US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines - Pinksheet

Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it can use real-world data and evidence for COVID-19 vaccine evaluation.

The US Food and Drug Administration is working with public and private partners to figure out how it could use real-world data to help evaluate COVID-19 vaccines, principal deputy commissioner Amy Abernethy said Tuesday at the Biotechnology Innovation Organization's digital convention. 

The COVID-19 Evidence Accelerator, a project launched by the Reagan-Udall Foundation, Friends of Cancer Research and FDA to bring together a variety of government, industry and academic health data experts to answer key COVID-19 questions, is “gearing up” to think about how the project can be used for vaccines, Abernethy said. 

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