When you get your COVID-19 vaccine, you can thank this federal pharmacist
MAJ Joseph Remesz-Guerrette, PharmD, U.S. Army, has had plenty of experience in the storage and handling of pharmaceuticals over his decade or so in pharmacy. When he joined Operation Warp Speed (OWS) as a medical planner, that know-how was a tremendous asset. “I didn't have to be brought up to speed on how to properly handle these vaccines,” he said. That has been a crucial part of a massive undertaking.
Making it happen
OWS is a partnership among agencies within the U.S. Department of Health and Human Services (HHS)—CDC, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA)—and other federal agencies, including the Department of Defense (DOD); Department of Veterans Affairs; and private firms, when necessary. Remesz-Guerrette is part of DOD’s 100-member team.
The OWS’s team task was to take an abstract idea—distributing COVID-19 vaccines to the public and outlining the logistics required to achieve that—and make it real. “It translates to, how will we manufacture the vaccine, to where to store them, how to distribute them, and then what it looks like when you’re all set to hand it out to each jurisdiction so they can start their programs, and ultimately get everybody immunized,” Remesz-Guerrette said.
OWS is a colossal mission. “We have to plan step by step, saying, ‘All right, what does distribution look like when you’re talking about a scale that spans 50 states and then 8 territories?’” he continued.
Countless factors go into distribution design. “What does that appear like when you have to contract with private partners—we have to rely on nongovernmental entities to do all these tasks, because there’s no way that we would be able to do all those things alone,” Remesz-Guerrette said. “We have to take that ‘whole of America’ approach, where everybody feeds into this process.”
Part of Remesz-Guerrette’s role is to “grease the wheels to help to integrate everybody together and say, ‘This is your part, this is my part,’ and determine if you’re going to be bracketed by other people who will assist you with this or you have to rely on a product from somebody else to do your job. What it ultimately comes down to is that everybody has to do their piece, and we’re all in this together.”
Pharmacist on the team
Here’s where Remesz-Guerrette’s vaccine handling and storage expertise comes into the picture. He has to think through the process backward from the end users about to administer the vaccine to manufacturing. “So, it’s ‘T minus 4 hours or 6 hours or 12 hours, we have to take this out of the deep freezer. Then we have to store it in the fridge. Then we have to reconstitute that, and then be able to lay that out to people,’” he said.
The strategy is related to aspects pharmacists must know to pass the Multistate Pharmacy Jurisprudence Examination exam. “The question may be, ‘You have this product that may have had a temperature excursion. Would you call this product misbranded, or would you call it adulterated?’ ” Remesz-Guerrette said. “No one else here has any idea what you’re talking about, but I know exactly what that means.” He can then translate it into lay language. He’s responsible for creating instructions that end users can easily understand.
One of the biggest challenges is supply. “We would love to not have that problem so that we could hand out all the vaccine. We actually don’t have enough for that,” he said. “To stay fairly equitable through this whole process—to say that we’re just going to go pro rata, it’s going to be based on population—there are all sorts of ‘what-ifs’ to that, and more than ‘what-ifs’ to that.”
There are so many things to consider: concerns about how many people use transit in and out of the city—where they live versus where they work; geographical concerns for people in rural areas; concerns for remote island territories that pose additional logistical challenges. “There are thousands of valid concerns, but at the end of the day, what it boils down to is that we don’t have enough vaccine for everyone to get their full allocation up front.”
Furthermore, there’s a limit to what OWS can do to ease the process. “States will have the ultimate say in this,” he said.
Things get real
Though two COVID-19 vaccines have now obtained emergency use authorization (EUA), communication between manufacturers and OWS begins long before approval. During the EUA process, manufacturers share information with OWS that won’t be shared with the public until they secure authorization. “They shared how to handle their product, what you would have to do for taking it out of the fridge; and then I would contribute to the CDC resources that explain the process of thawing a vaccine, how long that takes, the steps to reconstitute it, and how long it’s good for—it’s an end-user translation that is digestible,” Remesz-Guerrette said.
That translation has to be ready to go at a moment’s notice: OWS and all its partners work together to start shipping the vaccines within 24 hours of their EUA. “[The manufacturer] will ship, ultimately, but we will give them the green light to ship.”
The OWS team and partners shift from planning for this first vaccine into active operations. “We stop using hypothetical data to ask, ‘What if?’ We stop running scenarios, and start taking real data: ‘We’re having shipping problems here,’ or ‘This flight got canceled because of weather, what should we do?’ And then we have to react in real time,” Remesz-Guerrette said.
These issues are extremely real for the people on the ground. “For weeks and months now, we’ve been saying, ‘You’re going to receive a thermal shipper,’ and all of a sudden, they have to pop that open and they’re staring at dry ice that’s starting to sublimate in their face, and they’re on the clock. We’ve talked to them and said, ‘You’ll have X number of minutes to open the packaging,’” he said.
Many decisions will be made on the fly. “We all have roles to play that may vary based upon the issue and the exact time that we get that EUA notification.”
Remesz-Guerrette is deeply proud of how disparate groups came together to carry out a herculean effort.
“We have around 700 people who contribute to the daily effort on [OWS], mainly from [HHS] and then from DOD, obviously,” he said. “When you take two organizations and merge them, especially during a pandemic, when emotions are high and it’s a very stressful situation, that could go extremely poorly. But we’ve actually come together really, really well.”
Success required representatives from many fields and industries. “You have myself from pharmacy. We have medical experts here. We have logistical experts. We have manufacturing experts and many people we would call ‘niche’ experts. But we’ve all come together, and that means a lot to me.”
Remesz-Guerrette hopes that the pandemic response teams of the future recognize the value of what pharmacists bring to the table.
“We clearly have a role in patient care. Pharmacists do that every day. Then if you go all the way up to OWS, in charge of distributing this out, you have a pharmacist here, too,” he said. “We’re at both ends of the spectrum. One is super involved in patient care—giving this to patients and giving unbiased information so patients can decide if they’re comfortable with it—and then one is inside the planning piece. I think what that shows is that we’re extremely versatile, that we can do so many things.”
Pharmacists provide end-to-end support, Remesz-Guerrette said. “I’m not sure that there’re many other roles that would fit that well.”