KALAMAZOO, Mich. — The thing that returns our lives to normal and gets us out of the pandemic could be made in Kalamazoo County.
Pfizer stunned the world Wednesday, Nov. 18, 2020, with news that its COVID-19 vaccine was 95% effective. If the vaccine receives FDA approval, some doses might be administered before the end of 2020, or early in 2021. The vaccine would be produced at a Pfizer manufacturing facility in Kalamazoo County.
The country's top infectious disease expert, Dr. Anthony Fauci, called the efficacy of the vaccine extraordinary.
At the Western Michigan University Homer Stryker M.D. School of Medicine, Dr. Tom Flynn, chief of the Division of Infectious Disease, said he was cautiously optimistic.
"Sounds great. Let's see the details," Flynn said. "Some of the things that we would want to know: Is it going to be effective in the groups that need it most, like those over 65? How long does the immunity from it last? Is it two months, three months, six months? We don't know."
Pfizer said its vaccine is both safe and effective on seniors. The question of how long immunity would last is still unanswered.
We are learning more about how Pfizer will get a COVID-19 vaccine from Kalamazoo County to the country, to hopefully save lives.
Francesca Marzullo, the manager of Pfizer Global Supply Communications, in an email to News Channel 3, explained the role the Kalamazoo County facility will play in manufacturing the vaccine.
"The Kalamazoo site does the formulation, fill and finish steps of the vaccine production," Marzullo said.
The plant will receive all the necessary materials included in the vaccine, then combine them using specialized equipment and filtering procedures.
"The Kalamazoo site will receive the mRNA drug substance and other raw materials and combine them through a series of steps including impingement jet mixing and specialized mixing to construct the lipid nano particle, followed by sterile filtration," Marzullo said. "The bulk vaccine will then be transferred to an aseptic filling line where it will be filled into a sterilized vial and capped."
Then the vaccine will go through a complete inspection before it is transferred to packaging lines for labeling and packing.
"The packed containers will then go into blast freezers before being staged in storage freezers, awaiting final packing into dry ice shipping containers," Marzullo said.
Distribution comes next.
"For the U.S. market, our distribution approach will be to largely ship from our Kalamazoo site direct to the point of use," Marzullo said. "However, we will also be using our existing distribution center for the COVID-19 distribution in Pleasant Prairie, Wisconsin. This distribution center will have a dedicated area to store product that is not going direct from our Kalamazoo site to the point of use."
Once the vaccine is ruled safe and effective, and receives FDA approval, health and community leaders will face the challenge of getting billions of doses to people around the world.
"You need everybody to step up," said Tom Kelly, an instructor in the supply chain program at Western Michigan University's Haworth College of Business. "Do we have enough infrastructure in place to transport things such as this? Sure we do. Do we have enough of it?"
Kelly said getting a vaccine around the country and the world is bigger than a hospital or hospital network. It's going to require help from the business world, and government.
Preparations have already started on storing and distributing a vaccine.
"We are ready," said registered nurse Robin Scott, the manager of occupational health and infection control at WMed. Scott is in charge of vaccine storage for the school. "I am confident we can do this and figure this out. We do this every year for influenza. It's a very similar process."
Yet in one respect, it is quite different: The Pfizer vaccine must be stored in extreme cold.
The medical school has two freezers that reach 80 degrees below zero, Celsius, which could hold thousands of doses of the Pfizer vaccine.
"We understand the importance of this. That's why it's in a secure environment," said Prentiss Jones, the director of toxicology at the medical school. "We would love to do whatever we could to stem the tide of this pandemic. It's just an awesome responsibility."
Jones, who holds a doctorate in biomedical sciences, is an associate professor and researcher in the area of pharmaceuticals.
Moderna announced their vaccine candidate is also more than 90% effective. That vaccine candidate does not need to be stored in the extreme cold, which could make it easier to both transport and store.
Another awesome responsibility is deciding who would get the vaccine first. Healthcare workers are expected to be given priority and then at-risk groups.
"It will be better for al of us, if all of us get vaccinated," Flynn said. "But it has to be those most vulnerable, and that's those over 65, and those over 50 with serious conditions."