In March 2020, life took an abrupt turn for the team at Pfizer’s manufacturing plant in Kalamazoo.
During a Friday night phone call from the company’s New York headquarters, the Kalamazoo site was called on to produce the pharmaceutical giant's hoped-for vaccine to fight the COVID-19 pandemic.
The 1,300-acre facility — the company's largest production site — was accustomed to producing medicines for more than 100 countries, but now it faced an unprecedented challenge.
Pfizer Supply Team, Michiganians
Hernz Laguerre, Jr., The Detroit News
“I knew nothing about this product or this process or exactly what we needed to do to make this happen, but the message from New York was we want to make 100 million doses of vaccine by the end of the year,” said Chaz Calitri, vice president of operations for Pfizer’s Sterile Injectables US, who oversaw the Kalamazoo facility in 2020. “As a chemical engineer with 40 years’ experience in pharmaceutical manufacturing, we’ve never done that before. I can tell you that.”
Pfizer, with Germany-based biotechnology company BioNTech, eventually produced one of three vaccines widely distributed in the United States in a race against the deadly virus.
The company and its Kalamazoo employees who helped bring the vaccine to market have won plaudits for their efforts, including from President Joe Biden, who saluted them during a visit to the plant in February. “All of you here are doing some of the most important work in this facility, right here, that can be done,” the president told employees.
As Pfizer began its quest to develop and produce a vaccine, Calitri said the company told him money was no object. Time, however, was another matter.
“This is a humanitarian effort,” he said. “It’s not a business proposition. That made me really jazzed up, but on the flip side of that, I was horrified because we had nine months to get this done.”
A team was quickly mobilized to focus full-time on the vaccine.
As of early October, Pfizer-BioNTech had delivered more than 1.6 billion doses to more than 130 countries and territories in every region of the world, including 59 countries or territories in Europe, 30 countries in the Americas, 10 countries or territories in the Middle East, 19 countries in Asia/Pacific and 20 countries in Africa.
Pfizer expects to manufacture up to 3 billion doses of the Pfizer-BioNTech COVID-19 Vaccine worldwide in 2021 and up to 3 billion doses worldwide in 2022.
The vaccine team started with 10 to 12 people working on key areas — quality, maintenance and utility — to figure out what they needed, said Pat McEvoy, senior director of engineering and strategic projects at the Kalamazoo site. The facility employs about 1,300 people, with the majority focused on the COVID-19 vaccine.
“We segmented the project into smaller pieces that people could get their arms around,” McEvoy said.
One example: A team installed more than 600 freezers capable of maintaining a temperature of minus-70 degrees to store the vaccine.
“There were so many challenges that had to be overcome because we were discovering the process as we were building it,” he said.
Still, McEvoy said the process has been gratifying.
“One of the best days of my life was when we shipped those first lots out,” he said, his voice cracking with emotion. “That’s really seeing an idea come on, and not only was this the first mRNA vaccine, it was done in an unprecedented time frame.”
Even as the vaccines started leaving the facility in December, the challenge wasn’t over.
Melissa French, a technical project manager at the Kalamazoo site, recalls learning that month that the facility would also develop a cationic lipid, a specialized raw material that is an ingredient in the vaccine. Accomplishing that took a lot of flexibility from the team, she said.
“This was the holidays,” she said. “This was Christmas, so a lot of people dropped personal lives. They made accommodations to do everything. We had the full support of our site, of our network really collaborating.”
The Kalamazoo team worked with research and development colleagues in Groton, Connecticut, who developed the process and transferred it to Kalamazoo in a matter of weeks. By Jan. 20, they had started manufacturing the first lipid batch and completed it by Feb. 17, French said.
“Working on something that has really the potential to impact the world, it doesn’t get more gratifying than that.”
Community Award: Pfizer
Headquarters: New York City
U.S. manufacturing sites: Ten, including two in Michigan — Kalamazoo and Rochester
Number of employees: 29,400 in U.S.; 2,800 in Kalamazoo
Why honored: In partnership with BioNTech, Pfizer mobilized teams at its largest manufacturing facility to quickly develop and produce one of three vaccines authorized on an emergency basis by the Food and Drug Administration to protect people against the deadly COVID-19 virus. The FDA approved the Pfizer-BioNTech shot for full use on Aug. 23.