Less than one year after the COVID-19 pandemic launched the world into a health crisis, the goal of developing a vaccine for a return to normality was reached. Now, several different vaccines are already in circulation globally and hundreds more vaccine candidates are in various stages of preparation, showing a promising way out of the pandemic that has caused millions of deaths worldwide as well as damage to global economies.
By Arij Limam
However, while developing the vaccine is an impressive scientific feat, it is only one part of the challenge. Manufacturing and distributing these vaccines present complex logistical challenges unlike anything experienced for any other pharmaceutical product in history – and the success of this colossal task depends largely on the supply chain.
“The main challenge that we actually have, is we are creating a brand new supply chain,” Richard Wilding, a supply chain management expert, said.
“And part of the challenge is also the scale at which we are having to do it, because really the ultimate task of this supply chain is to vaccinate the world,” he added.
The process of manufacturing and distributing a product is quite often a long and complex one that requires meticulous planning. Infrastructure, equipment, logistics, storage and information systems are just some of the aspects which need to be considered.
When it comes to the supply chain for a COVID-19 vaccine, several challenges emerge involving all these different steps:
– Challenge 1: Manufacturing time
Manufacturing vaccines is a little different from and much more complex than other consumer products as it involves several extra steps and considerations.
“The actual process is a biological process, and it has to be done in various reaction vessels and so on and so forth… So it’s a process that takes quite a lot of time to actually go through,” explained Wilding, a professor of supply chain strategy at Cranfield University in the UK.
The manufacturing process of the vaccines may vary slightly between the different pharmaceutical companies producing it, but on average, it usually takes between 12-36 months to manufacture a vaccine – sometimes more with complex vaccines.
The process involves firstly, the raw material reception and active ingredient manufacturing, followed by coupling and formulation of the vaccine and then filling it into the vials or syringes. The vaccines are then packaged and lot released before being shipped and distributed.
– Challenge 2: Safety and testing
“The other thing about it is it’s highly regulated. And what I mean by that is safety is the number one concern in every single step of the process,” said Wilding.
According to most vaccine manufacturers, 70 percent of the time of production of a vaccine is dedicated to quality control, representing several hundred tests all along the manufacturing process.
Quality control and assurance is not only a vital part of production to ensure vaccine efficacy, sterility and safety, but also requires a number of people to be involved. Wilding says both internal and external regulators needed for quality assurances in various countries involved in the entire supply chain of the vaccines, creates a great challenge.
– Challenge 3: Component capacity
When looking at the end goal of inoculating the world, supply chain experts such as Wilding, say that it’s not just about the vaccine – the liquid which is injected into us – but it’s also important to consider all the components needed to achieve the end product.
“For example, if we talk about something called fill and finish [it] is where you take that liquid, and you put it into vials so that they can then be injected into people,” Wilding explained. “And globally, there is a shortage of capacity in that particular area,” he added.
Therefore, the capacity of all the components involved is having to be created as rapidly as possible. In the years before the COVID-19 pandemic it would take a number of years to produce that capacity – it is now having to be achieved in shorter time periods to ensure all the components that would allow a complete vaccine to be made, are available.
Vaccines need to be kept at a certain temperature to ensure they remain effective and safe to use, making it a difficult logistical operation.
– Challenge 4: Cold chain
The vaccine cold chain is a global network of cold rooms, freezers, refrigerators, cold boxes, and carriers that keep vaccines at just the right temperature during each link on the long journey from the manufacturing line to the syringe, to protect them from degrading or becoming ineffective.
The vast majority of cold chain vaccines in broad use are stored between 2 and 8 degrees Celsius – about the temperature of a common refrigerator, the same from a logistical point of view as moving yogurt or milk around a country into supermarkets.
Some COVID-19 vaccines can be stored and transported at this chilled temperature, such as the Oxford University-AstraZeneca vaccine, so do not present a huge challenge. Others, like the Moderna vaccine, need to be kept frozen at minus 20 degrees Celsius, much like frozen food. However, others still, need even colder temperatures.
“The big challenge is if we look at the Pfizer vaccine, for example, that needs ultra-cold, and ultra-cold is minus 75 Celsius,” Wilding explained. “So if you’re actually moving that, you have to store it at that ultra-low temperature of minus 75 Celsius and you need specialist freezers to actually enable that,” he added.
This presents a significantly increased challenge when it comes to distributing the vaccine in hotter climates, and especially when trying to reach rural communities where electricity is unreliable.
According to an estimate by the World Health Organization (WHO), up to 50 percent of vaccines are wasted every year, often because of inadequate temperature control in supply chains.
Experts say it is up to nations to mobilize efforts in infrastructure, equipment and personnel to ensure the successful roll-out of the COVID-19 vaccine.
– Challenge 5: The last mile
Another challenge as well as the cold chain when it comes to distributing the COVID-19 vaccine, is what supply chain experts call ‘the last mile.’
“The last mile is really the coordination that you actually need within the nation,” explained Richard Wilding. “So the vaccine manufacturers and distributors can get it into the nation, into the warehouses, but it’s up to the nation to get it from the warehouse into you or I,” he added.
The national effort required in all countries around the world to get their populations inoculated is a large one. It requires infrastructure, equipment, information systems and getting people mobilized – from healthcare workers to delivery people and so on.
In addition to this, another important consideration is for anybody to receive a jab, it’s not just about the vial of vaccine, it’s also about the other tools and equipment that need to be present to inject it.
“So that will include personal protective equipment (PPE), it includes cotton wool balls, alcohol wipes, the syringes, of course, the needles. In fact, there’s between 50 and 80 different items you need for a vaccination centre so that you can actually receive that… you need a well choreographed ballet to ensure all those things are present,” Wilding said.
While this equipment is of course already available in medical settings, the issue is with capacity and availability, as well as the logistics of moving it to vaccination centres which are not in medical settings.
Another problem when looking at vaccinated on a global level, is the last mile when it comes to vaccinating rural and remote communities, or even lower-income countries which may not have access to or the capacity needed for sophisticated logistical services.
Between 50 and 80 different items are needed to ensure the jabs are safely administered to people.
A shaky start
With all the challenges involved in both manufacturing and distributing the COVID-19 vaccines, it’s no surprise that there are already some problems.
As countries scramble to get their own populations vaccinated first, many have made deals with manufacturers to pre-purchase large amounts of jabs, leading to the richest nations being the first to secure the majority of global vaccines.
‘Vaccine nationalism,’ as it has been named, creates a problem not just in terms of equal and fair access to the vaccines, but also when considering the global supply concerns that could arise when problems occur in the supply chain delaying vaccine production.
Scientists and global health organizations such as the WHO have been calling for equitable access to the vaccines, and programs have been set up to encourage high-income economies to share the jabs.
“I would like to see these bilateral vaccine deals that are going on between rich countries and vaccine manufacturers, opened up,” Gavin Yamey, director of the Centre for Policy Impact in Global Health at Duke University, said.
“I’d like to see much more transparency about those deals, I would also like to see those deals being made in a way that could be a win-win for global health. Doses could be shared, the intellectual property could be shared, the know-how, particularly, for example, the manufacturing could be globalized,” he explained.
According to Vaccines Europe, a specialized vaccines group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), the majority of vaccine production in 2019 was in a handful of countries across Europe.
Experts say global supply of vaccines and equitable access is at risk if certain governments monopolize the vaccines manufactured in supply chains in their own country.
Difficulties in the supply chain of some COVID-19 vaccines have already led to pharmaceutical companies slashing their production targets and not being able to meet countries’ demands.
The COVAX initiative, led by the World Health Organization and the Gavi vaccine alliance, was set up to ensure richer nations helped buy vaccines for the world’s poorer nations.
Scientists have estimated the world needs between 12 billion to 15 billion doses of vaccines to get a good level of immunity among the global population – twice the world’s current total vaccine manufacturing capacity.
According to supply chain management experts, the key to a successful roll-out of COVID-19 vaccines to a large percentage of the global population, is for countries to work together.
“If we think about the supply chains, they’re global supply chains, anyway. From a supply chain perspective, the key thing we need to be able to ensure is that, you know, various countries are open to trade,” said Wilding.
“At the moment, everybody’s learning, every day is a school day for the supply chain professionals, the manufacturers and everything else – and they’re adapting and modifying the processes so that they can more effectively actually distribute and manufacture the vaccine, so we can achieve the goal of vaccinating the world,” he added.
Supply chains, especially new ones, often have a rocky start, but experts say that with time and experience, established global COVID-19 vaccine supply chains will have the capacity to successfully supply the world.
In an increasingly globalized world, scientists and economists say it is clear now more than ever that countries recognize the need to work alongside each other for their mutual benefit.
A new study commissioned by the International Chamber of Commerce Research Foundation has found that the global economy stands to lose as much as $9.2 trillion if governments fail to ensure developing economy access to COVID-19 vaccines, as much as half of which would fall on advanced economies.
So, it is important that countries move past vaccine nationalism and build on strengthening global supply chains to ensure there is a solid infrastructure in order to be able to continue developing COVID-19 vaccines, which will no doubt continue to be needed over the coming years.
“We’re in very early days on these things, we shouldn’t worry about it. The world is committed to actually dealing with this,” Wilding said.
“However, we would all like it tomorrow, and it might just take a little bit longer than just tomorrow for capacity to be reached and it to be distributed to all places around the planet,” he added.