EN Official Journal of the European Union CE 88/315

(2004/C 88 E/0320)

WRITTEN QUESTION P-0110/03

by Peter Liese (PPE-DE) to the Commission

(21 January 2003)

Subject: Vaccination against smallpox in the Member States

Various preparations are currently being made in the Member States to combat possible terrorist attacks using the smallpox virus. Media reports have caused great alarm among the general public. Since the smallpox virus would obviously not stop at the frontiers of the Member States, an EU-wide approach is essential.

Does the European Commission have any information about the various strategies in the Member States? What plans are there for transfrontier coordination of the various strategies of the individual Member States? Can the Commission offer to assist the Member States, with particular regard to an assessment of the possible side effects of vaccination against smallpox? To what extent will it be possible to take advantage of the benefits of the single market in order to ensure that supplies of highly-effective vaccines which have minimal side effects are available in all the Member States as rapidly as possible when required?

Answer given by Mr Byrne on behalf of the Commission

(12 February 2003)

As indicated in its Communications ‘Civil protection — State of preventive alert against possible emergencies’ (1) and ‘Civil protection — Progress made in implementing the programme for preparedness for possible emergencies’ (2), the Commission and the Member States are working together in the framework of a programme on health security to strengthen preparedness for and response to deliberate releases of biological and chemical agents to cause harm. This involves, inter alia, the confidential exchange of information and sharing of best practice on national strategies to face up to a smallpox outbreak and allow the highest possible degree of co-ordination in introducing counter-measures. It also involves the dissemination of information, reviews and guidelines for health professionals on priority issues such as surveillance, detection, laboratory analysis and case management.

The side-effects of smallpox vaccination dating from the World Health Organisation's (WHO) eradication programme have been well documented and published. New data arising out of planned vaccination in some countries will, however, be disseminated by the Commission's Task Force on Health Security once they become available.

There are currently no authorised small pox vaccines in the Community. New vaccines are in development, but no application for marketing authorisation has been received yet. In the absence of a product that has received market authorisation in the Community, Member States are building up national stocks from either first generation or second generation unlicensed vaccines.

The ad hoc expert group on vaccines established at the request of the Commission by the European Medicines Evaluation Agency (EMEA) developed guidance on the development of vaccinia virus vaccines against small pox (3). This was published on the Commission and EMEA websites in July 2002. It includes a section on the assessment of safety and post-authorisation studies.

Any new vaccine would be eligible to apply for marketing authorisation through the centralised procedure, for which an accelerated assessment could be provided. If the necessary criteria of safety, efficacy and quality were met this would result in a Community authorisation, immediately applicable in all Member States.

Under the Sixth Framework Research Programme, research leading to new vaccines against potential bio agents and novel therapeutics will be supported.

(1) COM(2001) 707 final.

(2) COM(2002) 302 final.

(3) Note for guidance on the development of vaccinia virus based vaccines against smallpox. http://phar-macos.eudra.org/F2/home.html or http://www.emea.eu.int/.