COVID Vaccine Temperature Monitoring for Ultra-Low Parameters

COVID Vaccine Temperature Monitoring for Ultra-Low Parameters

The United States is preparing to receive its first doses of the COVID-19 vaccine from Pfizer with its partner BioNTech. The vaccine has been found to be safe and about 95% effective. With an emergency use authorization underway for Pfizer and Moderna close behind, states are beginning to plan for initial distribution among the groups of the highest priority.

But in addition to determining who will receive the initial doses, there are other challenges. Temperature monitoring will need to be in place at facilities that store and distribute the vaccine due to ultracold storage requirements. Getting the vaccine out of the lab is the first step, but getting it to the patient is the step needed to truly get COVID-19 under control. 

Distribution of the COVID-19 Vaccine

The Pfizer vaccine, as well as the Moderna vaccine expected to follow, use a new approach, never before approved by the U.S. Food and Drug Administration. The vaccine triggers an immune response in the patient using messenger RNA (mRNA). If the patient is later exposed to COVID-19, the body will be able to fight the virus better.

States will need to rely on a network of providers to administer the COVID-19 vaccine to patients. Hospitals, doctor’s offices, health departments, and pharmacies are part of the initial scope. However, in the interest of expediency, this may also include community centers, schools, and long-term care facilities.

States must examine their network of potential providers in making the COVID-19 vaccine available as quickly as possible. Planners will need to give special consideration to the ultracold conditions under which facilities must store the vaccine.

Storage Requirements for the COVID-19 Vaccine

Both Pfizer and Moderna have produced COVID-19 vaccines that must be frozen. Frozen vaccines are typically stored between -50°C and -15°C. This temperature cold chain must be maintained from the manufacturing plant to transportation, storage, and administration of the vaccine.

Vaccine handling for the COVID-19 vaccine will be different. Pfizer’s vaccine must be kept at even colder temperatures: -70°C. This will require ultracold containers for storage and specialized delivery.

The logistics will need to be well-planned, as personnel must administer Pfizer’s vaccine within five days of being transferred to a refrigerator. As the vaccine development itself has occurred at an incredible speed, it will now need to be matched in rigor by hospitals, pharmacies, and other locations planning to provide the vaccine to the patient.

In this world of a global pandemic, spoilage of the vaccine would have a damaging impact. The initial shipment from Pfizer already falls short of what states need to cover their most critical groups. While more are likely on the way, any vaccines lost due to improper storage will slow down the process of curbing the spread of COVID-19.

Guidance for the COVID-19 Vaccine 

The CDC has provided guidance as facilities prepare for the receipt of the COVID-19 shipments. Part of this planning requires the training of medical professionals in vaccine management, administration, and reporting. Ongoing monitoring of the vaccine must occur as it is distributed in large quantities in the coming months.

The CDC has also prepared information on storage and handling. This includes best practices for storage and ongoing monitoring of temperatures. Improperly stored vaccines will result in less potency of the vaccine or limited protection.

The CDC addresses vaccine storage and temperature monitoring in the following ways:

  • Keep the data for three years so they can be analyzed for long-term trends and/or recurring problems
  • Use a digital data logger (DDL) or temperature monitoring device (TMD) for each vaccine storage unit and transportation unit
  • Have at least one backup TMD in case a primary device breaks or malfunctions
  • Perform calibration testing every one to two years to ensure the accuracy of a temperature monitoring device’s readings

In addressing the novel COVID-19 virus, these steps will be crucial to ensure vaccine viability, both in the near future and long-term.

Temperature Monitoring Systems

The CDC, along with the Vaccines for Children (VCF) program, have specific requirements for a DDL. The features include:

  • A detachable probe that best reflects vaccine temperatures
  • Alarms for out-of-range temperatures
  • A low-battery indicator
  • Current, minimum, and maximum temperature display
  • Recommended uncertainty of +/-0.5°C 
  • Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 30 minutes

The DDLs in use should have a current and valid Certificate of Calibration Testing.

Technology for Temperature Monitoring

While the requirements for temperature monitoring are rigorous, there are ways to implement technology for seamless temperature monitoring. Manual data logging to meet requirements can be time-consuming and waste precious resources. The technology must also be scalable to meet the necessary widescale distribution of the COVID-19 vaccine.

Technology should use your existing WiFi network to document ultra-low temperatures. The moment the temperature falls outside of range, immediate alert notifications should be sent to the proper personnel. All data should be time-stamped and recorded, ensuring vaccine temperature compliance and visibility.

Preparing for the COVID-19 Vaccine With the Right Systems

We don’t yet know the outlook for the COVID-19 on a recurring basis. It is possible that in the future, individuals will need boosters or annual shots. As the population increases in the future with additional births, the vaccine will need to continue its distribution. This places additional emphasis on facilities to ensure that they have the proper temperature monitoring for vaccine storage in place.

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