Cold Chain for Vaccine Storage: The Importance of Monitoring Cold Chain Temperatures

Did You Know the U.S. Does Not Regulate Vaccine Temperature?

A big challenge for pharmaceutical companies today is monitoring the cold chain for vaccines in need of refrigeration.  To make things more complicated, “colder is better” remains a common misconception among healthcare professionals when it comes to vaccine storage. In fact, accidentally over-chilling vaccines is more common than you may think and can result in the loss of money and time spent implementing revaccination programs.

Unfortunately, U.S. agencies do not require rigorous regulations for monitoring vaccine temperatures. That’s why leaders in the health system need to educate all stakeholders throughout the cold chain about the consequences of inconsistent temperatures. Only then can effective monitoring plans be put in place throughout the cold chain.

Why Is Cold Chain Temperature Monitoring Important?

The cold chain refers to the preservation of consistent temperatures for refrigerated vaccines from manufacture through delivery to health care facilities. During this process, stakeholders at each stop along the supply chain should monitor and maintain the vaccine’s optimal temperature range (ideally between 2°C and 8°C). The result of failing to monitor vaccine temperatures accurately—even for short periods—may result in:

• Formula degradation
• Loss of potency
• Waste of product and money
• Substandard immunologic responses
• Need to re-immunize patients

Cold Chain Temperature Data: What Do the Studies Say?

A number of studies have demonstrated how the cold chain is frequently broken in developing nations. Especially regions close to the equator, where ambient temperatures severely exceed more than 8°C. For example, a 2015 survey from Cameroon found that only 50% of vaccines needing refrigeration were regularly monitored in 81% of health care facilities.

Equally problematic, up to 35% of vaccines worldwide are exposed to freezing temperatures. To make matters worse, education programs to improve storage conditions for vaccines are sorely limited. In one study from India:

• Only 26% of all clinics had written instructions for handling vaccines.
• Only 60% kept up-to-date temperature logs.

Monitoring Cold Chain Temps Saves Time & Money

Beyond academic studies, the media has reported numerous instances where frozen vaccines had to be discarded and patients needed revaccination. Not surprisingly, vaccine wastage and revaccination are expensive. A U.S. survey suggested that 1%–5% of vaccines are wasted, potentially costing up to $31 million. Most of these incidences can be avoided simply by fixing breaks in the cold chain.