The most vulnerable health establishments face the dilemma of investing in the necessary technology to be able to store the preparations at that temperature or wait for another formula to allow them to avoid too great a cost
November 11, 2020 Share on FacebookShare Share on TwitterTweet Share on WhatsAppShare
REUTERS / Dado Ruvic / Illustration
As America's large urban hospitals scramble to purchase expensive ultra-cold freezers to store what is likely to be the first approved COVID-19 vaccine, most rural hospitals cannot afford these high-end units , which could make it difficult for workers to health workers and residents of those communities receive vaccines, says the specialized health and medicine media STAT .
The vaccine developed by the American Pfizer and the German BioNTech claims to provide 90% immunity according to the first data published last Monday. But the problem is that the vaccine has to be stored at -70 degrees Celsius and typical freezers do not get that cold , making distribution a logistical nightmare.
The Centers for Disease Control and Prevention ( CDC ) have advised the health departments of the different states of the United States not to buy ultra-cold freezers, which cost between $ 10,000 and $ 15,000 each As, according to them, other vaccines with less demanding storage requirements will soon be available . However, hospitals with money to spare ignored the recommendation : Four major health systems in North Carolina, Ohio, North Dakota and California told STAT that they have already purchased additional ultra-cold freezers, while Jefferson Health in Philadelphia He claimed to have rented five units.
Rural areas and small hospitals would be at a disadvantage
About 20% of hospitals serving Vizient , one of the largest group hospital buyers in the US, have purchased -80C freezers, said Azra Behlim , its senior director of pharmaceutical sourcing and services for the program. Vizient works with 60% of hospitals nationwide , which suggests that more than 10% of hospitals have gone out of business to purchase their own freezers . Behlim did not provide a breakdown, but another major group purchasing organization, Premier , indicated that the majority of its customers who buy ultra-cold freezers are academic medical centers.
” Rural areas and small hospitals would be at a disadvantage, ” said Soumi Saha , Premier's pharmacist and promotion director.
This purchase is beyond the reach of the poorest hospitals, especially those in rural areas that can barely handle daily expenses . Nearly half of rural hospitals in the US have been operating at a loss since April this year , said Alan Morgan , executive director of the National Rural Health Association. And the pandemic has further weakened its finances .
Rural populations are precisely the most vulnerable to COVID-19 and the most in need of a vaccine , Morgan noted: “Hundreds of small rural cities across the US have a higher percentage of elderly, low-income [residents], a higher percentage of the community with multiple chronic health problems ”. However, he added that “in this financial environment, you can imagine that there is simply no consideration for rural hospitals purchasing storage equipment for this ultra-cold distribution .”
In this way, wealthier urban hospitals have a great 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 are in the middle of the most divided election of my life, and I am in my 70s, and one of the most divided in the history of our country, “said Tim Size , executive director of Rural Wisconsin Health Cooperative. ” Much of that divide is rural and urban, and we are falling behind .”
In this financial environment, purchasing storage equipment for this ultra-cool distribution is not considered.
Asked about the challenges of distributing the vaccine in rural areas, a Pfizer spokesperson said the company ” is committed to ensuring that everyone has the opportunity to access our vaccine in close collaboration with the local government .” Pfizer is working on the distribution and storage of the vaccine as part of its phase 3 clinical trial, the spokesperson added.
Even without the ultra cold freezer issue, there are other obstacles to making 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 on dry ice, for 10 days . Once opened, the containers can be used for an additional 15 days with re-freezing every five days , although the boxes can only be opened for one minute at a time no more than twice a day . Doses can survive an additional five days while refrigerated.
“It takes a very, very coordinated effort,” said Paul Biddinger, emergency medical director at Mass General Brigham in Boston. Time pressure is most intense in rural areas, where delivery time is reduced to the number of days the vaccine can be safely stored in its boxes . Regions with smaller populations will have a difficult time using the 1,000-dose supply in the required time frame , creating the risk that some of the vaccines will go to waste , although Pfizer plans to have smaller boxes available by early 2021. For on the contrary, the vaccine can be stored in freezers for six months.
REUTERS / Fabrizio Bensch
The dilemma of an investment
In North Carolina, vaccine delivery sites were encouraged to have access to ultra-cold freezers, said Chris Ohl, professor of infectious diseases at Wake Forest Baptist Health in Winston-Salem. ” Without it, we will not be able to have a vaccine program, ” he said. Not only do they help with the Pfizer injection, but the ultra-cold freezers are also an asset for distributing Moderna's COVID-19 vaccine , which should be stored at -20 C. Although many medical and pharmaceutical freezers cool enough, an ultra-cold freezer will expand the availability of cold storage for those who don't have access to one.
The North Carolina Department of Health maintained that ultra-cold storage was not a requirement to be a vaccine supplier, but that the federal government advised states to identify such sites for the first vaccines distributed .
In Hamilton, Montana, a city of approximately 4,900 residents, Rocky Mountain Laboratories plans to contribute its ultra-cold freezers for COVID-19 vaccine storage . “There are a lot of cities our size and larger that don't have Rocky Mountain Labs,” said Marshall Bloom, associate director of scientific management at the lab, part of the National Institute of Allergy and Infectious Diseases. ” It will be a challenge for these cities to meet those requirements, ” he added.
Given the significant value of ultra-cold freezers, many healthcare practitioners are baffled by the CDC's recommendation against buying them. “A lot of the comments from the health department and the state have been that you don't have to buy. That's a little risky for me,” said Cameron Wolfe, an infectious disease specialist at Duke University Hospital.
It would be a large outlay for the entire health system of the country
Others note that there will be a limited supply of Pfizer COVID-19 vaccine initially and that many other candidates in the pipeline do not require ultra-cold storage. “ If you're one of those providers in a state or area where it's not a hot spot and doesn't have a high-risk population, it's probably not a good idea for you to invest in the freezer, ” Vizient's Behlim said. The CDC has emphasized that most vaccines will not require ultra cold chain support . “Assuming all goes well, there will be more vaccines available and products that can be handled at routine immunization sites across the United States,” said Jay Butler, CDC's deputy director of infectious diseases, during a news conference last month. .
Vaccine storage is also less of a problem if there are not 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 alleviate initial concerns about possible long-term storage of vaccine doses. ”Said a spokesman for the Department of Health and Human Services . Vaccines will be shipped to places where they can be administered quickly, meaning they won't need to be stored, and those at risk of expiration will be redirected to sites with higher demand.
Also, ultra-cold freezers are expensive. ” It would be a huge outlay for the entire health system in the country, ” Ohl said in Wake Forest. Without clear direction on who should invest in these freezers, states and hospitals have stood up for themselves, with mixed results. North Dakota has chosen to buy four freezers and nine portable freezers for $ 100,000, while in Pennsylvania, Cindy Findley, director of the immunization division at the Department of Health, said the state chose to follow the CDC's advice and not buy your own units.
But the Jefferson Health system in Philadelphia decided to rent freezers. “ I didn't want to be stuck in a situation where the products were available, but we couldn't receive them because we can't store them, ” explained Brian Swift , pharmacy manager for the system. “That would be a tragedy as far as I'm concerned.”
REUTERS / Bing Guan
“A perfectly choreographed dance”
Pfizer's vaccine aside, freezers are only useful for research, which means they're more attractive purchases for academic medical centers, which tend to be based in cities.
“Obviously, the people who have more money and better access to the supply chain are buying freezers, ” said Size of the Wisconsin Rural Health Cooperative. ” Instead of a cohesive national plan, we have created having against not having, state against state .”
The distribution of the COVID-19 vaccine will be a complex feat even with ultra-cold freezers. “The ultra-low storage conditions are unprecedented in that to be successful it has to be a perfectly orchestrated and choreographed dance,” said Premier's Saha.
Vaccine administration is so urgent that Duke University Hospital will have people travel to sites with ultra-cold freezers to receive their vaccines , Wolfe said. For those unable to travel, such as nursing home residents, the plan is to obtain consent in advance so that people are ready to receive vaccinations upon arrival, he added.
Our rural hospitals are at the end of a supply chain
The divide between urban and rural areas is not absolute: Sanford Health, the nation's largest nonprofit rural healthcare system, chose to purchase six -80 C freezers , a decision driven in part by the pandemic that led to many of its hospitals almost to the limit.
“All of this is happening at a time when our hospital volume is rising to a high point ,” said Jesse Breidenbach, senior executive director of pharmacy support services at Sanford Health , based in North Dakota, South Dakota, Minnesota. and Iowa, all states among the hardest hit in the country. When intensive care units are full and staff are exhausted, hospitals may not have the resources to respond to a last-minute arrival of rapidly spoiling vaccines on time.
Having freezers ” allows us to plan our strategy to do it on our terms rather than having to respond immediately when the shipment arrives ,” added Breidenbach.
It's the wild west of the supply chain; This is not how you fight a pandemic
Ultra-cold freezers also seem much simpler than relying on dry ice, which must be stored and handled with care. “You can burn your fingers if you touch those things without proper protection. It's a complicated packaging additive that comes with its own set of hazards,” said Swift of Jefferson. Dry ice has its regulations: It is considered dangerous when shipped by air or water, but not when driven, which is why the majority of dry ice in the United States comes from local suppliers, rather than national ones . Behlim said Vizient anticipates a dry ice shortage in some rural areas.
If the CDC was concerned about the shortage of freezers, it hasn't happened yet. One company, Helmer, has reached capacity and is now unable to deliver new freezers until March, but for the most part suppliers are delivering ultra-cold freezers in two to six weeks , Behlim said. However, as with vaccines, the distribution of ultra-cold freezers is not even found across the country . A local Wisconsin hospital investigated the possibility of purchasing freezers, Size said, but was told it would take two to three months for delivery. Larger hospitals with multi-purchase budgets are a priority , he added.
“It's another good example of how all of our rural hospitals are at the end of a supply chain with less leverage to make major purchases,” he said. “ It's the wild west of the supply chain; This is not how you fight a pandemic ”, he concluded.