Vaccines for Children (VFC) is a federally funded programme led by the US Centres for Disease Control and Prevention (CDC). The scheme aims to provide vaccines at no cost to children who, due to a lack of means, might otherwise miss out on being vaccinated. To achieve this, the CDC buys vaccines for discount prices and distributes them to grantees, including state health departments and certain local and territorial public health agencies, who can then distribute them for free to private physicians’ offices and public health clinics certified by the VFC programme.
To ensure that the vaccines provided under the scheme are safe and effective, there are certain conditions under which they must be stored. SmartSense Director of Product Management Jason Driscoll spoke to Pharmaceutical Technology about how his company’s temperature monitoring solutions can help guarantee the correct storage conditions for VFC suppliers.
Jason, what are the main requirements of the Vaccines for Children programme for suppliers?
These are mainly around continuous temperature monitoring. There needs to be a system in place that has an ISO 17025 calibration certificate; suppliers need to use a thermal buffered probe, for which we use glycol; they need to be able to document the temperatures twice a day, so in the morning and evening, which they can now do through our dashboard. And then there needs to be some sort of alerting procedure in place to notify them of excursions.
Do different vaccines or target groups require different storage conditions?
Yes ‒ depending on what the vaccine is, the package insert will dictate the appropriate temperature range, and the amount of time it can be outside of that range and stay viable. One particular example would be the Covid-19 vaccine that’s now available for use. The Pfizer vaccine has different storage requirements than the Moderna vaccine, given that one is a frozen vaccine while the other is a refrigerated vaccine.
Are there other vaccines or medicines that have, for example, differing temperature requirements?
They may all vary slightly, but the vast majority of them are kept at refrigeration temperatures, which is 36-46°F. That’s the common ideal threshold.
How does your temperature monitoring system help to meet these requirements?
So the solution was built with VFC in mind, just due to the nature of the complex requirements that are set forth in the various State Board of Pharmacy and State Department of Health handbooks. The requirements that deal with continuous temperature monitoring require you to have at least three years of temperature history, corrective action reporting, the calibration protocols, the thermal buffer probe and the visual display ‒ all of the requirements that the VFC programme has set forth as to what a continuous temperature monitoring system needs to have as far as a feature function. That’s how we built the system out to ensure that we met the most stringent requirements for each of the various VFC programmes, but also the CDC guidelines on vaccine storage and handling.
What do your solutions offer that others do not when it comes to meeting VFC requirements?
Our solution provides a wire-free temperature display that magnetises to the front of the fridge or freezer. That display not only includes the current temperature rating of that particular asset, but also the 24-hour high and low-temperature readings in the lower right-hand corner of the display screen. There’s also a digital checklist on the dashboard itself that alleviates the requirements to manually ascribe the morning and evening temperatures. This can now be done digitally through the website, which also tracks the staff member and the date and time at which they completed the check.
What about National Institute of Standards and Technology (NIST) recertification?
The NIST recertification process is extremely simple because we send new calibrated probes at the two-year interval as opposed to after one year. The process is as straightforward as removing the old probe and installing the new probe. At that point, the calibration certificate for the new probe will upload automatically to the dashboard. The old probe uses food-safe glycol, which can be safely discarded.
What are the advantages of a centralised, paperless vaccine monitoring system when meeting VFC requirements?
The advantages would be increased efficiency by centrally monitoring all locations and assets in an automated fashion versus the typical data logger, which requires manual download every 30 days with no alerting procedure. The email, phone and text alerts that are sent for power outages or temperature excursions allow for immediate action to be taken to protect the efficacy of the inventory and loss avoidance.
How do your solutions address differences between the storage units at pharmacies, hospitals and laboratories aiming to meet VFC guidelines?
We offer multiple types of NIST-calibrated probes for different storage conditions. For example, the glycol probe is used in most pharmacy applications for standard refrigeration and freezer storage. But we also provide probes that will monitor extreme temperatures of up to minus 200°C. These probes are mainly used for monitoring the Pfizer vaccine that is held at more extreme cold temperatures.
What about the cellular aspect of your solutions ‒ how does this benefit VFC suppliers?
So the sensors communicate with a cellular-driven gateway, which allows pharmacies, hospitals, associated clinics and laboratories to be more nimble and athletic as to where they place the gateway since it only requires AC power. We are not using Wi-Fi, we’re not using the facility’s network in any way. The cellular-driven gateways are communicating the real-time temperatures from the sensors to the Cloud at a set frequency, which is at 15 minutes by default and can be increased to up to every five minutes.
Are your solutions ready to use out of the box? Or would you recommend using them together with another solution?
Our solutions are plug and play and ready for use out of the box. The cellular gateways require only AC power and the wireless sensors operate on three AA batteries. The sensors themselves are turned on with the power button on the face of the sensor. Within 15 minutes of the gateway and sensor both being powered on, data is communicating to the cloud in real-time.