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NASH ups and downs, COVID-19 vaccines & real-world data for diagnostics: a BioCentury podcast

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The path to authorization for COVID-19 vaccines is beginning to take shape as FDA lays out its requirements and early data begin to trickle in. On the latest edition of the BioCentury This Week podcast, BioCentury editors discuss FDA’s COVID-19 vaccine guidance and the latest clinical data, plus developments in the long journey to a NASH therapy and the role of real-world data (RWD) in diagnostics.

Editor in Chief Simone Fishburn and Senior Editor Lauren Martz discuss how endpoints factored into FDA’s complete response letter for obeticholic acid (OCA) from Intercept Pharmaceuticals Inc. (NASDAQ:ICPT), and what that decision means for other NASH therapy developers including Akero Therapeutics Inc. (NASDAQ:AKRO) (see “Surrogate Endpoint Not Enough”; “Histology Data Builds on Growing Confidence Around Akero’s NASH Candidate”).

FDA’s new COVID-19 vaccine guidance sets appropriate requirements for companies, says Washington Editor Steve Usdin. Despite pressure to accelerate vaccine timelines, the agency won’t accept surrogate endpoints and stated a vaccine should reduce cases of COVID-19 by at least 50% (see “Borio, Dolsten say FDA’s COVID-19 Vaccine Guidance Hits Mark”).

That kind of data will take time, but early studies on immune responses are beginning to read out. The group discusses what the latest data on antibody levels generated by an RNA vaccine from BioNTech SE (NASDAQ:BNTX) and Pfizer Inc. (NYSE:PFE) indicate about its efficacy and how important inducing a strong virus-specific T cell response might be (see “BioNTech, Pfizer Vaccine Yields Highest Titers to Date”).

Usdin also breaks down the role of RWD in tracking diagnostic performance. The COVID-19 Diagnostics Evidence Accelerator will use RWD to reduce uncertainty around performance of PCR diagnostic and serology tests for COVID-19 (see “Accelerating the Fight Against COVID-19”).

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