Distribution of the COVID-19 vaccine across mid-Michigan could begin just before Christmas - during the week of Dec. 21 - if the Food and Drug Administration approves the vaccine on Dec. 10, as expected by many medical professionals.
“We are hoping that we will have all of our employees and all of those first-phase people on the list including our elderly patients with complex medical problems, or co-morbidities as we call them or other chronic medical conditions, [vaccinated] by the end of January,” says Dr. Lydia Watson, M.D., Senior Vice President and Chief Medical Officer at MidMichigan Health.
Watson explained that the Pfizer vaccine will likely be first to receive Emergency Use Authorization (EUA) by the FDA, and the Moderna vaccine is expected to follow about a week after. Additionally, there are a couple of other companies that are getting close to being able submit their requests for EUA.
“If, after the first of the year, we have three to five companies we may be able to vaccinate everybody that wants it I would say by the end of summer,” she says.
Watson says the MidMichigan Health system has purchased two ultra-cold freezers that can maintain a temperature of minus 94 degrees Fahrenheit to store the COVID-19 vaccine. Each freezer can hold up to 30,000 doses of the vaccine; however, she explains that MidMichigan Health system’s enrollment agreement requested 7,000 doses. It is expected that, initially, they will receive 975 and then will likely receive more on a weekly basis moving forward.
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MidMichigan Medical Center – Mt. Pleasant could begin distributing the COVID-19 vaccine to people in Phase 1 of the distribution plan as early as Dec. 21.
“The state has calculated how much is coming for the whole state and then divided up amongst everybody that submitted one of those enrollment agreements and got approved,” Watson explains. “We believe we're getting 975 doses, so the 975 doses will be divided to the first group that is being recommended get the vaccine… The 7,000 doses is what we requested to be able to vaccinate all of our employees, EMS staff, volunteers, contracted people within all of MidMichigan Health. And we know that when we get the first 975 doses that, in this case since it's likely to be Pfizer, Pfizer will then hold another 975 doses to send to us in 21 days when we have to give the second dose.”
Watson says in order for the vaccine to be most effective, both doses are required – at least in the Pfizer and Moderna vaccines. Because there will be additional storage space in the ultra-cold freezers, MidMichigan Health is able to partner with the health departments in regions they serve – a collaboration she says is part of a critical effort to ensure the safe, timely, and efficient distribution of the COVID-19 vaccine.
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Dr. Lydia Watson, M.D., Senior Vice President and Chief Medical Officer at MidMichigan Health“They don't have the ability to have those ultra-cold freezers and so they applied for their own doses, but they're going to store them in our freezer,” she says.
“We're trying to make sure that we're not overlapping in who we're trying to administer the doses to. So for instance, in that first group, emergency medical teams, ambulance paramedics, they are on that list. We employ some in Midland and Gladwin. We will vaccinate our own, and we're working with the county health department to vaccinate those that aren't our employees. They also are willing to help with long-term care facilities, as we try to get our employees vaccinated so there’s going to be a lot of collaboration going on.”
As the reality of distributing the COVID-19 vaccine grows closer, Watson knows that just as there are those who are eagerly awaiting its arrival there are those who have concerns about receiving the vaccine – both due to its seemingly quick turnaround time and the approval process.
Addressing the first of those concerns, Watson says there are three main reasons the COVID-19 vaccine was able to be produced in a shorter period of time.
The first reason is that work on the COVID-19 vaccine began as soon as it became clear the virus was highly contagious and could lead to a pandemic.
The second reason is that financial backing for research and production came through quickly.
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This Pfizer “test box” utilizes the same material the vaccine will be shipped in and allows the pharmacy staff at MidMichigan Medical Center – Midland to conduct safety checks ahead of the COVID-19 vaccine scheduled to arrive later this month. Additional preparation measures include the purchase of two “ultra-cold” freezers to house the health system’s vaccine shipments. Each freezer can hold 30,000 vaccine doses at the required temperature of minus 94 degrees Fahrenheit.
“Often times, if you need to go in and start to make a vaccine for the first time you've got to find the funding to do it; but, there were so many people that stepped up to the plate to offer that financial support to be able to do the research and get it going right away,” Watson says.
Finally, Watson says a large number of volunteers stepped up right away to be in the trials, which helped enable large-scale trials more quickly.
“To be able to get Emergency Use Authorization, you have to have a certain number of patients involved in those trials to know that your data is significant from a statistical standpoint,” she explains. “Sometimes it takes a long time to enroll volunteers to be the test cases in those trials, but I think there was so much awareness on how important it was to try to develop the vaccine we had many people step up and offer to be part of those pilots.”
Addressing concerns about the approval process of the vaccine, Watson says that just because the COVID-19 vaccine will likely receive Emergency Use Authorization does not mean it is held to any less of a standard. The FDA panel will still review all of the safety data from the clinical trials and ensure that it meets all necessary requirements.
“In addition to that, the CDC has an Advisory Committee on Immunization Practices - you may hear us referring to it as ACIP – they also review all the safety data before they recommend the COVID-19 vaccine for use,” she says. “Then, once we start to roll it out … the FDA and CDC will continue to monitor the safety of the vaccines as we vaccinate people.”
She explains that they will be required to document every dose of the vaccine that is administered and side effects must be reported to both the FDA and the CDC.
Watson says in trials about 80% of people did have mild-to-moderate side effects such as a fever, headache, or mild aches; however, they typically only lasted about 24 hours. While these can be some common symptoms of COVID-19, she adds it’s important to know the COVID-19 vaccine cannot give the vaccine recipient the virus.
“You will not get COVID from it because you are not getting the COVID virus,” she says. “It's not a live virus vaccine where you're actually getting injected with COVID. What happens is that there certainly are side effects, but the side effects are a sign - actually a good sign, a healthy sign - that your body is responding and starting to turn on your immune system.”
With distribution potentially just around the corner, Watson says she is excited that the vaccine is here and that there are great plans in place for distributing the vaccine to those who want it, adding that she plans to receive it herself.
“This has been politicized. There are people that are concerned that it's being done with shortcutting. I can tell you that as a physician, we believe science, we don't pay attention to politics,” she says. “I believe that the data is strong. I'll be getting the vaccine myself, so if you have physicians willing to step up, look at the science, look at the data, and say, ‘Yep, this is right on. I'm getting the vaccine,’ I think that speaks volumes.”