For many months, Miller County pharmacist Raybun Spelts diligently prepared for the granddaddy of all vaccination efforts.
She collected patient health data on emergency room visits and hospitalizations to provide information to the Georgia Department of Public Health about how many doses the area needs and created a local distribution plan to share with state officials about ways to handle some of the challenges with a vaccine that needs to be kept extremely cold.
But as December began, Spelts was on pause. She couldn’t get answers, as state officials said they were waiting on federal guidance. “The latest I’ve heard from DPH is that they’re reviewing my paperwork,” she said.
Now, with the FDA’s decision last week to authorize the first COVID-19 vaccine, Spelts and other rural health officials have concerns about the number of dosages they will receive and whether they will have the necessary resources and logistical arrangements to carry out the monumental task.
While many are leaning on local health care providers and local governments for assistance, the rural officials say they’ve been left in the dark for weeks about answers to even their most basic questions about preparations. Will some rural hospitals become distribution centers? Do health care providers need to stock up on dry ice? Will they get help arranging enough staff to administer the doses?
Northeast Georgia healthcare leaders will operate “as best as we can with the little information that’s currently available,” Melissa Frank, director of pharmacy services at Northeast Georgia Health System, told the Atlanta Journal-Constitution early this month.
To maximize access to the vaccines for all Americans, the U.S. Department of Health and Human Services has partnerships with large chain pharmacies and networks that represent independent pharmacies and regional chains. The partnerships are said to cover more than half of the pharmacies throughout the nation.
Credit: Courtesy of Northeast Georgia Health Sysem
Credit: Courtesy of Northeast Georgia Health Sysem
State leaders also have vowed to do whatever it takes to get the vaccines to hard-to-reach areas of the state, even if it demands the Georgia National Guard step in.
DPH Commissioner Dr. Kathleen Toomey last week said she is very confident enough doses will be available to inoculate Georgians in rural areas. To make sure those residents won’t be shorted, Gov. Brian Kemp said he has been in touch with the head of the state’s COVID-19 vaccine distribution task force, state Insurance Commissioner John King.
“These protocols and procedures and distributions we’re putting in place applies to everyone in our state,” the governor said.
But those goals seem largely unattainable to leaders in some rural communities, who worry that barriers to health care access in their areas will shunt their residents toward the back of the line. Some Georgia counties have no hospitals and in others patients might have to drive 30 minutes or more to get to a pharmacy or see a doctor, complicating distribution with Pfizer putting a minimum of nearly 1,000 doses in each thermal shipping package.
“We aren’t going to be forgotten,’' said Carly Benton, executive director of The Mercy Ministries, which runs free and charitable health clinics in Toombs and neighboring counties in southeast Georgia. “There’s just going to be as much as a six-month delay to get the vaccines. That’s really the long and the short of it.”
Already, some rural counties say they are being left behind.
Following CDC recommendations, Georgia decided that initial dosages of the Pfizer vaccine will go to health care workers and residents of long-term care facilities. One shipment is going out this week, and another by month’s end.
There won’t be enough to go around, though. And since the bulk of the vaccine will be delivered to more populated areas, shipments to isolated areas will be limited, said Evans Memorial Hospital CEO Bill Lee.
It could be February before enough arrives at his hospital in Claxton, he said. If that’s the case, he said, “we will be some of the last ones. From our perspective, that’s concerning.”
It’s not just their remote locations that put rural areas at a disadvantage. Many health care facilities in rural areas, like Benton’s clinics, can’t afford the ultra-cold refrigeration units, at $10,000 to $15,000 a pop, needed to store supplies of the Pfizer vaccine for up to six months. Without the units, providers will have to keep the vials packed in dry ice in thermal shippers, where they can keep for up to 30 days.
THINGS TO KNOW ABOUT THE PFIZER VACCINE
• Health and Human Services Secretary Alex Azar said the vaccine could get the green light as soon as this weekend.• The vaccine uses synthetic messenger RNA in a tiny lipid nanoparticle suspended in saline solution. The mRNA vaccine does not use the live virus that causes COVID-19. Instead, it gives cells instructions to make a harmless protein piece to trigger an immune system response.• The first doses will be given to health care workers and people who live and work in long-term care facilities. They will be asked to take two shots. The second shot should be taken about three weeks after the first one.• The company has reported the vaccine is 95% effective against COVID-19 beginning 28 days after the first dose.• It must be stored at extremely low temperatures, about -70° C (-94° F) to maintain its integrity.• More than 43,000 people participated in the Phase 3 research to determine its safety and efficacy. The primary side effects were fatigue and headaches lasting up to a few days. Two Pfizer vaccine recipients in the United Kingdom reported allergic reactions, prompting U.S. officials to say Wednesday the vaccine should not be taken by people with a history of allergic reactions.
The Centers for Disease Control and Prevention essentially told rural communities to just hold tight for the next vaccine that might be authorized that may not need such incredibly cold storage, said Bruce Ragon, a longtime public health educator and former professor at Albany State University who specializes in underserved and rural populations.
“When I heard that, my heart just sank to the floor for these people already experiencing increased levels of COVID patients, especially among their minority population,” said Ragon, now a professor of the master’s in public health program at Walden University in Minneapolis.
These are places that need the vaccine, and need it now, he said.
Frank said the Northeast Georgia Health System can store up to 80,000 doses by year’s end. But none will be available at its satellite hospitals in Braselton, Barrow and Lumpkin.
Anticipating the ultra-cold storage requirements, the medical system submitted an order for the purchase of an additional freezer, Frank said. That, and an existing freezer, now sit at the system’s flagship hospital in Gainesville.
“We aren't going to be forgotten. There's just going to be as much as a six-month delay to get the vaccines. That's really the long and the short of it."
- Carly Benton, executive director of The Mercy Ministries
Rural areas in Lyons and Valdosta also aren’t guaranteed to receive shipments of the new vaccine this month to inoculate healthcare workers that serve poor patients at local health clinics, said Donna Looper, executive director of the Georgia Charitable Care Network, which represents dozens of free and charitable care clinics in the state.
“Our clinics would probably would not be able to do the one that has to stay so cold,’' Looper told the AJC.
Hope and dread
DPH’s distribution plan also says more doses will go to providers with the capacity to administer the shot, and rural health care leaders will struggle to marshal other resources needed for a mass vaccination campaign.
Staffing is a significant challenge.
CDC recommends staggering vaccination of health care workers because some will suffer side effects that may waylay them for one or two days. That could deprive hospitals, nursing homes and ambulance services, already pushed to the limit by the pandemic, of critical staff.
Rural hospitals and nursing homes will need a partnership with health departments so they can stagger shots over time, CDC experts said.
Rural health care providers will also have to have staff to handle the recordkeeping required to keep track of the two rounds of shots each person needs, to ensure both are given.
They also may strain to monitor for side effects, particularly among nursing home residents who often have complex health issues. Caregivers will likely have to be trained on what to look for and how to complete the electronic documentation required to report adverse events.
A poll of pharmacists, physicians and nurses at U.S. health systems echoed concerns that state and federal authorities had “not prepared them” or “somewhat prepared them” to receive and distribute a COVID-19 vaccine. The survey was conducted by Premier Inc., a North Carolina supply chain provider of medical equipment to U.S. health systems.
And a survey last month of free and charitable clinics in 15 states including Georgia showed many of the providers are anticipating the same lack of resources they experienced in the early months of the pandemic.
“There is hope and dread,’' said Joe Agoada, CEO of a New Jersey nonprofit, Sostento that is heading a national initiative to help underserved communities fight the pandemic. Its “Project Finish Line” is supporting dozens of clinics, including rural facilities in Valdosta and Vidalia.
“Hope, because the vaccine could be the light at the end of the tunnel,” Agoada said. “Dread, because if you think about it, early on, if you were a healthcare worker, that didn’t mean you could get PPE, and if you wanted a test, that didn’t mean you would get one in a timely manner.”
‘All hands on deck’
Rural health care providers also may have to marshal forces to begin mass vaccination. They may need to have hundreds of people lined up to get vaccines in a short period of time — a challenge in sparsely populated areas.
“It’s going to be all hands on deck,’' said Shawn Whittaker, chief nursing officer at Miller County Hospital Authority, which throughout its network employs roughly 700 workers at several nursing and skilled home facilities, a hospital, standalone clinics, a mobile health center and a retail pharmacy.
Spelts, the Miller County pharmacist, will be racing the clock. Once shipments arrive, she must work to administer the doses within five days. She says she may also have to load up dry ice to avoid spoilage.
It’s a logistics feat, but it’s doable, said Dr. Sam Sun, director at inDemic Foundation, a New York-based nonprofit involving a cadre of scientists, physicians and epidemiologists working to analyze and aggregate data on COVID-19 vaccines. Rural communities will be able to safely deliver the vaccines if they can limit the delay between each shipment of the medications and the administration of the vaccines.
“You don’t want to be plucking one dosage at a time,” Sun said. “That would be to much heat transference and it’s not going to work out.”
The vaccine presents many unique challenges in rural areas, said Marilyn Helms, a professor of supply chain management at Dalton State College.
“Are we ready?” she wondered. “We hope so.”
Staff writer Eric Stirgus contributed to this report.