Lots of unknowns as Michigan hospitals await first COVID-19 vaccine shipments

The massive coronavirus vaccination effort to immunize Michigan's roughly 600,000 health care workers — and eventually the entire population — is in high gear as Pfizer's vaccine candidate undergoes a federal hearing Thursday to review whether it can be safely injected into the arms of millions of Americans.

In the scramble to stop a pandemic that's killed 288,000 people in the U.S. and 10,138 in Michigan, some metro Detroit hospital systems told the Free Press this week that they're mobilizing the biggest vaccination effort in U.S. history with so many unknowns that, in some ways, it's like they're flying in the dark.

Hospital leaders still don't know how many doses they will get initially or how soon they'll receive them if Pfizer is granted emergency use authorization (EUA) for its vaccine this week. The company has said it is prepared to deliver its vaccines "within hours" of approval, but "we cannot ship until there is an EUA, and we cannot speculate on when that will be," a spokesperson told the Free Press Thursday morning.

Even though federal emergency approval for Pfizer's vaccine could happen within a day, and another COVID-19 vaccine produced by Moderna could get similar authorization next week, "the day when they say it's available, that is when we will understand where the vaccine is going," said Dr. Joneigh Khaldun, the chief medical officer for the Michigan Department of Health and Human Services, told the Free Press.

"It all depends on the federal government, the supply chain. I have no control over how much vaccine is allocated to the state of Michigan."

Kelly Malcom, a spokesperson for Michigan Medicine, said Wednesday that the Ann Arbor-based health system has "no idea" how long it will take to vaccinate all 26,400 of its health care workers.

"We have no idea because we don't know how many doses a week we're going to receive yet," she said. "And a lot of it depends on that and then a lot of it depends on the actual operation and our ability to connect with everyone who is prioritized first and get them in for appointments in a timely fashion."

Trinity Health, which operates both Mercy Health in western Michigan and the St. Joseph Mercy Health System in the southeastern part of the state, also said it cannot estimate how long it would take to vaccinate its 27,545 employees.

"The speed at which we are able to vaccinate all our health care workers will depend on the quantity of vaccine we receive and the frequency of shipments," Laura Blodgett, a spokesperson for Trinity Health, said Wednesday. 

"New information becomes available every day and we are working hard to quickly develop processes and protocols. We have not been informed of how many doses, although we know that Pfizer ships allocations in packages of 975 doses so that will be the minimum we receive."

The hope at the Detroit Medical Center is that its more than 11,000 employees will be vaccinated in the next two or three months, said spokesperson Jason Barczy.

"As of today, there are no definitive dates for the release of the vaccines to hospitals. Immunization of all health care workers will happen in the first phase of immunization," he said in an emailed statement to the Free Press. "We have been told to prepare for this phase to last for two to three months. Over the past several weeks we have been working on our COVID-19 vaccination plans. We will be ready to start immunizations of health care workers as soon as the vaccine is available to us."

Despite the uncertainties, Carolyn Wilson, Beaumont Health's executive vice president and chief operating officer, said Wednesday that hospital leaders are willing to remain nimble and "flexible and do a lot of just-in-time adjustments. We're very optimistic and committed to mass vaccination." 

The eight-hospital metro Detroit health system created a coronavirus vaccine task force to plan for how it would immunize its 38,000 employees, she said.

Although they might not have all the answers, "we've been planning a very long time. … We do feel very well prepared."

First in line

Many health systems say they will follow guidelines established by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices in choosing which workers to push to the front of the line. The CDC committee recommends health care workers who have direct contact with patients should get first vaccinated first, along with employees who handle infectious materials.

The Henry Ford Health System, which has six hospitals and 33,000 employees, will include those who have contact with patients in acute care units, intensive care units and in emergency departments on its priority list, said Dr. Adnan Munkarah, executive vice president and chief clinical officer.

A similar plan is in place at Trinity, Blodgett said. 

But if 975 doses are all that each hospital system in Michigan will get in the initial batch, they'll have to determine who among even their highest risk front-line workers should go first.

At Michigan Medicine, Malcom said choosing the health care workers who'll get vaccinated first has been tricky "because there's some very basic questions that are not answered, like how many doses that each state is getting definitively and then how they're doling those out. It's really hard to plan.

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"So we're having to create … different scenarios. … The plan right now is to survey our personnel to figure out ... exactly where they're working currently, how much patient exposure, how much infectious material exposure they currently have, and use that information to put them into cohorts of who will be prioritized first.

"But that really is as far as we've gotten definitively. We're still working out how to be in alignment with the state's plans."

However, the state's vaccine distribution plans continue to change, too. The interim plan, which was submitted to the CDC in October, is still being updated, said Lynn Sutfin, a spokesperson for the Michigan Department of Health and Human Services, to reflect shifting federal guidelines.

Luck of the draw

Beaumont Health's vaccine ethics committee came up with a randomized lottery-type system to select the high-risk workers who will get first crack at a vaccine, Wilson said. 

Messages are expected to go out Thursday or Friday of this week to the 975 Beaumont employees who have been selected in the first randomized drawing process to get the first vaccines, Wilson said. They'll be invited to make appointments as soon as Monday for vaccinations at the hospital system's Southfield service center. 

But because Beaumont can't be certain the Pfizer vaccine will get emergency approval by Monday and will ship doses to hospitals by then, "we're going to have to put in that invitation that is subject to approval, receipt of a vaccine and all of that," Wilson said. "So we have plans. We have contingency plans and we're just going to have to be flexible as we learn more."

The hope, Wilson said, is that Beaumont will receive enough doses of the Pfizer vaccine — and eventually the Moderna vaccine — to immunize about 4,000 Beaumont employees a week in this initial phase. 

"We think we have the capacity to give a little bit more than 4,000 vaccines out in a very safe and effective way," Wilson said. "But to be honest, I have no idea. I don't know that I'm going to get 4,000 vaccines. It's an estimate right now.

"We're going to have to understand how much vaccine we can get and we also don't know how many people will consent to getting it. So we are hoping that it will only take us a few short weeks, but we just don't know."

She explained that no more than one-third of the staff of any unit at a Beaumont facility will be vaccinated at one time because the vaccine has been shown in clinical trials to sometimes trigger an immune response, such as a fever, headache and body aches for a day or two after immunization.

By staggering when workers of any particular unit are vaccinated, the health system will avoid personnel shortages, she said.  

"It's going to take us a little bit to figure this out."

With hospitalizations statewide from COVID-19 at about 90% of where they were during the spring peak, according to state data, adding a mass vaccination effort on top of an already strained workforce is yet another challenge. 

At Beaumont, employees who have training as nurses but who have shifted to administrative and other roles will be tapped to administer the vaccine. 

Wilson, who worked as an intensive care unit nurse, will be among them. 

"We're all pulling together those of us that aren't in care every day to vaccinate so that our nurses in the ICU, … for example, can stay in the ICU," Wilson said.

It'll be mostly nurses, especially in the beginning, "to be sure that we have observation of people post vaccination," she said, to watch for any kind of reactions. Pharmacy technicians will work alongside the nurses to prepare the vaccines. 

The Pfizer vaccine, she explained, must be stored in ultra cold temperatures of minus 94 degrees. The company says it can be stored at 36-46 degrees Fahrenheit for up to 24 hours or at room temperature for no more than two hours after it thaws. 

"So they're going to be mixing and drawing for us, and nurses will be administering," Wilson said.

Enormous undertaking

Henry Ford's Munkarah said that if the Pfizer vaccine is approved, it is expected to be delivered to health care systems in batches each week. And if Moderna's vaccine also gets emergency authorization from the FDA, that will bolster supply and be added to the weekly deliveries. 

"We anticipate that over a matter of weeks or a couple of months, we'll be able to get to the majority of the health care workforce that that is here in Michigan, as well as around the nation," he said.

Ultra cold freezers have been installed at each of Henry Ford's hospitals to store the Pfizer vaccine. Pfizer also developed thermal kits containing dry ice that can be used to keep vials of the vaccine ultra cold for up to 15 days of safe storage while they're shipped. Most will come from the company's Kalamazoo manufacturing site, Pfizer said in a news release.  

Still, Munkarah said, "all of this is still in play."

"We are in constant contact to understand what the CDC is doing. And, honestly until we know a the exact number of the vaccines that we'll be getting in the next couple of weeks, it will be hard to determine, you know when we will start at when we will end with vaccinating healthcare workers."

Dr. David Kessler, a former FDA commissioner and co-chair of President-elect Joe Biden's COVID-19 Task Force, said quickly vaccinating the American people for COVID-19 will be an enormous job. 

"I think we have issues with supply," Kessler said Wednesday during a virtual health summit organized by the Johns Hopkins Bloomberg School of Public Health. "We have issues with getting 330 million people vaccinated. It is an enormous undertaking that is maybe one of the most enormous undertakings that any administration will have to do.

"It can be done. ... There's going to be hiccups. It's not going to be perfectly smooth because of the enormity and the heroic nature of the task, but it will get better."

Dr. David Wood, Beaumont's chief medical officer, said it's vital to reassure the public —and the health care workers who will go first in this mass vaccination effort — that if the vaccines get regulatory approval, they are safe.

"We are having thousands of people dying in Michigan from COVID," Wood said. "COVID is not the flu. It is a much more dangerous virus, and it also has long-term effects. I was talking to a friend of mine yesterday who is having memory loss … and she had COVID.

"I think that that's really what we need to get across. It's safe. It's effective. And it's really the only way that we're going to be able to decrease the deaths from this virus."

Michigan Radio's Kate Wells contributed to this report. 

Contact Kristen Shamus: kshamus@freepress.com or follow her on Twitter @kristenshamus.  

Detroit Free Press, Bridge Michigan and Michigan Radio have teamed up to report on Michigan hospitals during the coronavirus pandemic. If you work in a Michigan hospital, we would love to hear from you. You can contact Kristen Jordan Shamus at kshamus@freepress.com, Robin Erb at rerb@bridgemi.com or Kate Wells at Katwells@umich.edu.