Michigan could receive several hundred thousand doses of Pfizer vaccine next month

Pending regulatory approval, Michigan is slated to receive several hundred thousand doses of the Pfizer COVID-19 vaccine that will ship as early as mid-December, health officials said Wednesday.

Shipments could be received by the Henry Ford Health System as soon as Dec. 12, hospital officials said. Five of its hospitals are preparing to distribute COVID-19 vaccines in mid-December as two promising vaccines await approval, the one from Pfizer and another from Moderna.

Pfizer expects it will make enough to vaccinate 3.2 million people by year's end with 6.4 million shots. The vaccine, which requires two doses administered between three and four weeks apart, has been submitted for Emergency Use Authorization and is expected to be reviewed by an FDA Advisory Committee on Dec. 10.

"At last word, the State of Michigan is slated to receive several hundred thousand doses of the 6.4 million doses Pfizer says it will ship before the end of the year, enough to vaccinate 3.2 million people," according to a statement by Henry Ford on Wednesday.

Health care providers around the country are being challenged to receive, store and distribute the two vaccines, both of which require storage at below-freezing temperatures to maintain potency. 

The Moderna mRNA vaccine needs to be stored and transported at minus 4 degrees Fahrenheit. The Pfizer mRNA vaccine requires more extreme refrigeration at minus 94 degrees Fahrenheit. 

Henry Ford was the only hospital system in Michigan chosen as a Phase 3 trial site for Moderna's vaccine study and "is one of the few health care organizations in the country that will be ready the moment one or both of these vaccines is approved," hospital officials said.

“We have been investigating these specialized refrigeration units needed to store these vaccines and preparing our facilities and operations since early summer,” said Ed Szandzik, vice president of pharmacy operations at Henry Ford Health System, in a statement.

Preparing for vaccine 

Over the past few weeks, the hospital system began installing six specialized freezers. Henry Ford Hospital in Detroit will have two of each vaccine freezer. Henry Ford Wyandotte, Macomb, West Bloomfield and Allegiance Health in Jackson, will each have one of each kind of freezer. The five hospitals were approved as vaccine distribution sites by the Michigan Department of Health and Human Services.

Some freezer units have been back-ordered as states, local health departments and providers across the globe scramble to obtain them.

"Since we saw this potential need a few months back, we put in our order and made a concerted effort to be very proactive by securing these super freezers early on," Szandzik said.

The freezers are expected to be installed by Dec. 1, before the arrival of the first vaccine doses.

"We continue to await what the state and allocations to all the health care system, but anticipate that all our hospitals will receive the vaccine," said Dr. Adnan Munkarah, Henry Ford's chief clinical officer.

Michigan Department of Health and Human Services spokeswoman Lynn Sutfin confirmed distribution in the state could begin as early as mid-December.

There are at least 31 hospitals and 11 local health departments in Michigan that have the ultra-cold freezer capabilities necessary to house the Pfizer vaccine.

"However, it is important to note that we expect the vaccine to be given to people very quickly after it is received, and they will be shipped in storage containers with dry ice that can be refreshed and will maintain the appropriate vaccine temperature. Thus, not every entity needs to have an ultra-cold freezer if they are able to receive and get the vaccine administered quickly, which is our expectation," Sutfin said.

"The exact number that will be allocated to Michigan is not known."

Hospitals across the state have been working with the state health department over the last three weeks to enroll in the COVID-19 vaccine program and lay the groundwork, said Ruthanne Sudderth, spokeswoman for the Michigan Health & Hospital Association.

Should the processes continue to move at the speed they currently are, hospitals will begin vaccinating the highest priority groups based on federal and state recommendations, Sudderth said, noting health care personnel are among those at the top of the list.

"Hospitals will prioritize within their own workforces and then reach out to other health care personnel in their region, even if they don't work at the hospital to make sure they're accounted for as well," she said. "We're continuing to plan and waiting for those vaccines to get approval so that they can be distributed."

Beaumont Health has two freezers at each of its eight hospitals, said Heidi Pillen, senior director of system pharmacy services. 

"We haven’t been in this situation before but ... we do know Pfizer has publicly stated they intend to distribute within 24 hours of FDA approval," Pillen said. "However, following a call with the state (Wednesday afternoon), we know that it will take longer."

Following approval, the process of distribution has to be sent to the Advisory Committee on Immunization Practices. Once that committee and the FDA approve the vaccination strategy, then the process will head to the Centers for Disease Control and Prevention for review.

"We don't believe distribution will happen right away, but that the process will be rapid," Pillen said. "We could be distributing by Dec. 15, but we may have the vaccine in hand before then."

The Pfizer vaccine that requires ultra-cold storage will be transported in a cold chain of freezers. However, the officials are hopeful the Moderna vaccine, which does not require ultra-cold storage will soon follow.

"Because the vaccine can be kept on dry ice for a period of time, that is helping to alleviate some of the concerns of obtaining appropriate freezers," Sudderth said. "We're very hopeful that the second vaccine that does not require those special freezers will again be right on the heels of the Pfizer vaccine so that people can use their traditional freezer and refrigeration systems, and not need to purchase special equipment."

McLaren Health Care is preparing for an expected shipment of 30,000 doses of the Pfizer vaccine in mid-December with a primary focus on health care professionals and caregivers, officials said Wednesday.

"McLaren’s vaccine distribution and implementation plan include preparing a delivery network including McLaren hospitals, outpatient facilities and aligned physician practices with multiple ultra-low cold storage units, as well as activation of community partnerships to extend the system-wide vaccine delivery strategy," spokesman James Curtis said. 

West Michigan's Spectrum Health officials say a multidisciplinary team has created a plan to ensure they have the capabilities to receive, store, distribute and administer when the vaccines become available.

"We are partnering with health systems and health departments in our region, as well as MDHHS, to ensure a coordinated approach," officials said in a statement. "Further, we are monitoring guidance from the CDC and the Advisory Committee on Immunization Practices as it becomes available."

Still, when the vaccine is first distributed, there won't be enough to serve every vulnerable group, Sudderth said.

"There won't be enough vaccine initially for everybody to be vaccinated, even the health care personnel," she said. "There will initially be some hub sites, but any hospital that has enrolled will ultimately get vaccines so that they can vaccinate their employees. Exactly how much they get, and how soon they get it, is yet to be determined."

Moderna vs. Pfizer

Moderna has indicated that it will also soon apply for Emergency Use Authorization and, if approved, the vaccine could be available in early January.

Moderna has said its vaccine was found to be 94.5% effective in initial results. Pfizer now says its shots are 95% effective after first reporting they were found to be 90% effective in initial results.

AstraZeneca said late-stage trials showed its coronavirus vaccine was up to 90% effective, giving public health officials hope they may soon have access to a vaccine that is easier to distribute because it needs “normal refrigerated conditions” of 36 to 46 degrees Fahrenheit.

Pfizer and Moderna both have developed two-dose vaccines that would be the first vaccines ever to be based on mRNA, or messenger RNA technology.

With conventional vaccines, a piece of inactivated virus, called an antigen, is injected into the body, where it's recognized as a toxin or foreign body. That triggers the body's immune system to produce specific antibodies to fight the invader and prepare for the next time it encounters the pathogen. 

With the Pfizer and Moderna vaccines, messenger RNA is injected into the body, where it enters the cells and provides instructions to make antigens. When the cell presents the antigens to the body's immune system, that triggers the production of T-cells and antibodies to fight the infection. 

Michigan and other states have been tallying their capacity for ultra-cold storage and purchasing ultra-cold freezers in anticipation of a vaccine.

The hospital systems are eager to prioritize their workers who have been impacted by the virus.

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In the past seven days, Henry Ford had 158 employees test positive for COVID-19 due to community exposure, causing a "significant" strain on staff, Munkarah said Wednesday.

While health care personnel might be the first to receive the vaccine, it's not determined how many will be opting-in.

"There will be a need for a campaign around vaccine hesitancy and how to mitigate concerns and fears," Beaumont's Pillen said.

Distribution in Michigan

Pfizer expects to produce up to 1.3 billion doses in 2021 between its Kalamazoo manufacturing operation and a Puurs, Belgium, plant tagged to provide the European supply. 

The New York-based company has designed and built specialized equipment including a 350-unit ultra-low-temperature "freezer farm" on its Kalamazoo campus to store the COVID-19 vaccine at -112 degrees Fahrenheit. The product will be packed in dry ice for shipping.

Michigan's Department of Health and Human Services has been working for months on a 63-page distribution plan to kick into action when and if a vaccine is approved. The plan covers training for health care professionals and pharmacies on issues like how to store and administer the vaccine. 

The plan involves hundreds of partners — such as local health departments, hospitals, nursing homes, pharmacies and other retailers — and provides a three-phase approach to distribution.

During the first phase, Michigan would target the vaccine at the state's 143 hospitals and health systems for use on health care workers, followed by Michigan's health departments. 

Local health departments will be able to hold off-site clinics to reach essential workers, such as utility and emergency preparedness staffers. Pharmacies will be able to reach and identify individuals over 65 years old who have underlying medical conditions and are at high risk of severe COVID-19 illness.

Local health departments will also distribute the vaccine to pharmacies that don't receive shipments directly from the CDC.

Phase 2 will occur when more doses become available and will focus on vaccinating essential workers, such as people who work in grocery stores and restaurants. Vaccines also will become available to vulnerable populations, such as people older than age 65, and those in communities likely to be hit hardest by the coronavirus. 

During Phase 3, the vaccine becomes widely available through a range of providers from doctor's offices to retail pharmacies. 

The state government's distribution plan outlines communications strategies, such as sending text messages to people telling them it's time to get their second dose. Michigan's health department also is collecting information from partners, such as pharmacies, on their ability to store the vaccines. 

srahal@detroitnews.com

Twitter: @SarahRahal_

Staff Writer Beth LeBlanc contributed.