Big questions remain about who should and will receive the first COVID-19 vaccinations as federal approval is expected to come this week for the first of two vaccine candidates.
A federal advisory panel Thursday recommended that the Food and Drug Administration grant emergency use authorization to a vaccine candidate made by Pfizer and BioNTech based on safety and efficacy results included in a briefing document released prior to the meeting. Full FDA approval could come as soon as Friday.
Federal health officials have estimated distributing enough doses to vaccinate as many as 20 million Americans by the end of year.
A Centers for Disease Control and Prevention advisory panel earlier this month recommended that front-line healthcare workers and residents of long-term nursing care facilities be given the highest priority for getting the vaccine. But there won't be enough doses initially for all of the people in the the CDC's highest tier and the federal government didn't recommend either group go first, leaving it to the states to decide.
Given how quickly COVID-19 spreads through a nursing home, representatives for the sector would like to see the doses go there first.
"If long-term care residents and those employees aren't vaccinated first, it is an enormous public health blunder," said Mark Parkinson, president and CEO of the American Health Care Association/National Center for Assisted Living.
"Vaccinating anybody that's in that top tier will be helpful but the single best way to very quickly reduce the number of COVID deaths is to get the population vaccinated who is dying from the disease," Parkinson said. "That is the people who are in these long-term care facilities."
Deaths among long-term care residents represent about 40% of the total COVID-19 death toll in the U.S. because the virus disproportionately affects those who are older and have comorbidities.
Adding to the tension and confusion, hospital groups are pushing strongly for their front-line staffers to be first in line.
"With a very limited supply of initial vaccines being available, the (American Hospital Association) has asked that healthcare workers who have been on the front lines in battling COVID-19, and saving lives over this past year, to be in the first group able to access vaccines. Ensuring that our front-line workers are protected against this virus will help guarantee access to the best care for all our patients and communities," said Nancy Foster, the AHA's vice president of quality and patient safety policy, adding, "For the same reason the flight attendant advises you to put your own mask on first before helping others, healthcare workers need to be protected so that they can go on helping others during this pandemic."
The vaccine won approval for use in the United Kingdom last week and is being distributed to patients. If approval is granted for the Pfizer vaccine, Walgreens and CVS clinics, which will administer the vaccine in nursing homes, could be set up on site the weeks of Dec. 21 and Dec. 28. A second vaccine developed by Moderna is scheduled to be reviewed in the U.S. Dec. 17.
Already, New York Gov. Andrew Cuomo has committed to sending the state's first round of the vaccine to nursing home staff and residents. Parkinson said AHCA/NCAL would like to see leaders publicly commit to administering the second round of the vaccines to the entire long-term care population by March 1.
"The federal decision to not mandate it and instead just recommend it has made this harder but it looks like we can still achieve this goal in getting folks the vaccine," Parkinson said.
Hospitals prepare for a vaccine
Some hospitals in Ohio have been allocated the first round doses. On Dec. 4, Ohio Gov. Mike DeWine announced the first phase of the state's vaccine distribution program would entail receiving 98,000 doses of the Pfizer COVID-19 vaccine by Dec. 15, with 10 hospitals receiving 9,800 doses each. Among the sites earmarked to receive the first doses of vaccine are OhioHealth's Riverside Methodist Hospital in Columbus and O'Bleness Hospital in Athens.
Dr. Doug Knutson, vice president of quality and leader of an incident command center at OhioHealth, said the planning process to receive, store and ultimately distribute a vaccine began in mid-September after HHS released an outline of its vaccine distribution strategy.
Knutson said personnel at highest risk for contracting the virus will have first access to the vaccine, which include both clinical and non-clinical personnel working directly with COVID-positive patients. Those working within the emergency department, as well as professionals who perform medical procedures that put them at higher risk for COVID transmission, such as anesthesiologists and trauma surgeons, will also have priority.
One of the first decisions the health system made in its planning was to purchase two additional ultra-cold storage freezers in anticipation of the Pfizer and BioNTech vaccine, which must be stored at a temperature of -75 degrees Celsius.
But storing the vaccine is only one part of the complexities associated with administering the Pfizer vaccine, said Dr. Joseph Gastaldo, medical director of infectious disease at OhioHealth.
Once the vaccine is taken out of storage it has a lifespan in about six hours before it becomes ineffective. Gastaldo said the small time window to vaccinate will require a more coordinated process to set up appointments than would normally be done for other types of vaccinations. He said the health system plans to send text message reminders to those scheduled to get vaccinated to ensure they do not miss or arrive late to their appointment.
Like OhioHealth, coordination has been a key part of the vaccine distribution program MidMichigan Health has been developing to administer the 975 doses it expects to receive for nearly 1,000 staff members identified as being the highest of the high-priority workers across its six hospitals and seven medical centers.
The Midland, Mich.-based health system last month started working on its distribution program, which will comprise six stations that will screen, register, document, vaccinate, monitor, and then re-schedule them for a second dose 21 days later. MidMichigan purchased two ultra-cold freezer units that can each store as many as 30,000 doses of vaccine.
Dr. Lydia Watson, senior vice president and chief medical officer at MidMichigan Health, said the process to vaccinate high-risk employees is tentatively scheduled to take place Dec. 21 through Dec. 23, depending on whether the Pfizer vaccine is approved and the health system receives its allotted supply by next week.
Among the employees slated to get the vaccine are staff within the intensive care unit, emergency department, emergency medical services and those who work on hospital floors that have been designated for COVID-19 patients. Because an estimated 80% of those who will take the vaccine are expected to have side effects, Watson said vaccinations will stagger across departments over the three-day period to ensure no more than one-third of personnel from any one unit is receiving the vaccine at one time to minimize the potential impact on staffing if complications occur.
"The fact that we are only getting a certain number logistically is helping us through some of this initial planning," Watson said.
Dr. Tim Williamson, vice president of quality and safety for the University of Kansas Health System, said he anticipated also receiving a relatively small supply initially. He said the health system was slated to get 775 doses of the Pfizer vaccine by next week, with plans of receiving weekly shipments thereafter.
Williamson said they are currently working on maximizing vaccine preparation within their pharmacy and reducing storage needs in other areas to accommodate vaccine supplies.
A primary concern is having limited amounts of space to conduct large-scale vaccination clinics while adhering to social distancing practices, as well as having enough staff available to administer the vaccine. Both concerns are a common problem other healthcare providers face as they look ahead at the prospect of expanding their vaccination effort to whole communities.
"There are no extra people to go out and get right now because of the pandemic touching everyone," said Dr. Richard Freeman, regional chief clinical officer for Loyola Medicine in suburban Chicago.
Loyola is slated to receive an initial supply of 16,575 doses of vaccine as part of its role as one of 10 health systems in Illinois designated as a regional hospital coordinating center to distribute COVID-19 vaccine to surrounding providers within their area.
Freeman said nearly 300 members of Loyola's clinical staff at its flagship facility, Loyola University Medical Center, are currently in quarantine due to either testing positive for COVID-19 or because they were exposed.
He said remaining staff has been asked to work longer hours, while plans are underway to ask medical school and nursing school students as well as retired doctors, nurses and pharmacists to volunteer to help administer vaccine doses and handle paperwork.
"We're really having to be pretty flexible with what we're doing ," Freeman said. "It's a stretch for our folks and it's the right thing to do, but we're going to have some very tired people by the end of this."
Long-term care readies for vaccine
For their part, long-term care facilities are waiting for guidance from CVS and Walgreens on how vaccine distribution will work. The two retail pharmacy chains were tapped by the Trump administration on Oct. 16 to handle vaccine administration in long-term care facilities to help "solve a logistical hurdle and decrease the burden of distributing, administering and reporting COVID-19 vaccination for both states and long-term care facilities," CDC Director Dr. Robert Redfield said at the time.
The pharmacy chains will be responsible for managing the vaccines and supplies, including syringes, needles and personal protective equipment; cold storage; administration of the vaccine and reporting vaccination data.
"They will be showing up on site with Band-aids," said Ruth Link-Gelles, an epidemiologist at the CDC, said during a call with members of LeadingAge, which represents aging services providers.
Even so, Dr. David Gifford, chief medical officer for AHCA/NCAL, called it a "monumental task" to quickly vaccinate the millions of residents and staff in nursing homes and assisted living facilities against COVID-19.
It's likely that staff and residents will get vaccinated at the same time in most facilities, Gifford said. In some cases, staff may be able to get vaccinated at a clinic in a hospital or retail pharmacy a week or two before residents, depending on the state's plans, he said.
"This has sort of been a rapidly evolving and changing process," Gifford said.
CVS and Walgreens both are hiring thousands of employees to help administer the vaccine. CVS announced in October that it planned to hire 15,000 employees this winter, 10,000 of whom would be licensed pharmacy technicians, a group the federal government recently gave the authority to administer the COVID-19 vaccine.
Link-Gelles said the pharmacies will work directly with facilities to determine if a centralized clinic can be set up or if residents will need to be vaccinated in their rooms.
The deal with pharmacies does not include the vaccination of those in independent living but Link-Gelles said some of those people could receive the vaccine if doses are available. The number of doses allocated to long-term care facilities is based on bed capacity but many sites are not operating at full capacity right now and not all staff and residents will want to be vaccinated, she said.
A big piece of the vaccination process in long-term care facilities will involve getting informed consent from residents, their families and staff, which includes full-time, part-time, contract and unpaid workers, Link-Gelles said, noting that it's important those being vaccinated know the risks and benefits of the vaccine.
Gifford said he doesn't expect there to be any mandates at the federal, state or facility level for residents to get the vaccine.
"We've heard a lot of interest in the vaccine. A lot of families and residents are really worried about this virus. So they're very excited and looking forward to getting the vaccine because of that concern," Gifford said.
Likewise, Parkinson expects that the majority of long-term care staff will want to be vaccinated.
"Our employees have really been through hell and back over the last eight months," he said.
More than 1,000 long-term care staff have died from COVID-19, and AHCA/NCAL estimates about 5,000 residents die per week.
"Tragically, our people have seen upfront how horrible this virus can be," Parkinson said. "So I would assume that the adoption rates would be much higher among workers and residents in facilities. ... Our hope is that we get widespread acceptance of the vaccine but, if we don't, I assure you that our organization, as well as individual operators. will be analyzing whether or not they can mandate the vaccine. We're just hoping we don't have to go there."
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