Two experimental coronavirus vaccines manufactured in Michigan have received “fast-track” status from the US Food and Drug Administration.
The vaccines are being jointly developed by US pharmaceutical giant Pfizer and German biotech firm BioNTech.
Initial clinical supply of BNT 162 vaccines is being made in Germany, but Pfizer and BioNTech plan to increase production in the United States, including at their Michigan facility.
Initial manufacturing in the United States is taking place at Pfizer’s manufacturing plant in Kalamazoo County, and general supply will take place in Andover, Massachusetts and Chesterfield, Missouri, the companies said.
The FDA Fast Track process streamlines the review of new drugs and vaccines, and the designation was awarded based on preliminary data from initial clinical trials in the U.S.
“The FDA decision to grant these two COVID-19 vaccine candidates the Fast Track designation marks an important milestone in efforts to develop a safe and effective vaccine against SARS-CoV-2,” Peter Honig, senior vice president of Pfizer’s 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 US clinical trial enrolled up to 360 healthy subjects in two age cohorts: 18-55 and 65-85, according to the statement.
Pfizer Michigan Made Coronavirus Vaccine in Clinical Trials
Subject to regulatory approval, the companies hope to begin a Phase 2b / 3 trial as early as this month and anticipate enrolling up to 30,000 subjects, according to the press release.
If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies currently hope 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 information, visit MLive’s coronavirus data page, here.
COVID-19 PREVENTION TIPS
In addition to washing their hands regularly and not touching their faces, officials recommend practicing social distancing, assuming anyone can carry the virus.
Health officials say you should stay at least 6 feet away from others and work from home, if possible.
Use sanitizing wipes or sanitizing spray cleaners on frequently touched surfaces in your home (door handles, faucets, countertops) and carry hand sanitizer when you go to places like stores.
Michigan Governor Gretchen Whitmer has also issued an executive order requiring people to cover their faces and noses while inside closed public spaces.
Additional information is available at Michigan.gov/Coronavirus and CDC.gov/Coronavirus.
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