Introduction of multi-dose PCV 13 vaccine in Benin: from the decision to vaccinators experience

Background In 2011, Benin introduced the 13-valent pneumococcal conjugated vaccine (PCV13), in a single-dose vial, into its Expanded Programme for Immunisation (EPI) with support from Gavi. In April 2018, with the support of the Agence de Médecine Préventive Afrique (AMP) and other technical and financial partners, the single-dose vial was transitioned to a four-dose vial. Here we describe the decision-making process and the experience of the vaccinators during the change. Methods We carried out semi-structured, individual interviews with 61 participants individuals involved in the EPI: 7 from central level, 5 from regional level, 7 from township level and 42 from district level. The interviews were recorded and transcribed, and the information categorised, using Nvivo software, and then analysed. Results The Inter-agency Coordination Committee (ICC), the Benin National Advisory Committee for Vaccines and Vaccination, (BNACVV) and the World Health Organisation (WHO) (i.e., the traditional governance structures involved in vaccination decisions) were not involved in the decision to change to the four-dose vial for PCV13. The decision was taken by the EPI, supported by Gavi. The vaccination errors observed in the first months following the change in presentation were due to the absence of guidelines for changes in vaccine presentation and the central-level actors’ perception that it was ‘only a change in the vial’, and therefore that the communication and training for a new vaccine were not required since the vaccine itself and its administration mode were unchanged. Conclusions It is important that the other countries eligible for Gavi support that are about to change to the multi-dose vial PCV13 presentation learn from Benin’s experience. The main lessons learned are that changes in the presentation of an established vaccine should follow the same process as the introduction of a new vaccine, and that all stakeholders involved in vaccines and vaccination should participate in the decision-making process and implementation.

which bring together one or more administrative communes, the operational unit of the health system.

The Expanded Programme on Immunisation
The Expanded Programme on Immunisation (EPI), a World Health Organisation programme, was established in 1974 to develop and expand immunisation programmes throughout the world [1].
In 1977, the goal was set to make immunisation against diphtheria, pertussis, tetanus, poliomyelitis, measles and tuberculosis available to every child in the world by 1990. Currently the EPI also includes human papillomavirus (HPV), inactivated poliovirus (IPV), rotavirus, Japanese encephalitis, meningitis A, measles-rubella, cholera, yellow fever, and pneumococcal vaccines In Benin, the EPI is implemented by the National Directorate of the Expanded Program on Immunization and Primary Health Care (NDEPI-PHC), the executing arm of State policy for immunization. It consists of four technical services: Immunization, Logistics, Primary Health Care and Cost Reimbursement. At the national level, the EPI is under the responsibility of the National Agency for Immunisation and Primary Health Care (NAI-PHC) that sits within the Minister of Health. Coordination is provided by a public health doctor, who is the National 2 Director for EPI and Primary Health Care. At the departmental level, the EPI coordination is provided by the Director of the Health Protection and Promotion Service, who is assisted by the Director of the Immunisation Division. At the health zone level, the EPI is coordinated by the Health Zone Committee (HZC) under the responsibility of the Health Zone Coordinating Doctor (HZCD). At the communal level, the EPI is coordinated by the Chief Commune Doctor seconded by an EPI Manager. At the local neighbourhood district level, the EPI activities are carried out under the guidance of the EPI Manager.

Process for Introduction of Vaccines in Benin
As Benin is eligible for Gavi funding, it can apply for support for its existing EPI and for the introduction and implementation of immunisation with new vaccines, including new vaccine presentations [2]. The Constitution of 11 December 1990 stipulates that 'the State shall protect the family and more particularly the mother and child'. Immunisation is free and compulsory for all children. The State does its utmost to mobilise sufficient resources to guarantee the procurement of vaccines and injection supplies. It relies on the expertise and facilities of its partners, in particular, UNICEF, which specialises in vaccine procurement.
The Inter-agency Coordinating Committee for EPI (ICC-EPI) provides the framework for partnership between the government of Benin and development cooperation agencies with a view to the programming, implementation, and follow-up of immunisation activities (Figure). The main ICC-EPI members are internal partners (government, NGOs, private sector and communities), and external partners consisting such as WHO, UNICEF, AMP, CDC and Gavi.
The National Immunisation Technical Advisory Group, or NITAG, guide policy and programme decisions at country level. The NITAG plays a critical role in ensuring sustainable immunisation programmes by promoting evidence-based decisions and enable the country to take full ownership of their policies and immunisation programmes. The NAI-PHC which sits in the Ministry of health is assisted by the National Logistics Working Group (NLWG) and the Technical Coordination Group (TCG) to implement the immunisation decisions taken by the Ministry of Health after consultation with the NITAG and the ICC and its