Vaccine cold chain in general practices: A prospective study in 75 refrigerators (Keep Cool study)
Anika Thielmann1,2, Marie-Therese Puth2,3, Christine Kersting1
1Institute for General Practice, University of Duisburg-Essen, University Hospital Essen, Essen, Germany.
Plos One
|November 20, 2019
Summary
Vaccine refrigerators frequently breach temperature limits, with two-thirds experiencing cold chain issues and 15% dropping below 0°C. This highlights critical problems in vaccine storage management that threaten vaccine potency.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Vaccine potency is compromised by improper storage, particularly freeze damage.
- Adsorbed vaccines are especially vulnerable to temperature fluctuations.
- Ensuring optimal vaccine storage conditions is a critical aspect of vaccine management.
Purpose of the Study:
- To analyze baseline data on vaccine storage conditions in general practices.
- To assess the prevalence of refrigerators maintaining the target temperature range (2-8°C).
- To identify the frequency and duration of temperature excursions, including critically low temperatures (≤0°C).
Main Methods:
- Prospective study involving 7-day continuous temperature recordings of vaccine refrigerators in German general practices.
- Standardized data loggers with ±0.4 °C accuracy were used.
- Statistical analysis included calculating prevalence rates, cumulative times, and durations of temperature deviations, using generalized linear mixed models to identify correlating factors.
Main Results:
- Only 32.0% of refrigerators maintained temperatures within the 2-8°C range.
- 14.7% of refrigerators reached critically low temperatures (≤0°C).
- Significant temperature cycling (>5°C) was observed in 29.3% of units, with average cumulative times outside the target range exceeding 49 hours for >8°C and 75 hours for <2°C.
Conclusions:
- Two-thirds of analyzed refrigerators exhibited cold chain breaches, indicating widespread issues in vaccine storage.
- 15% of refrigerators reaching critically low temperatures pose a significant threat to vaccine potency.
- The findings necessitate urgent action to improve vaccine storage practices and prevent potency loss.
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