Requires transport at -70°C, more akin to winter in Antarctica than usual pharmaceutical requirements. It can be stored at this temperature for up to six months or up to five days at standard refrigerator temperatures of 2-8°C.
Global distribution of a COVID-19 vaccine: aviation’s mission of the century?
Almost one year on from the first reported case of the novel coronavirus in the Wuhan province of China, pensioner Margaret Keenan and intensive care unit nurse Sandra Lindsay, have now received the first vaccines in the UK and US respectively.
With both Margaret and Sandra receiving shots of the Pfizer/BioNTech vaccine following emergency use authorisation by the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) on 2 December 2020 and the US Food and Drug Administration (FDA) on 11 December 2020, the race for global distribution of a COVID-19 vaccine has well and truly begun.
But with the Director General and Chief Executive Officer of the International Air Transport Association (IATA), Alexandre de Juniac recently describing global distribution of the vaccine as “the mission of the century” and predicting it as “the largest and most complex logistical exercise ever”, the aviation industry faces a monumental task in the challenge to vaccinate the world.
Won the battle but not (yet) the war?
Labelled by the Governor of New York, Andrew Cuomo as “the weapon that will end the war” and the UK Health Secretary Matt Hancock as “the start of a fight back against our common enemy, the coronavirus”, the emergency roll out of the Pfizer/BioNTech vaccine has certainly given great cause for optimism on both sides of the pond.
This is buoyed by the news that alongside the Pfizer/BioNTech vaccine, the US’ Moderna and the UK’s Oxford/AsraZeneca candidates have emerged as fellow front runners for global distribution.
Whilst vaccine development can usually take between five and twenty years, currently, just one year on from the outbreak, alongside the three front runners, there are some 250 vaccine candidates, at various stages of development. These candidates are utilising seven different technology platforms between them and include 13 vaccines currently in phase three efficacy trials, the stage before applying for regulatory approval.
This is not to mention vaccines produced by countries like China and Russia for domestic roll out such as Moscow’s Gamaleya Center ‘Sputnick V shots’ and China’s ‘Sinopharm’ candidate produced by the state owned pharmaceutical giant.
Barriers to distribution
Given the urgency for a mass vaccine roll out, scientists have not been afforded the time to continue testing the vaccine candidates in order to improve their stability. As a result, all three front runners require different handling, storage and transportation requirements, posing a significant hurdle to the aviation industry’s distribution of a vaccine.
Can remain stable for up to 30 days at 2-8°C and at room temperature for up to 12 hours. However, for transport or long term storage of up to six months, it requires -20°C conditions, around the temperature of a conventional freezer.
Can be stored and transported at temperatures of 2-8°C for up to six months.
IATA estimate that it will take the equivalent of 8,000 loads in a 110 tonne capacity Boeing 747 freighter aircraft to supply 14 billion doses of a vaccine over a two year period.
A DHL whitepaper on vaccine global distribution assesses that in practice this will take over 15,000 flights, 200,000 movements by pallet shippers and 15 million deliveries of vaccine cooling boxes.
In 2021 alone, Pfizer/BioNTech plans to ship 1.3 billion doses, Moderna over one billion doses and Oxford/Astrazeneca has manufacturing capacity to ship a colossal two billion doses.Accenture’s Seabury Consulting estimates that this will generate 65,000 tonnes of air freight which equates to five times the air vaccine trade in 2019.
This gargantuan operation will utilise almost the entire global fleet of commercial aircraft, and in many countries, both military and passenger aircraft in addition to freight aircraft. This is despite one third of all passenger fleets globally remaining in storage and many countries’ borders remaining shut or travel severely restricted.
The global demand will also necessitate reliance on a supply chain of carriers, ground handlers and logistics providers in many countries not well versed in the transporting of specialist temperature controlled pharmaceuticals. This is exemplified by a DHL study on the feasibility of the world’s existing in-country cold chain logistics infrastructure, which found that only approximately 25 countries have intact infrastructure capable of distributing the Pfizer/BioNTech vaccine. These countries represent just one third of the world’s population and exclude large parts of Africa, South America and Asia.
This is all whilst still having to meet international regulatory requirements such as EU Good Distribution Practices, US FDA requirements, World Health Organisation (WHO) standards and IATA’s standards for transport of temperature controlled products and dangerous goods.
It is perhaps then of no surprise that according to Reuters, a survey by an air cargo association and a drug shippers group found that only 15% of industry participants felt ready to transport a vaccine at the -70°C conditions required by the Pfizer/BioNTech candidate whilst 60% felt comfortable meeting Moderna’s vaccine requirement of -20°C.
In a year which has seen aviation brought to its knees, the entire industry has wasted no time in preparing for the challenge ahead and readying the world’s supply chains for the global distribution of the vaccine.
Many airlines have existing cold storage facilities at their airport hubs, and already use containers with cooling materials such as dry ice and cooling packs to transport pharmaceuticals. However, with usual pharmaceutical distribution requiring conditions of 2-8°C, virtually no aircraft are capable of keeping items at the temperatures required for the Pfizer/BioNTech vaccine, or at least without additional equipment. Existing methods employed by carriers also do not often utilise temperature control technology, essential in transporting the vaccine to avoid temperature fluctuations during unforeseen delays.
Pfizer thermal shippers
To tackle this issue (among others), Pfizer has developed specialised thermal cooling containers known as Pfizer thermal shippers for the transport and if required, temporary storage of their vaccine. The shippers can hold between 1,000 and 5,000 doses, are reusable and are installed with a GPS enabled thermal sensor to record the temperature and location of the vaccines at all stages of the supply chain. The containers do however, use dry ice (solid CO2) in order to regulate the temperature of the vaccines. Whilst many carriers, ground handlers and logistics companies will rely on the Pfizer thermal shippers to transport the vaccine, this does present an obstacle to quick and efficient global distribution.
Dry ice dangers
Dry ice is classified as dangerous goods by ICAO, the US Department of Transportation and IATA and as such, carriers are restricted on the amount of dry ice which can be carried on board aircraft. This is because dry ice sublimates over time releasing CO2 gas which can decrease the amount of oxygen in the cabin or storage unit and lead to asphyxiation.
Depending on the aircraft type, most wide body planes are allowed to carry around one tonne of dry ice in refrigerated and insulated containers. In light of the transport and storage requirements of the Pfizer/BioNTech frontrunner, many governments have already begun to raise limits on carrying dry ice for domestic carriers’ fleets. However, even with increases, it is estimated that only about 50% of Hold space can be filled with vaccine shipments packed using dry ice.
Airlines have therefore begun exploring other options to dry ice utilising both ‘passive’ and ‘active’ temperature controls including multi-layered canisters containing liquid nitrogen and both aircraft and non-aircraft Temperature Controlled Containers (TCC) such as ‘plug-in freezers’ and ‘active containers’ using electric motors to cool their contents. This in itself however, raises further issues including consideration of aircraft suitability, as many of these specialised TCCs are either not aircraft Unit Load Devices (ULD) designed for use on particular aircraft or are ULDs designed for use solely on cargo aircraft. Many TCCs also include lithium battery powered data loggers or cargo tracking devices which, like dry ice, requires special measures to be taken in line with the IATA Dangerous Goods Regulations.
IATA have produced a two part guidance paper, ‘Guidance for Vaccine and Pharmaceutical Logistics and Distribution’ which includes consideration of temperature controlled facilities, equipment and training staff for the handling of time and temperature sensitive vaccines.
On the ground
Both ground handlers and logistics companies have been adapting their procedures, services and facilities to cope with the requirements of the Pfizer/BioNTech frontrunner.
Once a Pfizer thermal shipper arrives at the country of destination, the vaccines can be stored in either:
- Ultra-low temperature freezers (up to six months)
- The thermal shipper by refilling the dry ice every five days (up to 30 days)
- At 2-8°C (for up to five days).
Ground handling considerations
Pfizer estimate that the total delivery time from a Pfizer/BioNTech distribution centre to the place of use will average just three days, creating a major race against time. Logistics companies have therefore begun developing warehouses and ‘freezer farms’ at key geographical locations to ease the logistical burden. These farms can contain up to 600 freezer units, with each unit capable of storing up to 48,000 vials of the vaccine.
Many ground handlers maintain a well-established global network for pharmaceutical distribution which is hoped to expedite the process with the addition of deep freeze capabilities. However, ground handlers across the globe have been implementing projects to ensure staff are trained and security measures, equipment and facilities are sufficient to handle the vaccine roll out.
These projects have led to specially adapted vehicles and modifications of ramp cool dollies to collect the vaccines directly from aircraft to ensure continuous temperature control. Other measures include risk assessments to review physical and cyber security controls, upscaling screening procedures and developing purpose built on and off airport secure facilities. Ground handlers have also seen some of their dedicated pharma facilities IATA Centre of Excellence for Independent Validators (CEIV) approved for the handling of the Pfizer/BioNTech candidate.
To ensure transparency on the level of infrastructure, operations and IATA classified stations, IATA has also developed the ONE Source industry platform for validated aviation capabilities and infrastructure information.
Away from physical security, IATA together with Aviation-ISAC have warned all those in the supply chain against neglecting to focus on cyber security during the operation.
Aviation-ISAC has highlighted an increased risk of both physical and cyber attacks during the transport of vaccines with threat intelligence research forecasting a surge in both organised crime group attempts to intercept vaccine shipments for sale on the black market and ransomware groups targeting aviation data processing and flight operations systems during distribution of the vaccine.
IATA have therefore encouraged increased monitoring of systems and strict data controls to ensure information relative to vaccines distribution remains confidential or privileged with restricted access, data loss prevention and encryption measures in place. IATA also stress the importance of reviewing business continuity, disaster and ransomware incident response plans.
The final orchestration
The final end-to-end supply chain for individual countries, will be down to their respective governments to coordinate. IATA have worked in collaboration with other international organisations to produce guidance to governments on the preparation for the global distribution of a vaccine.
- International Civil Aviation Organisation (ICAO)
- International Federation of Freight Forwarders Associations (FIATA)
- International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
- Pan American Health Organization (PAHO/WHO)
- United Nations International Children's Emergency Fund (UNICEF)
- World Customs Organisation (WCO)
- World Trade Organisation (WTO)
- World Health Organisation (WHO)
Administrations will be responsible for in-country logistics planning and cold chain infrastructure development as well as negotiating with other states on deals for the supply of vaccines, customs clearances and border relaxations. Governments will also play a big part in granting permissions for ad hoc flights, converting passenger aircraft to cargo only, shortening approval processes and developing sensible regulations.
IATA has emphasised that if borders remain closed, fleets grounded and employees furloughed, the capacity for countries to deliver the vaccine to their people will be severely affected. Bottlenecks could be created at customs and diminished air freight capacities could limit the flow of distribution, in turn causing greater issues given the constant cooling requirements of the vaccine front runners. IATA have therefore encouraged governments to support grants for temporary additional traffic rights for operations carrying vaccines where restrictions apply.
In relaxing custom clearance procedures for vaccine shipments, governments are forced to strike the difficult balance between increasing the speed of the vaccine’s distribution and ensuring supplier’s certification and product quality is properly verified. This is recognised by the European Commission which has contacted customs authorities to underline the importance of thorough quality controls. The European Commission and IATA have also encouraged the joint inspections of goods in temperature controlled areas, with the Commission informing EU Member States of the possibility to use EU customs laboratories to share the analytical capacity.
Collaboration also continues between the WCO and WHO to ensure vaccines and biological materials used in their manufacturing and testing are included on the list of critical items in their ‘Harmonised System Classification’ to promote swift customs clearances.
The WCO and WTO are working closely with individual government authorities and regulatory bodies regarding implementing common cross border processes, approvals, increased security measures, appropriate handling and custom clearances. To minimise cargo border blockages and ensure these can be responded to quickly, the WCO has also compiled a database of emergency contacts.
IATA have encouraged the use of ‘smart coordinated borders’ where customs authorities coordinate with local government, border agencies and law enforcement to ensure seamless door to door delivery.
Whilst governments explore the use of bond programs and deferrals in payments of customs duties, taxes, fees and charges, they have also begun altering border processes to allow for acceptance of electronic documents via single windows for submission, prior to arrival customs clearances, granting priority on arrival and contactless processing. Similarly, expedited clearance procedures via ‘green lanes’ are under consideration with a view to accelerating the release process at borders and reduce the volume of vaccine shipments requiring inspection at acceptable risk.
The aviation industry, founded by innovation and its ability to respond to adversity at its core, looks set to meet the immense challenge of the global vaccine distribution head on. The sheer scale of the task ahead may not yet be fully comprehendible, but the industry as a whole has taken a collaborative approach to ensure its readiness to deliver the vaccine to all corners of the globe.
Whilst it remains to be seen whether the world’s in-country cold chain logistics infrastructures will stand up to the task, the aviation industry is doing all it can to overcome its “mission of the century”.
As developments unfold, Kennedys experts across the world advise on what the COVID-19 pandemic means for you and your business.Go to focus area