Vaccine research and development
Following an assessment of the research capacity of African countries, capacity in regulatory and ethical oversight of vaccine clinical trials has been built and strengthened in 19 Member States (Botswana, Burkina Faso, Cameroon, Ethiopia, Kenya, Gambia, Ghana, Gabon, Mali, Malawi, Mozambique, Nigeria, Rwanda, Senegal, South Africa, United Republic of Tanzania, Uganda, Zambia, Zimbabwe) through the African Vaccine Regulatory Forum. This has significantly improved countries’ ability to undertake vaccine clinical trials.
In recent years, several vaccines have entered phases I, II and III of clinical trials in the WHO African Region, including candidate vaccines against tuberculosis, malaria and HIV/AIDS. On the recommendations of the Strategic Advisory Group of Experts (SAGE) on Immunization and other advisory bodies, other new vaccines have undergone clinical trials to establish their efficacy and safety.
Conjugate Meningococcal A Vaccine
Clinical trials were conducted in the Gambia, Mali and Senegal to establish the safety and efficacy of the conjugate meningococcal A vaccine, which led to its licensure and subsequent WHO prequalification in June 2010. The clinical trials proved that the vaccine is safe and better than existing polysaccharide vaccines currently used for epidemic response. The conjugate meningococcal A vaccine will be used for preventive mass immunization in the age range of 1─29 years. The vaccine will be marketed at an affordable cost of US$ 0.40 per dose.
Subsequent clinical trials are ongoing in Ghana to establish the safety and efficacy of the vaccine for use in infants. This will guide its introduction into the routine Expanded Programme on Immunization programmes of countries in the Region’s meningitis belt.
Candidate Malaria Vaccine
Currently only one candidate, GSK’s RTS,S/AS01E (MosquirixR) malaria vaccine is in phase III clinical trials at 11 sites in seven countries within the Region. These countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, United Republic of Tanzania) conducted a review of the protocol and are receiving support in ethical and regulatory oversight for the clinical trials. WHO has established a policy recommendation pathway in support of the development of this candidate malaria vaccine.
Accelerating HIV vaccine research
The African Aids Vaccine Programme was created to promote the accelerated development of a safe, efficacious and affordable vaccine against HIV/AIDS. The objectives of the Programme are:
- to develop advocacy and communication tools
- provide a network of people and institutions
- promote the development of appropriate candidate HIV vaccines
- facilitate clinical trials that will ultimately lead to a vaccine against HIV in Africa.
The secretariat for this important advocacy and capacity building effort for HIV vaccines was established at the Uganda Virus Research Institute in 2009.