FDA approves Pfizer's COVID vaccine: What's next in Minnesota?

The U.S. Food and Drug Administration gave its full approval to Pfizer's COVID-19 vaccine on Monday, which will likely spur more Minnesota employers to impose vaccine mandates and could convince some hesitant people to get a shot.

Pfizer is the first company to get the FDA's gold standard approval for its coronavirus vaccine. It covers people ages 16 and older. Pfizer's vaccine remains under an emergency use authorization for kids ages 12 to 15.

The FDA's move comes as hospitalization rates soar across the U.S. and steadily increase in Minnesota, where more than 500 people were hospitalized with the virus on Friday for the first time since early May.

Employer vaccine mandates

The FDA's approval triggered a vaccine mandate at the University of Minnesota. Students will get an email within days to confirm their vaccination status, while faculty and staff will have to attest their own status starting Tuesday, President Joan Gabel said in a system message.

President Joe Biden encouraged employers to impose vaccine requirements right away.

"If you’re a business leader, a nonprofit leader, a state or local leader who has been waiting for full FDA approval before requiring vaccinations, I call on you now to do that – require it," Biden said Monday. "Require your employees to be vaccinated or face strict requirements."

So far, it's mostly been health care systems and government institutions putting mandates in place for their workers. But that will likely change soon, said Susan Ellingstad, an employment law attorney at Lockridge Grindal Nauen in Minneapolis.

"While employers’ ultimate liability has not changed with the FDA’s decision, as the (emergency use authorization) designation did not impact employers’ legal right to mandate vaccines, the litigation risk has just decreased significantly," Ellingstad said.

Vaccine hesitancy

As of Monday, 69.6 percent of eligible Minnesotans ages 12 and older have gotten at least dose of the coronavirus vaccine, according to the Minnesota Department of Health.

That leaves more than 1.4 million eligible people who have not gotten a shot.

Federal health officials said they hoped that FDA approval of Pfizer's vaccine would convince some hesitant people. Approval followed three months of study involving tens of thousands of people, said Dr. Peter Marks, the agency's director of biologics evaluation and research.

"We know that for some people, FDA approval of a COVID-19 vaccine may give them the confidence they need to get vaccinated," Marks told reporters Monday.

$100 offer won't be extended

Gov. Tim Walz said Monday that he will not extend Minnesota's $100 offer for newly vaccinated people a second time after allowing it to end Sunday.

The program proved popular: 79,810 people signed up for a $100 Visa gift card, Walz's office said Monday.

That's nearly $8 million in gift cards. Walz had originally budgeted $2.5 million in federal COVID relief aid for the program, though a legislative panel later increased the budget.

The pace of vaccinations increased in late July and early August, a combination of the incentive offer, the new threat of the Delta variant, and the possibility of vaccine mandates. The seven-day average of new daily vaccinations has slowed somewhat, to 5,180 over the past week.

Younger kids not eligible

The FDA's full approval of Pfizer's vaccine means little to parents of younger children.

It's unclear when a vaccine will be approved for children younger than age 12, and FDA officials didn't provide a timeline Monday. Clinical trials are ongoing, they said.

"We need to get the information and data on uses in younger children – they are not just small adults. We’ve learned that time and time again," said Dr. Janet Woodcock, the FDA's acting commissioner.