title: Can thermostable vaccines help address cold-chain challenges? Results from stakeholder interviews in six low- and middle-income countries.
abstract: BACKGROUND
  This study captures the perspectives of stakeholders at multiple levels of the vaccine supply chain regarding their assessment of challenges with storing vaccines within recommended temperature ranges and their perceptions on the benefits of having vaccines with improved stability, including the potential short-term storage and transport of vaccines in a controlled-temperature chain.
  
  
  METHODS
  Semi-structured interviews were undertaken with 158 immunization stakeholders in six countries. Interviewees included national decision-makers and advisors involved in vaccine purchasing decisions, national Expanded Programme on Immunization managers, and health and logistics personnel at national, subnational, and health facility levels.
  
  
  RESULTS
  Challenges with both heat and freeze-exposure of vaccines were recognized in all countries, with heat-exposure being a greater concern. Conditions leading to freeze-exposure including ice build-up due to poor refrigerator performance and improper icepack conditioning were reported by 53% and 28% of participants, respectively. Respondents were interested in vaccine products with improved heat/freeze-stability characteristics. The majority of those involved in vaccine purchasing indicated they would be willing to pay a US$0.05 premium per dose for a freeze-stable pentavalent vaccine (68%) or a heat-stable rotavirus vaccine (59%), although most (53%) preferred not to pay the premium for a heat-stable pentavalent vaccine if the increased stability required changing from a liquid to a lyophilized product. Most respondents (73%) were also interested in vaccines labeled for short-term use in a controlled-temperature chain. The majority (115/158) recognized the flexibility this would provide during outreach or should cold-chain breaks occur. Respondents were also aware that possible confusion might arise and additional training would be required if handling conditions were changed for some, but not all vaccines.
  
  
  CONCLUSIONS
  Participating immunization stakeholders recognized the benefits of vaccine products with improved stability characteristics and of labeling vaccines for controlled-temperature chain use as a means to help address cold-chain issues in their immunization programs.
authors.affiliation: PATH, PO Box 900922, Seattle, WA 98121, USA. Electronic address: dkriste@path.org.
authors.forename: Debra D
authors.initials: DD
authors.lastname: Kristensen
authors.affiliation: PATH, PO Box 900922, Seattle, WA 98121, USA.
authors.forename: Tina
authors.initials: T
authors.lastname: Lorenson
authors.affiliation: PATH, PO Box 900922, Seattle, WA 98121, USA.
authors.forename: Kate
authors.initials: K
authors.lastname: Bartholomew
authors.affiliation: PATH, PO Box 900922, Seattle, WA 98121, USA.
authors.forename: Shirley
authors.initials: S
authors.lastname: Villadiego
mesh_terms: D001938:Brazil; D002681:China; D004355:Drug Stability; D004356:Drug Storage; D005615:Freezing; D006282:Health Personnel; D006358:Hot Temperature; D007194:India; D007407:Interviews as Topic; D010568:Peru; D010679:Philippines; D011786:Quality Control; D012034:Refrigeration; D013636:Tanzania; D014186:Transportation; D064166:Vaccine Potency; D014612:Vaccines / Q000191:economics
chemical_list: D014612:Vaccines
keywords: Cold chain; Controlled-temperature chain; Thermostable; Vaccine stability