WRITTEN QUESTION E-1684/01

by Marit Paulsen (ELDR) to the Commission

(14 June 2001)

Subject: Malaria vaccine

In October 1999, I asked the Commission whether it could submit a proposal, as an aspect of aid policy, under which the Member States would place an order for a malaria vaccine with the pharmaceutical companies and undertake to pay a certain price for a dose of vaccine.

The Commission subsequently replied that creativity and new partnerships were required to bridge the enormous gap between human needs, scientific input and market profits, that initial talks were being held in the Community on such an approach in relation to an AIDS vaccine for the developing countries and that similar strategies could and should be developed for malaria. It was also pointed out that the Community was funding a pilot project for clinical demonstration in Gambia in partnership with a pharmaceutical company.

According to the Commission, the Community was at that point, in November 1999, still in the initial stages of developing that approach. 18 months have since passed, culminating in a major debate on AIDS and the conduct of the pharmaceutical companies in South Africa. Will the Commission, therefore, say what the results of the talks concerning an AIDS vaccine were, what measures were taken concerning an AIDS vaccine for the developing countries on the basis of those results, and what the outcome of the pilot project in Gambia was?

Answer given by Mr Nielson on behalf of the Commission

(3 September 2001)

There has been significant progress on malaria vaccine research since the Honourable Member's Written Question E-1790/99(1). With Community support 14 candidate vaccines have been studied. This represents a major share of the global effort. The Quality of Life and the International Cooperation programmes of General Directorate Research have considerably increased resources dedicated to malaria vaccine and malaria drug development. It is expected that at the end of the Fifth Framework Programme for Research and Technological Development (R & D) of the Community more than 30 million will be spent on malaria research alone. In addition major integrated research consortia Clusters including major European vaccine manufacturers have been established. The European Malaria Vaccine Initiative (EMVI) has capitalised on this Community research strengths. EMVI is a response to an acknowledged bottleneck in publicly-funded vaccine research, whereby R & D efforts frequently stop at the late pre-clinical stage and do not move into clinical validation, due to lack of funds and technical know-how.

The Community's support to the African Malaria Vaccine Testing Network (AMVTN) represents a critical opportunity to link the Commission with partners in the South. It links long-term and ongoing investments into malaria vaccine development with capacity building in developing countries. The specific partnership between EMVI and AMVTN, which was conceived to move promising vaccine candidates further down the development pipeline, has added a great deal of credibility to the endeavour. The AMVTN, under the ownership of developing countries, represents a major opportunity over the coming years to further develop and assess efficacy and field effectiveness of malaria vaccines.

AMVTN is now developing trial sites based on earlier extensive epidemiological ground-work carried out by three African countries with support from the Community and Member States. The current effort to establish itself as a legal body under Tanzanian law is an important prerequisite to play an active role in supporting the expansion of clinical trials in the region.

Following a positive evaluation of a malaria vaccine candidate in adults, the Community funded Gambia pilot project is now conducting trials of safety, tolerance, immunogenicity and protective efficacy in children living in endemic areas.

Current research and development of human immunodeficiency virus (HIV) vaccines has shown that new vaccination approaches can work in animal models. These include approaches developed in the private sector (Merck, Glaxo Smith Kline) and under the current Community funded project cluster Eurovac in partnership with Aventis/Pasteur. Trials are starting in humans to establish safety, and the first results can be expected in 2002/2003. The Community is also funding preparatory work for trials in China and Tanzania. Again the European consortia are at the forefront of this research.

In the Commission's Programme for Action Accelerated action on HIV/acquired immune deficiency syndrome (AIDS), malaria and tuberculosis in the context of poverty reduction(2), endorsed by the General Affairs Council of 14 May 2001, and in the Commission's proposal for the specific programmes of the Research Framework Programme 2002-2006(3), the Commission proposed the creation of a European Clinical Trials Platform (ECTP) as a joint activity of Member States and the Community to support the fight against HIV/AIDS, malaria and tuberculosis in developing countries. The ECTP should have three main functions: to support the networking and pooling of national trial activities, to strengthen trial infrastructures in endemic countries and to sponsor its own trial activities.

(1) OJ C 203 E, 18.7.2000.

(2) COM(2001) 96 final.

(3) COM(2001) 279 final.