Cold Chain Management For Vaccines
Published: 17 December 2023
Published: 17 December 2023
Vaccines are fragile biological substances that are at risk of losing efficacy or being destroyed if stored incorrectly. Cold chain management aims to protect vaccines from being spoiled by ensuring they are kept at an appropriate temperature (DoH 2019).
The term ‘cold chain’ refers to the process of storing and transporting vaccines between the temperature range of +2°C and +8°C. This temperature must be maintained from manufacturing up until administration in order to ensure vaccine efficacy (Australian Immunisation Handbook 2021).
While vaccines vary in stability and sensitivity, optimal storage temperature is +5°C, which is in the middle of the safe temperature range (DoH 2019).
Vaccines can become spoiled if they are:
(WA Department of Health 2023a)
The effects of exposure to heat, freezing, and light are cumulative and cannot be reversed (DoH 2019).
Once spoiled, vaccines lose potency and are unsuitable for use on patients. They may:
(CESPHN 2020)
Other negative outcomes of a spoiled vaccine include:
(CESPHN 2020)
The National Vaccine Storage Guidelines outline national requirements for maintaining the cold chain.
(DoH 2019; WA Department of Health 2023a)
(DoH 2019; WA Department of Health 2023a)
As a general requirement, healthcare providers should ensure that all staff involved in transporting, storing, and administering vaccines have been trained in vaccine management to ensure that the potency and effectiveness of vaccines are maintained (DoH 2019).
Some states and territories have specific cold chain management training requirements for staff:
(Health.vic 2023; NSW Health 2020; WA Department of Health 2023b)
A cold chain breach occurs when a vaccine goes outside of the recommended temperature range (DoH 2019).
All cold chain breaches must be reported to the designated body for the state or territory in which the breach occurred. The only exception that does not need to be reported is if a vaccine reaches a maximum of +12°C for 15 minutes or less (DoH 2019).
Note: As of August 2023, Victorian providers must report all cold chain breaches for government-funded vaccines, except for fluctuations of up to +12°C for 15 minutes or less when restocking, cleaning the fridge or stock-taking (Health.vic 2023). Previously, Victorian providers were exempt from reporting first-time breaches if the breach was under 25°C for less than six hours (Health.vic 2022). However, this exemption no longer applies.
If a cold chain breach occurs, the following steps must be taken:
(DoH 2019; WA Department of Health 2023a)
When reporting a cold chain breach, the following information may need to be provided:
(WA Department of Health 2023a; CESPHN 2023)
Question 1 of 3
What is the optimal storage temperature is for vaccines?