As global wide populations continue to deal with the personal and economic impacts of the COVID-19 global pandemic, development and distribution of an eventual vaccine will likely be one of the most complex undertakings ever, raising urgent questions and associated decision-making needs among global supply chain process, people and technology dimensions.
Picture some of the biggest launches in history – perhaps the product launch of the original Apple iPhone in 2007, or perhaps the turbulent introduction of the Disney+ streaming service in 2019– and you’ll likely get a headache envisioning all of the logistical coordination that took place behind the scenes, not to mention the overall scope and frequency of required decision-making.
Now, combine the stakes of such launches- both highly anticipated products or services in very high demand, add the inherent disruption of a once-in-a-century pandemic, and one has a picture of the monumental likely business process and logistical challenges that will be associated with the distribution of a very sought-after vaccine.
While many are rightfully focused on the physical distribution aspects, there is always the multi-tier global supply network now supporting this effort. Each is a significant dependency or point of disruption. Each makes up an overall set of comprehensive plans that must execute at each tier and segment.
With COVID-19 impacting almost every country on the planet, this will be the single biggest product launch ever, with unprecedented demand as literally billions of people seek vaccination over the coming months/years. And this creates arguably the most unique and challenging logistical scenario the world has ever seen, one that cannot to accomplished without a coordinated global strategy related to resources and advanced technology.
For organization’s tasked with the mass distribution of vaccine supplies, the key question now revolves around preparation for what is likely to be one of the most complex logistical undertakings in quite some time.
Some Specific Challenges
As vaccine candidates continue to be developed and trial tested at a record pace among life sciences organizations, multiple groups are addressing dozens of critical, thorny questions across four key steps of the vaccine’s journey through the supply chain:
Development and Pilot Production
According to the World Health Organization (WHO) there are currently more than 100 COVID-19 vaccine candidates under development. The New York Times Coronavirus Vaccine Tracker updated last week indicates upwards of 63 vaccines undergoing various stages of clinical trials, with 11 currently participating in Phase 3, large-scale efficacy testing.
Production consists of bioreactors to produce the viral vaccine ingredient and high-volume production facilities for formulation and packaging. Pharmaceutical manufacturers and international groups such as the Gates Foundation have been contracting to retro fit existing facilities or build new facilities in anticipation of satisfying overall global demand. A realistic expectation is that initial vaccine supplies will be limited in supply among just a few dozen global manufacturers, at least until global-wide volume can be achieved.
Where such sites are ultimately positioned globally will determine the overall logistical challenges for moving vaccine into distribution. Likely, some or many governments or international bodies will attempt influence as to where such production facilities are actually located.
A given reality is that in the beginning, based on the sheer volume of ramp-up, vaccine supply will not be able to meet full global demand, and thus there will be a need for prioritization of populations, such as healthcare delivery providers or vulnerable populations initially gaining doses.
Supply Network Considerations
The tiers of the supply network range from the availability and production of specialty Borosilicate glass, made from high purity sand to the high volume, specialized fill and finish production facilities.
Glass vials are highly specialized regarding production needs and produced by just a limited number of producers. The two most prominent are Germany based Schott AG and U.S. based Corning. Plastic alternative vials are also being considered, with investments made for securing quantities of the hundreds of millions.
A reported vial demand magnitude ranges to upwards of 10 billion doses to achieve the vaccination of 70 percent of the global population, assuming the need for two separate dosings. Supplies and manufacturing capacity has been constrained, with added capacity investments ongoing. Vaccine developers continue to explore ways to administer multiple injections from a single vial in order to manage any potential limited supply of vials, but industry professionals and even Bill Gates warn that the global rollout of vaccine could be hampered by a shortage of vials.
Once a vaccine reaches stages of approval, higher volume bioreactors and fill and finish product facilities become the key focal point for volume production and distribution.
One of the largest integrated manufacturers of multiple forms of vaccines is the Serum Institute of India with a reported capacity of 1.5 billion doses per year, with plans to increase capacity to 2 billion doses. Other global and domestic fill and finish production sites have been contracted and the challenge becomes overall logistics and distribution to various countries and populations.
Depending on the specific vaccine, there are needs for Adjuvant Additive which serves as a stabilizer, each vaccine having a different requirement. Such compounds are derived from either raw sugar produced in Brazil or bark from Soapbark trees in Chile. Here again, plans are underway to produce upwards of one billion units.
Other supply network considerations are in supply of billions of injection needles with Becton Dickinson being the largest global supplier.
With ongoing needs for global wide COVID-19 treatment and testing, and with everyday needs for lab testing of various illnesses, hospitals and healthcare providers are already reporting shortages of test kits and lab media supplies because existing producers have capacity dedicated to COVID-19 vaccine ramp-up needs.
Transportation and Logistics
Because of the nature of such product, its supply sources, along with the urgency, travel by contracted air carriers is a highly likely scenario.
The vaccine will need to be distributed via a temperature controlled cold chains requiring specialized equipment and constant condition checks.
Health officials indicate that depending on the vaccine candidate that eventually become approved, they will likely have to be environmentally maintained at 2 to 8 degrees Celsius or 35.6 to 46.4 degrees Fahrenheit. Some advanced vaccine may require far colder levels, bordering on minus Celsius readings. In a recent webcast featuring DHL Air Freight executives, such a cold chain transport requirement likely requires upwards of 15 million dry ice transport containers.
Pharmaceutical air freight executives indicate that a single Boeing 777 freighter can transport upwards of one million doses of a vaccine under controlled conditions. When translated to potential demand, the notion of airlifting of double-dose regimens to protect one-half of the world population would translate to the capacity of 8,000 dedicated wide-body cargo aircraft over time. There is thus the opportunity to consider the added conversion or marshalling of existing passenger aircraft for priority airlift needs. Some advocate that national defense agencies such as the U.S. Defense Department contract for added airlift capacity among commercial air carriers.
Volumes of this magnitude likely exceed the airport capacity of established global airfreight carriers such as DHL, FedEx, UPS, all of whom have to maintain normal operations. Many global-based airports will need to be a part of the response and require a sense of what volumes of air freighters to expect at given times along with provisions for needed unloading infrastructure and turnaround. Big money investments are now pouring into cold chain real estate investment entities and specialty providers.
A chain of custody, requiring every party involved to participate from a data perspective, to ensure a verifiable transcript of the vaccine’s lifecycle and journey would be ideal. And traceability is a must – to the degree of real-time visibility into supply of doses at any given time, their condition and specifically where are they located.
Counterfeiting and fraud are already issues in the pharmaceutical industry, and with the intense demand for this vaccine, it’s certain that bad actors are watching, and that outright theft or black-market distribution are real threats. Track and trace capabilities that provide insight into shipment location and route, and logs of cargo access, have never been so important.
Distribution and Last Mile Administration
For the United States, one of the globe’s largest medical and vaccine distributors, McKesson Corp. has already been awarded an extension to a distribution contract based on this distributor’s built-up capabilities in cold-chain logistics and distribution.
There is the reality that besides hospitals, pharmacies, local distributors or individual healthcare provider vaccine administration sites, there is a strong likelihood that mobile or local pop-up sites, similar to COVID-19 testing sites, may be points of inoculation.
The questions being considered are:
Is there adequate cold storage capacity in the current retail environment to accommodate mobile pop-up inoculation centers?
Will alternative options be needed such as the re-purposing of grocery store or meat refrigeration units, or the heightened use of national emergency stockpiles of refrigeration units. What about the availability of large dry ice supplies?
Besides distribution and storage, many experts are already pointing out that the “last mile” of the vaccine journey may be the most challenging. This scope of effort requires forms of unified approaches involving private and governmental agencies.
Similar to the issues the U.S. and other nations have faced in COVID-19 testing, determining the sites for administration of the vaccine will be a massive challenge predicated on determining the regions and populations of most need at any given time.
Pharmacy capacity is limited, so will the majority of vaccinations take place at already resource-constrained hospitals? Are larger facilities like theme parks, stadiums, under-utilized airports or vacant retail spaces an option?
What will be the process for determining which individuals gain first access to the vaccine, and how will the logistics of priority-basis vaccinations be handled?
More than likely, Cloud based appointment systems that are predicated on the prioritization of groups will have to be directly linked with available vaccine supply at any given point. The same collection of systems will additionally have to be able to account for the location of the various vaccine delivery sites and ensure that people are scheduled without overloading any particular site during operating hours.
Where Advanced Technology Plays a Further Role
Since it’s logistically impossible to vaccinate everyone in a first wave, distributors will need to develop standalone strategies to accommodate multiple waves. Such waves will likely rely completely on “last mile” logistics, bringing patients back to traditional hospitals, doctors’ offices, pop-up centers and possibly schools – a standard venue for flu vaccinations in many countries, but a foreign concept in the U.S.
Many of the companies distributing or producing the vaccine rely on decades-old technology, which has never seen this level of demand and complexity. Similar to Disney+ sputtering under day one demand, expect some of these non-elastic supply chain technologies to struggle to keep pace.
With the additional security demands and quality assurance required, this global-wide product launch can be the ideal proving ground for Cloud-based scalability with embedded technologies such as blockchain, AI/machine learning and Internet of Things (IoT) being leveraged. Areas of opportunity are to intelligently assess vaccine demand and needed supply by region, track and trace shipments at a lot level, and account for the quality conformance needs of the vaccine thru its entire journey from production to injection site.
How Can Technology Providers Continue to Assist
Various enterprise and Cloud-based technology providers such as Oracle are already working with life science organizations, large global logistics providers, international governments and non-governmental healthcare agencies to leverage the learnings of the COVID-19 testing and supply chain disruptions to provide technology options.
Oracle itself has been helping the global healthcare community to better treat COVID-19 patients through physician use of Oracle’s Therapeutic Learning System. This system helps in being able to analyze large data sets, and spot patterns in patient response to treatments, helping healthcare professionals to narrow in on effective treatments while ruling out ineffective treatments.
Similar large data management challenges lie ahead in global wide distribution of coronavirus vaccine, such as which patients are more appropriate for a certain vaccine, and what is the status of vaccine supply across regions at any given time.
Supply Chain Matters applauds all information technology providers for their assistance rendered to support COVID-19 needs.
We now encourage appropriate technology options to address one of the complex logistical medical treatment and administration challenges that remains for supply chain, logistics and healthcare professionals throughout the world.
The stakes are high and the mission is critical, requiring the expertise and dedication of supply chain management and technology development professional across the globe and across all tiers of the vaccine supply and distribution network.
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Disclosure: Oracle is one of other clients of the Ferrari Consulting and Research Group, the parent of the Supply Chain Matters blog.