Last Monday (Dec 21, 2020), Asia’s first batch of Covid-19 vaccines from the American-German vaccine partnership Pfizer-BioNTech, arrived in Singapore.
One major concern with this first vaccine to be granted emergency use authorisation in a number of countries around the world, is its need to be stored at the ultracold temperature of -70°C.
Such deep freezing facilities are not common in many countries globally, including in our own region.
Even Japan said that it would buy 10,500 deep freezers, as well as dry ice in bulk, just to store and transport these vaccines, as well as those from American pharmaceutical company Moderna and UK vaccine partnership AstraZeneca/University of Oxford.
Malaysia’s own supply from Pfizer/BioNTech is expected to arrive sometime in February (2021), although not much has been reported about our own logistical arrangements.
For Singapore, their vaccines were collected from Pfizer’s manufacturing site in Puurs, Belgium, in thermal shipper boxes by German logistics company DHL and transported by a Singapore Airlines cargo flight to the island republic.
These thermal shippers are one of the tools Pfizer has come up with to help support the transportation, storage and continuous temperature monitoring of these vaccines.
In a distribution fact sheet posted on its website, the pharmaceutical company says, “We have specially-designed, temperature-controlled shippers utilising dry ice to maintain recommended temperature conditions up to 10 days unopened.
“These specialised thermal shippers are roughly the size of a carry-on suitcase and can weigh up to 81lbs (37kg). fully loaded.”
In this manner, the frozen vials can be transported directly from the factory to the point of vaccination, ensuring that they are constantly kept at the ideal temperature.
Pfizer has also installed a tracking system on these boxes as a third layer of protection.
”We utilise GPS-enabled thermal sensors in every thermal shipper with a control tower that will track the location and temperature of each vaccine shipment across their pre-set routes.
“These GPS-enabled devices will allow us to proactively prevent unwanted deviations and act before they happen,” says the fact sheet.
The transportation of the thermal shippers, whether by air or on the ground, will be handled by logistics companies like DHL and FedEx Express.
DHL Express Malaysia and Brunei managing director Julian Neo notes that the company ensures essential supply chains like those for vaccine distribution, includes various transportation modes like courier services, chartered flights and lorries; supplier networks ranging from carriers to packaging companies; and life sciences infrastructure, as well as the experience and expertise of their logistics specialists.
He shares that in Malaysia: “We are already involved in several confidential discussions with both manufacturers and representatives of the public sector to plan for what the supply chain would look like for the distribution.
“Complications might arise depending on where the successful vaccine or vaccines are manufactured and transported to.
“Understanding and reacting to the answers for these questions and others will form the basis of the challenge for the manufacturers, governments, NGOs (non-governmental organisations) and their logistics partners when a successful vaccine or multiples arrive.”
While we don’t yet know who our local shippers and ground handlers are, our vaccines are expected to arrive via Singapore.
The island republic is beefing up its capacity to store and transport Covid-19 vaccines, and is positioning itself to be a hub for the movement of these vaccines across the region.
Shipments from Europe, which will also involve the Moderna and AstraZeneca Covid-19 vaccines, are also expected to go through Singapore and onward to the rest of South-East Asia, as well as the South-West Pacific region, when broader regulatory approval is secured.
Cold chain flow
According to FedEx Express Malaysia managing director Chong Siang-Chung, the company has refrigerators, freezers and ultra-cold freezers at its 90-odd cold chain facilities around the world.
Cold chain refers to how the temperature of perishable products such as ice cream, frozen foods and medicines, are managed in order to maintain quality and safety from end to end in the distribution process.
He notes that: “There are a number of vaccines being developed and each has different cold chain requirements.
“The Pfizer/BioNTech Covid-19 vaccine is one that has been specified to require temperature-controlled shipping as low as -70°C.
“Hence it is necessary for the origins and destinations receiving this particular brand to be Dangerous Goods-certified and ready to handle pick-ups and deliveries of dry ice.
“All of this is made more complex by the geographic spread of the shipping requirements, transit times, regulatory requirements and special operating plans for each country.”
He adds that FedEx is augmenting their current cold chain facilities with additional deep freezers, temperature-controlled unit load devices or pallets, as well as standard refrigerated and freezer trailers.
“We are not new to vaccine-shipping and have decades of experience in shipping for our healthcare customers,” he says.
The company is also involved in transporting other supplies critical for the manufacturing and distribution of vaccines, such as vials, syringes and personal protective equipment (PPE).
Chong admits that logistics is just one of the challenges in the complexity of delivering the Covid-19 vaccine, as security and timeliness are also crucial.
“Our job is to make sure shipments move through our network quickly and safely,” he says.
“Every hour of the day, FedEx is moving valuable, lifesaving cargo all over the world.
“We are also taking special security precautions and using the latest technology to monitor vaccine shipments in real time.
One technology the company is utilising is a low-energy Bluetooth sensor device, which is affixed to its shipments.
The device enables the monitoring of the shipment’s current location, precise temperature, relative humidity, barometric pressure readings, light exposure and shock events, while providing near real-time updates to customers.
This technology is complemented by an artificial intelligence and predictive tool platform that proactively monitors the conditions surrounding the packages, allowing customer support agents to intervene if weather or traffic delays threaten to impede delivery times.
Chong says, “With this tech, customers are able to establish a virtual perimeter that triggers an action of immediate notification when a shipment passes through a specific area so that it can be retrieved immediately upon arrival.”
As for concerns over the SARS-CoV-2 virus being found in frozen packaging, Neo says, “The risk is low that Covid-19 can be spread through contact with objects, such as scanners, parcels or shipments.
“So far, an infection with the coronavirus through contact with objects has only been suspected in a few cases.”
Storage options
Once the vaccines arrive on planes in their thermal shippers or deep freeze storage boxes, ground handlers are tasked with unloading the shipment into temperature-controlled cool dollies and transporting them across the tarmac to cavernous cold rooms at the airport’s storage facilities.
For example, with Singapore’s first batch of Covid-19 vaccines, DHL handled customs clearance, followed by delivery to airport ground handler SATS Ltd’s cold-chain facility for storage.
The boxes will then be loaded onto refrigerated trucks or trailers that will send them to an external storage facility, and thereafter, to their final destinations like hospitals or clinics.
Once the clinic or hospital receives the Pfizer/BioNTech vaccine, there are three storage options suggested by Pfizer before the vaccine is administered:
- Ultra-low-temperature freezers, which are commercially available and can extend shelf life for up to six months.
- The thermal shippers containing the doses, which can be used as temporary storage units by refilling with dry ice for up to 15 days of storage.
- Refrigeration units commonly available in hospitals, which can store the vaccine for up to five days at 2-8°C conditions.
Once opened, and if being used as temporary storage by a vaccination centre, it can be used for a total of 15 days with re-icing every five days.
After these 15 days, vaccination centres can transfer the vials to refrigerators with 2-8°C storage conditions for an additional five days.
Once thawed and stored under 2-8°C conditions, the vials cannot be re-frozen or stored in freezers.
An added complication is that each vial usually contains at least five doses of the vaccine.
This means that healthcare workers need to carefully calculate the number of persons they are vaccinating in order not to waste any doses.
In addition, some of the Covid-19 vaccines require two doses.
In the case of the Pfizer/BioNTech one, one person requires two doses three weeks apart, which may complicate storage further.
Challenges in rural areas
When it comes to remote locations, the lack of transport infrastructure and electricity supply can make it very difficult to carry out routine vaccination campaigns, as international medical NGO Médecins Sans Frontières (MSF or Doctors Without Borders) can attest to.
“The cold chain always has to be in place and tested before vaccines are sent to remote places,” says MSF Malaysia medical coordinator Willemieke van den Broek.
“We make use of fridges run on gas, electric and solar power, depending on what is the best option.
“MSF is also supporting the development of vaccines that need no cold chain as this would make life a lot easier, but this might not be everybody’s priority.
“For transport, we can use all means from plane to horse or on foot in very difficult areas.
“We always put indicators in all vaccine carriers so that we can monitor any temperature breaches and decide if we have to discard the vaccine if the cold chain has been disrupted."
MSF emergency coordinator Gert Verdonck adds: “Our vaccine cool boxes or carriers (big or small) only have a limited safe cooling time (24-72 hours) and the cooling elements need to be changed regularly.
“Most of the time, a central storage (with stable electricity) will be set up, and depending on distance, the vaccination strategy will be defined.
“Sometimes, MSF hires daily workers who transport (by foot) cooling elements from the central storage to the vaccination site.
“Other possibilities are setting up a big cooling storage as was done during the 2017 yellow fever vaccination campaign in Kinshasa in the Democratic Republic of the Congo.”
Malaysia has currently secured enough vaccines to cover 40% of the population.
These will come from not only Pfizer/BioNTech, but also Moderna and AstraZeneca/University of Oxford.
The Government is also in talks with Chinese pharmaceutical companies Sinovac Biotech and CanSino Biologics, and the Russian Gamaleya Research Institute of Epidemiology and Microbiology, to purchase their respective Covid-19 vaccines.
These purchases are expected to allow coverage of up to 80% of the population.
While the Moderna vaccine should ideally be stored at -20°C, it can survive at normal refrigerator temperatures of 2-8°C for up to a month.
The four other vaccines from AstraZeneca/University of Oxford, Sinovac, CanSino and the Gamaleya Research Institute can all be stored at normal refrigerator temperatures.
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