Transport of vaccines by air

Andrea Gruber of IATA says quality in times of crisis cannot be jeopardised despite operational Covid-19 emergency challenges.

Air Cargo is critical in the global fight against Covid-19. Pharmaceutical and life science products are an important part of the air cargo business, making up 1.9 percent of all air cargo volume flown by air and contributing 2.6 percent of total airline cargo revenues or $2.5 billion.

The airline industry faces unprecedented challenges resulting in significant logistical constraints affecting all stakeholders in the supply chain. Following the Covid-19 outbreak, we all hope to see effective vaccines developed and delivered. Today, there are some 80 potential Covid-19 vaccine research programmes underway around the world, and the airfreight industry must prepare for its critical role in responding to the need for efficient global delivery.

Pharmaceutical and life science products require stringent handling and transport conditions, or potentially the medicine loses its potency and may become ineffective. This creates additional challenges within the current environment of limited air freight capacity and global connectivity resulting from the grounding of nearly two thirds of the passenger network.

Operational environment
In such times of crisis, business continuity and recovery plans are more important than ever. As the cancellation of 4.5 million passenger flights across all regions reduced international belly cargo capacity significantly, over 100 carriers have executed cargo operations by transforming passenger aircraft into cargo-only operations to address shipper’s connectivity needs. This allowed millions of tons worth of face masks, respirators, ventilators and other PPE as well as medical equipment and much needed medicines to be shipped around the world.

Handling and transporting vaccines bring another dimension to the supply chain logistics – it’s not just a box! Such high-value and sensitive products may not only require a temperature-controlled management environment but must also follow international regulatory requirements such as EU Good Distribution Practices, US Federal Drug Administration and WHO and IATA’s standards for temperaturecontrolled sensitive products published in the Temperature Control Regulations (TCR).

Today’s airfreight logistics capacity is designed to meet the existing planned programmes of vaccinations in each country. Both the infrastructure and the resources will be critical as countries prepare themselves for a massive vaccination response to Covid-19, impacting all countries and territories. The upcoming challenge for the supply chain stakeholders is to plan and execute a global network delivery mechanism for the Covid-19 vaccines, unlike any situation experienced previously. Will the temperature-controlled supply chain be capable of storing, handling and transporting such a drastic increase in quantities of vaccines?

Some carriers, ground handlers, forwarders and truckers may be unsure as to how to effectively handle temperature sensitive materials. Also, since it may not be suitable to transport temperature-controlled life science medical supplies in the passenger cabin, pharmaceutical manufacturers might be less inclined to have their valuable shipments transported in this manner. Therefore, all supply chain partners must familiarize themselves with the overall requirements to safely process vaccine shipments before looking to accept or handle such consignments. There may be a need to allocate specific or additional resources within their networks and designate additional and/or technically compliant storage space for the vaccine. Industry training and compliance certifications may also need to be increased.

Mitigating the impact and the risks
When transporting temperature sensitive pharmaceutical products, quality is key and cannot be jeopardized. Quality implies that whatever is done should be executed with quality precision and, in the direction intended. Companies that implemented quality-driven strategy programmes such as the IATA Center of Excellence for Independent Validators in Pharmaceutical Logistics (CEIV Pharma) programme are well placed to mitigate the impact of logistical constraints in their strategies, as they are already aware of:

• the operational challenges,
• the standards and requirements to be followed,
• the necessity to have trained and knowledgeable staff,
• the requirement to have dedicated equipment as well as infrastructure
• the importance of reviewing and if necessary, adjusting robust risk assessments.

Being part of such a programme will be a significant advantage in building confidence and trust, in a collaborative environment where the integrity of such sensitive products is maintained throughout the handling and transport journey until it reaches its end customer.

Moreover, enhancing patient safety and quality of care can be achieved by improving the usability of supply chain digitization, end-to-end visibility and transparency of existing capacity and facilities. This provides manufacturers and logistics providers the possibility to identify the level of competency as well as operational and technical preparedness at airports.

Non-standardized processes have a detrimental impact. Training is a prerequisite. This means that in the long term, a network of sustainable infrastructure, technology-driven initiatives and people are needed. Global standards must be implemented, reviewed and maintained through robust audit processes. If this is achieved properly, the beneficial results will positively impact everyone’s lives.

Business models transition
Airfreight logistics plays a key role, to allow and facilitate future access to global vaccination programmes, but it will not be able to act alone. More than ever, the industry needs to invest in implementing an integrated multimodal transport solution as an enhanced business model to strengthen the network and the last mile delivery. Access to and from airports and the improvement of land-based infrastructure are just initial examples.

In order to respond to an increased worldwide demand, the ‘distributed manufacturing’ approach may be privileged over the ‘traditional manufacturing’ one. In other words, decentralization of activities would lead to multiple manufacturing sites, closer to the end customers, reducing logistics and supply chain constraints. This can only be achieved for Covid-19 vaccinations if access to newly developed drugs and compounds is ensured. Today this remains a challenge as government authorities impose export restrictions to Covid-19 essential medical and life science supplies and implements different approval and certification policies for new drugs.

Regulatory framework
Because of the lockdowns resulting from the Covid-19 crisis worldwide, government authorities have enacted restrictive measures that impact trade movements and IATA is advocating with the regulators as well as with the national and international entities to reduce any negative impact. However, it is critical that countries continue to implement actions to facilitate and prioritize the movements of vital life science supplies without disrupting the supply chain. Otherwise, this will be detrimental to the public in the long run.

Working effectively with health and customs authorities will, therefore, be essential to ensure timely regulatory approvals, increased security measures, appropriate handling and customs clearance.

There are good initiatives like the ones taken by the European Commission. For example, waiving customs duties and VAT on the import of medical equipment from non-EU countries to combat the effects of Covid-19 or postponing by one year the date of application of the Medical Devices Regulation (MDR) that governs the production and distribution of medical devices in Europe. It is indeed important to implement expedited customs and other border procedures for vital shipments in order to avoid possible temperature excursions due to delays and thus putting the integrity of the shipment at risk.

Further considerations
Collaboration, cooperation and communication are key to ensure the continued flow of life science supplies. These should not only be words, but actions initiated towards industry transformation that can be achieved through an integrated, efficient and collaborative supply chain. Whether it is by using globally harmonized standards and aligning with industry initiatives following the same objectives, or by further implementing digitization, data sharing, risk lane assessment, visibility on capabilities as well as tracking and tracing. Following a continuous improvement approach, will result in a growing expectation of increased standardization and transparency across the supply chain. The air freight logistics supply chain is ambitious and must plan for resilient solutions.

This crisis must reinforce the public private partnership; the responsibility for the Covid-19 vaccination programme lies with governments but the distribution of the vaccines cannot be left entirely to the private sector. However, once developed, will countries be able to rely on other countries to provide access to the necessary vaccines? This and other questions are critical to be addressed;

How will a vaccine or its components be equitably shared amongst nations? Will pharmaceutical companies be able to produce the quantities required to ensure an effective global vaccination programme?

Will ground based distribution networks be capable of guaranteeing temperature integrity?

Will cool chain solutions ensure product integrity is maintained in high temperature countries?

Will national health agencies adopt fast tracked approval certifications?

Will border agencies ensure effective and expeditious clearance?

Will aid and public health agencies be able to mobilize and implement a global delivery mechanism covering the 200 countries and territories impacted by Covid-19?

Only by successfully addressing these questions can an effective global Covid-19 vaccination programme be assured of success.

Should a supranational body help coordinate and regulate the trade, availability and access to this critical lifesaving medication globally in response to such a pandemic crisis?

To quote Brian Tracy, a Canadian entrepreneur, “Excellence is not a destination, it is a continuous journey that never ends”. The aviation and the pharmaceutical industries have been working together in collaboration for many years to strengthen the quality requirements with realistic capabilities. Our industry has been adaptive, agile and responsive; therefore, air cargo will continue its journey by playing a critical role in moving lifesaving supplies to help collectively fight the virus and reduce the potential human impact.

Andrea Gruber is head, Special Cargo at the International Air Transport Association (IATA). Based in Geneva she developed and implemented for the industry three IATA Center of Excellence for Independent Validators (CEIV) quality audit programmes certifying the handling and transport of pharmaceuticals, live animals and perishable products.