2 potential coronavirus vaccines put on fast-track by FDA could be made in Kalamazoo

The U.S. Food and Drug Administration has Fast-Tracked two potential coronavirus vaccines created by Pfizer and BioNTech, the companies announced this week.

The Fast-Track designation could speed up the regulatory process and allow them to bring their mRNA coronavirus vaccines to market more quickly. 

Pfizer already is ramping up its Kalamazoo manufacturing site to aid in mass production of the vaccines, which are in human trials at the University of Maryland School of Medicine, New York University's Grossman School of Medicine and the University of Rochester Medical Center/Rochester Regional Health.

Those trials "are looking promising," said Dr. Kirsten Lyke, a professor at the University of Maryland School of Medicine's Center for Vaccine Development and Global Health, who is the lead investigator researching COVID-19 vaccine candidates.

The vaccines use a tiny piece of the coronavirus' RNA, its genetic code, to trick the body into making proteins and mount an immune response that could protect people when they are exposed to the virus. 

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  Lyke explained that four different constructs of a vaccine created by Pfizer and BioNTech, a German biotechnology company that until now has focused primarily on cancer treatments, were manipulated in slightly different ways at varying dose levels. The versions that got FDA Fast-Track approval are BNT162b1 and BNT162b2.

"The hope is that we can develop a vaccine that produces lots of immunity but none of the side effects of actually being exposed to the virus," she said. 

 During the Phase I/II trials of BNT162b1 conducted May 4-June 19, 45 people ages 19-54 were randomized and vaccinated at different doses. Some received a single, higher-dose of the vaccine. Others received two vaccinations at lower doses separated by 21 days. Nine people received placebo injections, according to early data that has yet to undergo peer review but was published on MedRxiv. 

Fever, headache, fatigue, chills, muscle and joint aches were reported by some of those who were vaccinated. Most reactions peaked by two days after vaccination and resolved by the seventh day after vaccination.  

All who received the vaccinations developed antibodies to SARS-CoV-2, the novel coronavirus. Although people who had two lower doses of the vaccine developed more antibodies than those who got the single higher dose. 

The BNT162 vaccine candidates, which also got FDA Fast Track status, are undergoing clinical studies that have yet to be published. 

Peter Honig, senior vice president of global regulatory affairs at Pfizer, called the Fast Track designation "an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2."

The companies plan to start Phase IIB/III clinical trials later this month, which could enroll up as many as 30,000 people.  

If it's proven effective, the vaccine will be  manufactured by Pfizer at its Kalamazoo plant as well as its sites in St. Louis, Missouri, and Andover, Massachusetts.

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"The efficacy trial will determine which construct the company takes to manufacturing but the plan would be for several million this autumn and up to 1.2 billion doses in 2021," Lyke said in an email to the Free Press. "We are waiting for peer review before making any announcements."

Chaz Calitiri, Pfizer's vice president of operations for sterile injectables  and the interim site lead for the Kalamazoo plant, told the Free Press in an interview in May that he's confident there will be an effective vaccine for COVID-19.  

"I have no doubt that we will solve this and there will be a vaccine," he said. "We've got to do this in an accelerated timeline. Normally, it takes four to five years to get something like this to market. So, you know, the fact that it's been just several months, and people are talking about potentially having a solution this year, is pretty astonishing.

"We can't go any faster. I promise you that. ... We're not holding anything back."

If this project is successful, it'll be the first mRNA vaccine on the market, Calitiri said.

"What we'll be doing here in Kalamazoo is ... we'll take the active ingredient, which is sent to us, formulate that into a dosage form, then we will fill that, inspect it, package it and distribute it," he said. "So it's quite an exciting project for us."

The goal is to manufacture the vaccine as soon as possible, he said, which means work has been under way for months already in Kalamazoo to modify the plant to create high-speed vial-filling lines to mass produce of a potential COVID-19 vaccine. 

"We're going fast and furious to scale up," Calitri said. "We have depth of technical knowledge and experience here, which is one of the reasons why Kalamazoo is one of the key manufacturing sites.

"We're working around the clock. We're making investments to modify our lines, and we're scaling up, hopefully to generate up to 10 million doses by year end."

Contact Kristen Jordan Shamus: 313-222-5997 or kshamus@freepress.com. Follow her on Twitter @kristenshamus.