The election is behind us (well, maybe not), and during the campaign COVID-19 was a key talking point for both President Trump and former Vice President Biden. One of the biggest questions that still does not have an answer is when a coronavirus vaccine will be ready. Beyond that, there are all the logistical hurdles of producing enough coronavirus vaccines which will then need to be stored, distributed, and administered. As pharmaceutical companies around the world race to get a vaccine to the market, logistics companies are readying for the job ahead as well.
Coronavirus Vaccine Development
The race is on to develop an approved coronavirus vaccine with more than 50 vaccines in clinical trials on humans and more than 85 preclinical vaccines being tested on animals. There are six phases in the development cycle to get a vaccine from the lab to the general public. First is pre-clinical testing, where scientists test a new vaccine on cells and then on animals. The US is facing a shortage of test monkeys due to more demand and a dwindling supply from China. The second stage is Phase 1 safety trials, where a small number of people receive a dose to test for safety and dosage size. Phase 2 expanded trials is when scientists give the vaccine to hundreds of people split into different groups to see how they respond. Phase 3 efficacy trials are large scale trials where scientists give the vaccine to a set number of people and others receive a placebo to see if the vaccine protects against coronavirus. Early and limited approval is the next phase and is based on the results of Phase 3. Finally, there is approval where regulators review the trials and determine whether the coronavirus vaccine is approved.
For some of the trials that are ongoing, scientists have combined phases to try to speed up the development and approval process. From a numbers standpoint, 36 coronavirus vaccines are Phase 1, 14 are in Phase 2, 11 are in Phase 3, 6 have been granted limited approval in China and Russia. One of the challenging parts of these late-stage trials is having enough participants develop symptoms to be able to check whether they had been given a vaccine or a placebo. Only when enough participants have become sick can scientists fully measure the effectiveness of the vaccine.
Moderna has just finished enrolling 30,000 participants for its late-stage trial (Phase 3), which began in July. The company is touting the diversity in its trial as a key piece to solving the puzzle. Moderna has enrolled more than 7,000 participants over the age of 65, plus more than 5,000 under the age of 65 with pre-existing conditions such as diabetes and severe obesity. These high-risk groups make up more than 40 percent of participants.
BioNTech, in partnership with Pfizer and Fosun Pharma, has moved ahead with its Phase 2/3 trials with 30,000 participants in the US, Brazil, Argentina, and Germany. The trial then moved ahead to expand that number to 43,000 participants, including children as young as 12. By the end of October, the coronavirus vaccine trial had not experienced enough cases to see if it was truly effective.
Coronavirus Vaccine Distribution
With so many trials ongoing, there are still considerable hurdles in the development process. Once an effective vaccine has been approved for mass distribution, there are a number of logistical hurdles that will need to be addressed as well. As such, logistics companies have been busy getting ready over the last few months. One issue that could slow down the development and distribution of a vaccine is a shortage of glass vials. The rush to manufacture a vaccine has resulted in a rush to secure supplies. The issue with the glass supply chain is that the market is traditionally fixed, and slow growing. This means that it is also prone to shortages, such as this one. The relatively low number of glass manufacturers contributes to the issue. Experts are concerned that the slow market, paired with the lack of manufacturers and the exponential rise in demand, could lead to difficulty in producing the billions of vaccine doses needed.
Assuming that glass manufacturers can keep up with the expected demand for vials, the next issue becomes setting up the infrastructure to move all those vaccines around the world. Temperature control is of utmost importance for the vaccine, as it will need to be stored at temperatures around -94 Fahrenheit. Both UPS and FedEx have established their freezer farm infrastructure to store and ship the vaccines when they become available.
UPS has built two freezer farms in Louisville, KY and the Netherlands near the company’s air hubs. The two locations should help to ensure global distribution of a vaccine once it is available. Each facility will house 600 deep freezers which can hold 48,000 vials of the vaccine at temperatures as low as -112 Fahrenheit. Between the two facilities, UPS will be able to store over 57 million doses of the vaccine.
FedEx began building out its freezer farm infrastructure nearly a decade ago in response to the H1N1 outbreak. FedEx now has nearly 90 cold-chain facilities around the world where the vaccines can be safely stored. The company has also begun using Bluetooth to transmit a location every few seconds. Combined with temperature sensors, if something goes wrong with a shipment, FedEx will be able to pinpoint its location and work to fix the problem in a rapid manner.
Pfizer has also set up a massive cold storage infrastructure as it prepares to distribute its vaccine. The pharmaceutical giant has turned a stretch of land in Kalamazoo, MI into a staging ground with 350 large freezers than will be able to store millions of coronavirus vaccine doses. To keep the vaccines safe during transport, Pfizer has developed a reusable suitcase-sized container that can keep between 1,000 and 5,000 doses at ultracold temperatures for up to 10 days. The containers will be also be equipped with GPS technology to allow for real-time tracking. The hope is to deliver nearly 1.5 billion does by the end of 2021.
Maersk has sealed a deal with COVAXX to ship the American pharmaceutical firm’s Covid-19 vaccine around the world when and if it gets approval by regulatory authorities. COVAXX is currently in phase 1 of its vaccine trial in Taiwan and will roll out phase 2 in the US as part of a partnership with the University of Nebraska Medical Center. COVAXX will also conduct a large-scale human efficacy clinical trial in Brazil. Maersk will oversee all logistics activities to ensure efficient transportation to developing countries. The agreement provides for end-to-end supply chain management, packing and shipping, via air or ocean, ground transportation, warehouse storage and distribution to facilities to support COVAXX’s requirements for a pharmaceutical grade, temperature-controlled supply chain. COVAXX is planning to manufacture 100 million doses of its vaccine during early 2021, and a billion doses by the end of 2021.
While there are a lot of vaccines in various stages of the development lifecycle, we still have some time before one is readily available. However, pharmaceutical and logistics companies are racing to make sure the infrastructure is in place when a vaccine becomes available. UPS and FedEx have built out expansive freezer farms to store a vaccine, Pfizer and Maersk have built out their infrastructure to store and distribute the vaccines, and many other companies are preparing in similar ways. Getting the vaccine distributed will take Herculean efforts, the likes of which have never been seen before. This, in turn, will have an impact on general air cargo. Cargo carriers will likely bump other shipments in favor of distributing a coronavirus vaccine. This could cause shipping delays as a shortage of available air freight capacity is to be expected. But in the interest of the greater good, delays in consumer goods can certainly be forgiven.