Freezing temperatures in the vaccine cold chain: a systematic literature review.

The dangers of accidental freezing of vaccines in the cold chain have prompted studies throughout the globe to better characterize the risk. To date, there has been no systematic review of these studies. This analysis highlights that accidental freezing is pervasive and occurs across all segments of the cold chain. Between 14% and 35% of refrigerators or transport shipments were found to have exposed vaccine to freezing temperatures, while in studies that examined all segments of distribution, between 75% and 100% of the vaccine shipments were exposed. More rigorous study designs were associated with higher levels of freeze exposure. As more expensive, freeze-sensitive vaccines are introduced into immunization schedules, freeze prevention will become increasingly critical for ensuring that the world's children are receiving fully potent vaccine.