Flu Season: Considerations for Compliant Vaccine Temperature Monitoring

vaccine and syringe

By Cindy Gisler, Product Marketing Manager, Analytics with Karen Danko, U.S. and the Cole-Parmer Blog Team

A vaccine cold chain requires strategy and specific temperature data loggers

If you are involved with vaccines, you realize that 3 to 5 million people will suffer from a severe illness due to seasonal influenza, and between 290,000 and 600,000 people will die as a result, according to the World Health Organization (WHO). Prevention is key and includes regular hand washing, good respiratory hygiene (such as covering your mouth when you cough or sneeze), not touching your eyes and nose, avoiding those who are sick, and getting vaccinated.

This year’s vaccine is currently being administered around the world, but it isn’t an easy feat to get it to the end user. There are four types of seasonal influenza, and the viruses acquire genetic variations every year, making vaccine development a challenge. Routine monitoring of global influenza activity and collaboration with jurisdictions around the world help coordinate the most effective vaccine composition, as well as the timing to ensure the most effective prevention and control. Distribution is also a challenge and millions of dollars are lost every year due to a variety of issues including incorrect shipping, logistic issues, a broken cold chain, and temperature excursions, as shown below.

graphs of temperature excusions losses and cost

Managing a vaccine cold chain

Vaccines are sensitive biologics that require a regulated and safe cold chain where temperatures must be constantly monitored in a cold supply chain. It is certainly not perfect with many moving pieces, but has evolved over the years to what it is today—a more strategic, regulated way to get safe vaccines to the end user. While risk remains, it is safer and more efficient today, especially since temperature monitoring has been implemented.

The search to mitigate risk

The Vaccine for Children’s (VFC) program and the Department of Health and Human Services (HHS) study and guidance are just a few of the initiatives that have paved the way for a safer vaccine cold chain.

The HHS study completed in 2012, titled Vaccines for Children Program: Vulnerabilities in Vaccine Management, looked at the current vaccine management in the US at that time. The study found that many vaccines were not travelling the cold chain properly, causing compromised and unsafe vaccines. The HHS made the recommendations below to mitigate the discrepancies they found during their research.

“We recommend that CDC (Centers for Disease Control and Prevention) continue to work with grantees and providers to ensure that (1) VFC vaccines are stored according to requirements, (2) expired vaccines are identified and separated from non expired vaccines, (3) grantees better manage providers’ vaccine inventories, and (4) grantees meet oversight requirements. CDC concurred with all four of our recommendations and noted that vaccination is one of the most successful public health tools in preventing and controlling disease.”

The recommendations from this study helped develop the current recommendations not only for the VFC program but also for all vaccines, as we can see stricter temperature regulations and monitoring across the board today. As a result, vaccine distribution continues to grow year after year, as shown below in the chart from the CDC showing U.S. data.

graph of influenza doses U.S. distribution by season

A critical factor for safer distribution

If you handle vaccines, you know they need to be stored between +2°C and +8°C with minimal tolerance outside of this range. If the temperature is 0°C, the vaccine become inactive. If the temperature rises above + 8°C, the effectiveness to induce the appropriate immune response is compromised. It is not surprising the first recommendation in the report above was “VFC vaccines are stored according to requirements”. Today, vaccine temperatures are highly regulated and consistently seen on the CDC’s list of recommendations.

Vaccine storage and handling tool kit

Edwards Deming once said, “In God we trust, all others must bring data”. This is a simple reminder of the importance for you to effectively measure and record temperatures when dealing with vaccines—something so important the CDC has published a Vaccine Storage and Handling Tool Kit. This kit, pertinent for providers and other healthcare providers who receive vaccines purchased with public funds, is a great resource for everyone involved with vaccines. It dedicates a large section to vaccine handling and temperature monitoring equipment and the role it plays in effective vaccine management.

Digital data logger (DDL) features needed for compliance

One recommendation you can find in the tool kit includes a list of DDL features needed in order to comply with the VFC recommendations. They include:

  • “Certificate of Calibration from an ISO 17025 calibration laboratory accredited by an ILAC/MRA signatory body and traceable to NIST”
  • Detachable temperature probe in buffered solution
  • ±0.5°C accuracy or better
  • Temperature readings stored —on unit 4,000 readings
  • Digital display with current, MIN, and MAX temperatures
  • Adjustable high/low alarm
  • Visual or audible alarm for out-of-range temperature
  • Can read storage unit temperatures without opening the door
  • Summary and detailed reports can be downloaded

Vaccine storage and transport temperature monitoring instruments

Cole-Parmer® Traceable® offers multiple solutions for vaccine storage temperature measurement and monitoring including DDLs with NIST-Traceable Calibration—accredited calibration you can trust. We also provide DDLs equipped with TraceableLIVE® cloud-based connectivity, so you can monitor your temperature from anywhere.

Final thoughts

Flu season is almost upon us and prevention is everything. Getting vaccines to the end user safely is critical. If you are involved in a vaccine cold chain, ensure you are following current regulations and recommendations. Remember, monitoring your cold chain with reliable and recommended temperature data loggers, with the features outlined above, can help mitigate some of the risks in the vaccine cold chain.

 

Cole-Parmer blog

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