Three Supply Chain Risks That Could Thwart A Successful COVID-19 Vaccine
About me: I am a co-founder of REFASHIOND Ventures, an early-stage technology venture fund that is being built to invest in innovations that will refashion global supply chains. I am a co-founder of The Worldwide Supply Chain Federation, a growing, global network of grassroots communities focused on supply chain, innovation, and technology. I am also an adjunct professor of supply chain and operations management at the Tandon School of Engineering at New York University. I write a weekly column on supply chain, innovation, and technology for FreightWaves, the world’s largest digital media portal for all things related to freight logistics and technology.
Introduction: Landmarks in the United States’ fight against COVID-19
The U.S. crossed the milestone of 100,000 deaths due to COVID-19 in May 2020. By the time you read this, that number will be closer to 150,000 deaths.
May 2020 also stands out for the rash of announcements about promising results from vaccine candidates against SARS-CoV-2 and COVID-19. For example; Moderna issued a press release on May 18; AstraZeneca and Oxford University’s Jenner Institute featured in news reports that emerged on May 22; And The Lancet published results from a study by CanSino Biologics on May 22.
President Trump unveiled Operation Warp Speed on May 15, 2020. That has also raised expectations that we will soon have vaccines against COVID-19.
On July 22, the New York Times reported that Pfizer and BioNTech — a German biotechnology firm, got $1.95 billion for 600 million doses of a COVID-19 vaccine, with the first 100 million promised before the end of 2020.
But, even if a vaccine is successfully developed, and passes all the tests for safety and effectiveness this year, there are many discrete sequential activities within, and components of, the supply chain that have to work successfully and in tandem, at global scale, before any vaccine is widely available.
Even as we have now crossed the 130,000 deaths threshold, with more than 3 million confirmed cases, as of July 8, it is still not clear that the U.S. government has a plan to address that looming challenge.
To avoid making an already bad situation worse, the Federal Government must take the lead in developing a supply chain strategy for the manufacturing, allocation, and distribution of a COVID-19 vaccine well before one is discovered. Time is of the essence.
This is a topic I started thinking about during the spring semester of the 2019–2020 school year, my first semester as an adjunct professor of supply chain and operations management at the Tandon School of Engineering at New York University.
Understanding The Steps In The Vaccine Supply Chain
A supply chain is a complex network of organizations that work collaboratively and interdependently to move products and services from producers to consumers. A vaccine supply chain is made up of the following 4 major steps: First the vaccine has to be developed. Second the vaccine has to be produced in mass quantities — raw materials must be produced and combined during manufacturing to create the final product. Third, the vaccine has to be allocated. Fourth, the vaccine has to be distributed so that it reaches the end consumers to whom it is administered.
As we have seen with the widely reported and ongoing scrambles for simple items like toilet roll and PPE, lack of centralized coordination and orchestration within the supply chain can pose a hurdle that is too high to quickly overcome during times of crisis.
In this context, supply chain orchestration is the centralized, end-to-end coordination of all the activities, resources, and partners required to ensure that COVID-19 vaccines can be mass produced, allocated, and distributed, taking populations and regions with the most need into account. A lack of coordination and orchestration will symie efforts to successfully deploy a vaccine against COVID-19, in the U.S. and other parts of the world.
Risks In Mass Producing A New Vaccine
Mass manufacturing vaccines is a difficult endeavour because the process involves biochemical processes and reactions that must be performed under strict environmental conditions to meet quality requirements. Slight deviations from these environmental conditions can lead to defective products that may be more harmful than if there were no product at all.
Given that SARS-CoV-2 is a new virus, among other things, the mass production of a vaccine to combat COVID-19 could require: The design and testing of new manufacturing processes. The design and building of new manufacturing facilities in different regions of the world. The procurement of sufficient quantities of raw materials for producing the vaccine — from different parts of the world; And, the training of personnel in the new manufacturing processes required to successfully produce the vaccine for distribution.
Difficulties in manufacturing billions of units of complementary products like medical grade glass vials, medical syringes, and needles will create bottlenecks to scaling the production of a vaccine for COVID-19. This is a concern that was expressed by the CEO of Becton Dickson, when he said there isn’t enough global capacity to quickly produce hundreds of millions or billions of syringes or needles.
Risks In Allocating The New Vaccine
How any new vaccine for COVID-19 will be allocated is becoming an issue of international debate with a number of reports in the press pointing to a trend of the world’s wealthiest nations making investments aimed at securing large, advance orders for their countries.
For example: AstraZeneca will deliver the earliest 30 million and 300 million doses of its vaccine to the U.K. and the U.S. respectively; AstraZeneca has struck a deal to produce 400 million doses of its vaccine for the European Union; And, with Johnson & Johnson poised to start human clinical trials of its vaccine this month, reports surfaced that the European Union is in advanced talks to buy up doses of the vaccine once it goes into commercial production.
There’s a precedent for this: The 2009 H1N1 Pandemic is estimated to have killed between 151,700 and 575,500 people, out of which 18,449 deaths were laboratory confirmed. During that pandemic vaccine allocations to countries that could not afford direct purchases from manufacturers was delayed since such allocations depended on donations, and donors typically waited till they could assure availability for their own citizens. Experts within the U.S. are already expressing concerns about how the allocation of doses of the vaccine will occur, given how politicised every aspect of the national response to COVID-19 has become, and given the difficulties that arose in allocating vaccines during the H1N1 Influenza Pandemic of 2009.
Writing in Foreign Policy on July 6 in ‘America First’ vs. ‘The People’s Vaccine’, Colum Lynch says “Major countries, including the United States, China, France, Germany, and Italy, have been locking in agreements with pharmaceutical companies to develop and mass-produce vaccines for their own populations, raising concerns among smaller countries that they will be shut out of the market.” he goes on to describe how the World Health Organization (W.H.O) is struggling to line up funding for a “people’s vaccine” for the world’s poor. This effort will evidently face additional challenges now that the U.S. has officially begun its withdrawal from the W.H.O.
Risks In Distributing The New Vaccine
Distribution includes supply chain logistics, warehousing and storage, and last-mile delivery to the hospitals, clinics, and pharmacies, and doctors offices where the vaccine will be administered to individuals.
According to the CDC, vaccines should be stored “between 35°F and 46°F (2°C and 8°C).” Storage outside that rage for any amount of time may result in the vaccines becoming ineffective. This is a difficult task since maintaining cold chain facilities during the transportation and distribution of vaccines requires uninterrupted power supply.
It is not clear that a new COVID-19 vaccine will be embraced by individual consumers. A survey of people in France found that 26% would not use it. A survey of people in the U.S. found that only 49% would definitely get themselves vaccinated. In contrast, experts think 70% is the lower threshold at which we may start to achieve herd immunity. If a vaccine confers permanent immunity, that means we need at least 5 billion doses of the vaccine for people around the world.
However, Marta Galanti and Jeffrey Shaman of the Mailman School of Public Health at Columbia University, in New York City report that “that re-infections with the same endemic coronavirus are not atypical in a time window shorter than 1 year” suggesting that protection from a vaccine for SARS-CoV-2 is likely to be temporary too.
This makes gaining control of the supply chain issues that accompany the creation and distribution of a vaccine for COVID-19 all the more urgent given the economic devastation it has already caused, and the inventory management challenges that arise if immunity is temporary, and varies from person to person.
In 2019, the World Health Organization listed vaccine hesitancy as one of ten threats to global health. Given the rift between public health experts and the White House over the use of face-masks as a protective measure, we can’t take it for granted that the White House will enthusiastically encourage people to get themselves vaccinated. This will make herd immunity even more challenging to achieve.
The challenges that remain ahead of us because so much about COVID-19 remains unknown are highlighted in Prevalence of SARS-CoV-2 in Spain (ENE-COVID): a nationwide, population-based seroepidemiological study, a research paper published in The Lancet on July 6. It covered a sample of more than 61,000 participants in a survey conducted in Spain to measure the presence of COVID-19 antibodies in study participants. It’s significant because Spain was hit so hard by the pandemic — as of July 8, Johns Hopkins University’s COVID-19 Dashboard shows Spain as having 252,513 confirmed cases with 28,296 deaths. Placing it 9th globally, ahead of Iran, but behind the U.S., Brazil, India, Russia, Peru, Chile, the U.K. and Mexico respectively. Media reports suggest that this is the largest study of its kind in Europe.
The study’s authors conclude that “Despite the high impact of COVID-19 in Spain, prevalence estimates remain low and are clearly insufficient to provide herd immunity. This cannot be achieved without accepting the collateral damage of many deaths in the susceptible population and overburdening of health systems. In this situation, social distance measures and efforts to identify and isolate new cases and their contacts are imperative for future epidemic control.”
Coordinating and orchestrating all the supply chain processes and activities required to achieve herd-immunity through a COVID-19 vaccine may be an even more daunting challenge than the invention of the vaccine because there is no single central authority that oversees all aspects of the complex, global supply chain for such a vaccine, or for any product for that matter.
On July 2, The Economist reported in Oxford University is leading in the vaccine race, that the vaccine being developed through the collaboration between Oxford University and AstraZeneca is now in 3 late-stage trials, far more than any of the other 180 vaccine candidates in development — the trials are being carried out in Brazil, South Africa, India, the U.K. and the U.S. The Economist also reports that Oxford University and AstraZeneca have already started developing an international supply chain capable of producing doses of the vaccine at scale.
Yet, given how the U.S. Federal Government has struggled to come to grips with orchestrating and coordinating the supply chain required to get PPE to each state. There’s no evidence we have a plan in place to tame the supply chain challenges that we will encounter for a successful rollout of a COVID-19 vaccine.
Originally published at https://www.linkedin.com.