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

Decision-making at the Country Level

Experience suggests that introducing a new vaccine into a national immunization program is influenced by multiple factors.[102,110] Activities need to be designed which will demonstrate the public health impact and need for the vaccine in the country and assess means of ensuring vaccine access for people at risk. The data generated can be used for other countries that subsequently introduce the vaccine.

Generating Research Evidence for Decision-making

The following key aspects are required to evaluate the budget requirements for the program, allocate government and partner funding, evaluate affordability of the program for the government and individuals and assess program sustainability:

Epidemiological surveillance: surveillance should include analyses of disease burden, incidence and prevalence, pathogenicity and seroprevalence, disease vector and transmission, distribution of the disease (agent and area) and the morbidity and mortality associated with the disease.

Economic studies: solid data should be obtained on the cost of the vaccine-preventable disease divided into public and private sector, disease severity, individual and household cost, indirect cost of illness (including absenteeism, loss of productivity) and willingness to pay for a preventive measure.

Policy studies: strategic assessment includes scheduling, coadministration, target age groups, duration of protection, herd effect, programmatic aspects, such as supplies and logistics, as well as risk–benefit analyses.

Social studies: social scientists should be involved early on to address the public opinion and the demand for vaccine.

Mathematical modeling: mathematical models should be employed to help estimate the impact of the vaccine on the disease and costs, assess public health impact.

Regulatory aspects: the country's National Regulatory Authority (NRA) should be able to licensee and control the safety and quality of the vaccine. The NRA should ideally be WHO recognized and be capable of approving and overseeing the Phases III and IV trials conducted in the country, be able to license novel vaccines, develop and validate lot testing for the novel vaccines, ensure the vaccine is manufactured to GMP conditions and be able to review AEFI from the clinical trials and vaccination campaigns.

WHO has played a key role in establishing the WHO Biological Reference Materials necessary to standardize biological materials and developing WHO guidelines and recommendations on the production and control of vaccines to ensure safe and effective products. These standards, based on consensus achieved through international consultations, assist WHO Member States in ensuring that the vaccines produced and used in their country conform to current international standards. This also involves close collaboration with the international scientific and professional communities, regional and national regulatory authorities, manufacturers and expert laboratories worldwide.[111]

By prequalifying vaccines, WHO provides a service to UNICEF and other UN agencies that purchase vaccines, with regards to the acceptability, of vaccines from different sources for supply to these agencies. Vaccines are added to the list after the evaluation of relevant data and the manufacturing sites being audited by WHO. This list is updated regularly. These vaccines are considered suitable for the target population, at the recommended immunization schedules and for use with appropriate concomitant products. This also ensures that there is independent and appropriate regulatory oversight of the vaccine by a responsible functional NRA.[111]

Among other aspects, decision-makers will need information on affordability and relative cost–effectiveness, to determine the value for money of the new vaccine. Other important considerations are the availability and market price of vaccines, the safety and suitability of available vaccine products for national programs and logistical considerations of how the new vaccine should be introduced. Different possibilities exist, such as a phased introduction into specific risk groups first, followed by the general population versus one-time preventive campaigns in the at risk groups by routine vaccine introduction in at risk areas, in the national immunization programs, etc..[66] Lately, WHO has focused on providing technical information packages, promoting the establishment and strengthening the capacity of national immunization advisory bodies and providing models and estimates of cost–effectiveness to help with the national or regional decision-making process. In this regard, the WHO has developed a comprehensive resource,[101] proposing a generic framework that can be used by the health officials working on immunization program. The WHO Vaccine Introduction Brochure[101] is available online, website provides useful information regarding programmatic aspects of introducing a new vaccine. Numerous vaccine and product-specific guidelines have also been developed to facilitate introduction, and WHO Position Papers are also available for all new vaccines.[112]

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