Is Your Facility Prepared to Provide the COVID-19 Vaccine?

Is Your Facility Prepared to Provide the COVID-19 Vaccine?
Posted in: Pharmacy
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As the COVID-19 vaccine continues to roll out on a global scale, facilities are embracing their role as vaccine providers. Whether administering to hundreds in a small rural community or to thousands in a major city, every facility needs to ensure they are compliant, efficient, and minimize waste. In particular to the U.S., a limited supply of the vaccine means essentials, like freezer vaccine storage and monitoring, are more important than ever.

That’s why we’ve provided this easy-reference guide to help you manage your vaccine storage with confidence.

COVID-19 Vaccine Storage


Not every facility has the means to store and administer every vaccine safely. That’s why it’s crucial that the limited supply of the vaccine be handled with the utmost care and concern to minimize waste.

Pfizer Vaccine Storage Temperature


The Pfizer vaccine uses synthetic messenger RNA (mRNA) to activate the receiver's immune system and is reportedly over 90% effective at preventing infection a week after the second dose is administered. However, that effectiveness is only possible if the vaccine is stored at an ultracold temperature range between -76 and -112 degrees Fahrenheit (-60 to -80 degrees Celsius). The vaccine will remain stable and viable at these temperatures for six months. It is possible to store that vaccine at a temperature range of 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius) for up to two weeks.

It’s also worth noting that the FDA has recently approved some flexibility into vaccine storage requirements. The adjustment gives your facility some flexibility, allowing the undiluted vaccine to be transported and stored at common pharmaceutical freezer temperatures for up to two weeks. This means many organizations won’t have to purchase ultracold refrigeration units if they didn’t already have them. It also means vaccines can be kept in your front office or on-site at other satellite or mobile vaccine stations. The vaccine will be administered at room temperature.

Moderna Vaccine Storage Temperature


The Moderna vaccine also uses mRNA vaccine design, but their storage requirements dictate a temperature range of -13 to 5 degrees Fahrenheit (-25 to 15 degrees Celsius) for multidose vials. Refrigerate individual vaccines at 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius) for up to 30 days. When thawing to room temperature to be administered, the vaccine can only remain at 46 to 77 degrees Fahrenheit (8 to 25 degrees Celsius) for up to 12 hours.

Johnson & Johnson Vaccine Storage Temperature


The Johnson & Johnson vaccine is a single dose viral vector vaccine instead of the double dose required by Pfizer and Moderna. Also, this is not a vaccine that can be frozen. Instead, each vial, which contains five doses, must be refrigerated between 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius).

The storage temperature requirement doesn’t change once the vial has been punctured, making it easy to store new and punctured vials in the same refrigeration unit. Once punctured, vials may only be stored for up to six-hours or at room temperature for two hours. Room temperature is interpreted as 77 degrees Fahrenheit ( 25 degrees Celsius). It’s important to note that you cannot combine the 2-hour and 6-hour time limit. Either refrigerate the punctured vials and discard at the six-hour expiration or store them at room temperature for two hours, then discard. You cannot, for example, store the vials at room temperature for two hours and then refrigerate them for an additional six hours.

Freezer Monitoring and Control


Perhaps most notably, it is not possible to refreeze or re-refrigerate these vaccines and still maintain their integrity and viability. This additional handling requirement, particularly from Pfizer and Moderna, makes it absolutely crucial that these temperature profiles are carefully monitored.

Plus, the U.S. is actively accelerating the pace of vaccinations to communities in need. All facilities that plan to handle the vaccine must be prepared.

Your role in the vaccine supply chain, whether as a staging facility, medical transport service, or as a front-end medical provider, means you are not only accountable for the vaccine's successful administration but also for its unique storage needs.

Primex OneVue Monitoring


The Primex OneVue Sense™ environmental monitoring solutions can offer protection and peace of mind as you store your valuable vaccine supply. With high-integrity and precision calibration, our automated temperature monitoring and alert system is invaluable. Most sites use manual data logging and local alarms, which means you won’t know vaccines are at risk during off-hours. Finding out the next day isn’t good enough. We provide the ability to get alerts on your phones or email notifications, ensuring 24-hour, real-time monitoring.

Don’t leave this precious resource unmonitored. Trust Primex monitoring solutions for your storage and compliance reporting.

*Information about and requirements for safe vaccination storage needs and compliance may change over time. This information is accurate from primary sources as of February 2021.

 

Sources:

Pfizer - Pfizer and Biontech Submit Covid-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA

Moderna - Storage and Handling

Whitehouse.gov - National Strategy for the COVID-19 Response and Pandemic Preparedness

FDA - https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-allows-more-flexible-storage-transportation-conditions-pfizer

University of Minnesota - https://www.cidrap.umn.edu/news-perspective/2021/02/real-world-trial-pfizer-covid-vaccine-finds-high-2-dose-good-1-dose

March 23, 2021
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