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As the frontrunner COVID-19 vaccines head towards the finish line, the next massive coordinated effort will revolve around the logistics and transport across the globe of these immunization shots.

Reports of the first mass air shipment of Pfizer Inc./BioNTech SE’s candidate, confirmed by the US Federal Aviation Administration, indicate that things are already in motion. But worldwide distribution is unlikely to be a breeze - potentially far from it, given varying temperature requirements in the supply chain and in-country logistics capabilities, diverse customs regulations and the need to factor in security risks.

 
Leonora Lim VP DHL Life Sciences

Leonora Lim, DHL Asia Pacific

At DHL it’s already all hands on deck and the major global logistics provider has established a dedicated international cross-divisional task force to oversee the readiness and upscaling of its current relevant capabilities, such as life science and healthcare facilities and temperature control solutions.

In an interview with Scrip, Leonora Lim, vice-president of Life Science and Healthcare, DHL Customer Solutions and Innovation, Asia Pacific, said that the firm expects to leverage its facilities across the 220 countries and territories where it operates. The entire cold chain logistics required for the distribution of vaccines will see all of the group’s business units work together, including warehousing solutions in the DHL Supply Chain, IATA's CEIV (Center of Excellence for Independent Validators)-certified facilities, and specialists in the DHL Global Forwarding division, as well as DHL Express’s Medical Express network including its South Asia hub.

IATA (the International Air Transport Association) created CEIV Pharma to assist organizations and the global air cargo supply chain achieve pharmaceutical handling excellence; it ensures that facilities, equipment, operations and staff comply with all applicable standards, regulations and guidelines expected from pharma manufacturers.

Systems, Tools For Tracking And Visibility

Lim indicated that DHL is now in talks with vaccine players (she declined to name them, citing customer confidentiality) and public institutions on their supply chain needs and is committed to ensuring that the inoculations reach as many people as possible.

But the industry-wide challenge is to scale up for the envisaged 10 billion doses that will need to be delivered, while numerous other uncertainties such as the temperature ranges (including ultra-low temperatures) that the vaccines will need, shipment volumes, shipping points and the freight capacity in the market will also require tight monitoring.

“We have systems and tools in place for tracking and visibility purposes. We also deploy data analytics in running lane risk assessments that can optimize the transportation of these sensitive shipments,” Lim explained.

The logistics giant, which has over the years transported flu, pneumococcal and human papillomavirus vaccines to name a few, added that its innovation centers also continue to scout for new technologies, such as those based on the Internet of Things (web-connected devices), to support the monitoring of such sensitive shipments.

Ultra-Low Temp Challenges

On the readiness of logistics players to deliver the mRNA COVID-19 vaccines predicted to be the first out of the gate, and for which there isn’t prior industry experience, Lim observed that in DHL's case it has transported goods at the specified “deep frozen temperatures” before.

“If required, shipping at the lower temperature thresholds can certainly be achieved with the right cold chain infrastructure, packaging and passive cooling solutions,” she explained.

The Pfizer/BioNTech mRNA vaccine, BNT162b2, requires storage at -70°C; Pfizer has developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain recommended temperature conditions of -70°C±10°C for up to 10 days. (Also see "Pfizer Pilots COVID-19 Immunization Plan In Four States As ‘Dry Run’" - Scrip, 17 Nov, 2020.)

Moderna, Inc.’s vaccine candidate mRNA-1273 remains stable at 2-8°C, the temperature of a standard home or medical refrigerator, for 30 days. For shipping and longer-term storage though, Moderna expects that the product can be maintained at -20°C for up to six months. (Also see "Moderna Files COVID-19 Vaccine After Second Impressive Read-Out" - Scrip, 30 Nov, 2020.)

Given the urgent need to control the pandemic, vaccines will likely be transported via air freight for longer distances and DHL expects to make use of its extensive international transportation capabilities across divisions, as well as to use charters where needed. 

But there may be some technical issues to navigate around the use of air cargo transport, one being the permissible limits for dry ice on aircraft. Such restrictions are in place since solid dry ice sublimates (changes directly) into carbon dioxide gas with time, displacing the breathable oxygen in the cabin.

These limits are calculated based on factors such as the airplane’s ventilation rate, the sublimation rate of dry ice, dry ice packaging, and safe carbon dioxide concentration limits, a recent paper by DHL, with analytical support from consultants McKinsey & Company, noted. Currently, wide body aircraft can carry a maximum of 816-1,088 kg of dry ice when deployed in refrigerated/insulated containers.

Lim said that restrictions on the amount of dry ice on a flight could limit air cargo capacity and that DHL is working closely with airlines on the permissible amounts allowed onto flights.

Interestingly, reports have indicated that a United Airlines flight, carrying the Pfizer/BioNTech vaccine from Belgium to the US, needed special approval from US federal regulators to carry more than the normally permissible amount of dry ice.

More broadly, the DHL research estimated that global coverage of COVID-19 vaccines for the next two years will require up to around 200,000 pallet shipments and roughly 15 million deliveries in cooling boxes, as well as some 15,000 flights across the various supply chain set-ups.

Lim added that there are alternative methods that vaccine providers could look into. With adequate packaging solutions, there could be viable multi-modal or road options should air freight capacity be lacking, or for shorter cross-border shipments, she said.

Broader Logistics Issues 

Nevertheless, the broader challenge for logistics providers is to establish medical supply chains rapidly to deliver vaccines of an unprecedented volume worldwide – also in regions with less-developed logistics infrastructure, where approximately three billion people live.

“Other than the tight airfreight capacity situation we face currently, there would need to be sufficient storage and distribution capabilities on the ground and a robust delivery network to cope with the staggering volume of shipments,” Lim underscored.

Experts have flagged concerns that countries in Africa, South America and some in Asia could potentially be at a higher risk of COVID-19 vaccine supply disruptions given sub-optimal in-country logistics. Inadequate cold chain infrastructure coupled with blistering outside heat conditions complicate the challenges, especially for those products with very low temperature requirements.

Lim maintained that cold chain logistics is always a challenge regardless of distance and that having robust processes, trained personnel and proper facilities and equipment in place are pivotal to facilitate the “temperature integrity” of such shipments during transit.

Delivering vaccines that require ultra-low temperatures to end users she said may require extraordinary measures to reach those outside of the estimated 25 countries with the most advanced logistics systems, which are home to just a third of the world’s total population. Such measures could entail innovative packaging and various supply chain archetypes such as the use of sub-regional distribution hubs, cross-docking and re-icing facilities.

Another aspect that could stretch delivery timelines is complex and varying customs regulations and requirements, though industry experts believe that it’s unlikely that these will be on a slow track for the new vaccines. Lim explained that DHL has customs clearance presence, expertise, accreditation (such as Authorized Economic Operator status) and experience with life sciences and healthcare products, but maintained that customs regulations remain specific to individual countries.

Security Risks

Meanwhile, as COVID-19 vaccinations head towards reality, experts say that the pharmaceutical industry also needs to be cognizant of potential security risks, including theft and diversion of the precious cargo.

Asked whether logistics players are factoring in such risks, given that demand will outstrip supply initially, Lim said that security is definitely a topic of concern in distribution discussions with customers. “Our robust security infrastructure combined with our real-time visibility capabilities should give shippers peace of mind,” she underscored, without giving further specifics.

A United Nations Office on Drugs and Crime research brief on "COVID-19-related Trafficking of Medical Products as a Threat to Public Health" has warned that a viable treatment and a preventive vaccine for the viral disease could be the subject of “falsification, theft and diversion” by organized criminal groups.

It also cautioned that criminals could seize new opportunities to market substandard and falsified vaccines as soon as a legitimate vaccine candidate is announced and before the genuine product can be legitimately produced and supplied.

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