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

 
• By Sarah Karlin-Smith
  
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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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FDA’s Vaccines and Related Biological Products Advisory Committee will weigh in on a third dose of Pfizer’s COVID vaccine on 17 September • Source: Alamy

Pfizer Inc./BioNTech SE appears to have met many of the goalposts the US Food and Drug Administration laid out for COVID-19 vaccine booster doses in guidance, but it’s unclear whether that will be enough to get the supplemental biologics application through the agency. The sponsors only have minimal data on the booster’s impact on currently circulating variants, and there is a lack of clear evidence that booster shots are needed at this time, particularly to protect against the most severe disease outcomes.

FDA asked companies working on boosters for their original COVID vaccines to follow the guidance laid out in May 2021...

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