2009/3/EC: Commission Decision of 18 December 2008 establishing Community reserves of vaccines against African horse sickness
Date: 2008-12-18
Institutions: European Commission
Subjects: Africa, animal disease, animal plague, equidae, health control, vaccine

6.1.2009

EN

Official Journal of the European Union

L 2/9

COMMISSION DECISION

of 18 December 2008

establishing Community reserves of vaccines against African horse sickness

(2009/3/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Decision 90/424/EEC of 26 June
1990 on expenditure in the veterinary field (1), and in particular
Articles 6(2) and 8 thereof,

Having regard to Council Directive 92/35/EEC of 29 April 1992
laying down control rules and measures to combat African
horse sickness (2), and in particular Article 12 thereof,

Whereas:

(1)

(2)

(3)

(4)

African horse sickness
is an arthropod-borne
(AHS)
disease of equidae primarily of sub-Saharan Africa. Occa­
sionally the disease has spread outside Africa as far as
India but also into northern Africa and onto the Iberian
Peninsula, and between the latter. The disease is caused
by an Orbivirus similar to the causative virus of blue­
in sheep and
tongue. However, unlike bluetongue
cattle, AHS is almost always fatal for horses.

Nine antigenically distinct serotypes of
the AHS-virus
have been identified by virus neutralisation but some
cross-reaction has been observed between serotypes 1
and 2, 3 and 7, 5 and 8, and 6 and 9, which is used
in vaccine manufacturing.

The persistent circulation of bluetongue virus in certain
Member States is sufficient proof for the almost uninter­
rupted presence of competent vectors in the affected
areas. The AHS-virus and bluetongue virus are trans­
mitted by the same vector Culicoides and therefore the
risk of virus introduction into Member States is higher
than negligible. The bluetongue affected parts of
the
Community are also core breeding grounds for valuable
horse populations that are thus particularly threatened by
AHS.

The early use of vaccines in case of an outbreak of AHS
is provided for in Article 6(1)(d) of Directive 92/35/EEC.
In accordance with Article 9(2) of that Directive, the
Commission may take a decision to carry out systematic
vaccination of equidae against AHS, however, no vaccine
against AHS is currently produced by the pharmaceutical
industry based in the Member States or registered in
Europe by an international manufacturer.

(5) With substantial Community support to Spain, Portugal
and later also Morocco, the 1987-91 outbreak in that
ecosystem was extinct, and since 1993 all Member States
of the European Union comply with the conditions for
an AHS free country according to the criteria set up by
Community legislation.

(6)

(7)

(8)

(9)

Chapter 12.1 of the Terrestrial Animal Health Code (the
the World Organisation for Animal Health
Code) of
(OIE) (3) sets, inter alia, the standards for movements of
vaccinated or seropositive equidae and provides for the
guidelines to be followed in order to maintain or recover
the free status following an outbreak.

In the absence of a specific monograph for vaccines
the
against AHS in the European Pharmacopoeia,
description in Chapter 2.5.1 of the Manual of Diagnostic
Tests and Vaccines for Terrestrial Animals (4) of
the
vaccine produced by Onderstepoort Biological Products
Ltd (OBP)
in South Africa is the only available and
authentic standard for live attenuated vaccines against
AHS.

In the light of the experience with vaccination against
bluetongue in Member States,
in order to prevent the
introduction of previously undetected serotypes in an
ecosystem,
it is necessary to establish the capacity for
resorting in case of emergency to monovalent vaccines
containing only the serotype already prevalent or directly
threatening the region. The OBP has the technology to
produce suitable monovalent attenuated vaccines from
the seven serotypes included in the routinely produced
tri- and tetravalent attenuated live vaccines for combined
subsequent use in endemic settings that
is effective
against all nine AHS-virus serotypes.

to provide effective vaccines
internationally

OBP is thus the only potential contractor with the
required capacities
for
accepted standards,
AHS that meet
within the meaning of Article 123(3) of Commission
Regulation
of
23 December 2002, laying down detailed rules for the
implementation of Council Regulation (EC, Euratom) No
1605/2002 on the Financial Regulation applicable to the
general budget of the European Communities (5).

2342/2002

Euratom)

(EC,

No

(1) OJ L 224, 18.8.1990, p. 19.
(2) OJ L 157, 10.6.1992, p. 19.

(3) http://www.oie.int/eng/normes/mcode/en_chapitre_1.12.1.htm
(4) http://www.oie.int/eng/normes/mmanual/2008/pdf/2.05.01_AHS.pdf
(5) OJ L 357, 31.12.2002, p. 1.

L 2/10

EN

Official Journal of the European Union

6.1.2009

(10)

(11)

(12)

(13)

The OIE Manual indicates an extended period of stability
when the lyophilised vaccine is stored at 4-8 °C; however
the commercially guaranteed shelf life is set at two years.
A decision on the renewal of the vaccine stocks should
therefore be taken in due course before the expiry of the
shelf life and in the light of the epidemiological situation
and the possible development of new vaccines.

Based on experience with other Community vaccine
reserves and taking into account that in case of AHS a
complete primary course of vaccination consists of a first
administration of
the vaccine followed by a second
booster vaccination, a total number of 100 000 doses
of each of
the seven attenuated serotypes would be
sufficient for a first emergency response.

For the protection of susceptible equidae it is therefore
appropriate to establish Community reserves of vaccines
against AHS and to make them available for emergency
use in Member States or in epidemiologically relevant
neighbouring third countries representing a particular
AHS risk to them.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Decision are in
Standing
the

opinion

the

of

The arrangements referred to in paragraph 1 shall include
2.
the supply and storage of
the total of 700 000 doses of
lyophilised vaccines and the shipment without delay of the
specified vaccines to a place in the European Union, or its
epidemiologically relevant direct neighbourhood, designated in
case of emergency by the Commission.

Article 2

The maximum cost of the measures referred to in Article 1 shall
be up to EUR 500 000 for a period of two years.

Article 3

To meet the objectives of Articles 1 and 2 the Commission shall
conclude for the years 2009 and 2010 a supply contract with
Onderstepoort Biological Products Ltd (OBP) in South Africa on:

— the supply and storage of

the vaccines described in

Article 1(1),

— the delivery of the vaccines together with the diluents as

described in Article 1(2), and

— the details of disposal of expired vaccines.

HAS DECIDED AS FOLLOWS:

Article 1

Done at Brussels, 18 December 2008.

use

For

emergency

the Community

1.
shall make
arrangements for the purchase of 100 000 doses of lyophilised
including the necessary
monovalent attenuated live vaccines,
diluents,
the
against African horse
serotypes 1, 2, 3, 4, 6, 7 and 8.

sickness of

each of

For the Commission

Androulla VASSILIOU
Member of the Commission