By Melinda Young

EXECUTIVE SUMMARY

The new vaccine candidates provide good news for a pandemic-weary healthcare world, offering case managers and other hospital professionals an opportunity to become vaccinated against COVID-19.

  • Case managers should expect uncertainty about how the first vaccines are distributed.
  • Regardless of whether an organization mandates all employees to receive the shot, case managers and others should be vaccinated to protect themselves and their patients, researchers say.
  • Leaders should educate staff about the vaccines and their efficacy and safety profiles.

The good news toward the end of 2020 was the emergency approval of two COVID-19 vaccines. Like certain celebrities, the “vaccine” did not need a first name or modifier. Everyone heard of the promising data coming out of Pfizer and Moderna, showing the vaccines to be about 95% effective against preventing COVID-19 in people who received two doses. Other vaccines also showed promising results, and the Food and Drug Administration has already given emergency use authorization (EUA) to the Pfizer and Moderna vaccines.

Doses of the Pfizer vaccine, which was the first vaccine given an EUA in the United States, were distributed to all states, but in quantities that would force officials to prioritize those who should receive the first doses.

Case management administrators should anticipate uncertainty in vaccine distribution, says Tinglong Dai, PhD, associate professor of operations management and business analytics at Johns Hopkins University Carey Business School in Baltimore. Dai also is core faculty at Hopkins Business of Health Initiative.

Physicians, nurses, and healthcare workers in hospital intensive care units, emergency departments, and long-term care facilities were at the front of the line to receive the COVID-19 vaccine in December and January. Other hospital workers and healthcare professionals in ambulatory settings also were expected to be in the first or second phase of vaccination.

“The timing of a vaccine would be uncertain,” Dai says. “I wouldn’t expect it to be later than March, so providers should get ready from both a supply and demand perspective.”

For vaccines that require two shots, employees will need to receive the same type for both shots. When administering shots, leaders should consider timing. For vaccines that need cold storage, leaving shots out to warm may spoil the batch.

“From the supply side, they have to think about how they are going to apply the vaccination schedule, carefully, to make sure they use the vaccine when it comes in,” Dai says.

The Centers for Disease Control and Prevention (CDC) issued recommendations on how to prioritize the first phase of vaccination. States have been left to decide which healthcare workers will be vaccinated first and which might have to wait for later phases of vaccine rollout — maybe even different COVID-19 vaccines — as supplies run out.

“Healthcare workers interacting with patients are in the first prioritization by the CDC, and this will be endorsed by most states,” says Eli Rosenberg, PhD, associate professor in the department of epidemiology and biostatistics at the University at Albany School of Public Health, SUNY – The State University of New York in Rensselaer.

Hospitals could mandate vaccinating all employees who have direct patient contact in the same way they mandate flu vaccination, Dai says.

Since it is unlikely there will be as many doses of vaccine available as needed through the winter of 2021, there could be a conflict between health system demand for vaccine and available supply.

“I think there will be a stressful situation because we’ll see a lot of shortages of vaccine in the first few months,” Dai says.

In some places, hospital case managers likely were included in the first phase; in others, case management leaders still are waiting for word about when their staff can be vaccinated. In a minority of hospitals, the vaccine is optional, creating more questions and logistical issues for directors and administrators.

“One of our two main hospital systems said [in early December] that they were not mandating the COVID-19 vaccine,” Rosenberg says. “Among our rank and file, there is a lot of hesitancy.”

Vaccine hesitancy is a problem that case management leaders and other administrators will need to overcome because of the problems that arise when staff refuses to be vaccinated.

“In addition to vaccines protecting [individual workers], vaccination can reduce absenteeism from the workforce at a time when we need all hands on deck,” Rosenberg says. “We have a very tired and exhausted workforce as it is, and we don’t need even more absenteeism due to exhausted and sick employees.”

There is a moral imperative to vaccinate healthcare workers, he adds.

With a little education, leaders can help staff understand how and why the vaccines are safe. For example, the Pfizer vaccine and some other vaccine candidates are messenger RNA (mRNA) vaccines. They provide genetic information for cells to produce the proteins or antigens encoded by the mRNA.1

“The mRNA vaccines trick the body into making just the spike protein of the virus, which is the target of these neutralizing antibodies,” says Sean A. Diehl, PhD, associate professor in the department of microbiology and molecular genetics at Larner College of Medicine at the University of Vermont in Burlington. “In a safe way, you can induce the appropriate immune response that is directed just to the spike protein, which is also what we found in natural infections.”

The vaccine copies this action in a way that is clinically safe and does not require the host to become infected, Diehl says.

“The vaccine does not use the complete virus,” he adds. “It is not in itself harmful to the host; they don’t contain any of the dangerous parts of the virus because they are not viral vaccines.”

RNA vaccines do their job and then are taken away, naturally, by enzymes in the body, explained Kathleen M. Neuzil, MD, MPH, FIDSA, director of the Center for Vaccine Development and Global Health, and Myron M. Levin professor in vaccinology at the University of Maryland School of Medicine in Baltimore. Neuzil also is co-director of the COVID-19 Prevention Network and is a fellow in the Infectious Diseases Society of America. She spoke about COVID-19 vaccine research at IDSA’s web briefing on Dec. 3, 2020.

“We wouldn’t accept any prolonged side effects from these RNA vaccines,” Neuzil says.

In a Phase III trial that included 44,000 participants, Pfizer’s data revealed that its safety profile was similar to other viral vaccines over a median of two months. Vaccine reactions included short-term, mild-to-moderate pain at the injection site; fatigue; and headache.2 Many Americans also are concerned about the speed with which the mRNA vaccines were created and studied in clinical trials. People need to know the idea of making mRNA vaccines did not begin in 2020, Diehl says.

“The vaccine field has wanted to do this for a while,” Diehl explains. “The idea of using mRNA vaccines against key parts of the virus has been around during other pandemics, the 2014 Zika virus, and H1N1 [influenza] in 2008, but the mRNA vaccines never made it to approval because those pandemics went away.”

With the COVID-19 pandemic, researchers built on that earlier research and reached the clinical trial stage quickly.

“This will open up the possibility of using this technology to do other vaccines in the future,” says Robert Salata, MD, professor of medicine, chair of the department of medicine, and a physician and chief of University Hospitals Cleveland Medical Center. Salata participated in Phase II and Phase III of the Pfizer vaccine trial.

“Part of this research has moved quickly, but no corners were cut, and that’s an important concept here,” Salata says. “I’ve never seen a clinical trial conducted so carefully and scrutinized so much.”

Usually, there are not 30,000 to 60,000 people enrolled in vaccine clinical trials, Salata notes.

“It’s very costly to conduct a trial of 44,000 people, which is the case for Pfizer,” he says. “Having this many people gives us comforting information about initial efficacy and short-term safety, and we’ll follow these folks for a longer period of time, making sure nothing comes up later.”

REFERENCES

  1. Pfizer. Get the facts on our COVID-19 vaccine candidates. May 5, 2020. https://www.pfizer.com/news/hot-topics/get_the_facts_on_our_covid_19_vaccine_candidates
  2. Polack FP, Thomas SJ, Kitchin N, et al; for the C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med 2020;383:2603-2615.