By Michael Gerhardt, Senior Director, Advisory Solutions and Greg Chavez, Senior Advisor, Pharmacy Advisory Solutions, Intalere
Among the latest challenges and questions facing many healthcare facilities is the need to assess cold storage resources for a forthcoming COVID-19 vaccine. Simply put, at this point, the situation is not clear as to which vaccines will win approval and what the temperature storage requirements will be.
Depending on the vaccine that wins approval, the long-term storage requirement may be approximately -80°C or -20°C (typical freezer temperatures) or 2°C to 8°C (typical refrigerator temperatures). This means, depending on which vaccine is approved or available in your region, there are three different possible models/types of refrigeration equipment that may be utilized. Many vaccine manufacturers are saying short-term storage can be done at 2°C to 8°C in refrigerators or cold packaging.
Following from that, the duration of short-term storage is not yet clearly defined. Regardless of which vaccine comes to market, there will be a window of time to use vaccines after they thaw – possibly up to 10 days. Dry ice and coolers will extend the storage or thaw window. There’s a possibility that the government or distribution channels may provide necessary cold storage packaging with vaccine delivery. One of the largest manufacturers is currently planning to ship 1,000-5,000 doses of the vaccine in insulated containers. The vaccines can remain in these containers until use, requiring replenishment of dry ice approximately every 10 days.
Some manufacturers are working on “lyophilized,” or freeze-dried, formulations that can be stored at typical refrigeration temperatures, thereby eliminating any need for freezer equipment. These are likely to be approved later than the first round of vaccines that will hit the market. Finally, a fully outsourced or turnkey vaccination delivery and injection strategy could possibly be implemented by the federal government, medical distribution or retail channels. In summary, given all the possible options with approvals, logistics and injection deployment strategies, ultra-low temp freezers may not be required at all injection sites.
As we stand today, most tertiary care facilities already have some ultra-low-temp capacity in lab or pharmacy. Ultra-low temperature freezers are also called minus 80 freezers or simply the acronym ULT. An ultra-low freezer is defined by being able to store materials between -40 and -86°C and is developed for storing biological material for a long time. Even so, the packing and relative storage size of the impending vaccines are unknown. An inventory of owned or locally available low-temp capacity should occur prior to investment in cold storage equipment. Availability and long lead times for cold storage supplies and equipment is already becoming an issue due to some pre-emptive purchasing. The picture is very unclear at this point. The best thing you can do is monitor the situation and perform ongoing risk assessments to help decide if or when you need to make the investment and get in line for low temp storage equipment.
Some sample questions to consider in your risk assessment:
- How many front-line staff will we be vaccinating?
- How long do we estimate it will take to deploy our front-line staff injections?
- How likely is our facility to be a public vaccine injection site?
- How much space is currently available in our ultra-low temp freezers, commercial freezers and refrigerators?
- Is our facility a long distance from potential ultra-low temp cold storage?
- Is our facility in relatively close proximity to use or share excess vaccines from other vaccination sites?
- Can we secure a guaranteed supplier for dry ice?
At this point, there is no crystal ball. The best you can do is constantly monitor the vaccine approval news, logistics announcements, and your facility’s probable role in deployment in order to analyze your risk and make your best judgment.
We Can Help. Intalere provides resources that can assist in vaccine storage solutions, general supply chain and many other areas of your healthcare facility. Review our Transformation Toolkit and reach out to see how we can help. Contact Customer Service at 877-711-5600 or email@example.com or your Intalere representative.