Pfizer's COVID-19 Vaccine Brings Gaps In Efficacy And Safety Data To US FDA Panel

Agency details a host of unknowns regarding the benefits and risks of the first COVID-19 vaccine to reach the advisory committee stage, including uncertainties about duration of protection, effectiveness against transmission and vaccine-enhanced disease.

Brokeen bridge with gap above city view
The FDA's external experts will decide whether or not to recommend a vaccine EUA despite large gaps in the efficacy and safety data. • Source: Shutterstock

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee on 10 December will be tasked with reviewing the available efficacy and safety data on Pfizer Inc./BioNTech SE’s COVID-19 vaccine.

However, given the unprecedented speed with which BNT162b2 was developed amid a pandemic that has killed more than 280,000 US residents, the panel’s attention also is likely to focus on what is not

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