As vaccine manufacturers around the world, including Pfizer and Moderna, work to create a safe and effective COVID-19 vaccine, McLaren Bay Region is preparing to store and distribute it to the community.
McLaren Bay CEO Clarence SevillianIn a prepared statement, McLaren said “COVID-19 vaccines from Pfizer and Moderna, developed as a part of Operation Warp Speed, are completing clinical trials and have demonstrated effectiveness rates of 90-95%. McLaren Health Care is directly connected to the Operation Warp Speed task force in Washington D.C. and, as of Nov. 24, have been told to expect final FDA approval for emergency use to occur sometime between Dec. 11-18.”
McLaren Bay Region Director of Pharmacy Dr. David Haugh says the vaccines were developed both quickly and safely.
“Usually they do the studies and then once they show proof in safety and efficacy, then they start making the drug,” Haugh says. “With Operation Warp Speed, they did the opposite. They started making the drug while the studies were going on. They’re still doing all the same studies that they normally would do. They just started making the drug at the same time. That’s how they’ve been able to speed this up.”
The idea is to have the vaccine ready for distribution as soon as possible, Haugh says.
“There’s several manufacturers,” Haugh says. “Pfizer is going to be the first. They’ve already submitted for their Emergency Use Authorization (EUA), and then Moderna is going to be the second one and they haven’t submitted yet.”
He assures that the EUA is still a form of FDA approval.
'We’re being hit with another surge here. I think it shows that we need to get some sort of innate immunity in our bodies that the vaccine is going to provide. We need to get our community members educated on the efficacy and the risk and safety of these vaccines.'
- David Haugh, McLaren Bay Region Director of Pharmacy
“EUA is the Emergency Use Authorization. It’s an accelerated approval process by the FDA to get things like this out quicker. It’s an emergency use approval to get this thing rolling, but it is still FDA reviewed,” Haugh says. “[Pfizer] applied for that EUA over a week ago and it’s still going to take a couple more weeks [before it’s approved]. They’re reviewing all this data to make sure it’s safe for our community.”
The vaccine will be ready for distribution to hospitals 24 to 48 hours after it is approved by the FDA and Haugh emphasizes the importance of getting the vaccine to as many community members as possible.
“We’re being hit with another surge here,” Haugh says. “I think it shows that we need to get some sort of innate immunity in our bodies that the vaccine is going to provide. We need to get our community members educated on the efficacy and the risk and safety of these vaccines.”
For more information on the number of COVID-19 cases in Bay County and suggested precautions, visit the Bay County Health Department website.
McLaren purchased a special freezer to meet the storage requirements of one of the COVID-19 vaccines expected to be approved in December.The Advisory Committee on Immunization Practices (AIP), which is the CDC’s immunization team, has started to develop guidelines for community distribution. Haugh explains, “They categorize it as 1A, 1B, and 2. 1A is going to be healthcare workers in the hospitals, so Emergency Room and those kinds of people. 1B is going to be high-risk people outside in the community, so EMS, fire, police. They might have a bigger need than the public. And then 2 is the general public.”
McLaren Bay Region President & CEO Clarence Sevillian echoes that by saying “We are prepared to accept deliveries at any time. We are working on a plan with McLaren Health Care, MDHHS, and Walgreens to start vaccinating staff who are interested, immediately upon arrival. Due to limited quantities of the vaccine, it may take several weeks to months before we will be able to vaccinate everyone.”
When the vaccine does arrive in Bay County, McLaren will be prepared for it.
“Our goal here at McLaren is that we’re ready and able to store the vaccine,” Haugh says. “It has that super ultra-low storage of negative 70 degrees Celsius. We purchased a special freezer for [storage] and McLaren is ready to receive it as soon as we can.”
McLaren’s new freezer has storage for 60,000 doses of the vaccine. When they received the survey from the state asking how many doses they would like for the first distribution, Haugh requested the maximum amount. “If we get enough to do all of our employees who are interested then we can move on to 1B then figure out how the public works.”
“In the meantime, we’re actively working on the procedure to who is going to get it and who is going to get it first. We’re surveying our employees to see who is interested in it. We’re working on education materials right now to talk about the safety and the efficacy and to answer any questions our staff and community may have.”
Although there are a lot of unanswered questions right now, medical professionals do have a bit of information on how the vaccines will work and how they can be the most effective.
“The Pfizer vaccine is one dose and then 21 days later another dose. The Moderna vaccine is one dose and then 28 days later another dose, but both are a two-dose series,” Haugh says. “The efficacy isn’t really proven until seven days after the second dose. Both vaccines have efficacy of 95%.”
While waiting for that second dose and waiting for the entire community to be vaccinated, Haugh emphasizes the importance of continue to follow guidelines to slow the spread of COVID-19.
“I don’t think it’s going to replace masks and social distancing in the near future,” Haugh says. “It’s going to take a while for everybody to get vaccinated based on supply. We’re still going to want to continue some precautions.”