A COVID-19 Vaccine is Ready; Now What?

by Diana Headrick, on December 17, 2020

Last month, Pfizer and Moderna were the first of several pharmaceutical companies to announce results from clinical trials of their COVID-19 vaccines. While both companies’ results demonstrate a greater than 90% effectiveness at preventing the disease, they also present logistical challenges for the vaccination process. Pfizer’s vaccine, developed in partnership with BioNTech, requires ultra-cold temperatures of -70°C (about 94°F below zero) throughout storage and transport. Moderna’s vaccine requirement is not as extreme, but, with a storage temperature of -20°C (-4°F), still needs a managed climate throughout storage and distribution channels, which can be especially challenging in warmer climates.

The Importance of the Cold Chain

And that’s where the cold chain comes in. The cold chain is a temperature-controlled supply chain that maintains an uninterrupted series of climate-controlled production, storage and distribution actions. This requires a broad network of equipment and logistics planning from manufacturer to vaccine administrator in order to maintain the desired low-temperature range. Cold chains already exist for common household items like ice-cream and have supported the production and distribution of therapeutics and vaccines such as the varicella vaccine for years.

The more extreme temperature restrictions for some COVID-19 vaccine candidates have organizations throughout the cold chain working to develop adequate resources for storing and transporting material. Pfizer, for example, has developed an insulated shipping “suitcase” containing between 1,000 and 5,000 doses that uses specially formulated dry ice to maintain required temperatures. Logistics companies such as Fed Ex, DHL and UPS have built cold farms and provide battery-powered freezers and GPS units to track and transmit temperature and location data during transport. Hospitals in major urban centers have purchased ultra-cold freezers to store the vaccines once they arrive. Nursing homes have developed partnerships with major pharmacy chains like CVS to manage the delivery and administration of vaccines to their workers and residents. While many organizations at the beginning of the cold chain have put the needed resources in place to deliver the vaccine, the greatest challenge will be the ‘last mile’ of the distribution chain.

Meeting the Last Mile

The ‘last mile,’ or when the vaccine is delivered to local medical facility or pharmacy, presents some of the greatest obstacles to overcome. For example, the Pfizer suitcase maintains temperatures for up to 10 days and can only be opened twice a day for less than three minutes at a time. After 10 days, the dry ice must be replaced -- which may be difficult in areas with limited supply. Storing the vaccine in the refrigerator can extend its life up to five more days before it begins to degrade. This means that the clock starts ticking as soon as the suitcases are packed and leave Pfizer’s facilities in Puurs, Belgium, Kalamazoo, MI or Pleasant Prairie, WI. Every day the vaccine is being transported is one less day it is available to be administered.

In addition, rural hospitals and clinics often lack expensive ultra-cold freezers or supplies of specialty dry ice while requiring patients to travel long distances to receive the vaccine. This makes meeting the short delivery window even more difficult. For them, administering a 1,000-dose delivery of vaccines within a limited time frame is unrealistic. If they do not have ultra-cold freezers, even large hospitals will have a tough time administering thousands of vaccines in such a compact window.

Moderna’s vaccine may reduce some of the issues along the vaccine’s last mile to distribution. Most medical facilities’ freezers support the -20°C temperature requirement of the Cambridge-based pharmaceutical company’s vaccine and should keep the vaccine stable for up to six months. Still, to prevent it from degrading, the vaccine will require cold-storage throughout its distribution channels, meaning it would require specialty cold-storage units like battery-powered freezers throughout transport.

Future Options Provide Greater Flexibility

Both manufacturers are also looking to produce variations of the vaccine with less stringent temperature requirements, but those versions will have to complete clinical trial testing before they are available.

AstraZeneca, in partnership with the University of Oxford, has announced a candidate that can withstand higher temperatures (between 2 and 8° C or 36 to 46° F), which requires only refrigeration. Variations in dosing during clinical trials, however, may require the company to complete additional testing before it is approved for release. German pharmaceutical company CureVac also has a less temperature-sensitive candidate, but it’s scheduled to be available later in 2021.

How Labeling Can Help Speed Vaccination Delivery

Labeling has always been a critical part of pharmaceutical manufacturing and distribution, but never more so than during the logistics phases of COVID-19 vaccine testing and delivery. Accurate labeling is essential to guarantee the efficacy of these temperature and time-restricted vaccines. Labeling that integrates with enterprise applications can also provide information critical to the planning and distribution of doses, speeding the delivery of quantities to sites where they are most needed. To prevent counterfeit product from entering the supply chain, labeling can be integrated with serialization systems, providing additional levels of security and traceability.

Loftware has long been a leader in delivering Enterprise Labeling Solutions to the pharmaceutical industry and is committed to supporting our partners as they provide vaccines, treatments and equipment to fight this and other deadly diseases. 

To learn more about new advances in the fight against COVID-19, please join us Tuesday, January 19, 2021 for a webinar with Dr. John Halamka, President of Mayo Platform at the Mayo Clinic.

Topics:PharmaceuticalsLife SciencesHealthcareTrack & TraceabilitySpectrumCOVID-19

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