WRITTEN QUESTION E-3904/00

by Jan Mulder (ELDR) to the Commission

(13 December 2000)

Subject: Use of marker vaccines in the European Union

It has been proved that marker vaccines can be used effectively for the fight against, and the controlled eradication of, infectious animal diseases.

1. Can the Commission say whether it really does intend to permit vaccination with marker vaccines if there are outbreaks of infectious animal diseases for which vaccination is not normally permitted, for example swine fever?

2. Can the Commission state for which animal diseases, for which vaccination is not normally permitted, marker vaccines are currently available which could limit a disease spreading if there is an outbreak?

3. Can the Commission state for which animal diseases an outbreak could be prevented from spreading by means of vaccination?

4. If the Commission intends to use the vaccination strategy referred to above, is it also considering accumulating stocks of vaccines at strategic points in the European Union?

Answer given by Mr Byrne on behalf of the Commission

(30 January 2001)

1. The approach of the Commission to the potential use of marker vaccines against classical swine fever is made clear in its proposal for a Council Directive on Community measures for the control of this disease(1).

The results of a trial, which was supported by the Commission, have indicated the need to be very cautious in this matter, as the use of marker vaccines might not lead to any advantage in comparison with the conventional ones.

However, in accordance with the Commission's proposal, these vaccines might be used within the framework of the current non-vaccination policy against classical swine fever, which does not exclude vaccination in the event of an emergency.

The eventual use of marker vaccines would be subject to the availability of suitable diagnostic tests, as the ones developed so far do not reliably discriminate between vaccinated animals and the infected ones, and to a case-by-case authorisation by the Commission to the Member State which intends to use these vaccines, following the advice of the standing veterinary committee.

2. Marker vaccines are widely applied in the prevention of a number of animal diseases in the Community and for some of these diseases legislation is in place in order that their use is ultimately successful, i.e. not only the vaccinated animals are protected against the disease, but its agent is also eradicated.

Efforts are being made by scientists and private companies to develop marker vaccines and/or associated discriminatory tests for other animal diseases, including some of major economic importance, such as foot-and-mouth disease and classical swine fever, for which the Community adopts a non-vaccination policy. The Commission has also financially supported some of these efforts.

However, as shown by the trial on classical swine fever, it is necessary to be cautious, before arriving at the conclusion that newly developed products can be successfully used.

3. In principle, any animal diseases for which effective vaccines have been developed might be prevented by means of vaccination. However, as with any other pharmaceutical product, vaccines may also lead to undesirable consequences and their efficacy and safety may be jeopardised by improper use. Before vaccines are used, both potential advantages and disadvantages must therefore be considered and the most appropriate conditions for use must be ensured.

4. The Commission keeps a bank of 30 million doses of antigen for the formulation of vaccine against foot-and-mouth disease, in order that this vaccine may be rapidly available in the event of an emergency. For safety reasons, the antigen is kept in three different places in the Community.

The Commission has also bought and kept in stock 500,000 doses of vaccine against bluetongue, that, upon request, have recently been made available to two Member States where outbreaks of this disease have occurred. The vaccine stock is currently being replaced.

Legal provisions are also in place, which would allow the Commission to establish stocks of vaccines against other animal diseases, if necessary.

(1) COM(2000) 462 final.