Cold chain

The cold chain describes the system of transporting and storing vaccines within the manufacturer’s recommended temperatures. It begins from when the vaccine is manufactured, transported through vaccine distribution centres, on to immunisation service providers and ends when the vaccine is administered.

Most vaccines are also sensitive to UV and fluorescent light and must be stored in their original packaging.

Failure to store and handle vaccines properly can result in reduced vaccine potency and inadequate immune responses in vaccine recipients as well as poor protection against disease.

Traditional vaccine storage

Most vaccines must be transported and stored within the traditional cold chain temperatures of between +2°C and +8°C.  The optimal temperature is +5°C.

Purpose-built vaccine refrigerators are preferred for storing vaccines because they are designed and constructed specifically for vaccine storage within these temperatures. Domestic refrigerators are not suitable for vaccine storage.

For mobile or outreach immunisation clinics, vaccines can be transported in high quality coolers. Coolers must be appropriately packed using ice or gel packs and reliable temperature monitoring used throughout. Coolers are not intended for long term vaccine storage (more than 8 hours) or in extreme weather conditions.

Further information regarding traditional vaccine storage and management can be found at National Vaccine Storage Guidelines: Strive for 5.

Ultra-cold chain storage

Ultra-low temperatures are required for the storage of some COVID-19 vaccines.

Comirnaty™ (Pfizer/BioNTech) requires ultra-cold chain storage in purpose-built freezers at temperatures between -90°C and -60°C. Thermal shippers with cartons of vaccine submerged in dry ice are required for transport.

Spikevax (elasomeran) requires ultra-cold chain storage of between -25°C and -15°C. Once defrosted, Spikevax can be stored and transported at temperatures of between +2°C and +8°C for up to 30 days.

Ultra-cold chain handling equipment must be used as per manufacturer’s advice when handling frozen vaccines. Once frozen vaccines are defrosted, they cannot be refrozen.

For further information, refer to the Victorian COVID-19 vaccination guidelines.

Community pharmacy–acquired vaccines

The cold chain needs to be maintained, not only for vaccines provided as part of the National Immunisation Program but also for vaccines that a person buys from a pharmacy with a prescription. Doctors who provide a prescription for a vaccine should advise individuals that it is important to only purchase the vaccine from the pharmacy immediately before attending the practice or clinic appointment for vaccine administration. The pharmacist also has a responsibility to advise on the importance of maintaining the cold chain. On arrival to the clinic, the individual should notify reception that they have a vaccine to put in the vaccine refrigerator.

If an immunisation service provider has any concern that a vaccine provided by an individual may have been stored outside the recommended ranges, the vaccine should not be administered.

Cold chain breaches

A cold chain breach occurs when vaccines are exposed to temperatures outside the manufacturers recommended range.

A cold chain breach also includes the exposure of vaccines to light.

If a cold chain breach is suspected it is important to isolate the affected vaccines. Do not use affected vaccines until further clarification from the appropriate bodies is sought. It is important to report any cold chain breaches so that individuals can be revaccinated (if required) or unused vaccines can be recalled, if needed.

Cold chain breaches of National Immunisation Program (NIP) vaccines, influenza and travel vaccines must be reported to the Department of Health as soon as possible using the Cold Chain Breach Report form. DH will outline recommendations for the next steps to take.

Cold chain breaches of COVID-19 vaccines should be reported to the Commonwealth Vaccine Operations Centre (VOC) on 1800 318 208. The VOC will provide advice on how cold chain breaches must be managed.

Resources

• National Vaccine Storage Guidelines: Strive for 5
• Department of Health – Cold Chain Management
• Department of Health – Victorian COVID-19 vaccination guidelines