By Keith Norbury
When Covid-19 vaccines receive approval from health authorities, they will need to be moved from where they’re produced to where they will be administered to recipients. Considering that most vaccines need to be refrigerated during storage and transport, it is expected that heavy demands will be made of all aspects of the cold chain. Two of the leading vaccine candidates — from Pfizer and Moderna — have to be kept well below freezing, which requires specialized equipment and handling practices. The Pfizer vaccine, for example, has to be stored below -70 Celsius, meaning it has to be packed in dry ice.
“Are you better off having a vaccine that is delivered earlier, that requires such careful handling, that is accessible only by relatively few people, or waiting until there is a vaccine that is, in a sense, more logistics friendly?” asked Dr. David Gillen, Director of the Centre for Transportation Studies at the University of B.C. in Vancouver.
On that score, the Covid-19 vaccine candidate from Johnson & Johnson is much more logistics friendly than the Pfizer or Moderna candidates. J&J expects to transport its Ad26.COV2.S vaccine, which began its phase 3 trials on September 23, to customer warehouses at 2-8 degrees C, “based on available stability data using this vaccine platform,” the company said by email to Canadian Sailings. That’s about the temperature range of a standard refrigerator. It’s also the temperature at which vaccines are traditionally stored and transported. As for how J&J’s vaccine will move around, “discussions are underway with the government concerning distribution of our vaccine candidate, which is anticipated sometime in 2021, pending Health Canada regulatory approval,” the company said.
Infrastructure not in place
The federal government has announced deals with several pharmaceutical companies to provide millions of doses of vaccines against Covid-19, the disease caused by the SARS-CoV-2 coronavirus. But are Canada’s transportation systems up to the task of moving those doses to the people who will need them, and halt the pandemic that has already taken more than a million lives in 2020 and ravaged the global economy? “In a word, ‘No,’” Dr. Gillen said. “I don’t think that the infrastructure is in place. I think there are some real challenges, particularly if that vaccine gets delivered in the winter.” Major cities like Montreal, Toronto, and Vancouver will be fine. The difficulties will come in distributing to places like rural Alberta and northern Ontario.
Dr. Gillen anticipates that most vaccines will go through Canada’s many airports. However, a protégé of his, Dr. Changmin Jiang, noted that a huge drop in passenger traffic during the pandemic has caused airlines to ground most of their jets. “So now we have not only a demand issue, but also a supply issue, a huge shortage of capacity,” said Dr. Jiang, an associate professor of supply chain management at the University of Manitoba in Winnipeg and a member of the university’s Transport Institute. While the pandemic has boosted the air cargo sector, the problem remains that “more than half of the capacity is not in cargo planes; it’s actually in passenger planes,” Dr. Jiang said.
Government seeks logistics information
On September 24, Public Services and Procurement Canada, on behalf of the Public Health Agency of Canada, issued a letter of interest “seeking information on logistic capabilities to support the transport, storage and distribution of Covid-19 vaccines,” said an email from PSAC media relations officer Jeremy Link. The letter of interest isn’t an invitation to bid. Its purpose is “to obtain information on the end-to-end vaccine supply chain to support the transport and distribution of Covid-19 vaccines in Canada, notably international and domestic transport of cold chain including ultra-cold chain requirements exceeding current requirements.”
That notice goes on to say that responsibility for distributing the vaccines rests with the provinces and territories as well as with Indigenous Services Canada. PHAC expects to coordinate planning for the distribution of the vaccines, among other things, with Health Canada, federal, provincial, and external partners, including the World Health Organization. Those vaccines might require refrigeration (2-8 C), freezing (around -20C), or ultra-frozen conditions (about -80C), the notice said. “The precise technical specifications for logistics support for a potential Covid-19 vaccine will vary, depending on the approved vaccine, and PHAC will ultimately define its requirements once a vaccine is approved,” Mr. Link said by email. “Should the vaccine technical specifications (such as frozen transport of vaccines, temperature monitoring, record keeping and rapid recall procedures) and distribution requirements exceed current warehousing and distribution capacities, a third-party logistics supplier(s) may be required, as well as transportation providers. Distribution will include remote regions of Canada, both land and air transport options, and associated supplies (such as needles and gauze) to accompany vaccine distribution.”
Several vaccine agreements
The federal government announced in August it has signed agreements with pharmaceutical companies to provide at least 88 million Covid-19 vaccine doses “with options to obtain tens of millions more,” said a news release from the Prime Minister’s Office.
A CTV News report went into more detail: “Novavax will supply 76 million doses of NVX-CoV2373, Moderna will supply 56 million of mRNA-1273, Johnson & Johnson will supply 38 million of Ad26.COV2.S, and Pfizer will supply 20 million BNT162 (also an mRNA vaccine).” Those add up to 190 million doses. More recently Canada signed deals with Sanofi and GlaxoSmithKline, as well as AstraZeneca. All of the vaccines are yet to be approved following successful clinical trials.
About 260 Covid-19 vaccine candidates are currently under development, noted a September 2020 white paper from DHL Group. The 27-page paper outlined how to secure stable supply chains for those vaccines, and other medical goods during the current and future health crises. “The exact logistical requirements for transport and storage differ between different vaccines and/or technology platforms, as well as between the different supply chain steps,” the paper notes. “Nevertheless, it is important to plan ahead and understand in detail the potential temperature requirements and their implications for logistics.”
New vaccines require special handling
The new mRNA vaccines, which employ strands of genetic coding material, can be developed more quickly than traditional methods such as growing viruses, noted a recent article in The Atlantic. The problem is the mRNA vaccines have to be kept at very low temperatures. “The freezer temperature required by Moderna’s vaccine makes it difficult to ship; the ultracold temperature required by Pfizer and BioNTech’s vaccine is nearly impossible to maintain outside of a large hospital or academic center with specialized freezers,” The Atlantic report noted. Pfizer also announced on September 15 “new stability data” that indicates vials of its vaccine can be stored 2-8C for up to five days at locations where they are to be administered. Moderna’s vaccine can last for two weeks after it thaws, The Atlantic noted.
DHL estimates that to provide the world with 10 billion vaccine doses over the next two years would require 200,000 pallet movements on 15,000 flights. The International Air Transport Association concluded that just one dose each for 7.8 billion people would fill 8,000 747 cargo jets. “The problem, though, is that this number is based on the assumption that everyone only needs one shot, and that there is zero waste in the transportation process, which is probably not possible,” Dr. Jiang said. IATA also warned of “potentially severe capacity constraints in transporting vaccines by air.” Dr. Jiang said it’s important to discuss factors such as temperature control in the transport of vaccines, but the foremost problem will be ensuring adequate transportation capacity.
Disaster plan equivalent needed
Dr. Gillen said the federal government should have the equivalent of a disaster relief plan in place all ready for Covid-19 vaccine transportation and logistics. When a hurricane is coming, authorities generally enact an action plan for distributing such things as food and water to people in the storm’s path. “Generally what happens is that the logistics companies, and firms that rely on logistics like Walmart, can get things going within two or three days. And governments can’t get them going within 30 days,” Dr. Gillen said. “So my tongue in cheek remark is they should probably hire Walmart to do this mission.” Dr. Gillen said Canada’s existing cold chain likely lacks the peak capacity requirements that the Covid-19 vaccines will demand. “And that capacity requirement is both in terms of the transportation, as well as the storage of these vaccines,” Dr. Gillen said.
Supply chain logistics are “the lifeline of humankind,” Dr. Jiang said. “But the problem is they are always invisible.” He expects the vaccines will cross the oceans by air rather than by ship just because the additional time creates higher risk. “An electricity problem on the ocean can seriously affect the quality of the vaccine,” he said.
The concern isn’t necessarily that failing to keep a vaccine at a prescribed temperature will render it harmful. The concern is that such an event would likely render the vaccine ineffective. “We may need to take into account all the possible capacity that we have. But personally, I just don’t think ocean transportation is going to take a huge part in this particular task,” Dr. Jiang said.
That the many vaccines have a wide range of temperature storage requirements complicates the issue “because right now, you don’t know who is going to win out,” Dr. Jiang said. “Eventually, I think we probably will use a few different vaccines in different parts of the world,” he added.
Ready for the last mile
Sergei Timoshenko, Vice-President of Operations for Access Air Smart Freight Solutions, said in early September that his company had not been approached by the government about moving vaccines. However, he held out the prospect that manufacturers or brokers might do so. “Honestly, I do not expect a phone call from the Ministry of Health directly to our office,” Mr. Timoshenko said. “I think that they will be looking for bigger players that can support it on a larger scale. But we’re still in that picture for various steps in between A and Z to help with last-mile delivery or anything in between.”
Access Air Smart Freight is a third-party logistics company that touts itself on its website as a pharmaceutical courier. However, Mr. Timoshenko said he couldn’t recall an instance where his company was involved in transporting anything deep frozen to -70C. The company has, however, had experience in moving vaccines and the like under strict temperature controls. They usually move in pallet-sized containers protected by specially designed insulation, almost always by air.
A company called Envirotainer manufactures various models of these containers capable of maintaining temperature within certain ranges. Its RKN t2 container, for example, has a cooling range of -20C to +20C, according to the Envirotainer website. “It’s not only major airports, it’s wherever the aircraft can land,” Mr. Timoshenko said.
Shawn Baird, President of Cambridge, Ont.-based Sharp Transportation Systems Inc., said his company has had preliminary discussions with pharmaceutical companies about the routing of vaccines, although not specifically Covid-19 vaccines. “But,” he hinted, “you can only speculate.”
However, he is bound by non-disclosure agreements from revealing who those companies are. “We do currently do a lot of vaccines, have for numerous years, so we would be in position to assist if the business did come our way,” Mr. Baird said.
Sharp has never transported pharmaceuticals at the -70C temperatures required for the Pfizer vaccine. “But we would definitely look at it,” Mr. Baird said. “I’m sure they would have well documented contingency plans. Even if part of its transportation is -70 degrees, at some point it has to get to a temperature where it can enter the human body.”
Mr. Baird said Sharp uses various hardware and software platforms on its reefer chillers and gensets for live monitoring. Each chiller has three monitoring systems for redundancy. Since 2008, Sharp has transported more than 17,000 temperature-controlled pharmaceutical loads, Mr. Baird said. “We’ve yet to have a temperature deviation.” That block of Sharp’s businesses consists of 50 53-foot trailers and 20 chassis.
Coming through ports
Sharp, which has a yard in Montreal, moves a lot of pharmaceuticals through terminals at the port of Montreal. About 98 per cent of Sharp’s business is cross-border. The Port’s director of communications, Mélanie Nadeau, said by email that “port authorities are not aware of the precise contents of the containers.” However, the port authority and CargoM are recent recipients of a $500,000 investment from Scale AI on artificial intelligence that “allows port partners to prioritize containers that contain materials dedicated to the fight against Covid-19.”
Halifax Port Authority, meanwhile, has not been contacted by Transport Canada or the port’s supply chain partners about Covid-19 vaccines, said Lane Farguson, the Port’s manager of media relations and communications. But earlier this year, port partners — Ceres Halifax, CN, ILA, and PSA Halifax — launched a “Fastlane” initiative to speed the movement of Covid-19 related cargo such as masks, gloves, and medical equipment.
Federal COVID-19 task force
The federal government has a Covid-19 vaccine task force that has eleven members, including two co-chairs, as well as four ex-officio members, but none of them appear to have any expertise in transportation. “It’s mindboggling, to tell you the truth,” Dr. Gillen said. “There’s nobody who understands that logistics is a key part of this whole thing.”
A co-chair of the task force — Dr. Joanne Langley, division head for infectious diseases at the IWK Health Centre at Dalhousie University in Halifax — referred our interview request to the media relations department of the National Research Council of Canada, which did not respond. We also sought an interview with another Dalhousie professor, Susan Bowles of the University’s College of Pharmacy. She conducted a webinar in 2017 for Immunize Canada on the cold chain for vaccines. However, she did not respond to an interview request either.
Mostly the webinar dealt with storage and handling of vaccines once they reach a pharmacy or a medical clinic. However, the presentation also touched on the transportation cold chain. An estimated 17 to 37 per cent of healthcare professionals expose vaccines to improper storage temperatures, the webinar noted. Aside from handling errors, power interruption and equipment problems are other common reasons for cold chain breaks, the webinar said, citing a 2009 report from the B.C. Centre for Disease Control.
Typically anywhere from 4 to 20 per cent of pharmaceuticals are lost in logistics, Dr. Gillen said. About 80 per cent of that loss is in the air sector. “That’s due to unexpected delays,” he said. “My expectation is that when those delays occur, the people who are handling the cargo do not understand how to handle pharmaceuticals.”
On the other hand, rates of theft are higher on the marine side than for air transportation. “There is certainly going to be a strong incentive on the part of certain nefarious individuals and organizations to try and hijack those vaccines and then sell them through a third party,” Dr. Gillen said. “We saw that with these personal protective devices.” For that reason, Mr. Baird of Sharp Transportation expects that Covid-19 shipments will require heightened security. He also expects that because of their high value, they’ll be shipped less than truckload. Instead of $200 million worth of vaccine stuffed into one 53-foot trailer, for example, that load would be split up into smaller units and transported in 10 trailers.
Rail likely to play a minor role only
Dr. Gillen said it would certainly be doable to ship vaccines by rail, noting that a train nicknamed The Salad Express leaves California each day loaded with fruits and vegetable for a four-day trip across the continent. “If they can move (vaccine) with reefers on trucks, they can do it on rail,” Dr. Gillen said. “But at some point where the last mile happens, it’s going to have to go on a truck.”
Dr. Jiang said he doubts Canada’s rail system is up the task, unlike the high-speed rail network in China where he is from originally. “I am not particularly optimistic that the rail sector is going to play a very important role,” Dr. Jiang said.
Communications people at Canadian National and Canadian Pacific railways did not respond to requests for comment. Mr. Baird and Mr. Timoshenko both said that truck is the most likely ground transportation, regardless of whether vaccine arrives in Canada at an airport or an ocean terminal.
Too early to talk logistics
“It’s a little early to discuss shipping logistics or shipping to Canada,” said an email response from Edna Kaplan, media contact for Novavax. Its vaccine is in Phase 2 clinical trials, “which will lead to initiation of the pivotal Phase 3 trial if supported by the data,” she said. She also confirmed that Novavax’s deal with Canada would supply two doses for every Canadian.
Pfizer is developing its BNT162 mRNA-based vaccine candidate in conjunction with BioNTech. Pfizer didn’t respond to specific questions about the challenges of storing and transporting its vaccine at -70C, as has been widely reported. However, in a statement Pfizer said: “For our potential Covid-19 vaccine, we have developed packaging and storage innovations to be fit for purpose for the range of locations where we believe vaccinations will take place. As the clinical development progresses, the requirements needed for appropriate storage of the vaccine during transportation will be identified.”
The Atlantic reported that Pfizer has developed “thermal shippers,” each holding at least 975 doses of vaccine, that can keep them frozen for up to ten days. “These shippers are supposed to be opened no more than twice a day to take out vials, and must be closed within one minute,” the article states. Such stringent conditions pose problems for remote areas with small populations. If people have to travel to get the vaccine, they are less likely even to bother, resulting in a smaller proportion of the population being immunized. “And as a consequence of that, the impact generally in terms of trying to get herd immunity is going to be diminished,” Dr. Gillen said.
A recent post on Pfizer’s website said Pfizer and BioNTech, which are both headquartered in Germany, plan to seek regulatory review by the end of December. “If regulatory approval or authorization is obtained, the companies expect to manufacture globally up to 100 million doses by the end of 2020 and potentially 1.3 billion doses by the end of 2021,” the post said. During clinical trials, the vaccine is produced at manufacturing facilities in Europe, according to BioNTech’s website. However, once they receive regulatory approval, the companies “will also work jointly to commercialize the vaccine worldwide.”
Warp speed initiative
U.S. President Donald Trump has also predicted that a vaccine will be available by the end of 2020. He also said that the U.S. military would mobilize to begin transporting any vaccine within 24 hours of its regulatory approval — as part of the U.S. government’s “Warp Speed” initiative to develop and distribute Covid-19 vaccines.
That’s among “dozens of interesting scenarios that could arise,” according to Dr. Anna Nagurney, a professor of operations management at the University of Massachusetts. “It is also expected that only certain airports certified for handling pharmaceuticals will be able to accept such valuable, perishable cargo, so bottlenecks may occur there,” Dr. Nagurney wrote in an essay on theconversation.com. Her area of study is pharmaceutical industry perishable product supply chains. Her learned opinion? “The current vaccine cold chain is not up to the task, and expanding the supply chain is not going to be easy.” Dr. Nagurney cited a 2019 study that estimated a quarter of vaccines degrade before they reach their destinations. Losses from temperature mistakes are pegged at US$34.1 billion a year. She predicted that a high spoilage rate of Covid-19 vaccines would result in “an immense financial loss” as well as more deaths and a longer global shutdown.
Africa lacks wherewithal
The cold chain is better equipped to handle the Moderna vaccine, which needs to be kept at -20C. That will be true for developed countries like Canada, the U.S., and Europe. “If you’re talking Africa, South America, some places and even Southeast Asia, that becomes a troublesome issue,” Dr. Gillen said. If, say, only 10 per cent of Africa’s population is vaccinated, the world won’t reach herd immunity, Dr. Gillen said. That would likely mean strict travel and trade restrictions.
Even a vaccine that can be stored at just above freezing will still have to be shipped by truck to an airport or marine terminal, then back onto a truck, or possibly rail, once it arrives in North America. Then it will go into inventory in a warehouse or cold storage plant. Finally, it will be delivered by truck to hospitals and pharmacies. “So you have all of those multiple nodes in there,” Dr. Gillen said. “You have all different people handling it with different skill sets and knowledge. Along that entire supply chain, you have to be able to monitor what has gone on with the temperature, and ensure that you know who handled it. And if there’s a problem that develops, you need to be able to identify what happened and where it happened so you can fix it very quickly.”
More freezer capacity
FedEx Corp. and UPS are reportedly building extra freezer capacity in anticipation that they’ll be called upon to transport Covid-19 vaccines. We requested interviews with media relations people at both companies but did not receive any answers by press time. However, Transport Topics reported in August that FedEx has added ten new freezer facilities and is planning more. FedEx has also worked with the Federal Aviation Administration to “dramatically” increase how much dry ice most of its planes can carry, the article said.
Richard W. Smith, who is leading the company’s vaccine preparations and is the son of FedEx founder Fred W. Smith, did speak with the New York Times, though. During the 2009 H1N1 flu pandemic, FedEx doubled its global freezer capacity at the behest of the U.S. government. That allowed FedEx “to really beef up our cold-chain infrastructure,” the younger Mr. Smith told The Times. New freezers in Paris, Memphis, and Indianapolis can go as low as -80C, the report said.
Complicating matters is a looming dry ice shortage caused by slumping demand for ethanol, of which dry ice (carbon dioxide) is a byproduct.
UPS is building two freezer farms, including one in Louisville, Ky., according to Transport Topics, capable of storing vaccines at -80C. That article also quoted UPS Healthcare President Wes Wheeler, who said Covid-19 vaccines rank as one of the top healthcare challenges ever.“ Every vial counts,” Mr. Wheeler said in the article. “There is not any spare vaccine to go around. The logistics of this are complicated.”
DHL has eight cold chain facilities, with super-cold-storage freezers, in the U.S., David Goldberg, CEO of DHL Global Forwarding USA, told Transport Topics. That includes a new centre in Indianapolis that opened in July, and a 430,000 square foot facility at Chicago’s O’Hare airport in operation since 2015. Goldberg told Trade Topics that DHL has improved its package-tracking technology, has specific loading docks, and the necessary personnel to deliver the vaccines. “We are trained and ready for this,” the article quoted him. However, he expects movement of the vaccines ramp up over several months and not all happen immediately.
A giant logistical challenge
Bloomberg News reported in late July that the world’s supply chain isn’t prepared for a Covid-19 vaccine. Supply chains for vaccines “are exponentially more complex” than supply chains for personal protective equipment, the article quoted Neel Jones Shah, global head of air carrier relationships at San Francisco-based freight forwarder Flexport. “You can’t ruin PPE by leaving it on the tarmac for a couple of days,” Mr. Shah said. “You will destroy vaccines.”
In August, a group called Pharma.Aero joined with the International Air Cargo Association (TIACA) to develop a global guidance for the air cargo industry.
According to a news release on the TIACA website, “The guidance will be developed gradually in four work packages through a joint working group to ensure feedback from all stakeholders in the supply chain of air cargo and pharmaceuticals.” That release also quoted Mr. Shah of Flexport: “Covid-19 vaccine delivery will be one of the biggest logistical challenges in modern history. No one company can own the end-to-end vaccine supply chain.” UBC’s Dr. Gillen offered a similar warning: “I really hope that your article gets traction and that somebody within the government starts looking at the importance of logistics and distribution because that’s a huge failure generally in Canada, let alone with this vaccine.”