FDA staff say Pfizer COVID-19 boosters improve immunity but may not be needed, plus Analysis

Sept 15 (Reuters) - U.S. Food and Drug Administration scientists said on Wednesday that a third booster dose of Pfizer's (PFE.N) COVID-19 vaccine generates a higher immune response in recipients, but stopped short of saying the extra shots are needed broadly.

The FDA staff members said in a document prepared for outside advisors that Comirnaty - the COVID-19 vaccine Pfizer developed with Germany's BioNTech SE - met pre-specified conditions the regulator had set to show that the shot was generating an immune response.

Whether the vaccine's efficacy is declining and if boosters are needed remains unproven, the agency said.

"Some observational studies have suggested declining efficacy of Comirnaty over time against symptomatic infection or against the Delta variant, while others have not," they said in the document. "However, overall, data indicate that currently U.S.-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States." ...

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