Optimizing presentation and packaging for HPV vaccinesby Debbie Kristensen and D. Scott LaMontagne, PATH
Working in collaboration with the Vaccine Presentation and Packaging Advisory Group (VPPAG), representatives from the public health community have initiated a series of studies to guide presentation and packaging decisions for future iterations of human papillomavirus (HPV) vaccines destined for low-income countries. Presentation and packaging decisions, such as the number of doses per container, type of container, and recommended storage temperatures greatly impact the way vaccines are handled, the quantity of vaccine doses wasted, and the ability of health workers to get the vaccines to remote, low-resource settings. By influencing these decisions early in the development process, public health officials can make sure that the specific needs of developing countries are considered.
HPV vaccines present unique characteristics that differentiate them from current World Health Organization (WHO)-prequalified infant vaccines. HPV vaccines target an older, gender-specific population; are currently available at higher prices than most existing WHO-prequalified vaccines; offer promising heat-stability profiles; and similar to pneumococcal vaccines, are currently available only as liquid formulations, in one- and two-dose vials, without preservative.
The following are a list of studies recently initiated to gather data from users, procurement specialists, and economists to better understand needs and constraints regarding HPV vaccines:
A retrospective, cross-sectional analysis of data on vaccination session size from three HPV vaccine demonstration projects in Uganda, Peru, and Vietnam.A small-scale, time-and-motion study to assess the time and ease of vaccine delivery across different HPV vaccine presentations.Documentation of ambient temperatures experienced during the final stages of HPV vaccine distribution and use in Vietnam and Uganda to assess the feasibility of controlled ambient temperature storage and transport.Surveys with immunization program managers and health workers in Vietnam involved in the HPV vaccine demonstration project to sample preferences for HPV vaccine presentation, packaging, and logistics. (Note: similar surveys may also be conducted in Uganda and Peru).Breakeven analysis of potential price, wastage, and cold chain costs for various HPV vaccine presentations using the Vaccine Presentation Assessment Tool.Analysis of qualitative data from questionnaires that assess individual experiences of those involved in HPV vaccine demonstration project activities in Uganda, Peru, and Vietnam.The VPPAG will compile the results of these studies and additional data available from industry into a preferred product profile for HPV vaccines describing characteristics, including optimal vial size, presentation, and storage temperature requirements, for future HPV vaccines for use in developing countries.
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