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BT-conference Brussels, 16 January 2008 European Commission

Summary
On the basis of the experience gained, and considering the new EU legislation as regards bluetongue, this conference had been organized, because the Commission thought it to be appropriate to discuss at Community level the strategy for the use of vaccination against bluetongue as a means of controlling the disease, taking also into account its importance vis-à-vis trade and the economical effects of the disease.

General opinion was that vaccination would be the only solution to tackle the BT-explosion. The Commission working groups concluded that mandatory vaccination would be preferable.

The BT-experience in the southern Member States showed that vaccination needs a minimum of 80% coverage and a follow up of monitoring and surveillance to be effective. Eradication of serotypes 2 and 4 is a fact.

Main questions were:

Will vaccination be voluntary or mandatory?

Should the Commission take a more leading role in the decisions and not leave it to MSs to decide?

How will the vaccine be distributed? Will countries that ordered with the manufacturers first come first?

Will animals which were infected in previous years be vaccinated or not?

Will animals in the protection zones be vaccinated first or animals in the surveillance zones?

Can animals in the free regions be vaccinated?

Will we be too late in 2008 to stop a new explosion? Orders should have been made months ago.

The Commission has announced co-financing the vaccination campaign, provided that 80% coverage will be achieved in the MS. Are they pressuring MSs this way after all?

All MSs have to send in their vaccination strategies before 31 January for the Commission to evaluate what next steps must be taken.

The Conference

Agenda

The first block of speakers consisted of the opening by Kyprianou [Kyprianou emphasized that climate change has brought BTV to Europe, when we all know that our own midges carry the virus and were most likely infected by an imported animal (antilope) from Africa] and an introduction by SANCO Deputy DG Testori-Coggi, both emphasizing the urgent need for vaccination as all other measures taken were apparently not sufficient. A financing programme is in place and a harmonized approach by ALL in the EU is essential, sharing information; and agreement on coherent strategies.

Then six stakeholder groups had ten minutes each to display their views.

Vannier (EFSA) laid out a wide range of conditions for the use of preferably inactivated vaccines. For modified live virus vaccines a solid risk analysis should be in place to justify the use. He also mentioned the role of wild fauna, but was not clear how this should be taken into account.

Ioannou (EMEA) pleaded for minimum data requirements for centralised BT-vaccines authorization in order to guarantee a harmonized pan-European approach. Although the Commission grants each MS to start vaccination without authorization, EMEA emphasizes the importance of centrally authorized BT-vaccines and is prepared to do so with a minimum requirement of data and to reduce the assessment time from 210 to 150 days.

Beyler (UECBV) stated that we do not want unforeseen consequences later because the vaccination strategy is not accepted by all MSs. He pleaded for vaccination of ALL herds and clear views from all concerning future positions of how to deal with vaccinated and non-vaccinated animals.

Terrand (FESASS) declared no other view: all measures taken so far have not stopped the disease vaccination is the only solution. He wants however a clear strategy on a voluntary basis with freedom to the breeder to decide, balanced on health terms and economic terms. Therefore we need EU-harmonisation (a task for the Commission). Application by the breeder (less costs), and for at least three years. Trade is particularly concerned about additional costs for certification.

Osinga (COPA-COGECA) showed us the statistics of the various losses caused by the disease (mortality, abortions, fertility, treatments, extra feed and labour, milk production, testing, and markets loss). He stated various clear questions for 2008 and beyond (see PPT pages 5 and 6) and concluded stating we need clear goals of a vaccination campaign and a common strategy.

OBrien (IFAH) strongly emphasized the fact that no one was prepared for BTV 8. A hard lesson to be better prepared for other exotic emerging diseases like African Horse sickness, West Nile virus, African Swine fever, etc.

But the industry needs to be sure of a market in order to invest the millions needed to speed up the development process (from 5-6 years to 2 years). All experts agree on mass vaccination for BTV8, yet no solid orders were placed in time, so the development and production have been delayed. Will animals be dying in June/July when hopefully a decision for mass vaccination has been made and will the supply keep up with the demand? Will we be too late for2008?

Caporale (OIE ) displayed the general OIE-standards on BT-vaccination, revised in the Code after the Taormina meeting. Never before have cattle been vaccinated on a large scale against BT. There are still a lot of questions about the duration of the immunity and stability after vaccination.

The four southern countries with BT-experience each gave presentations of their strategies so far.

Eloit (France) explained that partial vaccination campaigns in the beginning (2000) did not have the right results: spread in area and numbers, more morbidity revision of strategy: 80-90% of ovines only with inactivated vaccine 2 and 4 good results.

By the end of 2003 disease had calmed down, but still some virus circulation occurred. Corsica is an island with a relatively low probability of spread to other areas, so vaccination of sheep only was sufficient. But it cannot serve as an example for the continent. We must not forget that cattle can be a reservoir for infection of midges, so cattle should be vaccinated as well. The entire campaign was paid for by the government and the EU.

Romero (Spain) said that like in France the islands were the first to have outbreaks coming from Africa and the East. Like France the first years MLV-vaccines against sero-types 2 and 4 were used. No more virus circulation could be detected since 2005. But MLV vaccines can only be used in times with no midge activity; inactivated vaccines can be used all year through. In 2006 these (developed by Merial) were used for the first time. In 2007 serotype 1 appeared; a vaccine had to be developed in due course. Otherwise the Spaniards would have a vaccine against 8 by now. The first case of BTV8 was reported in northern Spain on 14 January 2008. It is crucial that all animals are vaccinated. Spain has compulsory vaccination with no costs for the farmers, paid for by the government and the EU. Vaccinated animals are tagged or chipped and have passports. Mass vaccination results in no more virus circulation. Coordination with other countries is vital.

Ferri (Italy) stated that vaccination (> 80% of susceptible population) should always be carried out with other control measures like surveillance and constant monitoring of the risk zones. Vaccination is an instrument to move animals safely. It limits the losses and suffering and virus circulation. We need a flexible approach where countries should be allowed to tackle the emergency situation by assessing for themselves. The advantage of MLV-vaccines is that they are available for nearly all types; inactivated only for 2, 4 and 8 (development). MLV side effects reports showed no specific negative results.

Amador ( Portugal) stated that Portugal has vaccinated against type 4 (alternately MLV and inactivated, but eventually only inactivated vaccine) during 2005, 06 and 07; and against type 1 since November 07. Extensive surveillance and monitoring, compulsory for ovines, only adult and replacement stock; paid for by the government, co-financed by EU. They carried out a trial vaccination of bovines in order to move fattening animals. Compulsory slaughter in national territory.

Conclusions: reduction of mortality and morbidity; spreading stops; safe animal movement; inactivated vaccines can be used all through the year and are perfectly safe and efficient.

Then the South African expert on BT Gerdes told us how in southern Africa all serotypes have been endemic for ages. The presentation was very technical about the development of vaccines from blood based to egg based to modified live and attenuated (inactivated) vaccines. As practically all serotypes occur in southern Africa multi- valent vaccines are used, but divided in groups, as one vaccine can reverse the efficacy of the other. So not all combinations are possible.

MacLachlan (University of California) told us that various serotypes of BTV have circulated in the US since WW II. First vaccines (egg-based) were developed in the 50s. These were not very efficient, but gave good insight in development of embryos and the effect of the virus on them. In the US only MLV vaccines are used. They are easy to develop and cheap, safe when applied with care for target breeds and induce long term immunity. Up till now the various eco-systems (north an south) of BTV remain distinctively separate. Only sheep are vaccinated.

Laddomada (DG SANCO) stated that since 2007 no longer EU authorization is needed for a country to initiate BT-vaccination. Vaccination is an extremely important tool for safe trade. The Commission has given clear messages to the MSs and the industry. The working groups both concluded that mass vaccination of >80% of all susceptible animals is the only solution.

Discussion and Round table with CVOs and stakeholders

The audience wanted to know how the vaccines available (definitely not sufficient to meet full coverage of the EU stock) would be divided among the various countries. What will the strategy be? Inside out or outside in?

Laddomada answered that this would be depending on the strategies of the various countries being submitted to the Commission before 31 January.

Caporale commented that he could not understand the reluctance of most towards MLV-vaccines, which would make the available supply so much easier. These vaccines are perfectly safe [note: mr. Caporale is the director of the Italian manufacturer ( I.Z.S. Teramo) of MLV-vaccines and is working on serotype 8]

Osinga asked if a BTV-vaccine bank should be in place and whether countries should be allowed to vaccinate in the free zones. Laddomada stated that the EU will eventually have a vaccine bank, but would not want to compete with ordering countries at this stage. And vaccination in the free zones would give unnecessary implications and restrictions. Caporale saw no reason for these restrictions. Van Goethem added that vaccination 2008 would not eradicate the disease, so start with the infected zones to bring down the effects.

Should vaccination be compulsory or voluntary? And should application de done by vets or farmers?

Eloit answered that there is no way to differentiate (DIVA) vaccinated from previously infected animals. Compulsory vaccination needs a very precise distribution scheme. Application of vaccine by vets is necessary to get movement certification. We must not expect the 2008 campaign to be 100% successful; whatever the preferred strategy we will have to settle for the best we can do.

Romero added that nobody seemed to bother about any implications for the southern countries for years and that they would have had a BTV8-vaccine if they had not had to develop a BTV1 vaccine last summer. Vaccination is the only solution and a joint strategy is needed to prevent the virus from spreading. The reluctance to adopt a mass vaccination strategy puts other countries at risk.

CVOs:

Germany opts for mass vaccination of sheep and has not decided yet for cattle.

Sweden, representing the ad hoc coordination of the northern countries, would apply attenuated vaccines for the affected areas; the EU should assess all programmes; reimbursement when programmes are not executed well; vaccination when stamping out is impossible. Possibly laid down in legislation.

Luxemburg prefers optional because after monitoring the cattle herds 90% appeared to have sero-converted. So only vaccination for young animals/followers.

Portugal emphasized again that vaccination is the only way to stop BT. We must stop playing the ball around and take decisions now. Portugal calls upon the responsibility of the northern countries because the fight against BTV8 in the south will be harder than in the north.

Netherlands are reluctant to decide for compulsory after the negative campaign for compulsory vaccination against BTR in the 70s. Only compulsory when eradication can be guaranteed and if Commission will co-finance for several years. Only vets will administer; vaccinated animals will be marked. An answer is needed to: How long will maternal antibodies last? Will they intervene with vaccination?

Van Goethem (DG SANCO) closed the day by saying that not many controversial issues were heard (they had expected otherwise J), that mass vaccination was the general opinion; co-financing will be with certain ceilings (we wondered where those suddenly came from and what they would be); the industry must have proper orders to get organized for production. And vaccination is THE way for free trade!

A video impression of the day:

http://ec.europa.eu/food/animal/diseases/controlmeasures/bt_conference_2008.wmv

(it takes some time to open)