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

Surveillance Post Vaccine Introduction

As countries begin to introduce newly approved vaccines into routine childhood immunization programs, monitoring the vaccines performance in real-world settings should be a high priority. Key considerations in the postlicensure period include: how the vaccine will perform against the target disease under routine public health use; how routine vaccination will impact the epidemiology of the disease with regard to the burden of severe disease and death, seasonality, serotype distribution and age distribution of cases; whether the vaccination will have a sufficient impact on transmission to reduce disease burden in unvaccinated individuals living in the vaccination area; whether the vaccine will confer protection through the initial years of the infants life, when most severe disease and mortality typically occur. Monitoring of the vaccine impact with focus on these public health considerations will allow public health authorities, health care providers, parents and decision makers to appreciate the health benefits of vaccination in reducing the burden of severe disease. It will also allow assessment of the cost and effectiveness of vaccines in programmatic use and the need for modifying vaccination formulations or schedules to enhance the performance of the vaccine.[67,68]

Monitoring disease trends in order to assess vaccine impact can be done using primary data sources, such as an active disease surveillance system or secondary data sources, such as national data on hospitalizations for disease. Although these data are often incomplete, monitoring data from 1 to 2 years before and after vaccine introduction, comparing rates in vaccinated age groups with those in unvaccinated age groups and assessing changes in seasonal and age patterns, may allow for a reasonable assessment of potential vaccine impact.

It is also necessary to ensure that long-term data on the safety of the vaccine is collected through postmarketing surveillance of AEFI to identify and manage safety concerns that could emerge after vaccine introduction. Efforts should be made to enhance disease surveillance in countries where the vaccine is introduced as cases of severe disease are less likely to be captured by the current AEFI surveillance systems in many endemic countries. The collection and long-term storage of serum or other samples from vaccinees would facilitate further studies (e.g., for correlates of protection and possible booster needs).

There is close collaboration needed between licensing national regulatory authorities and the vaccine sponsors.[69,70]

The importance of the measures listed above can be gaged from the example of India that is a leading producer and exporter of vaccines but has one-third of the world's unimmunized children. There are a number of reasons why India lags behind its less developed neighboring countries in terms of vaccination rates. These include huge population with relatively high growth rate, geographical diversity and hard to reach populations, lack of awareness regarding vaccination, inadequate planning and delivery of health services, inadequate supervision, monitoring and intersectoral coordination and weak vaccine-preventable disease (VPD) and post vaccination AEFI surveillance systems. Increased political and bureaucratic will, increasing demand for vaccination by using effective information, education and communication, proper monitoring of the VPD reduction, demand creation and successful AEFI and postmarketing surveillance systems are urgently needed. There is a need to strengthen the regulatory capacity of the country. Restructuring of the expanded Program of Immunization with the introduction of new vaccines and a clear-cut policy on the introduction of newer vaccines is required.[7,71]

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