As 2020 marches on and we move into the new season, the coronavirus continues to ravage the world, with over 50 million cases and edging over 1,000,000 deaths*. However, hope looms with the progress of several COVID-19 vaccine candidates.
To successfully bring an approved vaccine to the populace, it will require a pharmaceutical cold chain capable of unprecedented storage, fulfillment, and distribution potential. Vaccine storage of millions of vials under strict (and regulated) temperature requirements is essential, as is product tracking from pharma cold chain storage to distribution to final patient.
Who can bring these pharma cold chain capabilities?
It will take many third-party distribution teams and companies like SSI SCHAEFER, a world leader in providing the necessary cold chain equipment and tracking technologies to pharma warehouses and distribution centers across the world. SSI SCHAEFER and its customers are prepared and ready to deliver the next critical phase of the COVID-19 battle—vaccine storage, fulfillment, and distribution—to the world’s population.
Pharma Cold Chain Execution
Currently, there are 38 COVID-19 vaccines in Phase 1 development, 14 in Phase 2, 11 in Phase 3 and six in Limited use, according to The New York Times Coronavirus Vaccine Tracker. Phase 3 involves vaccines in large-scale efficacy testing trials—the final phase prior to approval. For a vaccine to receive U.S. Food and Drug Administration (FDA) approval, it must protect at least 50% of those vaccinated.
Once a vaccine is approved, its manufacture, storage, and distribution requires strict adherence to pharmaceutical regulations. The U.S. pharmaceutical and biotechnology sectors have some of the most stringent regulations of any industry.
For example, the FDA Drug Supply Chain Security Act (DSCSA), enacted in 2013 with phasing requirements occurring through 2023, is a set of rules for an electronic, interconnected system that identifies and tracks pharmaceuticals throughout their U.S. supply chain—standards that must be met by manufacturers, repackagers, 3PLs, and wholesale distributors.
The stakes are extremely high for pharma cold chain storage and distribution providers. So much so that the Centers for Disease Control and Prevention (CDC) developed a Vaccine Storage and Handing Toolkit.
Within the toolkit, the CDC identifies the three main elements of an effective cold chain:
A well-trained staff—full understanding of standard operating procedures for vaccine storage and handling.
Reliable storage and temperature monitoring equipment—use of temperature monitoring devices to ensure the accurate vaccine temperature range (between 2 and 8 degrees Celsius for refrigerators and -50 to -15 degrees Celsius for freezers).
Accurate vaccine inventory management—appropriate ordering and stock rotation of vaccine inventory, using stock records to track and trace every dose.
While temperature conformance, inventory management, and track and trace are absolute within the COVID-19 vaccine cold chain, supply chain collaboration is just as essential.
Julie Swann, department head and A. Doug Allison Distinguished Professor of the Fitts Department of Industrial and Systems Engineering at North Carolina State University, shares an analogy in a recent interview for Medical Xpress. Swann says the vaccine cold chain is a similar system for distributing Coca-Cola products.
“The Coca-Cola Company (TCC) doesn't necessarily know how many bottles are sitting in a particular convenience store, or when a product is purchased by a consumer, or when a location is out of stock,” she says. “If the information system and collaborations have been put in place, then they know through data sharing. For example, Walmart or Publix may share information back with TCC, who can then use the information to make decisions on production, distribution, allocation, promotional campaigns, etc.
“…We cannot wait until vaccine is available to begin designing our systems for distributing the vaccine. We should plan for several different scenarios, including ones where vaccine is in short supply and ones where vaccine is readily available. We need to think about what these systems would look like if multiple doses are needed, and what investments we need to make in our information systems now.
“We can also build partnerships between public health and private industry, such as occurred with retail pharmacies. These partnerships could also help inform best practices on information in the vaccine system, just as we have for beverages or other products that we consume.”
SSI SCHAEFER Steps In
Cold chain collaboration and best practices are where SSI SCHAEFER excels. With more than 70 locations throughout the world, SSI SCHAEFER is the ideal partner for pharmaceutical and biotechnology companies to store, fulfill orders and distribute their COVID-19 vaccines to pharmacies, clinics and hospitals.
In the same way that food and beverage companies establish DCs close to the customer for easy distribution, pharmacies, hospitals, clinics can leverage existing cold chain distribution networks to quickly distribute temperature-sensitive vaccines when and where they’re needed.
Using its leading warehouse management system WAMAS® as the control center for your cold chain logistics processes, SSI SCHAEFER enables extensive monitoring of pharma cold chain refrigerators and freezers to ensure compliance of temperature-sensitive vaccine storage.
WAMAS also enables SSI SCHAEFER and its customers a powerful network integration of enterprise resource planning systems critical for DSCSA compliance and information sharing. This is critical now in the cold chain where vaccines are stored and distributed with digital recordkeeping and real-time inventory data flow and tracking.
A software package like WAMAS is the perfect solution for handling something as important as the Coronavirus vaccine, due to its comprehensive track and trace capabilities that help insure an unbroken cold chain.
Because vaccines requiring storage in harsher environments (between -50 and 8 degrees Celsius), SSI SCHAEFER specializes in automated equipment and technology, such as automated storage and retrieval systems (ASRS), conveyors and order verifiers, for cold chain pharma fulfillment and pharma distribution of COVID-19 vaccines.
ASRS provides a smaller warehouse and DC footprint that is nearly 100% automated, leading to reduced energy costs, picking efficiency and compliant material handling. An ASRS links with other automated warehouse fulfillment and distribution technologies to ensure facilities are meeting DSCSA requirements.
With limited human involvement and the ability for automatic order checking, documentation and tracking, SSI SCHAEFER and its pharma cold chain warehouse and DC customers are ready to provide their expertise on cold chain coronavirus vaccine storage and distribution.
“Utilizing automation to distribute the vaccine will increase the distribution efficiency in a safe manner today while still meeting regulatory demands in the pharma and biotech industries in the future,” states Matt Rivenbark, an automation expert from SSI SCHAEFER.
SSI SCHAEFER comprehends the processes and best practices required for COVID-19 vaccine cold chain fulfillment and distribution, while leveraging its global position in cold chain solutions for helping defeat COVID-19.
*Accurate at time of publication