With two vaccines for the novel coronavirus nearing emergency approval, federal and state governments assisted by healthcare organizations are preparing a massive national inoculation program that rivals the scope and urgency of polio vaccination in the 1950s and ‘60s.
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In Ohio, Cleveland Clinic has a leading part in the COVID-19 vaccination process, advising public health officials and serving as one of the 10 designated vaccine distribution hubs.
Some details of the complex, fast-moving program are still being worked out. Initial supplies of the vaccine are expected to be extremely limited and will be prioritized for people with the greatest need. Distribution is expected to begin in mid-December, with only one or two days’ notice before shipments arrive.
Challenges include meeting the vaccines’ special storage requirements, distributing scarce vaccine supplies fairly and effectively, explaining the program to the public, tracking and determining the significance of any adverse reactions, and ensuring that recipients get required second doses.
“We’ve been working for several months to ensure that, as soon as a vaccine becomes available, we’re ready to get it to the people who need it most,” said Chief Medical Operations Officer Robert Wyllie, MD, who is leading Cleveland Clinic’s COVID-19 community protection efforts, including vaccine planning.
“We’re trying to minimize the unknowns as best we can and plan for different scenarios,” said Jeffrey Rosner, RPh, Executive Director of Pharmacy Sourcing and Supply Chain Analytics in Cleveland Clinic’s Department of Supply Chain Management. Rosner and Dr. Wyllie provided a preview of the vaccination program.
A new vaccine strategy
The first two COVID-19 vaccines likely to become available through the federal government’s Operation Warp Speed program both employ a nontraditional approach. The vaccines, developed by the drug companies Pfizer and Moderna, each use a lab-synthesized string of messenger RNA that encodes a modified version of the coronavirus’s spike glycoprotein, provoking a sustained immune response that destroys invading virions.
Pfizer and Moderna each recently reported their vaccines showed nearly 95% efficacy and no serious safety concerns, based on interim analysis of phase 3 clinical trials. Pfizer and its partner BioNTech have submitted an emergency use authorization (EUA) application to the U.S. Food and Drug Administration (FDA), which will be reviewed on December 10. The FDA is expected to review Moderna’s EUA application Dec. 17. Following approval, both companies say they will have tens of millions of doses ready for national distribution by the end of 2020, with hundreds of millions of additional doses available in 2021 as production ramps up. Other COVID-19 vaccines also are in the pipeline.
Vaccine allocations to individual states will be based on their populations and the rates of new COVID infections and hospitalizations.
Since there will not be enough supply initially to meet demand, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will decide the order in which various groups of people will receive the vaccine. The ACIP has incorporated guidance from the National Academies of Sciences, Engineering, and Medicine and has proposed a four-phase approach:
- Phase 1a: Healthcare providers including frontline caregivers, emergency responders and hospital cleaners; residents of long-term care facilities.
- Phase 1b: Essential workers in high-risk fields such as education, food and agriculture, public utilities, emergency response, prisons and transportation.
- Phase 1c: People with high-risk medical conditions; people older than 65.
- Phase 2: People with moderately high-risk medical conditions; residents and staff in homeless shelters and group homes; inmates younger than 65 in jails, prisons and detention centers.
- Phase 3: Young adults and children (if the vaccine is determined safe for them); workers in industries such as hotels, banking, higher education and manufacturing.
- Phase 4: All other U.S. residents.
Within those broad categories, individual state governments will then designate where and to whom their vaccine allotments will be distributed. The Ohio Department of Health has identified 10 “pre-positioning” sites — all hospitals — across the state where vaccine shipments will be delivered for temporary storage, distribution and administration to approved recipients.
The sites were chosen based on their geographic location, nearness to population centers, and their ability to rapidly administer the vaccine and provide ultra-cold storage. The Pfizer vaccine must be kept at -70° Celsius and the Moderna vaccine at -20° C. In Northeast Ohio, Cleveland Clinic and MetroHealth Medical Center are the designated vaccine pre-positioning sites.
Cleveland Clinic is the state’s largest healthcare system, with the most caregivers. That, coupled with the organization’s experience operating large-scale vaccination programs for seasonal influenza — with the personnel and infrastructure to manage inventory, compliance, record-keeping and other issues — made it a logical choice as a COVID-19 vaccine pre-positioning site.
A multidisciplinary Cleveland Clinic team has been working for months to plan the logistics of vaccine dissemination. Its members represent medical operations, infectious diseases, nursing, pharmacy, supply chain, occupational health, information technology, continuous improvement, primary care, facilities and space design, security and marketing/communications.
Cleveland Clinic has purchased and installed eight ultra-cold freezers in a “freezer farm” at a secure location on its main campus, enabling direct shipments from the manufacturer without a layover at the state’s vaccine storage warehouse. Delivery of eight additional freezers is imminent. The temperature-adjustable freezers can accommodate the storage requirements of either the Pfizer or Moderna vaccines.
“We’ll be notified by the state that we have an allotment,” Rosner said. “It will be shipped to us in 24 to 48 hours. That’s how tight the window is.”
From the freezer farm, vaccine doses can then be distributed to Cleveland Clinic regional hospitals or other locations for just-in-time vaccination of caregivers and designated recipients, as directed by the state. The setup minimizes the amount of time that vaccine doses are exposed to nonfreezing temperatures, reducing the potential for wastage.
Like other healthcare systems, Cleveland Clinic has experienced recent sharp increases in the number of caregivers infected with the novel coronavirus as the pandemic intensifies. In the last week of November, nearly 1,000 employees in Ohio had confirmed or suspected cases. That raises concerns that hospitals will be overwhelmed as shortages of healthy caregivers make it difficult to handle a rapidly increasing number of patients.
Ohio officials will decide how the initial vaccine doses are apportioned among hospital caregivers and older, COVID-vulnerable populations in group-living facilities. The former group is essential not only to care for COVID patients but others with urgent medical needs, such as patients with heart attacks, stroke or cancer. The latter group represents roughly 8%-10% of all COVID cases, but nearly 40% of fatalities from the disease.
Dr. Wyllie acknowledges the difficulty of the choice, and notes that the limited early vaccine shipments — whose numbers must be divided by two to account for follow-up booster shots — won’t be adequate to cover either group, necessitating prioritizations within each. Cleveland Clinic has nearly 42,000 caregivers whose work involves contact with patients.
“It’s imperative that we vaccinate caregivers, because this is a downward spiral,” he said. “We have to stop the infection rate.”
For vaccine doses destined for Cleveland Clinic caregivers, “we’ve gone through prioritization in terms of caregivers in the intensive care units and emergency departments being vaccinated first,” Dr. Wyllie said. “We have relatively more doctors than nurses, so the rate-limiting group is nurses, who we need to keep healthy and in place in order to provide care. But it’s also respiratory therapists and others, including the environmental service workers cleaning those units. So the ED and ICU personnel are going to be our top priorities, and then those working on medical and surgical floors after that.”
Caregivers may be further prioritized based on their age and the presence of comorbidities, which can determined using Cleveland Clinic’s electronic medical records system.
As Pfizer and Moderna increase production and additional vaccines gain approval, inoculation of broader segments of the population can begin. That will require the set-up of multiple vaccination sites that are geographically distributed to maximize public access — especially to underserved and economically disadvantaged communities — and that have adequate numbers of caregivers to administer the shots, supplies of personal protective equipment, and computers and data connections to upload vaccine records to the state’s registry for adverse event tracking and booster reminders. Cleveland Clinic is participating in that planning.
Mechanisms also will need to be in place to vaccinate immobile populations, such as prison inmates and residents of nursing homes and assisted-living facilities.
The federal government recently announced agreements with CVS and Walgreens pharmacies to administer COVID-19 vaccines to residents of long-term care facilities nationwide. The logistics of that program, as well as how pharmacies, doctor’s offices and other healthcare providers will coordinate to provide wider distribution of COVID vaccines in later phases of the nationwide immunization program, have not been made public.
“Traditionally, most people don’t get their immunization for the flu at a pharmacy,” Dr. Wyllie said. “They get it at their doctor’s office. But given the cold-chain storage requirements for the current COVID vaccines, it’s probably not practical for an individual doctor’s office to distribute it. So we’re going to have to think about how we’re going to set up those vaccination centers, and what roles CVS, Walgreens and the major health systems are going to play. There’s a tremendous amount of work still to be done. Anybody who says that this is all figured out is wrong.”