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

Challenges in Introducing a New Vaccine

Introducing a new vaccine in a developing country may face several financial and logistical challenges.[6–9] Global challenges include the fact that newer generation vaccines are often too expensive to be introduced in developing countries. Several vaccines that were previously used both in developed and developing countries are being replaced with newer generation vaccines in the developed world (e.g., whole-cell pertussis vaccine being replaced by acellular pertussis vaccine) but continue to be used in developing countries due to their low cost. Major global vaccine manufacturers tailor their selection of vaccines to the needs of the developed world. There is little incentive for them to develop vaccines for diseases largely prevalent in the developing countries alone (e.g., Japanese Encephalitis, Dengue, Cholera, Tuberculosis, Malaria, etc.).[10]

The in-country challenges include uncertainty of local health officials with regard to when and how the vaccine should be introduced as well as how to evaluate the program. To address these challenges, the vaccine introduction program should develop epidemiological and laboratory methods to quickly assess the burden of the disease in the country. Health officials need to be engaged to consider the introduction of vaccine, and the experience from the vaccine introduction programs should be documented to understand if there is competition or synergy between existing and new vaccine introduction program. They also need to investigate how to maximize the synergies. Surveillance should document the burden of the disease in countries and regions in sufficient detail to allow local health officials to make informed decisions about the need of the vaccine. The introduction programs will also require to move from 'demonstration projects' to projects of increasing scale in regions with higher disease burden and to integrate 'operations evaluations' and 'effectiveness evaluations'. Results from these evaluations will then inform the further use of the vaccine in this and other regions. These evaluations will also add to the knowledge base of the use of the new vaccine, which can lead to improved delivery of the vaccine.

Introducing new vaccines into a country's immunization schedule is challenging, particularly in developing countries. A comprehensive document issued by WHO details the policy and programmatic issues that need to be evaluated before making the decision of introducing a new vaccine.[101] The issues include the disease burden in the country, the effectiveness of the vaccine, financial sustainability, public perceptions and community pressures especially equity issues in a heterogeneous population as well as programmatic impacts including human resources availability and program sustainability.[11]

Less attention has been paid to the proactive monitoring of the safety of vaccines in developing countries. All countries, irrespective of the economic status of its population and technological advances, have room for improving vaccine safety monitoring. Vaccine safety concerns have existed for as long as there have been vaccines. The experience in countries with long-standing immunization programs tells us that, as vaccine-preventable diseases are brought under control and memories fade, public attention will shift to vaccine safety. Although the focus for many years has been on initiating and expanding vaccine programs for the progress to be maintained, it will be essential to pay close heed to public perceptions of vaccine safety.[12–15]