More folks are thinking about it now, but the cold chain is actually something we have always had to think about with all vaccines, not just COVID-19.
“It is expected that cold chain storage and handling requirements for COVID-19 vaccine products will vary in temperature from refrigerated (2°C to 8°C) to frozen (-15°C to -25°C) to ultra-cold (-60°C to -80°C) in the freezer or within the dry ice thermal shipper in which product was received.”
COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations
Of course, the need for ultra-cold storage temperatures for the Pfizer COVID-19 vaccine has led everyone to think about storing and handling these vaccines a little bit more.
Maintaining the Cold Chain for COVID-19 Vaccines
So what is the cold chain?
“A cold chain is a temperature-controlled supply chain that includes all vaccine-related equipment and procedures. The cold chain begins with the cold storage unit at the manufacturing plant, extends to the transport and delivery of the vaccine and correct storage at the provider facility, and ends with administration of the vaccine to the patient.”
Vaccine Storage and Handling Toolkit
Not surprisingly, if vaccines get too hot or too cold, they might not work as well, or might not work at all.
“Vaccines must be stored properly from the time they are manufactured until they are administered. Potency is reduced every time a vaccine is exposed to an improper condition. This includes overexposure to heat, cold, or light at any step in the cold chain. Once lost, potency cannot be restored.”
Vaccine Storage and Handling Toolkit
Fortunately, folks who administer vaccines are well trained to try and avoid disruptions to the cold chain. And many measures are put into place to catch any disruptions to the cold chain that might still occur.
“Earlier this week, Aurora Medical Center in Grafton had to throw away 500 Moderna vaccines because someone left them out of the refrigerator overnight.”
COVID-19 vaccine protocols in place, but doesn’t eliminate ‘human error’
From vaccine freezers and refrigerators and temperature sensitive shipping boxes to temperature indicators and dataloggers, there are many safety systems in place to make sure these vaccines are being stored at the right temperature.
So even with all of the extra cold chain requirements that some of the COVID-19 vaccines have, you can be reassured that the vaccine you get is safe and effective and was stored in the appropriate conditions.
And also know that:
- while typically stored frozen between -25º to -15ºC(-13º to 5ºF), Moderna vaccine vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use
- the Moderna vaccine vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours until the first dose is withdrawn
- the Moderna vaccine vial can be held between 8° to 25°C (46° to 77°F) for up to 6 hours after the first dose is withdrawn
For the Pfizer COVID-19 vaccine, the undiluted vials:
- should be kept frozen between -80ºC to -60ºC (-112ºF to -76ºF) and protected from light until ready to use
- can be stored in a refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 5 days (120 hours)
- can be left at room temperature for up to 2 hours after they are thawed (takes about 30 minutes)
- should be used within six hours after they are diluted and should be stored between 2°C to 25°C (35°F to 77°F)
So there is a little bit of leeway on the temperatures until you officially break the cold chain with these vaccines.
More on Maintaining the Cold Chain for COVID-19 Vaccines
- COVID-19 Vaccine Challenges
- Transporting Vaccines Safely
- What’s Your Plan for Storing Vaccines During an Emergency?
- COVID-19 Vaccine Safety Monitoring Systems
- Where Are the COVID-19 Package Inserts?
- The Truth About COVID-19 Vaccines
- CDC – COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations
- CDC – Vaccine Storage and Handling Toolkit
- CDC – Provider’s Role: Importance of Vaccine Administration and Vaccine Storage & Handling
- FDA – Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers
- FDA – Pfizer-BioNTech COVID-19 Vaccine Fact Sheet for Healthcare Providers
- COVID-19 vaccine protocols in place, but doesn’t eliminate ‘human error’
- Almost 15,000 COVID Vaccine Doses May Not Be Usable, Says Fresno County Health Official
- Vaccine cold chain Q&A
- We Protect the Temperature-Sensitive Shipments of the COVID-19 Vaccine
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