A Snapshot Look at COVID-19 Vaccine Distribution Logistics
In December 2020 when this blog series was planned, national attention had turned from developing a COVID-19 vaccine to distributing it. The expectation was that this blog would focus on the successes and logistical challenges that were overcome with respect to maintaining the extremely cold temperatures that are required for the vaccine (-94 F for the Pfizer vaccine), delivering it safely and keeping track of the supply to make sure that sufficient vaccines were available when second doses were needed. As of Dec. 23, 2020, Gen. Gustave Perna, Operation Warp Speed's chief operating officer, was still optimistic, predicting "By the end of the year, 20 million doses of vaccine will have been delivered."1
The transportation-related logistics seem to have gone as planned, and for that, the individuals and companies working to deliver vaccines to the states should be commended for this challenging feat. However, vaccines that are not actually administered fall short of the ultimate goal, and it is in this area that the vaccine rollout has failed to meet expectations. Although the pace has picked up during the first two weeks of January, according to the U.S. Centers for Disease Control and Prevention (CDC) as of Jan. 15, 2021, 31,161,075 vaccine doses were reported as distributed in the U.S., but only 12,279,180 vaccination doses have been administered, and just 1,610,524 persons have received their second doses.2 There are a multitude of opinions and solutions being offered in the scientific, academic and business communities to address this shortfall. This is taking place against the background of a continuing COVID-19 surge. In light of the nature of this series, this blog will focus on the transportation-related logistics. However, not wanting to lose sight of the reason that the transportation logistics matter in the first place – that is, to ensure that people are vaccinated – and looking toward changes that may come from the Biden Administration, the larger rollout of the vaccine will also be addressed.
The spread and surge of the COVID-19 infection has clearly become a national crisis that affects many in the transportation industry. Responding to an inquiry from Holland & Knight, the American Trucking Associations stated, "ATA has made it clear with public health officials and Governors that prioritizing vaccine access to truck drivers is critical to controlling the pandemic and keeping our economy moving. We are closely monitoring vaccine rollout and working with our state trucking associations and public health officials across the country to make sure that happens as smoothly and quickly as possible."
Current plans for distribution of the vaccine depend on whether the vaccine is produced by Pfizer or Moderna. According to Operation Warp Speed, while both vaccines are made and filled/finished by the manufacturers, Pfizer's vaccines are provided to UPS and FedEx for distribution and Moderna's are provided to McKesson distributors3 for delivery to distribution centers before transporting the vaccine to the states and other jurisdictions, such as tribal authorities and federal agencies.4 Two national drug store chains have contracted with HHS and the U.S. Department of Defense (DoD) to provide and administer COVID-19 vaccinations to residents of long-term care facilities (LTCF) nationwide without charge.5
The Pfizer vaccine must be stored at minus 94 F or below, and the Moderna vaccine must be stored at minus 4 F. The Pfizer vaccine gets stored in "freezer farms" for ultra-cold storage. The vaccine is tracked and ordered via an Operation Warp Speed software system called Tiberius, which works with the CDC's vaccine Tracking System (VTrckS), which has been in place for a decade.
To aid in the delivery of the vaccine, companies can rely on waivers of certain regulatory obligations from the Federal Motor Carrier Safety Administration (FMCSA) and Federal Aviation Administration (FAA). Since March 2020, the FMCSA has waived driver hours of service and other requirements when delivering COVID-related supplies, which certainly includes vaccines. The FAA has permitted larger quantities of dry ice to be transported by air, and even where no such special permission was required, has issued an alert to be aware of safety risks of carrying more dry ice than is typical.
Shipping temperature-sensitive pharmaceuticals requires many measures to insure safe delivery. Fleets are extensively audited for quality and to ensure that they meet global standards for such transportation. Two-driver teams are typically used for security. Fortunately, despite the complexity, shipping temperature-sensitive pharmaceuticals is not new, even if it has not been done on this scale before. UPS, FedEx and McKesson all have extensive experience in this area.
In Dec. 10, 2020, testimony before the U.S. Senate Committee on Commerce, Science, and Transportation's Subcommittee on Transportation and Safety at a hearing on the Logistics of Transporting a COVID-19 Vaccine, Richard W. Smith, Regional President, Americas and Executive Vice President of Global Support for FedEx Express, testified that:
Once the vaccines are approved and ready for distribution, vaccine and related healthcare shipments will be the top priority for the FedEx Express network, with support provided by our FedEx Logistics and Custom Critical teams. Our established FedEx Priority Alert team will actively monitor and track vaccine shipments for our healthcare customers using a suite of advanced tracking and monitoring tools to ensure the integrity of the shipments as they move through the system, including SenseAware ID (which uses FedEx patented technology), as well as our FedEx Surround platform. These technologies provide increased visibility and near real-time updates on sensitive packages. Our FedEx Priority Alert teams and healthcare customers will have access to this information, enabling us to intervene and intercept a shipment if necessary. Long ago, we recognized that information about the package was just as important as the package itself and invested in these innovative tracking and monitoring solutions for this exact purpose.
In a similar vein, Wes Wheeler, President of UPS Healthcare, the company's healthcare and life sciences division, testified that:
UPS has spent many weeks designing the supply routes and expected data flows for these vaccines. Capacity has been reserved in our air network, operating hubs and ground operations. Our pilots and drivers will know they are carrying vaccines. We will monitor all vaccine shipments in a newly dedicated 24/7 command center which collects data from all sources including our client's temperature recorders. Each package will also carry a UPS-exclusive active tag which provides visibility in our network. Command center staff have been trained to monitor and, if required, recover any vaccine package. UPS has also designed software that can detect network disruptions before they occur, and then recommend countermeasures in real time.
Importantly, Wheeler also announced that, "UPS has also invested in dry ice manufacturing capacity for replenishment at dosing sites where needed. UPS will produce over 24,000 pounds of dry ice per day in our Louisville facility, and we will ship a box with 40 pounds of dry ice to all Pfizer dosing locations a day after the vaccine arrives. UPS is also nearing completion of very large coolers and freezers in the same facility for storage of future vaccines in the pipeline. We have also invested in a 'freezer farm' for -80 C [minus 112 F] storage, and we offer a program to supply portable ultra-low temperature freezers for dosing sites where dry ice may not be available."
Despite these well-planned arrangements, by mid-December, governors in at least 14 states had complained about the shortfall in the vaccine allocated to and received by their states. Rather than a logistics problem, it was an error in planning. In a news conference on Dec. 19, 2020, Gen. Perna apologized, stating, "It was my fault. It was a planning error, and I am responsible."6
Because the federal vaccine distribution plan affects states differently, both in terms of selecting the recipients of the vaccine and the logistics for vaccine delivery, this in turn affects the logistical requirements for distribution. Moreover, at the federal level, there appear to be competing considerations for developing a coordinated vaccine distribution plan, and the distribution plan changes daily. As recently as Jan. 13, 2021, the CDC had recommended prioritizing delivery of the COVID-19 vaccine in phases, first prioritizing healthcare personnel and long-term care facility residents, followed by frontline essential workers and people aged 75 and older, followed by people aged 65-74 and, lastly, people aged 16-64 with underlying medical conditions and other essential workers.7
It is now reported, however, that the CDC has authorized an expansion of eligibility for the vaccine to include those aged 65-plus as well as those under 65 with comorbid conditions, which is consistent with announced Biden Administration plans for vaccine distribution and the release of more doses of the vaccine to ensure greater availability of the vaccine, the production of which will also be ramped up to provide for second doses. States have quickly followed suit. On Jan. 13, for example, California Gov. Gavin Newsom announced that people 65 and over are now eligible for the vaccine.8 While the California news was heralded, considerable skepticism was voiced at local levels, given the lag in administering the current doses that have been delivered statewide, as well as insufficient, confusing and conflicting information at all levels of state government, and glitches in using a different form of logistics — the software used for vaccine registration for the shots.
In an interview with Jeff Zients, President-Elect Joe Biden's choice for White House coordinator of the pandemic response, reported by The Washington Post,9 Zients described the need for a "whole of government response" to getting the vaccine out. This point of view was echoed by Howard Koh, a professor at Harvard University's T.H. Chan School of Public Health and an Assistant Health Secretary in the Obama Administration, who said, "The most ambitious vaccination effort in modern history involves delivering millions of doses to millions of people in a timely fashion. … It requires a one-government approach more than ever before, especially when that government is in the midst of a transition."10
In September, the Biden-Harris team announced a plan for "the effective, equitable distribution of treatments and vaccines – because development isn't enough if they aren't effectively distributed." The Biden-Harris team plans to "invest $25 billion in a vaccine manufacturing and distribution plan that will guarantee it gets to every American, cost-free ... ." On Dec. 29, 2020, President-Elect Biden announced that his administration has a plan to administer 100 million vaccine shots in his first 100 days in office.11
In an interview on ABC's "This Week with George Stephanopoulos" on Jan. 3, 2021, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), stated:12
The goal of vaccinating 100 million people in the first 100 days is a realistic goal. We can do 1 million people per day. You know we've done massive vaccination programs … in our history. There's no reason why we can't do it right now.
The classical one that people should just go back and look at, go Google it, it's really interesting. In 1947, when there was a case of smallpox of an American who vacationing in Mexico, came back to New York City and infected a group of people – there were a total of about 12 hospitalizations and two deaths.
New York City in March and April of 1947 vaccinated 6,350,000 people; 5 million of which they did in two weeks. I was a 6-year-old boy who was one of those who got vaccinated.
So, if New York City can do 5 million in two weeks, the United States could do a million a day. We can do it.
The transportation-related logistics of the COVID-19 vaccine distribution rollout appear to have been handled without any substantial incidents so far. However, vaccination continues to lag behind expectations. The Biden Administration has promised a coordinated, comprehensive approach, one that is directed by a federal government willing to provide oversight, clout and resources to ensure the delivery of the COVID-19 vaccine throughout the 50 states. Whether this promise is accomplished, of course, can only be assessed after the first 100 days of the new administration.
In the meantime, Holland & Knight will continue to provide guidance from members of our COVID-19 Response Team and top-ranked transportation law team, who have the skills and knowledge to advise on supply chain issues and help resolve related disputes.
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1 See "Operation Warp Speed Leader Provides Update on COVID-19 Vaccine Delivery," David Vergun, U.S. Department of Defense News, Dec. 23, 2020
2 CDC COVID Data Tracker, as of Jan. 15, 2021. Interestingly, one reason for the lag in vaccine administration numbers could be a hesitancy by many healthcare workers to receive the COVID-19 vaccine, with some hospitals reporting that 40 percent or more of their workers have not immediately signed up to receive the shot. See "It's essential to understand why some health care workers are putting off vaccination," Katherine Harmon Courage, Vox, Jan. 11, 2021.
3 In an undated report of the U.S. Department of Health and Human Services (HHS) to Congress, which was issued before the U.S. Food and Drug Administration's (FDA) approval of the Pfizer vaccine, it was noted that "On August 14, CDC announced its centralized distributor contract by executing an existing contract option with McKesson, which distributed the H1N1 vaccine during the H1N1 pandemic in 2009-2010. The current contract with McKesson, awarded as part of a competitive bidding process in 2016, includes an option for the distribution of vaccines in the event of a pandemic." See "From the Factory to the Frontlines: The Operation Warp Speed Strategy for Distributing a COVID-19 Vaccine," HHS Report, p.4.
5 See "Trump Administration Partners with CVS and Walgreens to Provide COVID-19 Vaccine to Protect Vulnerable Americans in Long-Term Care Facilities Nationwide," HHS and U.S. Department of Defense release, Oct. 16, 2020
6 See "Operation Warp Speed's General Perna Apologizes For Covid-19 Vaccine Delivery Shortfalls," Bruce Y. Lee, Forbes, Dec. 20, 2020
7 See CDC, COVID-19 Vaccines. See also The Advisory Committee on Immunization Practices' Updated Interim Recommendation for Allocation of COVID-19 Vaccine — United States, December 2020, published in the Morbidity and Mortality Weekly Report, HHS/CDC, Jan. 1, 2021, at Vol. 69 / No. 51-52.
8 See "California allows residents 65 and older to get COVID-19 vaccine, but doses remain limited," Melody Gutierrez, Colleen Shalby, The Los Angeles Times, Jan. 13, 2021.
9 See "How Biden will try to fix our vaccine rollout mess," Greg Sargent, The Washington Post, Jan. 4, 2021
11 See "Biden Promises 100 Million Covid-19 Vaccinations In First 100 Days, Warning That Trump's Approach Would Take 'Years'," Robert Hart, Forbes, Dec. 29, 2020