Editorial: Stabilization of vaccines: Lessons learned

Human Vaccines
Volume 6, Issue 3  March 2010

Stabilization of vaccines: Lessons learned
Debra Kristensen and Dexiang Chen

Exposure to extreme heat or cold can ruin desperately needed vaccines, especially in developing countries where intermittent electricity and a lack of resources make it challenging to maintain appropriate storage temperatures. PATH reflects on nearly eight years of work to optimize the heat stability of seven types of vaccines with 33 collaborators. We also explore the key logistical, regulatory, procurement, and policy issues associated with the development and use of temperature-stabilized vaccines.

In the editorial, we suggest seven recommendations for developing and commercializing vaccines with enhanced temperature stability:
– Stabilization efforts should be integrated into early vaccine development.
– There are circumstances where it makes sense to stabilize existing vaccines.
– Freeze stabilization is possible for vaccines containing aluminum adjuvant.
– Heat stabilization requires a customized approach, and results will be variable.
– The full benefits of heat-stable vaccines will only be realized after programmatic and policy changes are made to storage guidelines.
– Improvements in vaccine heat stability are inextricably tied to product format, and careful consideration should be given to the end-product attributes and priorities during vaccine development. Some heat-stability improvements result in inferior product formats while others enable new, beneficial formats.
– Products with enhanced stability can benefit both vaccine producers and purchasers.

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