The Challenges of COVID-19 Vaccine Transportation and Distribution
Important note: This blog is based on information publicly available as of October 9, 2020.
Although much of the news regarding the COVID-19 vaccine has been devoted to the research, development, testing and approval of the various vaccines, notable other issues have gone almost unnoticed. While the U.S. government, as well as the governments of other countries around the world have largely secured the manufacturing, already putting some vaccines into mass production, there are problematic issues involving the distribution of some of the vaccines. This blog will endeavor to give readers an overview of at least some of these challenges.
Overview of COVID-19 Candidate Vaccines
How do vaccines work? A vaccine is designed to train the body to recognize and react to the proteins produced by disease-causing organisms, bacteria or viruses. Traditionally, vaccines either use small or inactivated doses of the whole disease-causing organism or the proteins produced by the organism. This substance is introduced into the body in small amounts to incite an immune system response.
COVID-19 Vaccine Types
Of the less than 50 COVID-19 vaccine candidates currently in human vaccine trials, there are 4 U.S.-backed vaccine candidates in phase three COVID19 vaccine trials: Moderna, Pfizer, AstraZeneca and Johnson & Johnson. According to a news report published on October 14th, only Moderna and Pfizer have filed for Emergency Use Authorization (EUA) at this point. Realistically, a drug maker would have to file for EUA of a coronavirus vaccine by late November to be able to win FDA authorization by the end of 2020. Currently, both the AstraZeneca and Johnson & Johnson vaccines are paused for a review of potential safety issues. Vaccine developers are anxiously awaiting the results of the review. It is important to note that vaccine study pauses are not abnormal occurrences and are a normal checkpoint to help ensure that the products are safe and effective. It is anticipated that both clinical trials will likely resume within a relatively short period of time.
Two of the most promising vaccines, one by Moderna and another by Pfizer use mRNA, messenger ribonucleic acid, a molecule in cells to carry DNA codes to make proteins. The technology works by encoding proteins of a virus then inserting this material into a cell. It is rather like introducing a template with instructions into the body so that it will produce the viral proteins on its own. The viral protein is created but is on its own; it cannot assemble and form a virus. These proteins either resemble or are identical to those of the pathogen. Once the body produces the viral proteins, the immune system detects them and begins to produce a defensive response. This produces antibodies and a very strong immune response is generated, possibly stronger than that produced using traditional vaccines.
This is new technology based on the work done with cancer.
Scientific studies have demonstrated that mRNA vaccines are capable of eliciting immunity from Zika, rabies, coronavirus and the flu. The promise of this technology is that production can scale rapidly, and the vaccines are non-infectious. The technology used in other vaccines is different and often is based on eggs, cells or synthetic material.
At this point, it seems extremely likely that both the Moderna and Pfizer mRNA vaccines will require that patients receive two doses to achieve the needed immune response. If one dose is problematic to administer to a population of 330 million people, imagine the complications in dealing with two doses either 21 or 28 days after the original dose.
COVID-19 Vaccine Freight and Logistics Challenges
Large volumes of raw materials will be transported on pallets via air or sea from China and/or India to pharmaceutical manufacturing facilities in the United States, Europe, China and India. Once manufactured, the logistics of getting vaccines to patients from the vaccine maker becomes complicated. Because vaccines will be manufactured in various locations around the world, they will then need to be shipped to other locations, moving from one logistics hub to another until they reach their final destination, the point of administration to patients.
The pharma supply chain has not received the same level of concentration and investment that has been devoted to R&D and marketing of pharma products. Extending pharmaceutical manufacturing capacity has been one of the top concerns for many years, partially to prepare for pandemics. It is important to note that different vaccines require different manufacturing facilities and the distribution strategy will also depend on the type of vaccine.
The Logistical Complexity of COVID-19 Transportation and Logistics
Dosing 330 million Americans with COVID-19 vaccines is no small feat, especially if it will require two doses per patient. Add to that all the medical supplies and medical equipment that will be required, and it is a massive venture. For example, the massive vaccination effort will require syringes, vials, stoppers and other materials. Given the experience earlier this year with supply chain and logistical challenges involving PPE, medical supplies and medical equipment such as ventilators, it would seem that the public would have a valid reason to be concerned.
For many years, drug manufacturers have depended on a network of hundreds of suppliers worldwide to produce, package and deliver pharmaceutical products. To accomplish this, multiple teams were needed to manage the many international supplier sites. This work is labor-intensive, quite inefficient and expensive. One challenge in coordinating all this effort is a lack of uniform visibility for all supply chain and logistics partners working hard to bring safe and effective vaccines and the other necessities from the point of manufacture to the point of administration to the patient. In addition, shippers continue to struggle with cumbersome documentation and other paperwork that can slow down the transport of goods need to produce and then move vaccines expeditiously from point-to-point.
As the global economy has slowed, so has the need for freight shipment. The entire global supply chain has slowed down. Because there has been less demand to move goods, capacity on container ships and cargo aircraft has been shrinking steadily. It is anticipated that commercial flights will drive up the cost of transportation; the airline industry already is experiencing chaotic conditions.
After experts with Emirates SkyCargo pharmaceutical division estimated that a single Boeing Co. 777 freighter can carry 1 million individual doses of vaccine, the company began to free up air freight capacity. Emirates SkyCargo has been working on retrofitting idled passenger planes to carry a wide variety of products including medical supplies and has been using 70 passenger 777 planes to move cargo.
Another issue involves global cooperation. Some experts have voiced concern that some “protectionist governments” may not welcome international cooperation and instead may use their authority to exert sovereignty over supply chains. Economies across the world are struggling to recover. While there is a common reason for cooperation, not all governments are treating the pandemic in a similar fashion.
The U.S. Government Plan: “Operation Warp Speed”
The U.S. government plan calls for leveraging the military and a federal contractor, McKesson to coordinate distribution. FedEx and UPS will also be used as these major carriers are experienced and have networks of freezers that are already in use for shipping perishables as well as medical goods and supplies. In addition, FedEx already has equipment in warehouses to produce dry ice, an idea UPS may soon adopt.
Earlier this year, UPS and FedEx took on the herculean task of mobilizing to airlift thousands of tons of protective gear across the globe for healthcare workers. While the task involved with transporting the COVID-19 vaccine may seem similar, it has the added complexities of moving fragile vials of vaccines in extremely cold conditions and maintaining the temperature standard consistently through transport to the end destination.
UPS is in the process of building a freezer farm in their hub in Louisville, Kentucky. By positioning “rows of upright industrial Sterling Ultracold freezers, each capable of holding 48,000 vials” inside a warehouse, the facility will be prepared to handle the mRNA COVID-19 vaccines. UPS is building a similar facility in the Netherlands. This is a less expensive approach than building new warehouses, allowing the operation to scale up at a more rapid pace. In addition, building a freezer farm in this manner is more practical. The freezers are mobile and employees do not have to don cumbersome protective suits and gear to enter a walk-in freezer for mass storage. Ten to fifteen employees will be needed to manage each freezer farm.
FedEx ramped up their cold chain infrastructure in 2009 to handle the transportation of the H1N1 vaccine. In addition to expanding its investment in freezers, FedEx won approval from the U.S. Federal Aviation Authority (FAA) for its planes to carry more dry ice. Cryogenic freezers are being added to FedEx locations in Memphis, Indianapolis and Paris and more refrigerated trailers are being installed in Oakland, California, Dallas and Los Angeles locations to handle vaccines that require cold, rather than frozen conditions.
More Transportation and Logistics Challenges
The International Air Transport Association, (IATA), the trade association for the world’s airlines, estimated that the transportation of COVID-19 vaccines would require more than 8000 747 jumbo freighters to meet world population need. This is the equivalent of 800,000 tons of vaccine worldwide that need to be moved from manufacturing sites to the points of administration. But planes aside, there are other issues involving air freight of pharmaceuticals, specifically of vaccines that require cryogenic storage conditions exceeding -100 degrees Fahrenheit.
At this moment, the world lacks a proven logistics chain capable of guaranteeing worldwide vaccine distribution to patients qualitatively. There are a limited number of airports around the globe that have carriers certified to handle pharmaceutical goods. Included in this distinction are Miami, Brussels, Johannesburg and Frankfurt.
The four parts of the traditional logistics chain are incoming logistics, manufacturing/production, outgoing logistics and last-mile distribution. Incoming logistics deal with the large amounts of raw materials and other essential goods needed to produce the vaccine. These goods are usually transported on pallets via air or ocean freight and often originate in China or India. The huge impact of the COVID-19 pandemic has necessitated unusual action and forward thinking from governments across the world. Many countries have already invested in the production of multiple vaccines in advance of their testing and regulatory approvals. Vaccine production is not the biggest problem.
Pharmaceuticals are usually transported via air freight, often due to factors such as fragility, cost and the need for temperature-stable controlled environments.
Pharmaceutical experts have warned of several potential challenges:
- First, these vaccines are new and so there is a lack of experience in dealing with issues related to them.
- Second, vaccines have relatively unstable molecules which most likely will require storage at freezing temperatures that exceed -18 degrees Celsius. (-.4 degrees Fahrenheit).
- Third, it is likely that vaccines can only be defrosted approximately six hours prior to injection into patients.
These issues become more pronounced when reviewed in context with the need to transport and warehouse the vaccines.
Information Visibility for Supply Chain Logistics Collaboration
Recently IATA launched ONE Source, an online platform which independently verifies information and was developed to match up shipping needs with service providers and infrastructure capabilities. ONE Source will provide up-to-date information on airports, airlines, handling facilities, shippers and truckers. Consideration will be given to account security and risk analysis data the API platform will be provided at no cost to all service providers.
Using ONE Source will help supply chain and logistics partners to facilitate the planning and distribution process using readily accessed vital information. ONE Source will provide visibility of facilities and capabilities across the supply chain.
Packaging, Tracking and Monitoring COVID-19 Vaccines
Combining the best of manufacturing, innovation and design, optimal supply chain networking and infrastructure would seem to provide the best chance of successfully expediting the processes involves with manufacturing, shipping and delivery with the least amount of error. Packaging issues that impact drug efficacy, durability and shelf life must be tested on both primary and secondary packaging structures.
This includes the smart tracking systems that can be built into both primary and secondary packaging. This tracking technology manages and records activity in real time across the supply chain. It can identify the current geographic location and route the product traversed and this data can be used to ensure that there were no unauthorized interventions or movements. In addition, special temperature-sensitive monitoring devices can be installed on shipments to monitor and track the progression of the vaccines.
Cold Chain Logistics of COVID-19 Vaccines: More Challenges
Most pharmaceutical products are stored and transported in standard refrigeration conditions and distributed across the world via refrigerated containers. Although air cargo carriers are experienced in dealing with refrigerated cargo, they rarely have the facilities and equipment to handle pharmaceuticals that require frozen flows.
Reefer containers are used in handling goods that require frozen conditions and that is done in sea transport, a slower transportation mode. To keep cargo at the required extremely low temperature, dry ice is used. This adds considerable weight to the transport.
There are a limited number of airports across the world capable of guaranteeing adherence to cold chain conditions of at least -18 degrees Celsius.
Vaccines typically must be maintained at temperatures ranging from 2 and 8 degrees Celsius (35.6 to 46.4 degrees Fahrenheit), standard refrigeration range, from the point of production to administration to the patient. This necessitates that each vaccine that requires cold storage of any type have an effective cold chain logistics strategy.
These two vaccines by Moderna and Pfizer require that they be maintained at extremely low temperatures from the point of production to final destination to ensure quality and efficacy. The Pfizer vaccine needs to be maintained at an average of 103 degrees below zero Fahrenheit. They will require specialized glass vials that can withstand these temperature conditions. It is important to note that glass typically cracks at extremely cold temperatures. Manufacturers of specialized glass for vials contacted the federal government and are now engaged in production of vaccine vials for ultra-cold conditions.
This means that the vaccines must be kept at cryogenically low temperatures, at least -18 degrees Celsius continually from the point of manufacture until they reach the point of final destination. If the mRNA vaccines are not maintained in deep freeze conditions, the genetic materials fall apart when thawed. Moving vaccines from aircraft, across the hot tarmac, in trucks, through customs clearance, while loading and unloading each mode of transport is tricky and requires temperature monitoring technology. Temperature fluctuations can diminish the quality of the vaccines and lead to costly waste.
While dry ice is a valuable tool in maintaining the goods below -18 degrees Celsius, it does not solve every logistical problem and is a challenge in and of itself. Apparently, there is a shortage of dry ice in the United States. Medical-grade ultra-cold deep freezers are required to properly store vaccines that must be maintained in cryogenic conditions and are not widely used. This is not equipment that an average pharmacy or doctor’s office would have. Most typical vaccination sites will not have access to this equipment, and this will definitely alter the paradigm of where the vaccine can be administered.
According to federal officials including both Operation Warp Speed and the CDC, there is currently no collaboration with hospital associations or medical supply chain experts on a strategy or national plan to procure the needed medical grade freezers. As occurred earlier in the pandemic, the federal government is delegating this crucial task, this time to 64 vaccine jurisdictions. On September 23, 2020, the Department of Health and Human Services (HHS) announced the award of $200 million to 64 vaccine jurisdictions already established through the existing Immunizations and Vaccines for Children cooperative agreement. The intention is to leverage the experience and partnership of the jurisdictions to develop and execute plans for COVID-19 vaccine distribution and administration.
In making the states and vaccine jurisdictions responsible for securing the needed equipment and supplies, the federal government may again be setting up conditions which stall distribution of the COVID-19 vaccine rather than expedite the distribution of it. This includes both dry ice and medical grade deep freezers, both in already short supply.
Currently, the states are not receiving adequate federal support as they try to secure supplies of dry ice and medical grade deep freezers. The need for dry ice and medical grade ultra-low deep freezers may force states, territories and major cities into unnecessary competition, bidding against each other, driving prices up.
Dry Ice and Medical Grade Deep Freezers May Be Key to COVID-19 U.S. Vaccine Distribution
According to a recent market report, there are only five major companies in the United States that make dry ice. 2020 has seen a spike in the demand for dry ice due to the increase in meal kit deliveries. Ethanol is needed to make dry ice and its production ebbs and flows with the demand for gasoline. Due to the lockdown imposed earlier this year, less people were driving cars and the demand for gasoline dropped precipitously. Ethanol production decreased dramatically and along with it the supply of carbon dioxide needed to manufacture dry ice. Although Pfizer will make dry ice for its own manufacturing and distribution facilities, it will be up to states, major cities and territories to secure their own adequate supply for the vaccine.
There are fewer than 10 national suppliers of medical grade deep freezers and it takes from 10 days to six weeks to manufacture each unit. At a cost of up to $15,000 per freezer, many states are awaiting federal guidance before pursuing procurement. With a national need to store two doses per person of vaccine, 660 million doses will need to be stored in cryogenic conditions although not all at the same time. Pfizer has designed a special cooler or “thermal shipper”, the size of a carry-on suitcase. Each cooler can store unopened vaccines for 10 days, the period of time required by the FDA for vaccines to be shelf stable.
Once opened, vaccines can be stored at 36 to 46 degrees Fahrenheit for five days. The Pfizer cooler can store vaccines for up to 15 days if replenished with dry ice but can only be opened once every five days for no more than one minute. Using dry ice to store vaccines has never been tested in the United States.
Because of the ultra-low temperature at which the Pfizer vaccine must be maintained, it is unlikely to be administered in doctors’ offices as the facilities probably will not have access to the proper freezers. This is likely to mean that large administration sites such as hospitals will be the locations at which the COVID-19 vaccines will be administered.
Vaccine handling and storage protocols must be followed, or the product will be wasted.
Although the federal government does anticipate approving multiple vaccines, it is likely that other vaccines will have less stringent cold chain requirements. This may occur in 2021.
Last Mile Logistics and Distribution of COVID-19 Vaccines
As with e-commerce order fulfillment, the last mile of the logistics chain is the most challenging and costly. At this point in the logistics process, vaccines need to be moved from storage in warehouses to the point of administration. Once again, here is where there is a snag.
First of all, the average occupancy rate of U.S. cold storage warehouses is 85%, a rate that is considered “full”. Second, not all cold storage warehouses will have the capability for cryogenic storage. Third, the pharmaceutical distribution chain rarely transports frozen products, especially at this level.
Using dry ice during transport is untested and experts are concerned that doing so may reduce the quality of the vaccine. This may be especially problematic when transporting vaccines to rural areas or developing nations.
Specialized Equipment, Training and Tools Needed for COVID Vaccine Distribution
Here are a few more essentials needed for distribution and administration of the COVID-19 vaccine:
- Specialized gloves to handle ultra-frozen goods
- GPS-enabled thermal sensors to track and monitor frozen vaccines
- Specialized glass vials and containers
- Training and performance monitoring to ensure that workers all along the supply chain logistics have the knowledge, skill and ability to properly handle, store and transport vaccines to their final destination without damage
From the European Union to North Carolina, Africa, Australia, Latin America and beyond, patients across the world are anxiously awaiting an effective coronavirus vaccine. It seems that we are besieged by news on COVID-19 vaccine testing and updates from the National Institutes of Health and other advisory bodies as well as the news media on a daily basis. Social media is ablaze with information, supposition and theories often not aligned with that provided by health care practitioners and experts. The novel coronavirus has provided an education on infectious diseases, clinical trials and the responsibilities and nature of protections needed for public health.
The need for effective vaccines is critical and in the best interest of the public and the global economy. As medical research endeavors to create more effective therapeutics and treatments for hospitalized patients as well as for those recently diagnosed or otherwise suffering with this infectious disease, thousands of people wait patiently and long for in-person contact and engagement with the world around them.
- A comprehensive strategic plan needs to immediately be developed and executed to secure the needed materials, equipment, facilities and other essentials worldwide.
- During this global health crisis, a collaborative approach is needed. Think of the power of an international task force with experts in pharmaceutical logistics, technology and procurement and how this could benefit world health by streamlining the distribution of a vaccine globally.
- A worldwide effort needs to be made to streamline the distribution of the vaccine, including the production of all goods, equipment, facilities, technologies, etc. to handle these challenges.
- Other challenges yet to be overcome include border processes, ensuring that there is adequate staffing of trained professionals at import and export locations, flight permits
- If the Pfizer and/or Moderna vaccines are approved, administration at community clinics, doctors’ offices, local pharmacies and other similar sites would be unlikely to be used.
- At this point, it seems likely as if the two most likely vaccine candidates for COVID-19 regulatory approval by the Food and Drug Administration (FDA) in the U.S. are Moderna and another by a vaccine makers Pfizer and Biontech. Both require cryogenic storage and close adherence to freezer cold chain conditions. Clinical studies are in the final stages.
- These two COVID-19 vaccine candidates both leverage mRNA technology, proven to be safe and effective for cancer treatments.
The novel coronavirus has proven to be a powerful foe, one capable of mutating, confounding vaccine makers, healthcare providers and medical researchers around the world. It seems as if global health is teetering on the precipice of the approval of the COVID19 vaccine trials. Despite the daunting challenges involved with the distribution of the mRNA-based vaccines, hope abounds that health and human welfare will soon be better served by these recent advances and the distribution of a COVID-19 vaccine around the world.