As people contemplate life going back to normal, one of the biggest questions that still does not have an answer is when a coronavirus vaccine will be ready. That will depend upon when effective vaccines become available. But beyond that, there are all the supply chain hurdles associated with manufacturing, warehousing, distributing, and administering the vaccines.
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. For some of the trials that are ongoing, scientists have combined phases to try to speed up the development and approval process. From a number’s 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.
The first stage, focused on pre-clinical testing, does present some procurement hurdles for US drug firms. In pre-clinical testing 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.
Coronavirus Vaccine Distribution
With so many trials ongoing, there are still considerable hurdles in getting the vaccines to market. 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 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
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.
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.
Then there are the manufacturing hurdles. Pharma companies are subject to Good Manufacturing Practice (GMP) regulations. GMP is a system for ensuring that products are consistently produced and controlled according to quality standards.
Further, pharma manufacturers point out that the labeling documentation produced for new drugs creates supply chain hurdles that are not insignificant. The packaging and inserts must be approved by each nation. This means that instead of producing one global stock keeping unit, every nation requires a separate SKU. This SKU proliferation means that the documentation not infrequently delays launches in one country or another. Some drug companies have responded by producing the drugs in one location and then shipping those drugs in bulk to a specialized packaging partner that can respond quickly to these demands. Then the finished products are shipped from the pack partner’s facility into the global marketplace. In short, there is often an extra logistics leg required for pharma supply chains.
Finally, the developing COVID supply chain is apt to adversely affect other supply chains. 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.
The primary author of this article was Chris Cunnane.