By Ranjeet Banerjee, CEO, Cold Chain Technologies (CCT)
Fortunately, companies like CCT have been building a cold chain infrastructure for many years — CCT has 50 years of experience developing cold chain solutions. Along with our shipping partners, we started building up capacity at the start of the pandemic. While our recent response to the H1N1 pandemic was an important template for us, the cold chain has been growing steadily in recent years in support of clinical trials and new therapies and biologics that require consistent temperature for storage and shipping. It’s with great pride on behalf of my colleagues at CCT and the entire industry that I can say the cold chain has held up spectacularly well.
However, as vaccine delivery continues to ramp up, more organizations and people will have responsibility for maintaining temperature requirements — and many of them might not have experience with the cold chain. Adhering to cold chain requirements is critical not only now but also for the future as mRNA vaccines and other therapies that need cold storage will become more common tools in the arsenal of healthcare providers. Understanding the strict cold chain guidelines for unpacking, storage, and timing of administration can minimize spoilage and preserve the integrity of temperature-sensitive, life-saving vaccines.
Unpacking and moving the Vaccine
Each manufacturer has strict requirements for unpacking and repackaging the vaccine to preserve the efficacy and prevent spoilage. While both the Pfizer and Moderna vaccines are shipped in high-performance vacuum-insulated panel systems (VIP) with specially designed phase change materials and contain devices to monitor temperature and location, the unpacking process for each varies and, if done improperly, can greatly impact the efficacy of the vaccines.
Pfizer vaccines are packaged in cold chain VIP insulated packages with dry ice to maintain the ultra-low temperature of -70°C, and once opened, the vaccines should be unpacked and placed into storage within one minute. Layers of dry ice should be carefully removed in a well-ventilated area (to avoid CO2 asphyxiation) by at least two healthcare professionals wearing insulated gloves and eye protection, and the delicate trays of vaccine transferred to an ultra-low freezer for long-term storage. The Pfizer vaccine can be stored in a pharmaceutical freezer (-20°C) for up to 14 days and a hospital refrigerator (5°C) for up to five days (see storage table below.)
The Moderna vaccine is not packaged with dry ice and, when unpacked, should be immediately moved into storage which can be either a standard medical-grade freezer capable of maintaining temperatures ranging from -25 to -15°C or a medical-grade refrigerator maintaining 2 – 8°C. Moderna’s vaccine is good for 30 days once placed into refrigeration.
The Johnson and Johnson vaccine uses more traditional viral vector technology and is shipped and stored thawed at 2-8°C. It boasts the longest shelf life of the three approved US vaccines at 90 days while in refrigerated conditions.
Additionally, the thermal shipping coolers can also be used as short-term storage containers that are easily transportable to various point-of-administration sites and can help increase the availability and administration of vaccinations while mitigating the risk of spoilage. This can be done by changing the phase-change material, or dry ice, to preserve the thermal integrity of the packages. This is commonly referred to as “re-icing” in the industry. Passive storage options are available for ultra-low -70°C, frozen -20°C, and refrigerated 2-8°C conditions. These passive storage solutions provide accessible and compliant options for organizations that do not have the financial resources or volume requirements to pursue active medical-grade fridge or freezer solutions.
Administration
The Pfizer vaccine must be reconstituted prior to administration, while both the J&J and Moderna vaccines do not. Regardless of the vaccine, once they are punctured or reconstituted, all must be administered to patients within 6 hours.
Storage methods*1234
| Long Term Storage | Shipment | Hospital -20°C Storage | Hospital Refrigerator Storage | After Puncture or Mixture (as applicable) | Reconstitution/Mixture? | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name | Temp (°C) | Expiration | Temp (°C) | Temp (°C) | Expiration | Temp (°C) | Expiration | Temp | Time | |
| Pfizer | -60 – -80 | 6 months | -80 | -20 | 14 days | 5 | 5 days | Room temp | 6 hours | Yes |
| Moderna | -20 | 6 months | -20 | -20 | 6 months | 5 | 30 days | 2-25°C | 6 hours | No |
| J&J | 5 | 90 days | 5 | X | X | 5 | 90 days | Room temp | 2 hours | No |
| 5°C | 6 hours | |||||||||
*current as of 3/15/2021The Future of the Cold Chain and New Vaccines
The cold chain of the future will require an integrated approach to creating comprehensive solutions that include design optimization; use of newer / sustainable materials; use of near-real-time data for alerting as well as retrospective analytics to identify the packaging solutions that optimize cost while preserving vaccine efficacy; and ensure end to end traceability and condition monitoring throughout the supply chain.
To learn more about CCT’s COVID-19 vaccine transportation and storage solutions, click here.
References
