Pilot assessment of supply chains for pharmaceuticals and medical commodities for malaria, tuberculosis and HIV infection in Ethiopia.

To obtain preliminary data on the drug supply management system in Ethiopia, selected facilities were assessed for the availability of essential drugs and commodities for malaria, TB and HIV. Of the 48 surveyed hospitals and health centers, 9 (19%), 9 (19%) and 10 (21%) did not have malaria, TB or HIV drugs, respectively. Similarly, of 27 health posts, 9 (33%) and 6 (22%) did not have rapid diagnostic tests and antimalarial drugs, respectively. The findings indicated an inadequate availability of essential drugs and commodities in the surveyed facilities as well as weaknesses in human resources and training. Assessments of commodity supply chains to ensure operational program success and impact are important.

WHO policy development processes for a new vaccine: case study of malaria vaccines.

BACKGROUND: Recommendations from the World Health Organization (WHO) are crucial to inform developing country decisions to use, or not, a new intervention. This article analysed the WHO policy development process to predict its course for a malaria vaccine. METHODS: The decision-making processes for one malaria intervention and four vaccines were classified through (1) consultations with staff and expert advisors to WHO's Global Malaria Programme (GMP) and Immunization, Vaccines and Biologicals Department (IVB); (2) analysis of the procedures and recommendations of the major policy-making bodies of these groups; (3) interviews with staff of partnerships working toward new vaccine availability; and (4) review and analyses of evidence informing key policy decisions. CASE DESCRIPTION: WHO policy formulation related to use of intermittent preventive treatment in infancy (IPTi) and the following vaccine interventions: Haemophilus influenzae type b conjugate vaccine (Hib), pneumococcal conjugate vaccine (PCV), rotavirus vaccine (RV), and human papillomavirus vaccine (HPV), five interventions which had relatively recently been through systematic WHO policy development processes as currently constituted, was analysed. Required information was categorized in three areas defined by a recent WHO publication on development of guidelines: safety and efficacy in relevant populations, implications for costs and population health, and localization of data to specific epidemiological situations. DISCUSSION AND EVALUATION: Data needs for a malaria vaccine include safety; the demonstration of efficacy in a range of epidemiological settings in the context of other malaria prevention interventions; and information on potential rebound in which disease increases subsequent to the intervention. In addition, a malaria vaccine would require attention to additional factors, such as costs and cost-effectiveness, supply and demand, impact of use on other interventions, and distribution issues. CONCLUSIONS: Although policy issues may be more complex for future vaccines, the lead-time between the date of product regulatory approval and a recommendation for its use in developing countries is decreasing. This study presents approaches to define in advance core data needs to support evidence-based decisions, to further decrease this lead-time, accelerating the availability of a malaria vaccine. Specific policy areas for which information should be collected are defined, including studying its use within the context of other malaria interventions.

Policy challenges in malaria vaccine introduction.

Recently licensed life-saving vaccines have experienced slow introduction and gradual uptake in the developing world. Policy challenges at the national level contribute to the delay in making new vaccines accessible to people in poor countries. The hurdles that delayed the introduction of other vaccines can provide guidance for navigating the policy challenges that face the introduction of a new malaria vaccine. When a malaria vaccine is licensed, national leaders will rely on available data and analyses to draw conclusions about which malaria interventions have the greatest potential for public health impact. Epidemiologic and economic analyses can help facilitate their decision-making. This article draws attention to the importance of research to inform policy decisions and to minimize delays in the introduction of a new malaria vaccine.

[Malaria kills over 1 million people every year. Genomic mapping of malaria parasite and mosquito raise hope for a vaccine as well as more effective drugs]. / Malaria dödar över 1 miljon människor varje år. Genetisk kartläggning av parasit och mygga ger hopp om vaccin och effektivare läkemedel.

Every year, malaria kills between 1 and 2 million people. Another half billion get infected but survive. Most cases of malaria are found in sub-Saharan Africa. Because of drug and insecticide resistance and social and environmental changes the problems are still increasing. There is therefore a desperate need for vaccines and new drugs and insecticides. Several recently published research discoveries may help to speed up the development of new tools to fight malaria. Two years ago the draft human genome sequence was released. Now the sequencing of the genomes for the most common malaria parasite, Plasmodium falciparum, and the vector mosquito, Anopheles gambiae, have been completed. For the first time researchers have the genomic maps of all three organisms in an infectious disease available.

Initiating malaria control programs in the third world: directives for short- and long-term solutions.

Although malaria is a growing problem affecting several hundred million people each year, many malarial countries lack successful disease control programs. Worldwide malaria incidence rates are dramatically increasing, generating fear among many people who are witnessing malaria control initiatives fail. In this paper, we explore two options for malaria control in poor countries: (1) the production and distribution of a malaria vaccine and (2) the control of mosquitoes that harbor the malaria parasite. We first demonstrate that the development of a malaria vaccine is indeed likely, although it will take several years to produce because of both biological obstacles and insufficient research support. The distribution of such a vaccine, as suggested by some economists, will require that wealthy states promise a market to pharmaceutical companies who have traditionally failed to investigate diseases affecting the poorest of nations. But prior to the development of a malaria vaccine, we recommend the implementation of vector control pro- grams, such as those using Bti toxin, in regions with low vector capacity. Our analysis indicates that both endogenous programs in malarial regions and molecular approaches to parasite control will provide pragmatic solutions to the malaria problem. But the successful control of malaria will require sustained support from wealthy nations, without whom vaccine development and vector control programs will likely fail.

[Malaria vaccines--which vaccines to whom?]. / Malariavaksiner--hvilke vaksiner til hvem?

More than a third of the world's population is at risk of contracting malaria. It is estimated that 200 people, primarily children in Africa, die of malaria every hour of every day all year round. Malaria is one of the main obstacles to socio-economic development in Africa. Vaccines against malaria are considered to be the control tool most in need of development. Fundamentally there are three types of malaria vaccines: vaccines against the invading sporozoite or the parasite's development in the liver cells, vaccines directed against the parasite's invasion of and development in the red blood cells; vaccines directed against the fertilisation process in the mosquito. Each malaria vaccine has its own area of application. In spite of promising results in animals it has been difficult to reproduce the results in clinical trials in humans. Recently, however, an experimental vaccine containing a sporozoite protein coupled to a hepatitis B surface molecule with a new adjuvant has been tested in Gambia. The results of these tests are promising, but it is unlikely that the vaccine will be of use in endemic areas. Increased focus on one of the world's biggest health problems has to a certain extent promoted the funding of development work on malaria vaccines. Despite minimal interest from the pharmaceutical industry, a number of experimental vaccines for clinical phase I trials are on their way. However, it will take a huge increase in public financial resources to secure effective and safe malaria vaccines for those most in need of them: people in developing countries and particularly in Sub-Saharan Africa.

[Antimalarial vaccination: advances and controversies]. / Vaccination antipaludique: acquis et controverses.

Since 1993 the new worldwide position of WHO is to encourage the development of an anti-malaria vaccine. The antigenic complexity of the parasite makes such development difficult. Twenty or more candidate molecules are being tested with different stages of development. They are directed against pre-erythrocyte or erythrocyte stages, or gametes, multivalent, or directed against the pathogenic metabolites of the parasite. Recent results have shown the interest of further study of the adjuvants. Controversy was crystallised by the disappointing results of the Pattaroyo vaccine, Spf66, which associates antigens of the sporozoite and the erythrocyte stage. These results nevertheless showed that vaccination against malaria is possible, but they underlined the undesirable effects of performing clinical studies too early or making premature recommendations.