US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines
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.
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But principal deputy commissioner gives FDA an ‘8 or 9 on vision’ of how to use RWD to address the pandemic and other challenges. The low ‘execution’ score is due to the large amount of effort needed to understand what datasets are available, how they can be used with confidence and what questions they can answer, Abernethy says.
Pricing set somewhere down the middle as Moderna reaches deal with US government on initial supplies of its mRNA vaccine. Also, Evidence Accelerator's next joint parallel analysis projects are remdesivir in hospitalized patients and coagulopathy.
The efforts to upgrade FDA’s information technology infrastructure may be opening up into an opportunity to reinvent its processes for regulatory decision making.