Tools and approaches to ensure quality of vaccines throughout the cold chain

Expert Rev Vaccines. 2014 Jul;13(7):843-54. doi: 10.1586/14760584.2014.923761. Epub 2014 May 28.


The Expanded Program on Immunization was designed 40 years ago for two types of vaccines: those that are heat stable but freeze sensitive and those that are stable to freezing but heat labile. A cold chain was developed for transport and storage of such vaccines and established in all countries, despite limited access to resources and electricity in the poorest areas. However, cold chain problems occur in all countries. Recent changes to vaccines and vaccine handling include development and introduction of new vaccines with a wide range of characteristics, improvement of heat stability of several basic vaccines, observation of vaccine freezing as a real threat, development of regulatory pathways for both vaccine development and the supply chain, and emergence of new temperature monitoring devices that can pinpoint and avoid problems. With such tools, public health groups have now encouraged development of vaccines labeled for use in flexible cold chains and these tools should be considered for future systems.

Keywords: cold chain; cool water pack; supply chain; temperature monitoring device; temperature sensitivity; vaccine development; vaccine freezing; vaccine vial monitor.

Publication types

  • Review

MeSH terms

  • Drug Stability*
  • Drug Storage*
  • Freezing
  • Hot Temperature
  • Humans
  • Immunization
  • Quality Control
  • Refrigeration
  • Transportation*
  • Vaccines / adverse effects
  • Vaccines / immunology
  • Vaccines / therapeutic use*


  • Vaccines