Around the world, scientists and citizens alike are hoping for a COVID-19 vaccine. Dr. Anthony Fauci is “cautiously optimistic that we will have a vaccine within a reasonable period of time, not only from Moderna, but from other companies too.”
Healthcare Packaging spoke with MIT’s Dr. David Simchi-Levi, an operations research scientist who has thought through some of the challenges of preparing for the rollout of a vaccine. His research currently focuses on developing and implementing efficient techniques for logistics and manufacturing systems.
HCP: What do you feel is that first hurdle that people are overlooking in distributing an effective vaccine?
Dr. David Simchi-Levi: The vaccine rollout has many different challenges. I’ll start with some of the observations about the vaccine development. Part of the challenge is making sure that we focus on the safety of the vaccine itself in providing long-term protection for all the people. There are several technologies considered for the vaccine
When we talk about product, we don't know which one will be successful just yet and we don't have many examples where the scientific community has been successful in developing vaccines for infectious diseases in the last 100 years.
So which one will be successful? And once you develop one, it’s typically a sequential process. You start in the lab, you test on animals, then you test on people in several trials, then you create specialized manufacturing processes. It’s a very linear process that can take several years. The problem is that we don’t have time now, and we need to do many of these steps in parallel. And challenge number one is that we don’t know which technology will be successful so we don’t know which manufacturing process to invest in.
HCP: And with different manufacturing processes, there could be different supply chains?
DSL: Exactly. The Gates Foundation is now building or investing in the seven most promising technologies, because they don't know which one it will be. You may not use all of them because maybe only one of the technologies will be effective.
HCP: How does packaging come into play?
DSL: The second challenge is that in order to use the vaccine effectively, you need to provide storage to make sure that the vaccine itself does not degrade. The entire process has to be controlled, just as with any drug. Vaccines are extremely sensitive. They lose effectiveness if stored at the wrong temperature. So packaging, distribution, and the temperature-controlled supply chain are a critical part of the challenge.
In addition, each dose, each unique vaccine requires all sorts of components that are low-cost, but we don't have the supply. We don't have the ability to produce a package for the product right now: vials, stoppers, needles, caps and so forth. Making sure that we have the inventory of specialized glass for vials domestically is a challenge. These components are produced mostly in China and in India. For example, there is only one company in North America able to produce needles in large scale.
You can expect that—and this is not politics—we will see some countries blocking, say a shipment of this type of supply because they want to keep it for their own citizens. So logistics is going to be a challenge.
And finally, no matter what we do, there will not be enough supply to cover the demand, so there will be a need for a decision: who gets it and who doesn't? Should it go to elderly people because they are at high risk? Should it go to medical staff first because they are exposed? Should it go to young people because they interact a lot with others?
All of these questions are on the table, but for now the main question is, for all the steps that normally follow a sequential process, how do we do many of them in parallel?
HCP: What are your thoughts on effective and ethical allocation?
DSL: It’s a critical question: What is that allocation mechanism? How can the federal government, health insurance companies, etc. make reasonable allocation decisions that benefit the population as a whole?
This is exactly what my team at MIT is working on now: a model that tries to identify an effective allocation strategy that will allow us to improve the effectiveness of the vaccination, when not being able to give it to everyone. We need to vaccinate as many as 70% of the population, while making sure there’s no spread of the epidemic because we couldn’t get to everyone.
My team studies what we need to decide, what is the best way from a community point of view to allocate the available inventory. Our government here in the U.S. is looking into this, the EU, the Chinese government—everybody's looking at the same issue.
HCP: We hear a lot about “a vaccine” or “a treatment,” but what are some of the supply chain considerations if there’s a combination of drugs that works versus one silver bullet?
DSL: If there is one silver bullet that is successful, one advantage is that we can scale very well, but the disadvantage is not having enough capacity. If only one is successful, six of the manufacturing facilities that, say, the Gates Foundation is focusing on will not be able to produce this one silver bullet, unless they build flexibility into these manufacturing facilities to change from one technology to another.
That will allow us to scale very quickly once we know which technology is effective, but flexibility does not come free… there is a cost associated with that. I'm not sure what exactly the plan is, but flexibility is one important element that can help us scale very quickly if we are willing to invest in it.
HCP: Any comments on vaccine traceability?
DSL: One thing I'll note is that people talk about the use of blockchain as a way to allow you to trace the product and origin and make sure that it is not counterfeit. I'm sure traceability technology will be one part of the solution.
HCP: How might climate change and the carbon footprint of manufacturing and logistics tie into the effort to reshore operations?
DSL: This is a very interesting topic. We know that for a lot of these manufacturing processes, you need certain chemicals and a lot of these chemicals are now produced, not here, but in India and in China.
People often say the reason they’re produced oversees is to reduce cost. This is only part of the reason. The second driver of the move of these chemical manufacturing activities to India and China is because chemical manufacturing processes are highly polluting. And so the move to Asia in part is driven by environmental concerns.
Now, if companies say they’re moving API manufacturing to North America or Europe, this will increase cost, but the issue is that nobody's going to agree to build these chemical manufacturing facilities that will be highly polluting.
So you need clean chemical manufacturing processes, and that requires time and significant investment. Who will make this investment? Is this going to be the federal government, or private investors? The European Union may have one opinion and the U.S. federal government here may have a different opinion.
These manufacturing challenges are not only about the cost. It's a lot about environmental issues. China is not relaxing their effort either. They’re looking for clean manufacturing processes. So if China figures this out and has a low cost, it will be very difficult to motivate the move to North America. That's why I'm saying it's time and investment.
People will be looking for reusable packaging materials. But to me, even before that, there are issues with pollution and the fact that the U.S. is already coping with a shortage in the specialized glass needed for the vials. Even before packaging exists, these are important challenges that you need to address today, in order for packaging to be there five months from now.
HCP: With the sheer size of the target market (essentially, everyone) do you foresee workforce shortages either in drug manufacturing or with healthcare workers?
DSL: This is another important issue. It's both in healthcare and in manufacturing because in the manufacturing process, you need to maintain social distancing because of the virus which reduces productivity. You also need to make sure that people have core skills training to be able to move from one technology to another. Remember that we don't know which technology will dominate, and there are seven different factories in the Gates example. You need a workforce that is capable of switching from one to another, depending on which one is successful. I think this becomes really a critical part of the supply chain solution.
Make plans to visit PACK EXPO International, November 8-11, to see on-trend traceability systems as well as packaging machinery and materials.