Pfizer coronavirus vaccines being manufactured in Michigan get FDA’s ‘fast track’ status

Pfizer

Pfizer Inc.'s global manufacturing campus in Portage, Michigan. Joel Bissell | MLive.comJoel Bissell | MLive.com

Two experimental coronavirus vaccines being manufactured in Michigan have received “fast track” status from the U.S. Food and Drug Administration.

The vaccines are being jointly developed by U.S. pharmaceutical giant Pfizer and German biotech firm BioNTech.

The initial clinical supply of the BNT 162 vaccines are being made in Germany, but Pfizer and BioNTech plan to scale up production in the United States, including at its Michigan facilities.

Initial U.S. manufacturing is taking place at Pfizer’s manufacturing plant in Kalamazoo County, and the overall supply will be made in Andover, Massachusetts and Chesterfield, Missouri, the companies have said.

The FDA’s Fast Track process expedites the review, of new drugs and vaccine, and the designation was granted based on preliminary data from the initial clinical studies in the U.S.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, Pfizer’s senior vice president for Global Regulatory Affairs, said in a press release.

Pfizer and BioNTech announced in May that it was starting clinical trials in Germany and the United States.

Stage one of the clinical trial in the U.S. enrolled up to 360 healthy subjects into two age cohorts: 18-55 and 65-85, according to the release.

Michigan-made coronavirus vaccine from Pfizer in clinical trials

Subject to regulatory approval, the companies are expecting to start a Phase 2b/3 trial as soon as later this month and are anticipating enrolling up to 30,000 subjects, the press release said.

If the ongoing studies are successful, and the vaccine candidate receives regulatory approval, the companies currently expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021.

For more statewide data, visit MLive’s coronavirus data page, here.

COVID-19 PREVENTION TIPS

In addition to washing hands regularly and not touching your face, officials recommend practicing social distancing, assuming anyone may be carrying the virus.

Health officials say you should be staying at least 6 feet away from others and working from home, if possible.

Use disinfecting wipes or disinfecting spray cleaners on frequently-touched surfaces in your home (door handles, faucets, countertops) and carry hand sanitizer with you when you go into places like stores.

Michigan Gov. Gretchen Whitmer has also issued an executive order requiring people to wear face coverings over their mouth and nose while inside enclosed, public spaces.

Additional information is available at Michigan.gov/Coronavirus and CDC.gov/Coronavirus.

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