Large urban hospitals across the U.S. are rushing to buy expensive ultra-cold freezers to store what’s likely to be the first approved Covid-19 vaccine. But most rural hospitals can’t afford these high-end units, meaning health workers and residents in those communities may have difficulty getting the shots.
The vaccine, developed by Pfizer and the German firm BioNTech, seems to provide 90% immunity according to early data released on Monday. But there’s a catch: The vaccine has to be stored at -70 degrees Celsius. Typical freezers don’t get that cold, making distribution of this vaccine a logistical nightmare.
The Centers for Disease Control and Prevention has advised state health departments against purchasing ultra-cold freezers — which cost $10,000 to $15,000 each — saying other vaccines with less demanding storage requirements will be available soon. Hospitals with money to spare are flouting this guidance. Four major health care systems, from North Carolina to Ohio, North Dakota, and California, told STAT they had bought additional ultra-cold freezers, while Jefferson Health in Philadelphia said it has leased five units.
About 20% of the hospitals that work with Vizient, one of the largest group purchasers for U.S. hospitals, have bought -80 C freezers, said Azra Behlim, its senior director of pharmacy sourcing and program services. Vizient works with 60% of hospitals nationwide, suggesting that more than 10% of hospitals have shelled out for their own freezers. She couldn’t provide a breakdown, but another major group purchasing organization, Premier, said most of its clients buying ultra-cold freezers were academic medical centers.
“The rural and the small hospitals would be disadvantaged,” said Soumi Saha, a pharmacist and Premier’s director of advocacy.
This purchase is out of reach for poorer hospitals, especially those in rural areas that can barely manage daily expenses. Nearly half of U.S. rural hospitals were operating at a loss in April of this year, said Alan Morgan, chief executive of the National Rural Health Association. And the pandemic has further weakened hospitals’ finances.
Rural populations are precisely those that are vulnerable to Covid-19 and most in need of a vaccine, noted Morgan: “Hundreds of rural, small towns all across the U.S. have a higher percentage of elderly, low-income [residents], a higher percentage of the community with multiple chronic health issues.” Yet, he added, “in this financial environment, you can imagine that there is simply no consideration of rural hospitals purchasing storage equipment for this ultra-cold distribution.”
And so, wealthier, urban hospitals have a huge advantage in gaining access to the vaccine that is expected to be one of the first authorized for widespread distribution. “The optics are horrible. We’re in the middle of the most divided election of my lifetime — and I’m in my 70s — and one of the most divided in our country’s history,” says Tim Size, executive director of Rural Wisconsin Health Cooperative. “A lot of that divide is rural and urban, and we’re being left behind.”
Asked about the challenges of distributing the vaccine to rural areas, a Pfizer spokesperson said the company “is committed to ensuring everyone has the opportunity to have access to our vaccine working closely with local government.” Pfizer is practiced at distributing and storing the vaccine as part of its Phase 3 clinical trial, the spokesperson added.
Even without the ultra-cold freezer divide, there are other obstacles to making the Pfizer vaccine available in rural communities. The company plans to ship the vaccine to distributors in storage containers of 1,000 to 5,000 doses.
The containers will keep the vaccines at -75 C (plus or minus 15 degrees) on dry ice, for 10 days. Once opened, the containers can be used for 15 more days with re-icing every five days, though the boxes can be opened only for a minute at a time no more than twice a day. The doses can survive five more days while refrigerated.
“It requires a very, very tightly coordinated effort,” said Paul Biddinger, medical director for emergency preparedness at Mass General Brigham in Boston. The time pressure is more intense in rural areas, where the longer delivery time eats into the number of days when the vaccine can be safely stored in their boxes upon arrival. Regions with smaller populations will struggle to use the thousand-dose supply in the necessary time period, creating a risk some of the vaccines will go to waste, though Pfizer plans to have smaller boxes available by early 2021. In contrast, the vaccine can be stored in ultra-cold freezers for six months.
In North Carolina, the state encouraged vaccine shipment sites to have access to ultra-cold freezers, said Chris Ohl, professor of infectious diseases at Wake Forest Baptist Health in Winston-Salem. “Without it, you’re not going to be able to have much of a vaccine program,” he said. Not only do they help with Pfizer’s shot, but ultra-cold freezers are also an asset for distributing Moderna’s Covid-19 vaccine candidate, which must be stored at -20 C. Though many medical and pharmaceutical freezers get that cold, an ultra-cold freezer will expand the availability of cold storage for those that don’t have access to one.
The North Carolina health department said that ultra-cold storage was not a requirement to be a vaccine provider, but that the federal government advised states to identify such sites for the very first vaccines distributed.
In Hamilton, Mont., a city with about 4,900 residents, Rocky Mountain Laboratories is planning to contribute its ultra-cold freezers for Covid-19 vaccine storage. “There are a huge number of towns our size and larger that don’t have Rocky Mountain Labs embedded in them,” said Marshall Bloom, associate director for scientific management at the laboratory, a part of the National Institute of Allergy and Infectious Diseases. “It’s going to be a challenge for these towns to meet those requirements.”
Given the clear value of ultra-cold freezers, many people in health care are puzzled by the CDC guidance against buying them. “Some of us were kind of scratching our head — you know, storing in a box for only 10 days when you have a certain amount of drug would be a little bit hard,” said Shelly Wiest, vice president of pharmacy services at UC Health in Cincinnati. “A lot of the commentary from the health department and state has been to not go ahead and purchase. That to me is a bit risky,” added Duke University Hospital infectious disease specialist Cameron Wolfe.
Others point out that there will be a limited supply of the Pfizer Covid-19 vaccine at first, and many other candidates in the works don’t require ultra-cold storage. “If you are one of those providers in a state or an area where you’re not a hot spot and you don’t have a high-risk population, it’s probably not a good idea for you to invest in the freezer,” said Vizient’s Behlim. The CDC has emphasized that most vaccines won’t require ultra-cold chain support. “Assuming everything goes well, there will be more vaccines available and products that can be handled at routine immunization sites throughout the United States,” Jay Butler, CDC deputy director for infectious diseases, said during a media briefing last month.
Vaccine storage is also less of a problem if there aren’t many vaccines in distribution. “In the first phase of vaccine distribution, OWS [Operation Warp Speed] anticipates having a limited supply of COVID-19 vaccines to distribute, which should ease initial concern over potential long-term storage of vaccine doses,” said a spokesperson for the Department of Health and Human Services. Vaccines will be sent to locations where vaccines can quickly be administered, meaning storage won’t be required, they added, and vaccines at risk of expiring will be redirected to sites with higher demand.
Plus, ultra-cold freezers are expensive. “It would be a huge outlay for the entire health system of the country,” said Ohl at Wake Forest. Without clear direction about who should invest in these freezers, states and hospitals have fended for themselves, with varying results. North Dakota has opted to buy four freezers and nine portable freezers for $100,000, while in Pennsylvania, Cindy Findley, director of the division of immunization in the Department of Health, said the state chose to follow CDC advice and not purchase its own units.
But Philadelphia’s Jefferson Health system did lease freezers. “I didn’t ever want to be stuck in a situation where products were available but we couldn’t receive them because we can’t store it,” explained Brian Swift, the system’s chief pharmacy officer. “That would be a tragedy as far as I’m concerned.”
Pfizer’s vaccine aside, ultra-cold freezers are otherwise useful only for research, meaning they’re more attractive purchases for academic medical centers, which tend to be based in cities.
“Obviously people who have more money and better access to the supply chain are buying freezers,” said Size, of the Rural Wisconsin Health Cooperative. “Rather than a cohesive national plan, we’ve created have versus have not, state versus state.”
“Rather than a cohesive national plan, we’ve created have versus have not, state versus state.” TIM SIZE, EXECUTIVE DIRECTOR OF RURAL WISCONSIN HEALTH COOPERATIVE
Covid-19 vaccine distribution will be a complex feat even with ultra-cold freezers. “The ultra-low storage conditions are so unprecedented that in order to be successful it has to be a perfectly orchestrated and choreographed dance,” said Premier’s Saha.
Administering the vaccines is so time-sensitive that Duke University Hospital will have people travel to sites with ultra-cold freezers to get their shots, Wolfe said. For those who can’t travel — such as nursing home residents — the plan is to get consent in advance so that people are ready to receive vaccines on arrival, he said.
The divide between urban and rural areas is not absolute: Sanford Health, the country’s largest rural nonprofit health care system, opted to buy six -80 C freezers — a decision driven in part by the pandemic stretching many of its hospitals to near the breaking point.
“All this is happening at a time when our volume in hospitals is surging at a high point,” said Jesse Breidenbach, senior executive director of pharmacy support services at Sanford Health, with locations in North Dakota, South Dakota, Minnesota, and Iowa, all states now among the hardest hit in the country. When intensive care units are full and staff are run off their feet, hospitals may not have the resources to respond to a last-minute arrival of fast-decomposing vaccines in time.
Owning freezers “lets us plan out our strategy to do it on our terms instead of having to respond immediately when the shipment comes,” Breidenbach added.
Ultra-cold freezers also seemed far simpler than relying on dry ice, which has to be stored and handled carefully. “You can burn your fingers if you touch that stuff without the right protection. It’s a complicated packaging additive that comes with its own set of risks,” said Jefferson’s Swift. Dry ice comes with regulation: It’s considered hazardous when shipped by air or water, but not if driven, so most dry ice in the United States comes from local, rather than national, suppliers. Behlim said Vizient is anticipating a dry ice shortage in some rural areas.
If the CDC was worried about a shortage of ultra-cold freezers, it hasn’t happened yet. One company, Helmer, reached capacity and now can’t deliver new freezers until March but, for the most part, suppliers are delivering ultra-cold freezers in two to six weeks, said Behlim. Much like for vaccines, though, the distribution of ultra-cold freezers isn’t even across the country. One local Wisconsin hospital looked into acquiring freezers, said Size, but was told delivery would take two to three months. Larger hospitals with the budgets for multiple purchases come first, he said.
“It’s another good example of how all our rural hospitals are at the end of a supply chain with less leverage to make important purchases,” he said. “It’s the wild west of the supply chain; that’s not how you fight a pandemic.”