Currently, most of us have a better chance of getting jabbed in the face than receiving our COVID jab. For all the accolades to those that were able to bring a viable vaccine product to market in record time, our ability to get that product into the arms of the masses has been another story entirely. Today, will change gears a bit. Today’s blog topic is going to be a lesson in supply chain management. The task at hand is not a simple one, but without pointing too many fingers today, will outline some of the more obvious and avoidable failures of our government’s handling of getting us all vaccinated.
State of The Union: COVID Style
A Brief COVID-19 Update
Mostly good news here for a change!!! Overall rates of infection are on the decrease both nationally and locally. This is based both on the number of infections as well as the percent of positive tests performed. It is also evident in the R-value which is now below 1 in over 80% of states. Death rates continue to be obscene, and are currently at close to 4,000 per day. They will continue as such for a least the next couple of weeks, as they are related to those infected over the holidays. After that, we should see hospital beds becoming available again, and funeral parlors experiencing a small and welcomed recession. We are not out of the woods yet by any stretch, but the light at the end of the tunnel is clearly visible now.
Time is of the Essence
While it is great news that the case rates are in decline, we must push forward and quickly in getting the vaccine delivered to the population as a whole. There are two reasons for the time sensitivity. First, as you have noticed by now, infectious diseases like this come in waves. Part of it is related to holidays and events. We have a couple of months before “Spring Break” which includes super-spreader events galore. Second, and perhaps more importantly, the quicker we get this done, the less the risk from emerging escape variants. Escape variants are new strains of virus that could be resistant to current (albeit poor) therapies and potentially not preventable with the current vaccines. Escape variants are introduced as random events in viral replication that provide some survival advantage. The lower the number of viral replications that occur, the lower the number of escape variants, and the lower the chance of some new strain showing up that throws a giant monkey wrench in the process.
Supply Chain Management
Supply chain management is defined as managing the sequence of processes involved in the manufacturing and distribution of a product. There are five components, or stages, to supply chain management, and we will touch on all briefly today with a focus on how they apply to our current problem at hand of getting COVID-19 vaccines into the arms of everyone who desires such. These stages are: planning, sourcing, manufacturing, distributing, delivering. Depending on where you read and what industry is being discussed, these stages will go by different names, but the principles are all the same.
Stage 1: Planning
Planning for a pandemic is not a new concept, primarily because pandemics are a recurring theme. While the timing and type of disease causing the pandemic cannot be predicted, the fact that they will occur periodically is a given. Our government is not naive to this, and has had plans in place for decades at least to address preparing for a pandemic. An example of an overview of a plan for influenza pandemic can be found on the CDC site, dating back to 2005. The first, and in some ways biggest, failure of our government was not being ready for this pandemic. This is in large part due to constant budget cuts to planning for the inevitable with the hope that it won’t actually occur on the watch of those making the cuts. While it would be very easy to point blame at our now former President Donald Trump for massive cuts to funds such as the Complex Crises Fund, it would be unfair to pin it all on him. For example, Congress in the 2008 omnibus spending bill allotted only $76 million of the $870 million requested for pandemic influenza preparedness planning. As we walk through the next steps in the supply chain management, you will see very quickly that failure to plan has severe downstream consequences.
Stage 2: Sourcing
This stage is primarily the responsibility of the manufacturer. It involves being able to obtain the raw materials needed to manufacturer a product, in this case a vaccine. Fortunately, to manufacture COVID-19 vaccines there does not appear to be any issues with sourcing raw materials. I am sure one of you out there is thinking “aren’t there scarce metals needed from China to make the microchips in the vaccine?” The answer is NO, because THERE ARE NO MICROCHIPS in the vaccine. For arguments sake, if there was scarcity of a raw material, it would be up to our government to procure it either by printing the money needed to buy it, or finding a way to compel those in possession of the material to give it up to assist the manufacturers.
Stage 3: Manufacturing
This stage is all about how much you can manufacture in given time period. Overall, this stage has been well managed, both by the manufacturer, as well as the prior administration. Producing hundreds of millions of doses of a vaccine is no simple undertaking in a short time period. The most obvious constraint is the capacity of the factories that make the vaccine. This is the ultimate rate-limiting step in the process at hand. Even if we handled distribution and delivery of vaccines perfectly, there would not be sufficient supply at this time to vaccinate the country in the immediate term. This stage could have been much worse though. That was avoided by the governments decision to pre-purchase vaccines from multiple manufacturers, despite the fact that they had yet been proven safe or effective. My grandfather would have called this strategy “throwing money at the problem to make it disappear.” This strategy protected the manufacturer in the event the vaccine was not safe and effective and they had to toss all of it. Under normal circumstances, without such financial guarantees, they would never have invested the effort and own capital into making so much product in advance of knowing it was marketable.
Could you increase capacity in the short term? Yes, you can have the factory cranking out product over more hours of the day for example. There is a maximum of 24 hours though, because Spinal Tap technique does not work in real life situations. You might be able to repurpose another factory in the same industry to manufacture this product. It is not realistic to build a factory on short notice to solve the problem. The government may be able to assist here a bit using the Defense Production Act. The new administration seems poised to do such for manufacturing vaccine much like the prior administration did for expediting delivery of testing instruments and supplies. There is a potential downside for commandeering a factory that produces other vaccines however….they can’t make both at the same time. You still need to make the routine vaccines. Perhaps increasing their current production to the max for a short period of time to build a surplus and then transition to making COVID-19 vaccine could be part of the solution. Having additional companies succeed in making a COVID-19 vaccine would also help. Johnson and Johnson and Astra-Zeneca both appear to be on the list for helping in this manner over the next month or two as their trials conclude and the data is analyzed.
Stage 4: Distribution
This stage is all about getting the vaccines from the manufacturing plants to the locations where they will be administered. This stage is the first where proper planning can have a major impact. It is not as simple as just sending trucks to help ship the vaccines from the factory to the facility. This is because there are limits to the amount of vaccine available to ship, and these limits are lower than the demand currently.
So what needs to be planned? Establishing appropriate priority groups. Estimating with high accuracy the number of individuals expected to take the vaccine in each priority group and where they are located geographically. Making appropriate arrangements such that the actual supply from each manufacturer is known and obtainable. Making appropriate arrangements to pay for the vaccine and its distribution. Establish an effective system to allocate vaccine geographically. And even this is a gross oversimplification of the planning required to accomplish the task at hand.
The Vaccines For Children (VFC) Program in the United States does handle distribution of vaccines, and has significant infrastructure in place to distribute vaccines to the states. It however generally functions to distribute non-scarce vaccines on a much smaller scale that the current task at hand. It also clearly has some inefficiencies as we notice annually with the delivery of influenza vaccine. We generally obtain our vaccines directly from the manufacturer for commercial insurance plans at least one month prior to delivery of influenza vaccine from VFC (where supply for Medicaid and Child Health Plus plans is obtained). There have been a lot of folks joking about letting Amazon handle this task as everyone in the country would be vaccinated in the comfy confines of their home in one week, those with Amazon Prime within two days. Kidding aside, consulting with a company such as Amazon and using their insight and technologies is a very reasonable strategy assist our pre-existing distribution network.
Stage 5: Delivery
Delivery of vaccine is the final stage in the supply chain. This is the stage where people actually receive their jab. Again, sounds simple, but is where planning again has a major impact.
What is so tough about jabbing folks in a pandemic? You need infrastructure in place to register and schedule based on priority grouping. You need facilities to safely administer vaccines. This involves physical space, staffing, storage for vaccines, supplies and workflow considerations to permit maximum throughput while maintaining appropriate social distancing. You need to track the lot numbers and specifics about who got what shot, where and when. This data needs to find its way into a state registry. You need a system to monitor local usage that permits real-time adjustments to further allocations or redistribution of vaccines that are not used to avoid spoilage.
Rate-Limiting Steps and Where We Failed
While I mentioned it briefly before, the concept of the rate-limiting step in supply chain management is critical to understand. The supply chain follows the order outlined above: planning, sourcing, manufacturing, distribution, and delivery. Like any chain, it is only as strong as its weakest link. If you can only source raw materials for ten units of a product, having a manufacturing plant that can make 100,000 units per day is of no use. In this case raw materials is the rate-limiting step and must be addressed before any downstream considerations. The role of our government at this time is to make manufacturing is the rate-limiting step. It needs to ensure that every dose that is obtainable is rapidly distributed and delivered to people in order of their priority standing. Priority standing is only needed because there is limited supply, though if this bottle neck were alleviated, we would need to ensure that distribution channels did not become a rate-limiting step of its own.
Our government to date has failed in its efforts to make manufacturing the rate-limiting step. There are unused vaccines being stored. There are vaccines being used in groups that were not intended as priority at the expense of high risk individuals. The ability of priority groups to properly schedule and receive their vaccine has been nothing short of a disaster. The communication between the government and those that are trying to administer vaccines has been poor. Many of you can easily relate to trying to schedule a dose for a grandparent online. Our office has been trying to obtain vaccine to deliver to the currently prioritized groups, yet we have no guidance as to when we may get a shipment or how many doses we will get. We simply have to be prepared to get them on a moments notice and administer them within a week of arrival.
Had our government planned better, they would have known how many folks met specific criteria in a given area and only permitted vaccination to the priority group for which they had supply. Instead, they opened the delivery criteria to a number of individuals for which supply did not exist. This ensured that many of the highest priority were unable to receive their vaccine. It also has created inefficiencies in the system. When there are shortage issues, there are cancellations of appointments due to lack of supply. This leads to people scheduling appointments in various facilities hoping that one of them comes through. In turn, this prevents others from obtaining any appointments. Many folks that have multiple scheduled appointments will fail to cancel their extra appointments once they receive their vaccine at one. This leads to no-shows at sites which then administer vaccine to non-priority groups or waste doses they had on hand in expectation of delivering to the scheduled individual. I can make arguments that it is a state level issue or a federal level issue. At the end of the day, I don’t care because they should have communicated better and not placed many lives at risk due to delays in distribution and delivery of available product.
Post authored by Jason Halegoua PhD, MD, MBA, FAAP. Jason is the founder of Peds First Pediatrics in 2009, and has been a practicing general pediatrician since completing residency at Schneider Children’s Hospital in 2004. In addition to earning his medical degree from the Medical College of Pennsylvania, Jason earned a PhD in Molecular Pathobiology for his work contributing to the understanding of the genetic regulation of immune responses to murine leukemia viruses from Hahnemann University in Philadelphia and an MBA in Finance from Hofstra University.