Developing a Safe, Effective Vaccine Against COVID-19 is Just the First of Many Hurdles | Deloitte US has been saved
By Laks Pernenkil, principal, and Joe Lewis, consulting managing director, Deloitte Consulting LLP
More than 200 COVID-19 vaccines are in development, 29 are in clinical testing, and at least nine have reached phase III clinical trials.1 But approving a vaccine that is both safe and effective against COVID-19 is likely just the first step in a long journey. Pharmaceutical companies should ensure they have enough raw materials, vials, syringes, and packaging to transport hundreds of millions, if not billions, of doses. They will also have to determine how to efficiently transport and distribute a vaccine that might have to stay cryogenically frozen until it is ready to be used. Moreover, governments need to determine who to vaccinate first, and understand that the first vaccine to cross the finish line might not wind up being the most effective in the long-run. This all assumes that the virus doesn’t mutate and make the first approved vaccine(s) less effective.
Vaccine-operations simulator could identify manufacturing, storage, and distribution bottlenecks
Hundreds of millions of COVID-19 vaccine doses—that have limited ambient temperature stability—could become unusable if the transportation time increases from current assumptions, according to Deloitte’s supply-chain simulator. This could happen even in the case of short delays, which are common (e.g., on the tarmac in transit, while stuck at border crossing or when storage capacity is compromised). These hard-to-avoid delays have been modeled in a tool, available here. The tool was designed to identify potential bottlenecks along the chain of manufacturing, storage, and cold-chain distribution. The model simulates the end-to-end flow of goods and lets users change any step in the process to see the likely downstream impact on total vaccine operations output.
Five areas of focus for manufacturers, distributors, and governments
It’s safe to assume that most companies in the race to develop a vaccine have already made key decisions about how their products will be manufactured once they receive regulatory approval. However, an unprecedented global pandemic calls for an unprecedented approach to manufacturing and distribution. Here are five issues that are being tracked closely by manufacturers, distributors, and governments:
1. Ensuring sufficient manufacturing capacity: At this point, there does not appear to be a significant capacity constraint, and many manufacturers have already secured the space they expect to need. Moreover, many vaccine candidates have different manufacturing profiles. Some manufacturers have already ramped production of their COVID-19 vaccines in advance of approval. The current mantra is to produce as many doses as possible so that there is enough supply if approval is granted. However, companies that wind up with the most effective vaccine could quickly reach capacity, especially if governments and other buyers start making large purchases (consider a parallel to the hoarding of toilet paper we saw earlier this year). Given that manufacturing capacity is finite, companies that emerge first with a safe and effective vaccine might need to partner with less successful competitors to secure additional capacity. Enabling shared-capacity agreements could reduce the risk of demand outpacing supply. However, it doesn’t seem that many companies are discussing shared capacity at this point.
2. Agreeing to packaging interoperability: The ancillary packaging of a vaccine could wind up being a significant hurdle for vaccine manufacturers. Shortages of raw materials, syringes, glass vials, or other supplies could limit dose availability. Lockdowns and restrictions on travel, along with unforeseen geopolitical risks, could also hinder the distribution of critical materials to manufacturing sites around the world. As it stands today, there is no harmonization around the packaging that will be needed to transport and distribute vaccines. Most companies have their own set of product security standards and packaging requirements. Given that there could be multiple products in the market at the same time, it might be beneficial to establish some level of interoperability in primary packaging for similar vaccine types. If one company’s vaccine isn’t selected or has problems, can the packaging or vials that one company procured be directed to another manufacturer? In September, nine pharmaceutical companies issued a joint pledge not to release a vaccine until it had been thoroughly tested for safety and effectiveness. If competing manufacturers are able to come together and agree on such a pledge, perhaps they could also agree on some level of standardized packaging.
3. Preparing the cold chain: Two frontrunners in the vaccine race are based on a messenger RNA (mRNA) platform technologies, which might need to be stored at temperatures as low as -112 degrees Fahrenheit.2 Keeping doses frozen until they’re needed will likely require tight coordination. At this point, there are only a handful of frozen distribution and logistics providers with the potential to handle this requirement. Vaccine manufacturers should try to establish an order-handling and distribution network that follows existing networks but allows them to deal with the growing complexity in the various routes-to-market. Manufacturers/distributors should consider supply chain approaches from outside industries to help ensure doses stay frozen. Freezers used by the food industry, for example, could be secured to transport vaccines. Super-freezer containers might be used for over-the-road and even short-sea or rail transport. The International Air Transport Association estimates that 8,000 jumbo jets would be needed to transport vaccines around the globe, but those aircraft would need to meet storage-temperature requirements.3
4. Distributing vaccines to administration sites. Governments, including the US, are essentially acting as vertically integrated R&D, manufacturing, distribution, and potentially administration entities. Vaccine manufacturers should fulfill the commitments they have made to governmental and NGO entities. This is a key difference from a traditional commercial model, particularly where multiple vaccine products are available.
On September 1, the National Academies of Science released a four-phase approach for distributing the vaccine throughout the US. The “Jumpstart Phase” would include front-line health care workers and first responders. This would be followed by older adults who live in group settings, and people of all ages who have comorbid and underlying conditions. The federal government will likely allocate doses to states in each phase, based on estimates of how many residents fall into each category. The challenge will then be for states to distribute vaccines to administration centers that can get doses to patients. Consider this: If vaccines need to be stored at ultracold temperatures, then the doses either need to be delivered just prior to administration (and used while they are still stable at ambient temperatures), or administration sites need to be equipped with ultracold storage. This calls for significant coordination among the federal government, states, health care providers, retailers, and other possible vaccine administration facilities.
States might not all pursue the same method of administering the vaccine. One strategy is for states to stand up dedicated vaccination-administration centers. Another approach would be for major health systems to vaccinate their front-line workers and at-risk patients first. They could then schedule appointments with workers from high risk industries. Some states might have specialized vehicles (akin to blood mobiles) that could be driven to companies where workers are at a high-risk of infection. And maybe school gymnasiums could be dedicated as vaccination sites. At the other end of the spectrum, vaccines could be distributed to pharmacy chains or primary care offices. Regardless, a heterogeneous approach to vaccine administration could require revisiting business processes across the entire vaccine distribution value chain.
5. Getting people vaccinated: States and distributors might not have a fully accurate picture of demand given that some people, even within priority groups, might not opt to receive the vaccine. As a result, some doses might not get used and could be wasted. Real-time tracking of vaccine demand will likely be critical to optimizing the allocation of supply. Vaccine manufacturers should be agile in adapting their operations as priorities shift as vaccines enter the market. Importantly, a significant percentage of the public would need to get vaccinated to achieve herd immunity. My colleagues Sarah Thomas and Greg Szwartz recently published a blog that discusses some strategies to overcome vaccine hesitancy. A well-coordinated strategy is also required to track who has been vaccinated and possible adverse events.
Implications now and beyond the pandemic
The competitive landscape might continue to shift as newer vaccines enter the market after the first round has been distributed. This dynamic environment accentuates the need for flexibility and collaboration. As clinical data starts to emerge, stakeholders across the vaccination value chain should be coordinated to quickly deliver doses to the public. This means that potential challenges around manufacturing capacity, packaging, storage, distribution, and administration should be addressed now. Federal and state governments, vaccine manufacturers, distributors, and health care providers should work together to help ensure patients have access to safe and effective vaccines.
Endnotes
1. COVID-19 treatment and vaccine tracker, Milken Institute, October 14, 2020
2. Another challenge for vaccine makers: Keeping it at minus-112 degrees, Bloomberg, May 21, 2020
3. Covid vaccine: 8,000 jumbo jets needed to deliver doses globally, says IATA, BBC News, September 10, 2020
