In the quest for a new, reliable malaria vaccine, GlaxoSmithKline (GSK) is way ahead. Their product, known under the code name RTS,S/AS02D, is the most promising candidate to become officially registrated as a vaccine against malaria. After encouraging results in children in Mozambique in 2004, a pivotal fase III randomized controlled clinical trial has recently been initiated in Mozambique, Tanzania, Gabon, Ghana and Kenya and the stakes are high. So will these achievements eventually bring a world where malaria can be contained closer or are they just part of a vulgar pharmaceutical rat race?
In Verona last September at the 6th European Congress on Tropical Medicine and International Health, there was a pleasant mixture of lectures, workshops and round-table discussions. A wide range of tropical diseases was covered with a special emphasis on malaria. And so the stage was set at one point for GlaxoSmithKline to deliver a lecture on the development of their vaccine and the latest results. The message was clear and encouraging: what started in 1987 with the first steps has now resulted in a safe, reliable and effective vaccine against malaria in infants and young children. Colourful graphs and fancy tables were shown to the public: after a 3 dose regimen 1442 children were followed for 18 months for episodes of malaria and side effects. RTS,S reduced clinical malaria episodes by 35 percent and severe malaria episodes by 49 percent. No serious side effects were reported. Overall it turned out that children vaccinated with RTS,S were 29 percent less likely to develop malaria after the full follow up period. The fase III trial will bring the definite answer to the question of reliability, safety and effectiveness of RTS,S.
And so after these hopeful sounds there was room for a couple of questions from the audience. A gentleman from England introduced himself: he was a microbiologist. He wondered whether a vaccine that is effective in only half of the population will increase the virulence of the parasite in the other half. Should we be aware of an increase in cases of severe malaria after final introduction of the vaccine? The answer was all but straightforward: that could not be predicted yet. The trial lacked data on the severity of malaria episodes witnessed in the control group. Time should tell us. Next question please. A woman from Kenya raised her finger. First of all she praised all the work done by GSK and was hoping for a quick introduction of the vaccine after the fase III trial. In her opinion, the vaccine had already proven its use. Her question was whether GSK was willing to sell the vaccine for its actual value. Or else, was the company willing to produce the vaccine in cooperation with other (local?) pharmaceutical companies so that it could be spread among the population at the lowest possible cost? The representative of GSK had been expecting this question. He swiftly replied. “We have developed this vaccine for over 20 years and we have put a vast amount of our resources into producing it. We cannot afford to have other companies profit from all the effort we have put in."
Hence, after a one hour session one item remains unanswered while on one item the company’s position is crystal clear. For the future it remains doubtful whether the effectiveness in about half the children will have serious consequences on the severity of malaria episodes experienced in the other half that actually gets infected despite vaccination. However, when the malaria vaccine by GSK will be approved after the fase III trial and its distribution in the developing countries can commence, it will not be for the lowest possible amount of money. For that, GSK already had to make to many financial sacrifices.
