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Pfizer Seeks FDA Authorization for Updated COVID-19 Booster

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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 ...