A vaccine against malaria, something that a few years ago we could only dream about, could be a reality in the next five years.
Are we ready to decide whether this vaccine is right for infants and children in Africa and to determine how it should be used within our health system? Given the magnitude of malaria and lack of a malaria vaccine, every person in the country is at risk—and given the traditional delays between the introduction of new medical solutions and their implementation, our country must begin to prepare for malaria vaccine introduction now.
Results of a clinical trial in Mozambique reported in 2007 showed that the most advanced malaria vaccine—GlaxoSmithKline (GSK) Biologicals' RTS,S—provided similar protection in infants against infection and illness as it had shown previously in children ages one to four. Additional testing is underway in Ghana and four other countries in sub-Saharan Africa, with support from the US-based PATH Malaria Vaccine Initiative and its partners, including GSK.
This testing will provide the data needed to move into a large, multi-center Phase 3 trial, which is currently scheduled to begin toward the end of this year. If all goes well, the vaccine could be submitted for review in 2011 to the European Medicines Evaluation Agency in collaboration with the World Health Organization.
While this timeline is exciting, it presents a challenge to Africa. It would be very frustrating indeed to produce a safe and effective malaria vaccine only to have its introduction delayed by an inability to objectively determine whether it is appropriate for our country and our people. The price of our delay could be measured in unnecessary deaths and illness from malaria.
In the fight against malaria—and in dealing with any new medical advance—such delays are not uncommon. For example, after scientists determined that new drugs known as artemisinin-based combination therapies should comprise our front-line treatment against malaria, their widespread use was delayed, as countries conducted their own assessments of the medications.
Discussions are taking place among African countries, including Ghana, as well as the World Health Organization and other institutions to plan for the eventual use of a licensed malaria vaccine. These discussions have already produced a plan that sets out the kind of data and processes needed to make sound decisions about adopting and using a malaria vaccine. This plan, known as the Malaria Vaccine Decision-Making Framework, is expected to be endorsed by countries in the region and their partners.
The decision-making process is essential to the effort to defeat malaria. Ghana—and all of Africa—need to establish specific processes and gather the expertise needed to properly evaluate a potential vaccine and come to a clear, prompt resolution whether to implement it. As this process goes forward, I also urge the leaders of Ghana to ensure that regular consultations take place among scientists, government officials, and other stakeholders to lay the groundwork for the introduction and use of a malaria vaccine.
It is up to national health leaders in Mozambique and other African countries to take the initiative now. On this World Malaria Day, let us remember the critical need to take early steps to avoid the needless delay between the licensing of a vaccine and its deployment in Africa, so that together we can start saving lives as quickly as possible.
In Ghana, malaria vaccine trials are being conducted at the Kintampo Health Research Centre and the Kumasi Centre for Collaborative Research/KNUST School of Medical Sciences.
Dr. Pascoal Mocumbi is the former Prime Minister of Mozambique and current High Representative of the European and Developing Countries Clinical Trials Partnership Programme (EDCTP).