The Pfizer vaccine, with a shelf life of ten days, will require supply chain innovation
The pandemic response tops this weeks headlines. Pfizer PFE -2.5% and Biotech announce that the COVID-19 vaccine candidate, mRNA-based vaccine candidate BNT162b2, has 90% efficacy. The Coronavirus recorded global cases hit 52,147,653 with 1,284,99 deaths. US hospitalizations on Tuesday reached 61,964 outstripping hospital capacity in the parts of the states of Montana, Nebraska, North Dakota, South Dakota, Wisconsin, and Utah. President-elect Biden forms a new Coronavirus task force composed of eleven distinguished scientists.
The path from a vaccine to a vaccination depends on supply chain innovation. The Pfizer vaccine, with a shelf life of ten days, requiring two dosages and -90 degree shipping requirements, is unlike any other supply chain in the industry posing many challenges that are not being addressed holistically. At this historic juncture, we cannot take the logistics for granted.
UPDATE: We are proud to announce, along with @BioNTech_Group, that our mRNA-based #vaccine candidate has, at an interim analysis, demonstrated initial evidence of efficacy against #COVID19 in participants without prior evidence of SARS-CoV-2 infection.
— Pfizer Inc. (@pfizer) November 9, 2020
Reflection
This week, I celebrated Pfizer’s press release and mourned the tragic deaths of the COVID-19 pandemic. On Sunday, following a 60 Minutes spot focused on the logistics team designed to deliver the vaccine to the United States population, I reflected. Absent in the narrative was the fact that the product has a ten-day shelf life. This shelf life requirement of the vaccine is similar to bread, but handled at -90 degrees Fahrenheit, using dry ice. The 60 Minutes story glossed-over the challenges of the vaccine supply chain: the combination of short shelf life, ultra-cold shipping and the need for a controlled two-dosage vaccine.
In the discussion, the governance question of “Who gets the vaccine?” looms large. Ethically, Pfizer is focused on improving global health. Operation Warp Speed is designed for US distribution. Pfizer announcement is for a global vaccine, not the start of a US program. With a ten-day shelf-life there is a need for tight governance of who gets the vaccine along with extensive tracking for efficacy and application of the second dose. The design of state and local processes is a requirement for success.
The launch of the vaccine will have far-reaching consequences. As I unpacked my shipment of salmon from Alaska packed with dry ice, I reflected. How will the looming shortage of dry ice affect other supply chains? Where is the supply chain presence on Biden’s task force? How will the Biden task force coordinate with other countries in the face of a divided US populace in a contested election?
Overcoming the Challenges
One thing is clear. The road from a vaccine to a vaccination hinges on supply chain design, cold chain innovation, and clear direction. When vaccines are launched, scientists assume that the supply chain is capable. This launch will test this assumption. Handling this vaccine requires the reliability of a swiss-train in a South Pole climate at scale. Assuming that the goal is vaccinate 1/3rd of the population in phase-1, as soon as the vaccine is approved, would be 44.5 million doses in the United States. Due to the ultra-cold condition requirements, Pfizer is planning to directly ship and control the product while working with McKesson to move administration kits into the field.
This is not a military operation: it is a humanitarian mission. The vaccine requires education and flawless execution. The administration needs tracking for the first and second dose. Few states are ready. For success, Biden needs to forge a task force of state, local and supply chain experts to examine:
Packaging. The vaccine packaging will affect the ability of dry ice to maintain temperature in shipping. A ten-day shelf-life necessitates air shipping. Due to the decline in commercial flights, air capacity is down 40%. While the surge can be accommodated by planning, efficacy is time and temperature dependent. The longer the transit in the air, the greater the variability. This needs testing. What good is a vaccine shipped from California to New York if it loses effectiveness in the air?
Logistics Coordination. While the vaccine is produced in Michigan and California, the kits to administer the vaccine are moving through the McKesson MCK +0.1% network. Each kit will contain supplies to administer 100 vaccine doses including syringes, alcohol prep pads, surgical masks/face shields, needle information, and vaccination cards/credentials. McKesson operates a network of 47 distribution centers in the United States.
Over the last week, I worked with Llamasoft, a Coupa company, to model the theoretical flows from McKesson to parts of the United States. As shown, the flows from the McKesson Distribution Centers (DCs) cross state boundaries. Strong merge-in-transit capabilities to link the supply kits with the vaccine supplies is a requirement.
The Design of Politically-free Flows. A ten-day shelf life requires clear direction on the origin, destination and patient administration instructions. The United States cannot screw this up like we did with state ordering of Personal Protection Equipment (PPE) at the beginning of the pandemic. We need to mitigate costs: the states cannot compete against each other. No state can effectively order as an individual entity. All of the order administration issues need to be resolved before we begin distribution. Normal order cycles in the best supply chains are one day. This inventory needs to be cross-docked and shipped at time of manufacture with clear tracking and serialization.
Pending Dry Ice Shortage. The estimates of dry ice shortages average from 30-40%. Dry ice is normally manufactured from Carbon Dioxide as a byproduct of petroleum production. Should we be driving scientific discovery for alternative methods to produce dry ice? Could we remove it from air like we do nitrogen? Or look for other opportunities to harness CO2 from other manufacturing processes? And, how do we thwart the issues of the pending dry ice shortage for other goods like food and pharmaceuticals before we begin shipping the vaccine?
Design and Orchestrate the Last Mile. The movement of vaccines to administration vary by region and country. In Europe, the vaccine is picked up at the pharmacy and hand-carried to the physician. A woman’s purse is a far-cry from a -90 degree controlled shipment.
Cold chain in Middle-east and Africa are not up to the task. In 2015, as a part of a strategy to strengthen vaccine supply chains and achieve better immunization equity and coverage, Gavi the Vaccine Alliance, UNICEF and other partners like the Bill and Melinda Gates Foundation, launched the Cold Chain Equipment Optimization Platform (CCEOP) – a $400 million, five-year project to upgrade existing cold chain equipment in 56 countries by 2021. We need to design last-mile delivery capabilities for each country and region based on a clear understanding of capabilities and practices.
Conclusion
A vaccine is only one part, albeit an important one, for a successful vaccination. When it comes to the launch of the COVID-19 vaccination process, we cannot take logistics for granted. The answer is not a US military operation. Instead, it will require the concerted effort of an orchestrated village of supply chain participants clear on the mission and strategy.
Thank-you Pfizer for the vaccine, but I hope the readers of this article now understand that we have a long way to go to design a supply chain to deliver successful vaccinations.
