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Pfizer Comes Close To Meeting FDA’s Guidance Standard For COVID Booster Dose, But It May Not Be Enough

Executive Summary

Study data met two key endpoints laid out in agency guidance, but Pfizer may not have enough evidence of the booster’s impact on current circulating virus variants, particularly Delta. It is also unclear if Pfizer has made the case to FDA that a booster dose is needed at this time or that they provided enough safety data.

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