COVID-19 and the Cold Chain: Lessons from the front lines of the vaccine rollout
Ensuring the safe handling, delivery and administration of more than a half-billion COVID-19 vaccines in the United States in less than two years was an unprecedented logistical feat. But distributing the two approved mRNA vaccines from Pfizer-BioNTech and Moderna has been a particular challenge, given the vaccines’ extreme temperature control requirements, according to a recent webinar on the topic and interviews with several experts in vaccine and drug distribution.
The good news is some of the resources invested in COVID-19 vaccine cold chain supply management will still be available in the future.
“A tremendous amount of investment has been made in strengthening temperature management at all levels of the supply chain, and even end-user institutions have devices to be able to handle these products, as well as real-world experience with them,” said Eric Tichy, PharmD, the vice chair of pharmacy formulary for the Mayo Clinic Health System. “It’s a lot easier to replace things once you have them than to do an initial mobilization. We’re not going to have to reinvent the wheel in the same way again.”
Some providers fared better than others, based on existing capabilities and infrastructure. “At Mayo, we were well positioned because we had a strong inventory of ultra-cold temperature freezers for other uses, such as cellular and gene therapies, but we have already made additional investments in these devices and distributed them further throughout our institution,” Dr. Tichy said. “We’ve seen that the future of vaccines and these types of treatment advances will require more and more of these capabilities.”
As for the early days of COVID-19 vaccine distribution, many of those capabilities had to be developed on the fly, a panel of experts noted at a recent webinar hosted by the ELPRO Leading Minds Network. Adapting and streamlining the contractual process was a key starting point, noted Geoffrey Glauser, a former Pfizer/ Merck supply chain executive. “We did not have a suitable template or boilerplate language for the contractual operations with multiple manufacturers that we dealt with through Operation Warp Speed,” he said. “That was something we had to address, to coordinate the manufacturers for COVID-19 operations such that they could standardize what they proposed to the government for response time, supply chain questions, production quality and regulatory requirements.”
The proposal and quotation process also had to become much more efficient, responsive and flexible, said Rich Nelson, the senior manager of global logistics for packaging coordinators at the consulting firm PCI Pharma Services. “We had to figure out how to do something that typically took six weeks and condense it into a much shorter time period,” he said. Before COVID-19, PCI employed a cyclical, back-and-forth quotation process that involved multiple departments. During the pandemic, in contrast, the company created a streamlined process by obtaining vaccine sponsors’ assessment on all packaging options very early on. “They could see right away everything we had available and how long it was going to take. As soon as they were ready to go, we were ready to start.”
Even so, sometimes contracts needed to be signed with limited information available about volume of vaccine, what distribution center would be shipping, and the destination country. “It’s hard to choose the right supplier if you don’t know the origin and destination of your product,” said Victoria Wilmore, the director of the temperature control support center for Johnson & Johnson. “We had to take into account the global footprint of our suppliers and make the best decisions we could at the time with the information we had.”
Vendors quickly came to understand that just-in-time inventory wasn’t going to work for COVID-19 vaccine temperature control packing supplies. Instead, PCI kept sufficient supplies and packaging components in stock and found standardized solutions for requirements, such as labeling, so special orders were not required.
“As soon as the contract was executed, we could keep momentum moving into operations because we didn’t have to go order or look for things,” Mr. Nelson said.