It's been called the biggest logistical challenge of all time. Senior editor, Meagan Parrish, chats with PwC's Omar Chane to find out how pharma and the government can quickly deliver COVID-19 vaccines to waiting Americans.
Meagan: This is Meagan Parrish, and you're listening to "Off Script: A Pharma Manufacturing magazine podcast." Vaccines. If you've become obsessed with watching the play by play action in the race to develop a coronavirus vaccine like we have here at Pharma Manufacturing, you're likely to be feeling a bit optimistic right about now. Although the one-year timeline that was initially being proposed by drug makers to develop a new vaccine seemed far-fetched way back in the spring, it's now starting to look like a reality. Major phase three trials are underway for several candidates and Americans all over the country are already getting the poke.
Data is likely to start rolling in this fall, manufacturing infrastructure is being set and production lines are getting ready to roll. Finally, we're approaching the finish line. But you know what they say about that light at the end of the tunnel, sometimes it's an oncoming train. So even though several drug makers could be on the cusp of filing for some kind of approval from the FDA, there are still a few major roadblocks left on the race track. Yes, it feels like we're getting closer to having what we need to reach herd immunity but really we're maybe just somewhere in the middle of this journey.
One big challenge is getting Americans to get the shot. With close to half of Americans now expressing doubt that they'll be willing to take one of these new vaccines, that issue is threatening to derail progress in the fight to bring the pandemic to an end. And this is such a huge challenge that we devoted our next cover story to this topic in our October issue. And we're going to take a deeper dive into that problem with the article's author, our Chief Content Director Karen Langhauser, on our next episode. But today we're focusing on the other potential roadblock now facing the pharma industry — distribution. Let's be honest, this isn't the sexiest part of the pharma world. I mean, we're talking about cargo planes and refrigerators, but many have said that when it comes to getting vaccines into the waiting arms of Americans, the pharma industry and government are facing the biggest logistical distribution challenge of all time.
The issues here are many. Cargo space has already been limited by the reduction in passenger plane travel and distribution channels are already under strain. Also, some of the lead vaccine candidates will need to be shipped in precise and frigid temperatures, meaning that they can't travel on the traditional routes, and specialized equipment is needed at every link of what we call the cold chain. Pfizer's vaccine, for example, which, at the moment, looks like the front runner, will need to be stored and shipped at about -90 degrees Fahrenheit, much colder than typical vaccines. And by comparison, Moderna is pushing to make its vaccine stable at -4 degrees. Given the need for such cold conditions, analysts say the Pfizer's vaccine would only last up to 24 hours at a typical refrigerator temperature.
Pfizer, it's worth noting, has pushed back on this assessment and argued that its vaccine will last up to two days, but tomayto, tomahto, either way, it's not a big window of time. The company is also looking at innovating new shipment containers using dry ice, which would allow them to be shipped using the traditional distribution network. However, these containers have such strict rules that they would create new tricky issues. For example, it's possible that distribution sites would only be able to open the boxes two times and each time just for a minute, which means that if the site doesn't take out enough vaccines for the day, they could risk running out. But if they take out too many, some of these life-saving shots could end up being tossed.
So it all boils down to is that when vaccines are traveling through the cold chain network, they can't travel in any old box, on any old plane. Instead, they'll most likely need to be sent on a subset of our distribution network, which creates complexity and could slow down the process. Recognizing what's at stake and what needs to be done, PwC, one of the world's biggest accounting and consulting firms, recently released a report called "Developing COVID-19 Vaccines may not be Enough: Turning Vaccines into Vaccinations." In the report, the authors aimed to pinpoint some of the ways the pharma industry can overcome these issues, such as relying on existing cold chain networks being used for advanced therapies, including cell and gene therapies. They also looked at how pharma can work to understand consumer care patterns so that the vaccines are delivered to the most effective sites for distribution and how we should leverage advanced analytics platforms to connect all the dots through the supply chain.
To help us get a better sense of how pharma companies are working to navigate this whole mess, I'm joined today by one of the reports' authors, Omar Chane, a principal at PwC, who can speak to what's being done to handle these issues and how long it might take for all of this to amount to a successful vaccination campaign in America. Omar, thank you so much for taking the time to be with me today.
Omar: Absolutely. Happy to be with you on the show here.
Meagan: I wanted to start by asking you about the report you co-authored, "Developing COVID-19 Vaccines may not be Enough: Turning Vaccines into Vaccinations." Why did PwC decide to tackle this issue of distribution in the report?
Omar: This is something that we mobilized on fairly early and fairly quickly in the onset of the COVID crisis because we knew early on there was a lot of technology innovation that was going into developing a potential COVID vaccine. We knew that companies were also working very hard on developing and ramping up the manufacturing capacity. There was a lot of money and a lot of funding that came from the U.S. government to help accelerate the development, help accelerate and scale up the manufacturing. But we felt very early on, given the experience and how overall as a healthcare system we responded to the pandemic and the PPE, the testing that there's even kind of more at stake when a vaccine comes available.
So, we wanted to make sure that we anticipate early on what could be some of the challenges that can get in the way of addressing a distribution and then what are some potential ideas. And for that effect, what we did, we actually mobilized executives from about 14 different companies, 15 different companies across the health value chain. So we mobilized executives from vaccine manufacturers, distributors, providers, payers, supply manufacturers. And that was the whole intent. We had that coalition to say, "In anticipation of a vaccine eventually hitting the market, what are the roadblocks that we expect to face? And then what can we start doing to address those roadblocks now?" And that resulted in this first white paper that we published.
So this is something we started working on back in April with partnership from other industry partners, and we're still continuing to invest in, we're still continuing to monitor this space and iterate through it. So that's what led to us initially. And frankly, the only thing that I would say is, listen, there has not been a medical product where there's so much at stake as we've seen with this COVID vaccine. A lot hinges on the successful distribution of a COVID vaccine, the economy, our personal lives. And I think the only thing that may compare to this innovation, maybe the polio vaccine 50, 60 years ago. This is the first such innovation where there's so much at stake in making sure that we do have a successful vaccine and a successful vaccination. All these things is what eventually led us to say, "Let's focus on this topic here."
Meagan: I think it's fair to say that the government understands what's at stake, and it has a lot to do with why Trump has made some lofty goals about getting vaccines into the hands of Americans. Specifically, the goal of Operation Warp Speed is to have 300 million doses of a vaccine manufactured by January. But more recently, President Trump has said he's hoping the government will be able to distribute 100 million doses by the end of this year. What do you think it's going to take to make that happen?
Omar: So listen, and we need to distinguish between distributing 100 million doses or 200 million doses, and then administering 100 million doses or 200 million doses. And I think these are two separate things. So, I think it's well-known that from a manufacturer's perspective, many of these manufacturers have been going in manufacturing at scale, at risk as soon as they had vaccine candidates. So I do believe that having tens of millions, potentially hundreds of millions of doses available soon is a realistic thing. That's different than saying that we're going to have 100 million doses in arms. And let me map out kind of just at a high level how we think, how we anticipate this whole campaign and this whole immunization is going to go.
Think of it as three phases essentially. The first phase is going to be the phase where we're operating under an emergency use authorization, where one, two, three manufacturers are going to be granted the emergency use authorization to be able to have the product on the market. And then the CDC through the ACIP or the CDC through other kind of public health channels will determine who will be getting those doses. And most likely they will start with very narrow populations and progressively they will start expanding that population and that recommendation. That has not been announced yet.
The CDC requested, I think, about five, six weeks ago, they sent the request to five states and one city to come up with their own plans and to come up with recommendations. Those recommendations were due back in the beginning of April. And I think that, based on that, based on what we know about the products, based on what's happening with the infection itself, the CDC will start passing some recommendations. So that will start as soon as an E-Way is granted. And most likely it will start with, you know, you might anticipate that this will start with population that are at risk, you know, immunocompromised population, nursing home population, 65-plus, healthcare workers, frontline workers. And progressively, we will start expanding as we fine-tune the engine of how the distribution is happening and the administration is happening, we'll start expanding. So that's the first phase.
The second phase is when we start seeing broader expansion of those recommendations but also the BLAs starting to be approved, then that's when we can open up broader immunization because now we do have an approval on a product. We do have higher confidence in the science behind the product, and then we can start expanding the recommendations. But that would still most likely be under a government-run program, it's just that now we're expanding into broader populations with the intent to have essentially every American who's eligible for the vaccine, which is everyone above 18 years of age, receive the vaccine. Then that will set the stage for what potentially could be phase three, which is a big unknown still.
But phase three is any event that this vaccine becomes a seasonal vaccine. Lots of unknown there, lots of unknown on how the virus itself is going to mutate, lots of unknown around the duration of immunity of the vaccines. But there's a lot of anticipation that we're going to be in this for a while and that we are going to need a seasonal vaccine. So the third phase is going to be when we get into a seasonal cycle about a year and a half, maybe two years down the road. So again, that's why I'm saying, listen, this thing, between 100 million doses by January, I think it's going to take a while until we get to a point where we have broad coverage of the vaccine under an EUA and eventually the early stages of a BLA vaccine.
Meagan: Okay, great. You mentioned the polio vaccine from the '50s and '60s and our efforts to get that out. I was wondering how this rollout of a coronavirus vaccine might be similar or different to some of those other widespread vaccination roll-outs. And if there are sort of any lessons learned that we can glean from those experiences.
Omar: I mean, probably the closest analog will be the flu vaccine. It's a seasonal business flu in the U.S. You know, the flu season starts from around this time, late August, September until February, March. And it's a season where we have, on average, 150 million people in the U.S. who receive the vaccine. So we're talking maybe roughly same order of magnitude, potentially, for what a COVID vaccine would look like. That's where the similarities end because this COVID vaccine is going to be a two-dose schedule versus the flu vaccine where you go and you get one dose. Their refrigeration requirements are vastly different. The recommendations on who's going to get the vaccine are going to be step-wise and increasing over time, as we mentioned, versus flu is a universal recommendation. But that's probably the closest thing where we can say there's a short period of time where there's resources directed towards the distribution, administration of the vaccine is probably flu is the closest analog.
Meagan: I'm wondering, given how much demand there's going to be for this, I mean, really right away for this vaccine, as soon as we have enough doses ready for the general population to take it, are general distribution sites, such as pharmacies and clinics, going to be enough or do we need additional distribution sites?
Omar: So I think we're covered in terms of the number of outlets. Like I mentioned, we're able to immunize 150 million people in the U.S. with flu. And there's hardly a street corner that you turn in the U.S. where you don't see a sign for flu vaccines. So the issue is not so much the number of outlets. The issue is going to be the number of outlets that can handle the refrigeration requirements that these vaccines have. And I think you're aware that the mRNA vaccines have a refrigeration requirements of -80 to -20 degrees centigrade. You could put them into, you know, a liquid form, but then the stability of the vaccine is even shorter, which is going to require a more rapid administration once the vaccine is in its liquid form.
So the question is not so much around the number of outlets. The question is, do we have sufficient outlets that can handle the number of the refrigeration requirements? The short answer is probably not. And that's where I think what we're going to need to have is a model that allows for a just-in-time inventory delivery of these vaccines to the points of administration. And this is going to create a lot of complexity, but I can imagine a model where you have to sign up in order to receive a vaccine in your physician office or in the retailer. Those retailers need to schedule your visit. They will know ahead of time how many vaccines they need every day. And then those vaccines get shipped to them on daily basis so that they can store and administer them in their existing refrigeration capability. Otherwise, we're going to have a lot of vaccines that will go to waste because of mishandling with the cold chain requirements.
Meagan: Is the issue there that these retail outlets don't have the capacity to store these vaccines for longer than a day?
Omar: Well, again, it depends on which temperature requirement we're talking about. There's very few healthcare settings in U.S. that can store any kind of a medical product at -20 and -80. There are some, as we mentioned in our report. I mean the cell therapy, gene therapy products are such products, and there are, you know, handful of healthcare settings in the U.S. that are able to handle these kinds of refrigeration requirements. But if we really want to be able to create access to a large volume of individuals to be able to get the vaccines, that model is not scalable. We will need to find a model like the one that I was describing, where you have a very efficient supply chain and just-in-time inventory delivery of these vaccines to the outlets.
Meagan: So there's no way to add cold chain capacity to these sites is what you're saying?
Omar: I mean, listen, companies are crying. There's a lot of innovation that is happening. I think one of the vaccine manufacturers is developing these refrigerated compartments that are used to manage the distribution. But even then, if you read through the handling of these products is that you can only open that compartment twice a day, or you can only leave the vial when it's in liquid form for so many minutes out of the refrigerator. These are tough, tough handling requirements. It's almost like an assembly line approach to scheduling, managing the administration, we're going to be limited in our ability to administer the vaccine on a mass basis. Plus not to mention that probably in the early stages, the people who need the vaccine the most may have the least access to these outlets that can handle these refrigeration requirements.
So, for example, if you want to immunize nursing home residents, well, then, nursing homes, to begin with, have very little capabilities in terms of managing frozen products, for example, let alone products that require these kinds of refrigeration requirements. So that's going to require the need for us to think about a model where it's what I call the push immunization model. It's not the poll where I choose to go into the Dwayne Reed next door and get a vaccine. It's more of a push to bring the vaccine to where the patients are, to where the customers are. And that's gonna require all kinds of new types of fleet, new types of refrigeration trucks, training of the people who are administering the vaccine. That's one example.
The other example, if you think about it from a social determinants of health, the communities and the populations that have been the most impacted by COVID probably reside in areas where you have fewer access to points of care. And we have to find a solution to this because that's how we would be able to manage the spread of the disease is by going to the populations that need it the most essentially.
Meagan: Now, I'm wondering now if you could talk about what's happening now to address some of these challenges, which sound really massive. What are pharma companies doing and what is the government doing? And I'm wondering because there are already a lot of private-public partnerships going on in this whole effort, whose responsibility is it to make sure that these vaccines get through the right distribution channels?
Omar: I mean, there's a lot happening, which is the good news, bad news, kind of a story. There's a lot happening in terms of a lot of funding that's being directed by the U.S. government to fund the development and the establishment of the distribution network. There's a distributor that was selected to manage the distribution. That's a distributor that manages, you know, the vaccine for children program. So they have the capability, they have the infrastructure. It's not that it is not happening. I think where there needs to be more happening is around connecting the dots between the different players. So, for example, manufacturers are working on a lot of things. Distributors are working on a lot of things. Providers are starting to think about how to handle the administration.
I think there's more that needs to happen across those different players given how fast that everyone is going, so that they can talk to each other, that there's an efficient and transparent ways to communicate so that that coordination happens. And we don't have things where, you know, things fall through the cracks. I think that's going to be the next horizon is on figuring out how to manage that end-to-end and continuity in the intent.
Meagan: And what kinds of solutions are you envisioning would help with that end-to-end continuity?
Omar: So I already mentioned one of them. I think a solution around the just-in-time delivery of these vaccines is going to be required. I'm not going to rehash it, but something that starts with very accurate demand planning at the site of care to understand how many doses are they going to expect, scheduling those visits, make sure that the patients come in, and then deliver the doses. And that requires a high degree of sophistication and collaboration across the value chain. So that's going to be one. The other one is, I just alluded to it, which is sophistication and analytics. Because you want to make sure that you're able to anticipate where demand could come from and rapidly reallocate those as to where the demand is emerging. Because the last thing that you want to have happen is that you have doses stuck in one region of the country when the demand is emerging in another region of the country, and then you're having to play catch up.
So analytics to make sure that you have accurate demand planning and then distribution to the regions that require through various sophisticated analytics is going to be required. And then the third piece is definitely thinking about this from a consumer perspective, from a patient perspective around what is the preferred site of care that me, as a patient, that me, as a consumer, would like to get the vaccine in this setting, especially given the experience of what happened during COVID and the shutdown. And you can start seeing consumer preferences around where they choose to go, where they choose not to go, where they choose to engage. And I think the more we are able to provide these outlets where the consumers feel comfortable in going to get the vaccine, we're going to improve the likelihood of having a high coverage rate of these vaccines.
Meagan: To your knowledge, are any of these advanced analytics tools already being implemented?
Omar: The tools themselves, the basic analytics tools, pharma companies use them to drive efficient resource allocation, for example, in their sales forces. Distributors use those tools to drive resource allocation and those allocation of their products. Just want to make sure that there's enough coordination across the value chain so that that analytics, that that forecasting is happening. And that's most likely going to be driven at a state level where the states need to be in the leading role to drive where the demand is, and then the distributors can follow and allocate those doses accordingly.
Meagan: Are the states doing enough to prepare for these challenges?
Omar: I think so. I mean, they've been asked to prepare. And I think they were asked to prepare for the possibility of having a vaccine, I remember, in early November. So different states are starting to plan accordingly but, again, this is the kind of thing where we're really in unprecedented territory. So I think you can never be prepared enough, so to speak. But I think each state is developing its own plan on distribution outlets, potential volumes that they're going to need, etc.
Meagan: So basically, despite this massive coordinated effort and the fact that we've identified these challenges, it sounds like it's still going to be a bumpy rollout to some extent, especially in some places.
Omar: Yeah. I hope it's not going to be a bumpy rollout. It's going to be a fast and furious rollout, and it's going to be a fast ride. But I think anything and everything that we can do to anticipate any such challenges and stop preparing for them is going to be important. And that's one of the reasons why we published the report, for example. And I know there's been a lot of other publications that are starting to emerge on this topic. So hopefully, as an industry, as a private sector, we can all mobilize and we can all start anticipating and planning accordingly here.
Meagan: So what can the pharma industry be doing? Are they doing enough or is there more they need to do in order to prepare for this rollout?
Omar: Listen, like I said before, I think every portion of that value chain, they're really doing everything that they can do. And I can tell you firsthand experience when we formed this coalition that I was referring to, the kind of response that we got was frankly overwhelming around everyone's willingness to put aside all interest with except for the interest of what can we do to address this public health threat? So I think everyone is pursuing this with a lot of sincerity, with a lot of commitment. And the question is that the only concern that I will always have is, given how fast everybody is going in their own swim lanes, who's orchestrating this thing? Who's orchestrating this massive dance?
And that's the piece that I hope that through Operation Warp Speed, that that's the orchestrating body and that there's a lot happening behind the scenes to help...we start getting these vaccines shipped, that that orchestration is going to be managed centrally. We cannot have an example of, for example, the PPE distribution that we encountered early in the crisis just because of the importance of vaccines. Like, you don't want to do anything to disrupt the trust that people have in vaccines. They're so important for our ability to get over this crisis, that the communication, the alignment, the distribution has to be managed very well.
Meagan: I'm curious about that as well. You did say earlier that it sounds like the onus of this distribution challenge is going to be put on the states. Now it sounds like a more centralized network might work better?
Omar: I think it's both. You need both. You need to have the state that's driving the procurement, that's driving the allocation, that's driving the distribution. And then you need to have the states drive the creation of the points of immunization and making sure that they have sufficient points of immunization and they have sufficient communications locally so that everyone who's eligible for a vaccine then knows where to go get the vaccine, knows when they're supposed to get their second shot. So the orchestration has to start on top and then it needs to be very closely coordinated with efforts that happen at the state level. And then even when you go from a state level, it needs to be at a local jurisdiction level as well, at a county level, for example, public health level. So you have to have this cascade here.
Meagan: And I'm curious, given what you've seen with how we've attempted to distribute other critical supplies and medicines during the pandemic and given what you saw when you were putting this report together, how confident are you that this rollout is going to be a success at these different phases?
Omar: So the hope is that we've learned, number one. I think when we encountered the early distribution challenges that occurred, if you take PPE as an example, that was very early on in the COVID crisis. It's fair to say that we were not ready, not from a public health perspective, not from a private sector perspective, to address that challenge. But I think we've learned over time. We've learned over time in the PPE. We've learned over time in the distribution of remdesivir, for example. And then given how much attention that an eventual vaccine is getting and given how much activity we're seeing out there, again, I want to be optimistic here and I want to say, I hope that we will be ready, but hope by itself is not a strategy. And that's why we see a lot of proactive initiatives from various players starting to develop this kind of thinking around what are the barriers and what are the potential solutions. At a small scale, we're driving such thinking bio from a pharma perspective is driving that thinking. There are many other industry coalitions that are starting to drive similar thinking here.
Meagan: Were there other key takeaways from the report that we haven't discussed yet?
Omar: I think there's one aspect and I think that is being managed by Operation Warp Speed. I think if not, then I hope, which is these vaccines, because it's a two-dose vaccine, number one, you want to make sure that whoever gets the first dose gets the second dose because that's how you're going to be protected. And you want to make sure that they're getting the right kind of dose because you cannot cross-immunize. So if you get a dose from one product, the second dose has to be from the second product. So this is going to require a high degree of sophistication in terms of the cracking and almost creating a national registry to track, okay, when did you take your first dose? When are you eligible to come for your second dose? And what kind of dose are you eligible for? And that's the one piece I haven't seen or heard enough, if there are solutions out there that someone is driving or not. So that, in my mind, is still an open question, even though I'm hearing from some of our clients that maybe the government is developing such a solution.
Meagan: Omar, it's almost as if we've been so laser-focused on the approval of a vaccine as sort of the finish line to all this. But really, it sounds like, the approval is just the start of a whole new race.
Omar: The approval is probably one-fourth, one-third way through the race, and then it's about distributing the vaccines. It's about making sure that patients get them. It's about making sure that people don't forget about their second shot. This is a very complicated endeavor.
Meagan: Yeah. So we're a long way from the finish line, it sounds like.
Omar: We're a long way from the finish line. And I think they are probably some interesting analogs that we can learn from other countries of how they manage broad immunization programs. Like, I find that interesting, in Brazil, they have a program called the D-Day Immunization, like the D-Day as in D-Day of the landing D-Day. So they labeled it D-Day, and it's a massive immunization campaign that Brazil launches every year to immunize people with flu, and it works incredibly well. They really have great coverage. There's a lot of publicity behind it. It's fueled by a lot of social awareness. Obviously, you can do something similar here with all the restrictions that we're working through, but it's going to require something like that to make sure that we're able to get to the masses and being able to kind of get the vaccines out there at a broad enough coverage so that we can get that elusive herd immunity that we're all hoping for.
Meagan: Well, Omar, thank you so much for your time. Listen, this was really interesting and informative and has opened my eyes to a lot of the challenges we still have ahead of us. So thank you so much for explaining it.
Omar: Absolutely. Happy to talk, happy to be here with you.
Meagan: You've been listening to "Off Script," a Pharma Manufacturing magazine podcast. Join us next time when we'll discuss our October cover story and find out what's behind the anti-vaccine sentiment that's growing in America and what pharma can do to win the public's trust.