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EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL

D1 - Animal health and Standing Committees

Brussels, D1/MCG/mb (07) D/412948

Working Group on an EU harmonised strategy on vaccination against Bluetongue, Brussels 3 December 2007

Participants: O. Hansueli (CH), F. Verkallen (BE), P. Heinen (BE), P.Mortier (BE), S. Ralchev (BG), P. Kucnisky (CZ), J. Lacina (CZ), T. Mork ( DK), H. Weinandy (DE), P. Duignam (IE), O. Debaere (FR), N. Ferrarini (IT), R. Lelli (IT), T. Pavlos (CY), P. Chritodoulos (CY), D. Daukste (LV), R. Scerbavicius (LT), C. Dahm (LX), L. Ozsuri (HU), A. Ionescu (RO), S. M. Valentin (RO), S. Samojdakova, (SK), T. Tollesrud (NO), K. Levonene ( FI), A. Karlsson_Nosstrom (SE), S. Sternberg Lewerin (SE), H. Elliott (UK), P. Reed (UK), H. van der Griendt (NL), W. Pelgrim (NL), A. Hoflechner (AT), R. Amador (PT), E. García-Muro (ES), P. Demetriou (SANCO-04), F. Reviriego-Gordejo (SANCO-D1), M. Cainzos-García (SANCO-D1).

Annexes:

Outcome of the meeting

1. Conclusions:

  • Some Member States suggested that the Commission could establish a vaccine bank for bluetongue. This is not the option preferred in principle. The preferred option is that the Member States draw up national plans in accordance with Directive 2000/75/EC and Art 3 or 24 of Decision 90/424/EEC.
  • The Member States agreed to allow the Commission to make public information on the data submitted by them as regards the situation of the Call for Tenders and estimation on the doses needed for vaccination plans for 2008.
  • Preliminary criteria for the vaccination plans of the Member States were discussed and the agreed minimum requirements will be presented at SCoFCAH.
  • A reflection on the key issues for establishing vaccination programmes has to be made by the Member States at local/regional level, in particular as regards the establishment of the surveillance zones and the control measures to monitor the implementation of the programme (to assure mass vaccination is carried out).
  • Member States agreed that the deadline for submitting their vaccination plans for 2008 to the Commission could be 31 January 2008.
  • It was agreed that an evaluation of the vaccination plans and strategy at EU level implemented in 2008 would be necessary in order to refine or review the future strategy. This evaluation should be carried out at the end of the 2008 campaign (in the beginning of 2009)
  • The Member States presented the criteria they apply in order to establish when the bluetongue seasonally free period starts and ends. Most of the Member States have already established the criteria and decision trees. They are more or less the same as those used last year.

2. Discussion:

Presentation of the conclusions of the meeting between DG SANCO and vaccine producers

The main conclusions of the meeting were that the vaccine producers have a strong commitment and the capability to supply vaccines in enough quantity to support a mass vaccination strategy against bluetongue in the EU. Vaccine producers insisted on the need that Member States launch their call for tenders as soon as possible in order to have the vaccine in due time to start vaccination programmes in 2008 and in enough quantity to carry out mass vaccination.

At the request of the Commission the Member States provided information on the state of play of the launching of Call for Tenders for the purchase of the vaccine.

Possibility to establish a bluetongue vaccine bank at EU level.

To establish a vaccine bank at EU level was suggested by several Member States in order to establish a harmonised vaccination strategy in the EU. Another reason for establishing such a vaccine bank highlighted by them was the need to make sure that vaccine will be available also for the buffer zones on time (as these areas represent a small share of the market for the vaccines producers they fear that they will prioritise the supply for the affected areas).

A possible further advantage of purchasing the vaccine at EU level is that the quantity of vaccine ordered will be much larger and therefore there will be a better bargaining position vis a vis the producers. This option would also imply less administrative burden for the national administrations as the Commission would directly purchase the vaccine.

Preparation of vaccination plans

The Commission concluded that the preferred option would be for each Member State to establish its own national vaccination plan, which will better take into account the local situation.

3. Next steps:

The next forum where a vaccination strategy against bluetongue will be discussed at EU level is the "Conference on vaccination strategy against bluetongue" organized by the Commission in Brussels on 16 January.

During 2008, a meeting of this working group will again be organized by the Commission to further discuss and evaluate the vaccination campaigns against bluetongue. During that meeting special attention will also be given to surveillance programmes put in place where vaccination is carried out.

Annex I Estimations on bluetongue vaccine needs submitted by Member States

MEMBER STATES PRELIMINARY ESTIMATES ON VACCINE NEEDS AGAINST BLUETONGUE

BTV-1

MS N cattle N doses cattle N sheep/goats N doses sheep Total animals Total doses Comments
ES 2429434 4858868 9271934 18543868
FR 751888 1503776 907599 907599 Provided buster needed for cattle
IT 900000
PT 1975776 3951552 Cooperating with the Spanish authorities to obtain it
Total 3.181.322 6.362.644 12.155.309 23.403.019 21.699.275 41.920.972

BTV-2

MS N cattle N doses cattle N sheep/goats N doses sheep Total doses Comments
IT 1921100
HU* 716000 250000 1400000 500000 Assuming animals are vaccinated once a year
Total* 2.671.100
Total 1921100

BTV-4

MS N cattle N doses cattle N sheep/goats N doses sheep Total animals Total doses Comments
ES 2.000.745 2.400.894 7.605.557 9.126.668
HU* 716.000 250.000 1.400.000 500.000 Assuming animals are vaccinated once a year
IT 1921100
PT 2.064.776 2.459.931 Vaccine already ordered
Total* 2716745 2650894 9005557 9626668 14373196 21283119
Total 2000745 2400894 9670333 11586599 14071972 23657826

BTV-8

MS N cattle N doses cattle N sheep/goats N doses sheep Others doses others Total animals Total doses Comments
AT* 1,800.000 1,800.000 300.000 300.000 10.000 10.000
BE 2800000 5600000 400000 400000
CZ 650000 1391393 50000 196000 5000 10000 650000 1391393
Animals included in the Danish
restricted zone Provided booster
DK 580000 1160000 120000 120000 needed for cattle
DE 12152054 24304108 3002189 3002189 55530 111060 Cattle and others vaccinated with two doses, sheep and goats with one dose Vaccination will protect for one year
FR 19366508 38733016 10133005 10133005 Provided booster needed for cattle
HR* 300000 300000 600000 600000
HU* 716000 250000 1400000 500000 Assuming animals are vaccinated once a year
IR* 7000000 14000000 4000000 4000000 or 8000000 Based on total population
LT* 850000 850000 50000 50000 200 200 850000 850000 Based on all susceptible population
LU 180000 360000 18000 36000
LV* 400000 400000 80000 80000 400000 400000 80000 80000
NL 3500000 7000000 3000000 3000000
PL* 6000000 1200000 350000 700000 Vaccination twice a year
PT* 984804 1969608 2801464 5602928 Considering all the animals because of the high risk of introduction
1000000 Estimations made simulating bt
(350000MLV+ outbreak
RO* 500 000 650000inact) 940000 1840000
SE* 1119745 2239490 272731 477609 Provided booster needed for cattle and first vaccination of sheep and goats at six months
Provided booster for cattle
UK 10300000 20600000 33600000 33600000 Worst-case scenario
Total* 66899111 118997615 61117389 68841731 106730 131260 128123230 187970606
Total 49528562 97988517 50323194 50691194 96530 121060 99948286 148800771

BTV-9

MS N cattle N doses cattle N sheep/goats N doses sheep Total animals Total doses
RO* 500000 1000000 940000 1840000
IT 690100
HR* 300000 300000 600000 600000
Total 690100
Total* 800000 1300000 1540000 2440000 1440000 900000

BTV-16

MS N cattle N doses cattle N sheep/goats N doses sheep Total animals Total doses
HR* 300000 300000 600000 600000
HU* 716000 250000 1.400.000 500000
Total 1016000 550000 2000000 1100000 3016000 1650000

* MS currently free from the serotype

Total Excluding Member States not affected

Total* Including Member States not affected

NO NEED FOR VACCINE: Estonia Finland Greece

Annex II Draft Criteria for bluetongue vaccination plans 2008

The vaccination plans submitted by the Member States shall contain at least the following:

(1)
If appropriate, a description and data on the epidemiological evolution of the disease in the last years. If it is a case, in wildlife as well.
(2)
A description and demarcation of the geographical and administrative area, in particular the surveillance zone, including maps, in which the plan is to be applied;
(3)
The likely duration of the plan, and the objective to be attained by the completion date of the plan;
(4)
An analysis of the estimated costs of the plan and a description of the national finances involved (i.e. funds, regional/national budget)
(5)
Identification and designation of the central authority charged with supervising and coordinating the departments responsible for implementing the plan;
(6)
Full description of the departments, services or other means to be used for implementing the plan
(7)
A system for identification/registration of vaccinated animals involved in the plan and traceability systems in place.
(8)
Where necessary, rules for adequate compensation to farmers for losses due to vaccination accidents.