THIS EXTRACT FROM SHOT IN THE ARM BY YOSSI SHEFFI IS © 2021 AND REPRODUCED WITH PERMISSION FROM THE MASSACHUSETTS INSTITUTE OF TECHNOLOGY (MIT) CENTER FOR TRANSPORTATION & LOGISTICS. ALL RIGHTS RESERVED.
The race to deliver a COVID-19 vaccine has been likened to a moonshot, but in several ways landing a man on the moon was easier. In MIT Professor Yossi Sheffi’s new book, Shot in the Arm, he explores how science, engineering, and supply chain converged to vaccinate the world.
In Chapter 2, Sheffi recounts the many challenges that pharmaceutical companies faced as they sought to mass produce and distribute the approved vaccines to the entire world. These included: overcoming supply shortages for key ingredients and equipment; ramping up fast for production of hundreds of millions and then billions of doses; developing and implementing brand new manufacturing processes; and transporting supplies and finished product through a constrained global supply chain.
In this excerpt, Sheffi discusses the cold-chain innovations that companies created to respond to the challenge of transporting and storing the new mRNA vaccines at subzero temperatures. As Meri Stevens, a global supply chain leader in Johnson & Johnson’s consumer health business, told Sheffi in an interview about J&J’s vaccine, “Initially it was very much about the science and discovery, but very quickly we were having to create whole cold chains that didn’t exist before.”
“Ensuring over a billion people globally have access to our potential vaccine is as critical as developing the vaccine itself,” said Pfizer’s CEO [Albert] Bourla.1 Adding to the challenge of both the volume of shipments and the urgency of delivery was the need to properly handle the vials of vaccine while sending them to the far corners of the earth.
Whereas most vaccines require some refrigeration, the new mRNA vaccines require the most careful handling because of the delicate constitution of their lipid nanoparticles. Molecular biologist Phillip Sharp of MIT explained, “This is an oily particle with carbohydrate around it. So, it’s a pain to keep it from fusing. It’s just one big ball of oil if it’s not taken care of. That’s why all this shipping and freezing and thawing and everything is really very important.”2 Moderna’s vaccine requires freezing between –50°C and –15°C (–58°F and 5°F), and Pfizer’s requires ultra-low-temperature freezing between –80°C and –60°C (–112°F and –76°F). As a result, these vaccines require cold-chain handling: global distribution activities at very low and controlled temperatures.
The colder the temperature, the more challenging the cold-chain transportation and storage issues. In the case of the Pfizer vaccine’s deep-freeze needs, very few facilities—only a handful of pharmaceutical distribution centers, hospitals, and research laboratories—had the kinds of deep freezers needed. “I don’t think we have all the cold storage that people think we have,” commented James Bruno, president of the consulting firm Chemical and Pharmaceutical Solutions.3
Helping Shipments Keep Their Cool
As part of its development strategy, Pfizer began setting up its downstream supply chain for the finished product in March 2020—at the same time as the kick-off of its COVID vaccine development. Pfizer said it developed a “just-in-time system, which will ship the frozen vials direct to the point of vaccination.”4 That system included packaging for shipping, continuous monitoring of vaccine temperatures to ensure safety, and a means to store the vaccine for up to a month at clinics, vaccination centers, and distribution facilities that lacked deep freezers. These efforts used supply chain partners with respective expertise in cold-chain packaging and supply chain monitoring.
Pfizer worked with SoftBox, a multinational British manufacturer of temperature-controlled packaging, to develop a reusable insulated thermal shipping box5 that holds 1,200 to 6,000 doses. The box, measuring 17 x 17 x 22 inches, holds up to five small “pizza box” trays, each with 195 vials, in an inner payload sleeve box nestled deep in the heavily insulated outer box.6 On top of the precious cargo sits a “pod” with up to 50 pounds of dry ice at –109°F (-79°C). An insulated lid completes the cozy ensemble.
The result is a medium-sized, robust, 70- to 80-pound box (with side straps) that can be handled by any air or ground parcel delivery service. (Pfizer and SoftBox even designed the box to reduce the sublimation of the dry ice during flight, reducing the generation of potentially hazardous caron monoxide (CO) levels in air freighters and significantly increasing the number of doses that air-freighters were permitted to safely carry.)7
As an added bonus, this thermal container can maintain ultra-cold temperatures for up to 10 days. Moreover, if needed, the recipient can replenish the dry ice every five days to extend storage in the box for up to 30 days.8 That enables facilities that lack the required freezers to temporarily store, distribute, and dispense the vaccine. Finally, when needed, the vaccine is thawed and can be kept in an ordinary refrigerator for up to five days before dilution and injection.
A view to a chill
To maintain 24/7 visibility of shipments, Pfizer contracted with Controlant, a provider of real-time supply chain monitoring devices that go into shipping boxes.9 A small, battery-powered sensor tracks vaccine temperature, the opening of the box, and its GPS location. Using a standard cellular data connection, the sensor sends the information in real time to Controlant’s cloud-based software, where customers can receive alerts and view the information. When the box is opened, red-green status lights show the shipment’s temperature status, data connection status, and battery status. “Controlant’s reusable, real-time data loggers and visibility and analysis platform integrates with Pfizer’s existing control tower technologies,” said Tanya Alcorn, vice president of biopharma global supply chain at Pfizer, “to help manage temperature proactively, identify and react expeditiously to any events that can impact the supply chain, all while automating quality and logistics processes.”10
One tricky issue with the monitoring system occurred at the handoff when Pfizer delivered the doses to government distribution or vaccination centers. As the shipment left Pfizer’s hands, Pfizer turned the monitoring off for legal liability and practicality reasons; once delivered, Pfizer had no control over the status of the shipment or the means to make the recipient take a corrective action. But recipients wanted the ability to monitor the boxes too, especially if they planned to use them for interim storage by refilling the dry ice. Fortunately, because the monitoring device was actually made and monitored by a third party, Controlant, all any recipient had to do was to sign up with the tracking company to restart monitoring and route the data and alerts to the recipient.11
Getting ready to move ’em out
Pfizer bought large numbers of deep freezers to set up freezer farms to buffer and distribute the output of its production facilities in Michigan and Belgium. The company also built its own dry ice plant to make the freezing pods that keep the vaccines cold during transit. As of November 2020, Pfizer planned to have a fleet of 24 trucks to ferry shipments from Pfizer’s facilities to local airports, where a combination of air charter and air freight companies such as FedEx, UPS, and DHL could carry the vaccine anywhere in the world within a day or two. As the clinical results of the Phase 3 trials confirmed the efficacy of the Pfizer–BioNTech vaccine, Pfizer announced plans to move roughly 7.6 million doses per day.12
Similarly, airfreight companies and facilities prepared for the vaccine distribution campaign. UPS, for example, built its own freezer farms and dry-ice production equipment at key air hubs.13 Airports invested in additional security and cold storage.14 Airlines conducted trial runs of vaccine deliveries to both debug systems and ensure the CO emissions from the dry ice remained within Federal Aviation Administration (FAA)-required limits.15 In coordination with Operation Warp Speed, FedEx and UPS divided the U.S. in half to improve delivery efficiencies.16 The efforts were intended to ensure fast, efficient, and problem-free delivery of the vaccines once they were approved and started shipping.
The bigger picture of bigger demand
Overall, vaccine suppliers had to face and overcome a long list of challenges: Shortages began in the product development labs, moved into the ingredient supply chains, and then hit the packaging ends of vaccine development and production processes. Shortages also hit capital equipment supply chains as pharmaceutical makers attempted to ramp up their capacity. As the adage goes, supply chains are only as strong as their weakest links. Successfully delivering large quantities of a new product depends on delivering all of the required quantities of every one of the raw materials, ingredients, and all other parts in the bill of materials (BOM) of the final product, as well as all the plant equipment and machinery needed for manufacturing and delivering the product. Supply chains aren’t about doing one thing well; they are about doing every one of many things well, because final products and customer satisfaction depend on every one of those many things for a complete, high-quality product delivered on time.
Even the packaged final product—billions of doses of safe and effective vaccines—wasn’t the end of the challenge. Those vaccines still needed to get to the customers: all people in all the countries of the world. Although modern supply chains have become adept at quickly and accurately making and moving millions of shipments of consumer products per day anywhere in the world, actually getting those doses into people’s arms was a real challenge that tested national and local institutions.
1. Paris, Costas, and Jared S. Hopkins. “Pfizer Sets Up Its ‘Biggest Ever’ Vaccination Distribution Campaign.” Wall Street Journal, October 21, 2020. https://www.wsj.com/articles/Pfizer-sets-up-its-biggest-ever-vaccination-distribution-campaign-11603272614
2. Author interview with Phillip Sharp, Nobel Prize-winning biochemist and Institute Professor at MIT, March 17, 2021
3. Mullin, Rick. “Pfizer, Moderna Ready Vaccine Manufacturing Networks.” C&EN. November 25, 2020.
4. Pfizer, Inc. “Pfizer-BioNTech COVID-19 Vaccine U.S. Distribution Fact Sheet.” November 2020. https://www.Pfizer.com/news/hot-topics/COVID_19_vaccine_u_s_distribution_fact_sheet
5. Packaging Europe. “Softbox Supports Pfizer in Global Cold Chain Distribution of COVID-19 Vaccine.” March 11, 2021. https://packagingeurope.com/softbox-supports-Pfizer-in-global-cold-chain-distribution-of-COVID-vaccine
6. Lamers, Vanessa. “FAQs on the Pfizer Vaccine: Shipping, Handling, Preparation, and Administration.” PHF Pulse [blog]. December 15, 2020. http://www.phf.org/phfpulse/Pages/FAQs_on_the_ Pfizer_Vaccine_Shipping_Handling_Preparation_and_Administration.aspx
7. Bailey, Joanna. “Pfizer Increases Dry Ice Life Span Improving Vaccine Capacity On Boeing Aircraft.” Simple Flying, December 15, 2020. https://simpleflying.com/boeing-aircraft-vaccine-capacity-increased
8. Bourla, Albert. “Distributing Our COVID-19 Vaccine to the World.” Pfizer, Inc. Accessed September 29, 2021. https://www.pfizer.com/news/articles/distributing_our_covid_19_vaccine_to_the_world
9. Butcher, Mike. “Iceland’s Controlant, with $50M backing, emerges as key player in Cold Chain for COVID-19 vaccine.” TechCrunch, December 15, 2020. https://techcrunch.com/2020/12/15/icelands-controlant-with-50m-backing-emerges-as-key-player-in-cold-chain-for-COVID-19-vaccine
10. Controlant. “Controlant now providing monitoring and Supply Chain Visibility for Pfizer- BioNTech COVID-19 Vaccine distribution and storage.” [Press release]. December 15, 2020. https://controlant.com/blog/2020/controlant-now-providing-monitoring-and-supply-chain-visibility-for-Pfizer-BioNTech-COVID-19-vaccine-distribution-and-storage
11. Goldhill, Olivia. “Pfizer Decision to Turn Off Temperature Sensors Forced Scramble to Ensure COVID-19 Vaccines Kept Ultra-Cold.” Stat, December 17, 2020.
12. Meredith, Sam. “Pfizer, BioNTech Say COVID Vaccine Is More Than 90% Effective—‘Great Day for Science and Humanity’.” CNBC, November 9, 2020. https://www.cnbc.com/2020/11/09/covid-vaccine-pfizer-drug-is-more-than-90percent-effective-in-preventing-infection.html
13. Sigalos, MacKenzie. “Pfizer’s COVID Vaccine Is Now Shipping. Here’s How the U.S. Plans to Deliver It.” CNBC, December 12, 2020. https://www.cnbc.com/2020/12/12/how-fedex-ups-plan-to-distribute-fda-approved-covid-vaccine-when-will-you-get-the-coronavirus-vaccine.html
14. Katz, Benjamin, Doug Cameron, and Alison Sider. “How Airlines Are Rushing to Deliver COVID-19 Vaccines.” Wall Street Journal, December 16, 2020. https://www.wsj.com/articles/COVID-19-vaccines-are-coming-airlines-are-rushing-to-deliver-them-11608147229
15. Brett, Damian. “US cargo carriers fly US COVID-19 vaccine shipments following FDA approval.” Air Cargo News, December 14, 2020. https://www.aircargonews.net/sectors/pharma-logistics/fedex-united-and-ups-fly-us-COVID-19-vaccine-shipments-following-fda-approval
16. Kulisch, Eric. “FedEX, UPS trucks depart with first Pfizer COVID vaccines.” American Shipper, December 13, 2020. https://www.freightwaves.com/news/fedex-ups-trucks-depart-with-first-pfizer-covid-vaccines
Copyright ©2022. All Rights ReservedDesign, CMS, Hosting & Web Development :: ePublishing