amended domestic legislation comes into force, and relevant policy decisions on the potential use of vaccination have been made, it is important to note that the use of Bluetongue vaccine across GB currently remains prohibited.

When the regulations allowing vaccination with inactivated BTV come into force, announcements will be made on the relevant Government websites, in the farming and other specialist press and in the Official Veterinarian.

Further information is available at:
http://www.defra.gov.uk/animal-diseases/files/guidance-bluetongue-vaccination.pdf