What does FDA approval of vaccine mean?

The upgrade in status means the Pfizer vaccine will still be available after the health emergency ends, but also means employers and others can mandate vaccination.


National News

August 24, 2021 - 10:17 AM

Toribio Cruz, 13, of Detroit looks on as medical assistant Stephanie Yang puts a bandage on his arm where she administered the Pfizer COVID-19 vaccine. The vaccine is approved for children age as young as 5. Photo by TNS

The U.S. Food and Drug Administration approved the Pfizer-BioNTech coronavirus vaccine on Monday for people 16 and older, making it the first of three COVID-19 shots available in the U.S. to be upgraded from an emergency use authorization (EUA) to full approval.

For children aged 12 to 15, the vaccine can still be administered under an EUA, as well as third doses for certain immunocompromised individuals. Both the Johnson & Johnson and Moderna COVID-19 vaccines still await FDA approval but remain available for adults under an EUA.

The upgrade means the Pfizer vaccine will still be available to the public even after the “current public health emergency” the original authorization was based on comes to an end. The approval also means employers, local leaders and other businesses may be more willing or likely to mandate COVID-19 vaccination.

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