Also categorized in Business of Medicine:
Flu deaths jump to 1,800: CDC
x hide permanently

Pfizer Seeks FDA Authorization for Updated COVID-19 Booster

Pittsburgh PA News, Weather and Sports

Photo: Pixabay

Pfizer and BioNTech have submitted their application to the U.S. Food and Drug Administration for emergency use authorization of their bivalent COVID-19 vaccine for use in people age 12 and older, the companies said in a statement on Monday.

This updated formulation will combine the original vaccine with one that targets omicron sublineages BA.4 and BA.5, and would be administered as a 30 microgram dose.

The companies say they are following "guidance from the FDA" and are including clinical data of their bivalent BA.1 vaccine and pre-clinical and manufacturing data from the ...