The decision making process on new vaccines introduction in South Africa.

South Africa has a functional decision making process for the introduction of new vaccines; with an established National Immunisation Technical Advisory Group (NITAG), referred to as National Advisory Group on Immunisation (NAGI). South Africa has played a leadership role in the African continent with introduction of new vaccines, which dates back to 1995 with the introduction of hepatitis B, followed by the Haemophilus influenzae type b in 1999 and recently the national roll out of the pneumococcal conjugate and rotavirus vaccines in 2009. NAGI has the responsibility to deliberate on key policy issues as part of the process for decision making on the introduction of new vaccines. In developing recommendations NAGI considers: disease burden, cost effectiveness, and the impact on the Expanded Programme on Immunisation (EPI). Although guidance and recommendations from WHO are considered, the decision to introduce a new vaccine in South Africa is based on local data. NAGI recommendations are presented to the National Department of Health (NDOH). The NDOH pursues the matter further through the involvement of provinces. When an agreement has been reached to accept the NAGI recommendations, the NDOH seeks funding from the Ministry of Finance (MOF). Once funds are available, the new vaccines are implemented by the immunisation programme. Although there is an established functional system for decision making in South Africa, some areas need to be addressed. A system should be developed to allow the NDOH, NAGI and the MOF to engage in the deliberations on financial and economic impact of new vaccines. It is further recommended that a committee be established that will assess the programmatic issues to weigh the potential benefits of a new vaccine. Furthermore, political commitment should support the immunisation programme and strengthen it so that it can make an impact in the achievement of the Millennium Development Goal no. 4 of reducing child mortality.