Introducing New Vaccines in Developing Countries

Sonali Kochhar; Barbara Rath; Lea D Seeber; Gabriella Rundblad; Ali Khamesipour; Mohammad Ali


Expert Rev Vaccines. 2013;12(12):1465-1478. 

In This Article

Building a Vaccine Safety Infrastructure

Although many developed countries have systems for spontaneous reports of adverse events following immunization (AEFI) through their respective national centers for pharmacovigilance (NCPV), these systems are just emerging in developing countries. WHO and its partners are actively engaged in developing or strengthening these systems.[50] The WHO program on international drug monitoring was established in 1968.[51] Many developing countries have now joined the program and set up NCPV reporting to the WHO collaborating centre for international drug monitoring (now known as the Uppsala Monitoring Centre, UMC), as well as national advisory committees.

There are specific reasons for having a vaccine safety monitoring system in developing countries.[52,53] The vaccine may not be produced under good manufacturing condition.[54] The vaccine potency and safety may become impaired by improper storage or administration. Also, some adverse effects may not become apparent in prelicensure trials because they occur rarely and may not be measured in such trials. Assuring high-quality vaccine production and high-quality postlicensure surveillance for vaccine, adverse events are complementary and integral components of a well-functioning system of vaccine regulation and control. This would help gain public confidence. The introduction of a new vaccine in any setting will be more effective and sustainable if publicly known safety surveillance is already in place.

The processes for and completion of AEFI reporting from developing countries are highly variable. Some countries have no NCPV. In countries where NCPV are established, adverse drug reaction reporting is a regular activity. In contrast, AEFI may or may not be received and forwarded on to the UMC.[55] There may be dual systems for AEFI reports with those involving adults being reported directly to the NCPV, whereas those involving childhood vaccines being reported via the national immunization program. Any AEFIs reported to the NCPV are likely to be sent on to the UMC, but when AEFIs are reported via the immunization program, they may be sent to the UMC directly, or via the NCPV, or not at all.[13,39,55]

In the face of limited resources, active collaboration between NCPV and EPI programs is extremely important though recent assessments by WHO indicate that such collaborations are few. Although benefiting from improved collaboration between existing systems, vaccine safety surveillance systems will need to accommodate for and 'fit into' the very different public health and vaccine safety environments in developing countries.

The efficient implementation of pre- and postmarketing surveillance systems requires well-trained personnel. The process of economic globalization leads to a continued loss of human resources due to migration to industrialized countries creating acute shortages in developing countries.[56,57] The monitoring and reporting of AEFI in areas of low health practitioners' coverage will often be undertaken by laypersons. This may have an impact on the nature and types of AEFI reported as well as the quality of reports. Caretakers of children who have been immunized will have to be educated and informed about reporting mechanisms, including contacting personnel in the event of medical problems following immunization.[58] In areas where there are few health professionals, village healers or midwives are often asked to take part in mass immunization programs without legal protection. When there are programmatic errors or AEFI, these workers are left to fend for themselves – an issue of poor communication and poor governance. Adequate training for those who will engage in mass immunization programs will be crucial for the long-term success of such programs.

New concepts have been developed recently, including the systematic analysis of vaccine safety inquiries from public health officials vaccine providers and the general public for the tracking of vaccine rumors,[59] as well as safety monitoring systems developed in the context of the recent H1N1 pandemic.[60] Another recent approach developed by the London School of Tropical Medicine includes a monitoring system of social networks to measure vaccine confidence in different groups and regions.[61]