No vaccine has ever been required to be produced at such a high speed in such large quantities as that to treat Covid-19.
While manufacturers created an effective drug and received regulatory approval with impressive speed and efficiency, distributing these vaccines to every corner of the globe is proving more challenging.
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Of the first three vaccines to receive approval and reach the roll-out stage in the West, two of them, Pfizer/BioNTech and Moderna, are mRNA vaccines, which have to be transported and stored at an extremely low temperature, sometimes as cold as -80°C. The other, the Oxford-AstraZeneca vaccine, is a more traditional DNA-based vaccine that can be transported and stored at fridge temperature.
This so-called ‘cold chain advantage’, and the fact that it is cheaper than the other two, makes the Oxford-AstraZeneca vaccine the most likely to reach wider parts of the world’s population.
However, when it comes to vaccines produced during pandemics, there are numerous factors to take into account such as new variants that are likely to emerge. The cheapest and easiest vaccine to transport won’t necessarily be the one that is most-used.
Improper storage at any point during the supply chain process can ruin valuable batches. Dr Edward Meinert, the University of Plymouth
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By GlobalData
From test tube to vein: Manufacturing the vaccine
Pharmaceutical companies need to have Good Manufacturing Practice (GMP)-compliant capacity ready for the production of vaccines. This can be done through building or repurposing existing facilities or contracting out to manufacturing organisations.
To put things in perspective, Pfizer/BioNTech is targeting production of between 1.3 and two billion vaccines for 2021; Moderna is targeting between 600 million and one billion; and Oxford-AstraZeneca is targeting up to three billion for the same period.
To meet such an unprecedented demand, these companies have all established partnerships with other manufacturing organisations.
AstraZeneca, for instance, has organised production and distribution on a regional basis to minimise potential logistics challenges and has contracted, among others, Oxford Biomedica for production and Wockhardt’s CP Pharmaceuticals for bottling in the UK.
Packaging
Once the substance has been produced and tested in labs, it needs to be packaged.
Syringes, vials and needles are all essential to this phase and so is the raw material needed to produce them in large quantities to meet the high targets mentioned above.
Again, pharma companies have sub-contracted specialised manufacturers for both the production of this equipment and, sometimes, for the so-called ‘fill and finish process’, which consists of physically putting the drug in vials and making it ready for distribution to the outside world.
Distribution and logistics
Now that effective drugs have been manufactured and approved, the world is focusing on their distribution to the wider population. This is where difficulties have emerged, especially as the two types of vaccines present different challenges.
Vaccines from Pfizer/BioNTech and Moderna require ultra-cold/cold-chain storage. This means that throughout the whole shipping process the temperature they are stored at must be maintained to ensure product quality.
Temperature control issues have already started to emerge. At the end of December, Spanish authorities said they had received notification from Pfizer that the batch the country had ordered was going to be delivered a day late due to “a problem in the loading and shipping process related to temperature control”. The delay was said to have impacted eight other European countries.
While we appreciate the need to offer equal provision across the country, the UK government needs to be honest both with the public and practices about what supplies are available. Dr Krishna Kasaraneni, BMA GP committee
As the vaccine is needed in such large quantities, upgrades in production capacity have also begun to cause delays. In mid-January, the UK emerged as one of the countries to be affected by delays in delivery of the Pfizer/BioNTech vaccine.
The US company decided to increase its production for 2021 and therefore had to temporarily reduce deliveries to all European countries.
“As the current approved Covid vaccines are biomolecules (mRNA and adenovirus), they are not stable outside of validated temperatures, causing them to lose potency,” says Dr Edward Meinert, associate professor of eHealth at the University of Plymouth. “Improper storage at any point during the supply chain process can ruin valuable batches.
“This implies requirements for training logistics technicians to handle the products properly, specialised shippers and lorries, and ultra-cold/cold storage facilities in airport hubs or ferry ports, which are limited in capacity,” he adds. “Airports around the world have been actively preparing to handle the vaccines. For instance, the KLM Cargo warehouse at Schiphol has four cold storage areas for pharmaceuticals and was preparing a fifth one at the beginning of this year.”
The logistics industry, however, appears to be confident that it will meet the targets and rise to the challenge even as more vaccines are produced.
“FedEx is prepared to ship the Covid-19 vaccine for as long as is necessary,” says a spokesperson for the US company. “We have the experience, global network, aircraft fleet and technology solutions needed to transport vaccines safely across the region, and around the world.”
The spokesperson adds that in order to maintain the cold chain distribution, FedEx has developed a near real-time tracking technology with the ability to monitor the status and location of shipments. It has also added more than ten secure cold chain facilities across its global network, and the company is exploring a combination of solutions including stationary freezers, temperature-controlled ocean containers and refrigerated trailers.
Speaking at the Davos World Economic Forum 2021, Deutsche Post DHL CEO Frank Appel and Lufthansa Cargo chief commercial officer Dorothea von Boxberg also sounded optimistic about the transportation of vaccines.
“We are currently operating 250 flights a night and we can easily increase that capacity should we need to,” said Appel. Von Boxberg added: “The industry is prepared for what is to come. There won’t be any bottleneck at our end.”
Like other airline companies, Lufthansa Cargo has been using grounded passenger aircraft as well as freighters throughout the pandemic to ship protective personal equipment (PPE) and other goods, and is now using these aircraft and freighters to ship vaccines around the world.
The last mile
There is an agreement within the logistics industry that ‘the last mile’ is where the real challenge is, especially in developing countries. Once the vaccine has been manufactured, approved, packaged and shipped around the world, it then has to successfully reach individuals.
At this point, lots more stepping stones and, indeed, physical hands get involved, from doctors and medical staff to patients themselves.
Once again, temperature is crucial. Vaccines must be delivered to a point-of-care location that can provide adequate storage infrastructure.
For instance, Pfizer/BioNTech’s vaccine is delivered in temperature-controlled thermal shippers that utilise dry ice to maintain recommended storage temperature for up to ten days unopened.
Cases have already emerged of Pfizer/BioNTech’s vaccine batches having to be sent back or becoming unusable due to either the wrong storage conditions or refrigerator failures.
Human error can also play a role at this point, as happened in the case of eight care home workers in Germany who were inoculated with five doses of the vaccine at once.
Has the UK got its vaccine roll-out right?
Temperature management is undoubtedly the biggest hurdle to successfully distributing and delivering Covid-19 vaccines on a global scale. For this reason, the Oxford-AstraZeneca vaccine – which can be stored at normal refrigerator temperature – is believed to be the most suitable for mass distribution.
The UK government, which is running one of the most advanced and successful vaccination campaigns in the world at present, has ordered 100 million doses of this vaccine, significantly more than its 40 million Pfizer/BioNTech doses and the 17 million Moderna doses.
The Oxford-AstraZeneca vaccine is also produced domestically at Oxford BioMedica, which has been contracted to manufacture tens of millions of doses.
The UK government has also signed a partnership with India-based Wockhardt to gain exclusive access to its subsidiary CP Pharmaceutical ‘fill and finish’ production line in Wrexham, Wales, which is expected to yield millions of doses of multiple Covid-19 vaccines.
Despite such efforts, public opinion and particularly the medical community are concerned that the vaccine roll-out in the UK could result in a PPE-style fiasco unless the process speeds up and is made more efficient.
Solutions need to be super agile as any delay in accessing data could potentially result in the loss of human life. Mikkel Brunn, Tradeshift
Among the most critical voices, the British Medical Association’s (BMA) regional chair Gary Marlowe has told the press that the government does “not seem to be world-beating at logistics”.
His comments followed calls from MPs, doctors and care workers before Christmas warning that many GP surgeries were still waiting to receive their allocated batches despite more than 100 million doses being ordered by the government.
Dr Krishna Kasaraneni, BMA GP committee executive team member, told Investment Monitor that supply has not kept up with demand and GP-led sites are unable to immunise their patients at the rate at which they could if they had continued access to vaccines.
The AstraZeneca vaccine has the potential to increase the number of people GP teams could immunise, he says, but the government needs to step up.
“Not having regular deliveries, or even worse having them delayed at short notice, is incredibly frustrating for GPs and their teams who just want to get their patients and staff vaccinated,” he says. “This is doubly frustrating when they see mass vaccination sites nearby receiving regular, reliable deliveries.
“While we appreciate the need to offer equal provision across the country, the government needs to be honest both with the public and practices about what supplies are available and provide clear information to vaccine sites so they are able to plan their campaigns effectively.”
How the UK gives its population a shot in the arm
In the UK, Public Health England (PHE) is responsible for the storage and distribution of most vaccines used in the national immunisation programme.
PHE manages the distribution of the AstraZeneca vaccine to the NHS for England, Scotland, Wales, Northern Ireland and the Crown dependencies.
Once all checks are complete, the vaccine is made available to order by authorised sites in the NHS across the UK. In England, NHS England decides how many doses are allocated to each NHS location or wholesaler. The onward distribution to GP networks and so on is managed by NHS England from these locations.
The UK’s Department of Health and Social Care is confident that its vaccine roll-out plan is logistically sound and in a position to cope with a significant increase in supplies.
“We have signed deals for substantial future supply of both vaccines to replenish our stocks and enable swift vaccination of first and second doses across the UK, and we have sufficient doses to maintain our vaccination programme as it continues to accelerate,” a spokesperson said.
“Through the government’s Vaccines Taskforce, the UK has secured early access to 367 million doses of seven of the most promising vaccine candidates and invested millions in the Rapid Deployment Facility to ensure that the Oxford/AstraZeneca vaccine is available to the public as quickly as possible,” they added.
Minding the data gap
While the Oxford-AstraZeneca vaccine may have significant advantages over the mRNA equivalents, and despite the UK government’s efforts to secure as many doses of it as possible, broader logistics challenges of a different nature could still pose problems.
Timely access to data, for instance, can prove vital to carrying out last mile distribution, which at present is thought to be the part of the supply chain that is most at risk.
Together, the partners will need to consider how much capacity can be made available and/or how long it will take to increase that capacity if necessary. Chris Halling, Catalent
Mikkel Brunn, co-founder of Tradeshift, a company providing supply chain digitisation solutions on a global scale, explains that having access to up-to-date data in a timely manner can save lives. “Sometimes, we are looking at two-weeks-old data, while in a pandemic scenario access to live data is of the essence,” he says.
Tradeshift has worked with the NHS in the past to help it go paper-free, and since the start of the pandemic the company has seen a significant drive towards digitisation across its pharma clients as supply chains have been disrupted.
“Solutions need to be super agile as any delay in accessing data could potentially result in the loss of human life,” says Brunn.
Monitoring is essential and needs to be maintained through several steps and handovers, particularly when it comes to guaranteeing that the cold chain holds up.
“Making data available to everyone at this stage is critical,” says Brunn. “The tube-to-vein part of the Covid-19 vaccines supply chain is where we are seeing blockchain solutions being considered and tested, for instance.”
Could a glass shortage shatter the vaccine effort?
The sheer volume of syringes, vials and needles needed to support the ‘fill and finish’ part of the vaccine supply chain also presents challenges.
In mid-2020, for instance, there was concern about a shortage of vials, which are essential as they store multiple doses of the vaccine and need to be a specific size in order not to spoil the drug.
For this reason, German company Schott, the world’s largest producer of pharmaceutical glass, denied requests from drug makers to reserve its borosilicate glass in advance.
Suddenly, [these specific syringes] are needed by the hundreds of millions, which creates a challenge but not a huge one as there are already manufacturers available to meet higher production targets. Ronald Piervincenzi, US Pharmacopeia
Italian firm Stevanato Group, which aims to produce enough glass for two billion vaccine doses, says it has proactively increased its worldwide capacity to accompany the industrial scale-up of its pharmaceutical customers.
“We have secured glass tubing supplies and we are working with other players in the pharmaceutical supply chain to provide the needed containment solutions to our customers,” a spokesperson says. “We are in daily contact with our customers to supply the containers when and where they are needed.”
Catalent is one of the partners that was subcontracted by AstraZeneca to carry out the fill and finish part in Europe. To meet the challenge, the company uses high-speed fill and finish lines, capable of filling and sealing up to 400 vials per minute.
Chris Halling, director of global communications and marketing at Catalent, explains how crucial it is that parties cooperate. “Together, the partners will need to consider how much capacity can be made available and/or how long it will take to increase that capacity if necessary,” he says. “In the short term, additional capacity can be found through varying working patterns.”.
Another significant challenge is in procuring the components used in manufacturing vaccine containers, such as vials, stoppers, seals, filters, labels, cartons and other consumables. Component supply issues can be overcome by creating partnerships between suppliers and help alleviate some of the associated risks, Halling adds.
While they need to be identified and tackled properly, distribution and last mile challenges tend not to be as catastrophic as the obstacles encountered at the manufacturing stage.
Ronald Piervincenzi, CEO of non-profit organisation US Pharmacopeia (USP), explains how, for instance, the production of specific types of syringes is being scaled up. “Such types of syringes could increase vaccine production by 15%, which is significant in this scenario,” he says. “Suddenly, they are needed by the hundreds of millions, which creates a challenge but not a huge one as there are already manufacturers available to meet higher production targets.”
USP has been producing a vaccine-handling toolkit to assist the industry and Piervincenzi hopes the bottleneck will soon move to where it needs to be. “It has and it will shift month by month,” he says. “First, it was the approval, now it is focused on distribution and logistics.
“Soon, it will be on how to effectively reach patients and finally it will move up to the manufacturing phase, as more vaccines will be needed, but manufacturers will be in an advantaged position to produce effective ones compared with a year ago.”
The Covid-19 pandemic has thrust the decidedly unsexy topic of supply chains into the spotlight. Getting billions of vaccines into the arms of the world’s population is a dizzying task, and one that was always going to come with obstacles. Countries such as Israel, the UK, the US and the United Arab Emirates have shown just how quick and affective a vaccine roll-out can be. However, getting these vaccines to their intended destinations in the developing world, where infrastructure and storage facilities are of a lower standard, will be the acid test for the logistics industry.
Interactive graphs by Georges Corbineau.
