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

Choosing the Right Vaccine/Formulation & Logistics

The planning of the introduction of a new licensed vaccine starts with the right choice of vaccine and vaccine formulation as well as the accurate planning of the vaccine provision and logistics for the immunization program. During the introduction phase, infrastructure and systems established during prelicensure clinical trials should be reutilized to establish logistics for routine use of new vaccines including postmarketing surveillance.[16] Immunization plans should not be developed in isolation, but always in coordination with the global vaccine action plan.[17] Specific requirements regarding the use of multidose vaccines in warm climates with difficulties in maintaining the cold chain have to be considered.

Cost estimates should be conducted comparing the production/cost of single-dose vials and ready-to-use syringes versus multidose vials and the need to coordinate multiple immunizations from the same vial.[18] The exact mode of transportation from the airport/site of delivery or production to the vaccination clinic or site should be determined, making sure that an uninterrupted cold chain can be maintained, whether roads and trucks are available, the cool house has an emergency power unit and sufficient reuse prevention syringes and needles are available.[19]

Regarding the stability of the vaccine, questions to be considered include how many people can get vaccinated, before the expiration date of the vaccine approaches? How will doses be used without wasting the remaining vaccine in the multidose vial? What is the role of preservatives with respect to vaccine reactogenicity? The rule 'one needle per vaccinee' should have highest priority to prevent blood-borne infection, and immunization safety should be emphasized at all stages of the vaccine introduction. Depending on the vaccine composition, there may be cultural and/or religious implications. These have to be taken into consideration early on in the planning phase. Examples include whether a vaccine could be considered 'halal' under Islamic law; for example, a meningococcal (Group A, C, Y and W-135) conjugate vaccine that is commonly used to protect Mecca pilgrims. If aborted cells are used in the production process, a vaccine may have little acceptance in certain groups of the population.