How to Prepare for COVID-19 Vaccine Storage & Transport: Understanding the Latest Government Guidance

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Presenters:
Steven Rowley - Field Sales Specialist
Cindy Gisler - Marketing Product Manager
Renaud Foret - Analytics Product Sales Manager

Time: 35-mins presentation, 25-mins Q&A: 60-mins total show time

In this webinar you will learn how to:

  • Cope with the increased temperature monitoring challenges for COVID-19 vaccine storage and handling
  • Ensure the safety of your vaccine product during storage and transportation
  • Understand COVID-19 vaccine storage, handling requirements and recommendations from government agencies, such as CDC and the World Health Organization (WHO)

Every aspect of our lives has been affected by the current global situation. While navigating through the daily challenges of the COVID-19 pandemic, everyone is looking towards science for a solution in the form of a viable vaccine.

Vaccines, like other biologics, contain delicate biological molecules and can be irreversibly damaged by both heat and freezing temperatures. It is, therefore, crucial to carefully monitor vaccine temperature throughout its lifetime, from manufacture to administration.

According to the latest news, a COVID-19 vaccine could be ready as early as the end of this October. In preparation, government agencies such as the Centers for Disease Control and Prevention (CDC), the European Center for Disease Prevention and Control (ECDC), and the European Medicines Agency (EMA) have released guidelines for the storage and transportation of the vaccines, mandating specific conditions.

Whether you are involved in vaccine administration, distribution, or logistics, you understand the importance of accurate temperature control and monitoring when it comes to vaccine storage and handling. Ineffective temperature monitoring and recording can not only result in unnecessary delays and expenses, but in this case, loss of invaluable samples of novel COVID-19 vaccines that are likely to initially be available in limited quantities.

Cole-Parmer / Traceable® have a range of tools and solutions to ensure precise temperature monitoring that can help you ensure vaccine viability throughout its journey from the manufacturer, through distributors, to the end user.

You will have the opportunity to submit questions to the panel and receive focused responses that address your query.

Cole-Parmer temperature monitoring experts

Steven Rowley - Field Sales Specialist
Steven holds a BSc in Chemical Engineering from the Colorado School of Mines and an MBA from the University of Colorado. He has extensive background in aerosol particle counting and trace-level gas detection within semiconductor and high purity gas sectors. Since joining Cole-Parmer in January 2019, he has focused on Test and Measurement solutions for a wide variety of industries and applications, with particular emphasis on cold storage and cold-chain temperature monitoring and data logging tools and techniques.

Cindy Gisler - Marketing Product Manager
Cindy Gisler holds a BS in Medical Technology and a BA in Biology. For the last 21 years, Cindy has helped design and market Traceable® monitoring products in the clinical and vaccine industries. She has extensive knowledge of the needs and concerns of these fields, including the importance and issues that arise with maintaining cold chain.

Renaud Foret – Analytics Product Sales Manager
Renaud holds a First Degree in Sales and Marketing Management and a Business School Degree from ICL in Lyon, France. He began his career selling medical implants before moving to one that dealt with lab supplies. This is when he fell in love with the scientific world. He joined Kinesis / Cole-Parmer 4 years ago and over time has been responsible for different business areas, including fluidics, spectroscopy and academic labware, before settling in his most recent role looking after Analytics products, including Traceable®, TraceableLIVE® and Digi-Sense® brands. He has worked with partners across the UK and EMEA region, leveraging his multilingual skill, albeit with a hint of his French accent.



Webinar Question and Answer

Is the NIST Traceable Certificate included with the product when shipped and how long is the certificate good for?

Yes, the NIST-Traceable Certificate of Calibration is included with Traceable® product purchases, and the certificate is good from a 2-year time period from the date of calibration.

How long is the TraceableLIVE® information stored on the cloud?

The data is stored on the cloud for as long as the account is active.

How long is the battery life of the TraceableLIVE and are there warnings when the battery needs replacement?

Devices with TraceableLIVE have a battery life from 6 to 12 months depending upon the sample interval, and the frequency and duration of alarm events. A low-battery notification is sent out when the battery level reaches 20% and will repeat every 3 days until the batteries are replaced. Devices with TraceableLIVE use four AAA batteries.

For these devices, is the temperature monitoring continuous or is it at specific intervals (10 min, 15 min, etc.)?

The data loggers continuously monitor the temperature and will alarm when the sensor is outside of the alarm parameters. The sample intervals when data is stored in on-board memory or in the cloud occur on user-defined intervals, between 1 minute and 24 hours, depending upon the product type.

How are the cold chain data loggers typically placed in the packaging/coolers?

The sensor probes, such as buffered bottle probes or stainless steel probes, are placed within the packaging near the actual products/specimens. The electronics portion of the data loggers are placed outside of this area. For example, in a double box package, the probe would be within the inner box, and the electronics would be within the outer box. Another example might be a flexible courier pack in which case the probe is placed within the bag, and the electronics would be either outside but mounted on the bag, or within the bag but outside of any insulation or additional packaging protecting the product.           

What is the IP rating of the TraceableOne™ transport data logger?

The TraceableOne is IP67 rated (dust-tight and water resistant).

AstraZeneca/Oxford vaccine - What is the required temperature range?

The official temperature range for storage and transport of the expected AstraZeneca/Oxford vaccine has not been formalized and announced yet as of 10/8/2020.  Some media reports have reported that the storage temperature for this vaccine may be 20°C.

For these handhelds, customer will want to leave it 24/7 monitoring, but these are battery powered so can you get AC power adapter?

Some Traceable products, such as the Excursion-Trac® USB data logger and the TraceableLIVE Ethernet units, have a power adapter. This allows for wall power as the main power source. The devices also include batteries, used as backup power. Some other products, such as the TraceableLIVE Wi-Fi units, use only battery power. We are happy to discuss the right product for your applications that will take into account power availability.

Can you explain to us how to interpret term excursion?

An excursion is any sensor data point that exceeds alarm conditions (either the high or low alarm). For example, if the sensor reaches a value of 8.1°C when the high alarm is set for a value of 8.0°C, that point when the value reaches 8.1C will be the beginning of the excursion event. 

Can we access the playbook somewhere; what storage capacity will be required to enroll; 100 doses, 100,000 doses?

  • The COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations can be downloaded from the CDC site at:  https://www.cdc.gov/vaccines/imz-managers/downloads/COVID-19-Vaccination-Program-Interim_Playbook.pdf
  • Please refer to the playbook for any relationship details surrounding storage capacity requirements in order to be considered as a potential COVID-19 vaccine provider.
  • Because my clinic is in a rural area, we have had problems with delivery of vaccines either not being here on time or being delivered after hours, and no staff to take care of them. Would we have a tracer on the incoming vaccines, so we can see when they will be delivered or where they are at?

    The Traceable data loggers, used for monitoring temperature during transport, do not have GPS or cellular capabilities that allow for movement tracking. They are designed for temperature monitoring and data logging during transport conditions and will record the temperature at set intervals through the trip and provide a data report at the end destination.

    Do you have any information on dry ice and using it to maintain temps?

    Dry ice is a valid method to maintain very cold temperature (such as –70°C). In addition to dry ice considerations, the design of the packaging including insulation and double boxing will impact the ability of the dry ice to maintain temperatures for specific durations of time.

    What is the best modality of continuous temperature monitoring in very low resource settings Like Afghanistan South Sudan? (No Internet)

    The best method for continuous temperature monitoring in a low resource area is a stand-alone digital data logger, such as the Traceable Excursion Trac, which stores up to 500,000 samples onboard and can use either wall power or battery power for daily operation. When transporting samples in low resource areas, a low-cost single-use disposable data logger, such as the TraceableOne is an ideal product.

    Can you expand on CDC's requirement for personnel to review and record data twice daily for vaccine storage? How would this work with the traceable Wi-Fi products?

    The CDC indicates that, at a minimum, vaccine coordinators or appropriate personnel should check and record storage unit minimum and maximum temperatures at the start of each workday. If the temperature monitor does not read or record min/max temperatures, then personnel should check and record the current temperature a minimum of 2 times per workday (at the start and end of the workday). Digital data loggers, such as the Wi-Fi data loggers with TraceableLIVE technology, complement this practice because all data is stored for future reference. Additionally, when the device is checked once or twice a day, a “Check” button can be pressed on the TraceableLIVE device which saves the temperature readings at that time, highlights it in the data history, reports the device was checked by the personnel and provides the corresponding temperature data. This makes it very easy to show auditing or regulatory agencies that you are in compliance with regulations.

    We currently do not have large freezer space. Are you seeing supply issues with buying freezers?

    Current demand for freezers and refrigerators is high due to preparation for COVID-19 vaccination storage. However, we do have availability of many freezers with short lead-times. Please contact us and we can walk you through the available products, provide a quote, and identify any estimated lead-times.

    Can you speak to the recertification process of Traceable thermometers once their certificate of calibration expires?

    Once the Traceable Certificate expires, you can either purchase a new one or send it back to our ISO 17025 calibration lab, InnoCal, for recalibration. http://www.innocalsolutions.com/.  In some cases, such as with our TraceableLIVE Ethernet connected cloud temperature data logger, there is a replaceable probe which allows for users to swap out the old probe for a new probe, which recalibrates the instrument since the calibration parameters are stored in the probe.

    I have heard that the government may supply freezer trucks for storage of this. Has anyone heard of this?

    We have not heard about this as of October 8, 2020.

    Do you know if there is any safety and efficacy data available on the 4 vaccines mentioned?  If so, how would you obtain that data?

    Safety and efficacy data will be provided by the manufacturers of the vaccines to the Food and Drug Administration (FDA) as part of their approval process. The FDA documents and makes available public information as part of their approval processes, and so they should be contacted for any current information on safety and efficacy data available to date.

    The bottle that mirrors what is happening to all the vaccine attached to the data logger can only work in a cold chain equipment carrying/storing one type of vaccine. Right?

    Both the Traceable Excursion-Trac and the Wi-Fi connected data loggers with two bottle probes have the capability of setting different alarm parameters for each probe. Two different spots in refrigerator\freezer. Or if there is a refrigerator and freezer right next to each other one probe can monitor the refrigerator and the other one the freezer.

    Does the data logger have flexibility for adjusting excursion ranges in case one wants to use it for vaccines with different ranges?

    The digital data loggers alarm ranges are user adjustable. If you have one with two probes, different alarm ranges can be set for each one.