Vaccine and Pharmaceutical Supply Systems and Equipment

Vaccine Presentation and Packaging Advisory Group

A forum for discussion and learning

The Vaccine Presentation and Packaging Advisory Group (VPPAG) was a unique forum for industry, public health, and immunization program stakeholders to discuss vaccine product characteristics and their impact. PATH as a member of and a contributor to the VPPAG worked alongside other members to identify and define preferred product profiles for vaccines in early stages of development and to create a generic preferred product profile (gPPP) for all vaccines designed for low-income country markets.

The role of the generic preferred product profile

In 2009, the VPPAG published its first gPPP for vaccines intended for use in public-sector immunization programs in low-resource settings. The gPPP provides guidance to vaccine manufacturers on key presentation and packaging decisions in four domains: formulation, presentation, labeling, and packaging. It also identifies areas in which further evidence or data are needed. Each recommendation has been crafted to mitigate programmatic challenges by making vaccine administration safe and efficient—ensuring that the products are simple to use, limit cold chain burden, and reduce unnecessary vaccine wastage.

PATH contributions to the gPPP include research and discussion on optimal packaging sizes, vaccine label requirements, green packaging, reuse of tertiary packaging, barcoding, and radio-frequency identification tags.

In 2011, the World Health Organization (WHO) used the gPPP to inform guidelines on the Programmatic Suitability of Vaccine Candidates for WHO Prequalification (PSPQ). The PSPQ guidelines have been in place since January 2012 to help the international community assess whether new vaccine products satisfy both mandatory and critical requirements for vaccination programs in developing countries. In 2015, the VPPAG updated the gPPP to reflect results and recommendations from further research.

Developing a preferred product profile for human papillomavirus vaccine

Human papillomavirus (HPV) vaccines present unique characteristics that differentiate them from current, WHO-prequalified infant vaccines. The HPV vaccines:

  • Target an older, gender-specific population.
  • Cost more than most existing WHO-prequalified vaccines.
  • Offer promising heat stability profiles.
  • Product format is only available as a liquid formulation without preservative.

PATH has collaborated with other members of the VPPAG on a series of studies to guide presentation and packaging decisions for future iterations of HPV vaccines destined for low-resource settings. These studies were used to create a preferred product profile for HPV vaccines and their packaging to help vaccine manufacturers develop HPV vaccines that are best suited to the unique needs of health care programs in developing countries.

Additional information