Introducing New Vaccines in Developing Countries

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

Disclosures

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

In This Article

Conclusions

According to UNICEF, the past 20 years have seen an exponential increase in the number of available and new vaccines.[113] However, there is a concern that inadequate access to vaccines is responsible for over 2 million deaths annually in low- and middle-income countries.[72] These suggest that additional work needs to be done to meet the Fourth Millennium Development Goal, that is, to reduce, by two-thirds, between 1990 and 2015, the under-five mortality rate.[114]

The global immunisation vision and strategy (GIVS), established in 2005, aims to facilitate the achievement of this goal.

The GAVI Alliance has been instrumental in funding new vaccines in the poorest countries. Vaccines against Hepatitis B and Haemophilus influenzae type b (Hib) have been widely introduced. An increasing number of countries are now offering pneumococcal conjugate and rotavirus vaccines in their programs, thus offering protection against some of the leading causes of child mortality: pneumonia and diarrhea. Poliomyelitis is on the verge of eradication,[73] measles deaths have been reduced by 74% between 2000 and 2010[74] and maternal and neonatal tetanus have almost been eliminated as a public health disease.[115]

Several global health initiatives have been established to promote immunization within the context of the other primary health care interventions. So far, over 70 countries have developed comprehensive Multi-Year Plans, outlining their plans for implementing the GIVS strategies.[75,76] The GAVI, established in 2000, provides financial support for immunization to the poorest countries of the world.[77] Initiating in 1990, the accelerated vaccine introduction Priority Project is an effort to find mechanisms for accelerating the introduction of new as well as underused vaccines of public health importance in the developing world. The project finds barriers to new vaccine introduction in developing countries includes lack of efficacy, burden and cost–effectiveness information for developing country settings, the need for technical assistance with introduction, logistics, supply and quality control issues and lack of funding for vaccines. The accelerated vaccine introduction project also focuses on critical points in the vaccine evaluation and introduction continuum at which WHO activity can make a substantial difference. The project involves activities in each of Vaccines and Biologicals teams, and addresses the following areas – efficacy, burden and cost–effectiveness, vaccine quality, vaccine supply and financing and introduction into immunization programs. social network analysis can be employed prior to vaccine introduction to improve the understanding of structural and relational features of the network of actors involved.[78]

The Johns Hopkins Bloomberg School of Public Health has been awarded a 4-year, US$5 million grant from the Bill & Melinda Gates Foundation to promote the effective use of oral cholera vaccines around the world.[116] The endeavor under the delivering oral vaccine effectively (DOVE) program will provide local health officials with technical assistance on how to use a vaccine (currently focusing specifically on the cholera vaccine), evaluate current vaccine-use practices and develop new field surveillance methods for monitoring and controlling outbreaks of the disease. In partnership with the WHO, UNICEF and other national and international agencies, the delivering oral vaccine effectively project will provide the knowledge, technical assistance and encouragement to bring a life-saving vaccine to those who need it the most, in particular the high-risk people of the developing countries. The program will greatly facilitate the appropriate use of the new cholera vaccine, and the knowledge will help facilitate introduction of the other new vaccines in the developing countries.

Lessons learned, guidelines for implementation and relevant data from successful previous vaccine introduction campaigns should be compiled and shared in a national, regional and global context. The decision of a national government to introduce a vaccine can significantly influence the decisions of other countries in the region.

Some of the lessons learnt include the fact that the introduction of new vaccines should include sufficient time factored in for technical and regulatory approvals (which are often time-consuming in developing countries), interdepartmental coordination and communication between different national government departments are key to successful vaccine introduction, training helps in strengthening the vaccine-specific AEFI and the country's AEFI monitoring systems, improving vaccine and logistic forecasting improves procurement of the vaccine, improving the vaccine supply chain minimizes vaccine wastage due to vaccine expiry, strong monitoring and supervision leads to scare in-country financial and human resources being utilized well, need-based revision of budgets leads to better vaccine campaign implementation and continued epidemiological assessments of the disease burden in different population strata, operational research, surveillance to better understand the disease burden (including the disease incidence, age distribution, case fatality rates, sequelae, disability-adjusted life years averted) and cost–effectiveness analysis is helpful in policy making. Economic evaluations can help determine appropriate resource allocation and design services.

Information on the disease burden, vaccine supply and sustainable financing are prerequisites to a successful vaccine introduction campaign. It is necessary to adequately estimate the programmatic time and resources costs of the vaccination program as this is often underestimated by countries. This includes the transportation of the vaccine, training and supervision, surveillance, waste management, monitoring for AEFI and cold-chain maintenance. It is importance to have standardized procedures for clinical case evaluation, consistent specimen collection, assessment of disability, national laboratory and regional reference laboratories to aid in confirmatory testing, evaluated assays and national uninterrupted supply of validated diagnostic kits.

Sensitization of key stakeholders, regular media updates and public awareness campaigns help in addressing concerns regarding the new vaccine. Political support and support from the National and Local communities is required. Communication plans should be developed for the different stakeholders including the public health experts, policy makers, health community, general public and the media. Well-developed and rapidly implemented crisis communication plans to ensure immediate clarification to vaccine-related concerns are critical.

International procurement support to developing countries to ensure access to safe and affordable vaccines, technical assistance and the regulatory experience of neighboring countries is important for reviewing available information, generating data for product licensure and helps speed up introduction efforts.

Dedicated advocacy helps keep the disease burden and the importance of the vaccine on the national, regional and international agenda. Advocacy efforts can help highlight the impact of regional diseases to the funding agencies and global health bodies.

New vaccine introduction and immunization strategies (including vaccine transition in the country) help in improving the countries health system infrastructure, enhance disease surveillance and strengthen AEFI monitoring.

Although there may not be a 'one-fits-all' solution for all developing countries, a consensus protocol can be developed to cover common issues and priorities in different parts of the word.

In conclusion, the key to success of introducing a new vaccine in a developing country is how it can be integrated with other intervention programs of the country.

The program should protect synergistically with other interventions, but this synergy needs to be documented in a variety of situations where the vaccine will be used. Mechanisms of the synergy include both biological and logistic synergy. Biologically, the vaccine may induce herd protection by reducing the environmental contamination of the pathogen[79] making other intervention programs activities more effective. In turn, the other interventions reduce the inoculum that potential patients consume and this increases the effectiveness of the vaccine. Further activities include the functions of policy advice, process guidance, other quantitative assessment and experience sharing and planning. The need to make important decisions about the use of new vaccines provides an excellent opportunity for countries to consider the use of broader advisory committees to deliberate and address strategic issues and health priorities at national level. These activities are important for a developing country for introducing a new vaccine, though they should be carefully tailored to meet the different needs of the individual country.

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