ANN ARBOR, Mich. – Pfizer and BioNTech submitted their COVID-19 vaccine to the FDA to be considered for an emergency-use authorization Friday.
The massive amount of data that has been collected through the clinical trials will be scrutinized by the scientists of the FDA and a critical committee of advisors.
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“For total transparency, it is going to be on YouTube and we are going to hear the data presented by the company,” said Dr. Arnold Monto. “The FDA is going to give us their interpretation of the data all out in public.”
Monto is a world-renown expert in infectious disease prevention and vaccine effectiveness. In 2018, he showed Local 4 his “Flu Lab” at the University of Michigan School of Public Health.
Monto will lead the committee that will advise the FDA on whether or not to grant an emergency-use authorization for any coronavirus vaccines.
“There is a public member of the committee who does have a vote. There are other people who represent other various medical disciplines and they are very careful to have minority representation as well,” Monto said.
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The FDA is not required to follow the recommendation of its advisory committee, but it typically does.
“It’s an intellectual pressure, not a political pressure,” Monto said. “There is no pressure on us to make a decision. We are independent. We have no financial interest and we take seriously our responsibility to represent the American public in a very important decision.”
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Is Monto concerned with how quickly the vaccines were developed?
”I think they should ignore the rush because the rush happened because of extra funds and extra attention that was given,” Monto said. ”The platform, the way these vaccines were produced were already there.”
Some committee members have voiced concern that most of the vaccine recipients have only been followed for two months, but acknowledged waiting for more time to pass would only lead to more COVID-19 deaths each day.
“That is the only issue I think that is floating around out there,” Monto said. “How long do you want to wait to see what happens? You dont want to wait too long.”
Monto said every vaccine will be fully evaluated, something he encourages every American to do.
“With anything else that you put in your body, there will be some level of risk and everybody is going to have to make a determination once they can get the vaccine on a risk-benefit,” Monto said.
The FDA had previously asked the committee members to plan on meeting Dec. 8-10.
The event will be livestreamed.
U-M economists: ‘Unbalanced’ job recovery from COVID-19 will worsen income inequality in Michigan
Economists at the University of Michigan said that while the state’s economy will gradually bounce back from the COVID-19-induced recession, low-income workers will be disproportionately affected and suffer more long-term losses.
Over the next two years, employment and incomes are forecast to increase, with Michigan’s construction and automotive industries expected to see growth. However, the hospitality industry and sectors that employ lower-income workers will continue to see job losses, said the experts.