A vaccine against malaria was, for many years, considered the holy grail of medical science. The challenge was to develop a vaccine against a parasite—an extremely complex organism capable of constant change—and that was something that had never been done before. Given the circumstances, the fact that registration of the first malaria vaccine is just around the corner represents a giant step forward for both science and the fight against malaria.
After more than 30 years of joint public-private efforts a malaria vaccine is currently in the final stage of the evaluation process for marketing approval So much has been said about the malaria vaccine that it is important to explain exactly where we are today. After more than 30 years of joint public-private efforts involving many partners—institutions, pharmaceutical companies, funding agencies and philanthropic foundations as well as research centres in America, Europe and Africa—a malaria vaccine is currently in the final stage of the evaluation process for marketing approval. This means that the European Medicines Agency is reviewing all the product data, including the results of the clinical trial that was conducted in 11 sub-Saharan African countries, enrolling nearly 16,000 children to provide data for the regulatory review. Once this vaccine has been approved, the World Health Organization (WHO) will make policy recommendations regarding its use in endemic countries.
The results of the trial show that the vaccine can prevent clinical and severe forms of malaria in infants when administered together with routine childhood vaccines to breastfeeding infants in the first few weeks of life and also when it is given to somewhat older children, aged between 5 and 17 months. However, since the protection demonstrated in this study was moderate and limited over time, the final decision on whether or not to use the vaccine will be made by the WHO and the national authorities in each endemic country. In this regard, it should be noted that the vaccine could serve as an important control measure, especially when used in conjunction with the other preventive interventions currently in use, such as insecticide-treated bed nets, intermittent preventive treatment in pregnant women and infants and, of course, prompt and appropriate treatment of episodes of clinical malaria.
Whatever the final decision, the development of an effective vaccine against a parasite is a great scientific breakthrough. Until now we have only been able to develop vaccines against viruses and bacteria, which are much simpler organisms than the parasite targeted by this vaccine. Consequently, this first malaria vaccine should be valued for what it is: a milestone, but at the same time only the first step on a long road.