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HICprevent

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This award-winning blog supplements the articles in Hospital Infection Control & Prevention.

FDA OK of Pfizer Vaccine Could Open Floodgates to Hospital Mandates

August 23rd, 2021

By Gary Evans, Medical Writer

Many hospitals and healthcare facilities are expected to mandate SARS-CoV-2 vaccine for healthcare workers now that the U.S. FDA has removed the emergency use authorization (EUA) label and fully licensed the Pfizer-BioNTech COVID-19 vaccine. Although some early adopters of mandates went ahead, many healthcare facilities said they would move the day a vaccine received final approval.

That day came Aug. 23, 2021, for the Pfizer mRNA vaccine, which will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older, the FDA reported.

“The vaccine also continues to be available under EUA, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” the FDA stated.

There was no mention by the FDA of the booster shoots that have already been announced by the Biden administration to begin September 20, but it’s hard to imagine this landmark approval hindering that effort.

Indeed, it is expected the full licensure will open the floodgates on vaccine mandates and requirements in healthcare settings and beyond, says William Schaffner, MD, a professor of healthcare policy at Vanderbilt University, which had already mandated vaccination for all employees.

“I will think this will eliminate that barrier to more institutions, healthcare facilities, colleges, [business] employers, entertainment venues, you name it," he says. "Governmental agencies will be able to implement requirements for vaccination. And I certainly think that healthcare workers, wherever they are located — including nursing homes — have a professional and ethical obligation to be vaccinated.”

Many hospitals waited for the EUA to be lifted so they could avoid legal challenges, but those who went ahead saw court rulings go in their favor. Now it is a fait accompli that many healthcare workers will be mandated to take COVID-19 vaccine — at least with the fully approved Pfizer shot — or agree to frequent testing or other measures if their employers permit.

With the Delta variant spreading all over the country and some 90 million people unvaccinated but eligible, the real question is whether the FDA approval will convince some of the skeptics and anti-vaxxers to be immunized against the pandemic virus. Certainly a hardcore group will remain, but the full licensure and the call for booster shots may be persuasive to some on the fence.

“The public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.