COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval

With pandemic progression, the COVID-19 convalescent plasma safety and efficacy evidence quality increased. Ultimate regulatory approval required robust randomized control efficacy data. Future infectious disease outbreaks require randomized controlled trials in the convalescent plasma roadmap.

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Publication Details

Journal
Expert Review of Anti-infective Therapy
Published
2026-01-02
DOI
https://doi.org/10.1080/14787210.2026.2623136
Primary Topic
SARS-CoV-2 and COVID-19 Research
Type
article
Field-Weighted Citation Impact
0.00
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article

COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval

Daniel F. Hanley, Michael J. Joyner, Arturo Casadevall, David J. Sullivan et al.
Expert Review of Anti-infective Therapy
SARS-CoV-2 and COVID-19 Research
article

COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval

Daniel F. Hanley, Michael J. Joyner, Arturo Casadevall, David J. Sullivan, Suchitra Pandey, Jonathon W. Senefeld, Liise-Anne Pirofski, Karen Lane, Aaron A. R. Tobian, Shmuel Shoham, Daniele Focosi, Kelly A. Gebo, Nichol A. McBee, Sabra L. Klein, Alicia Prichard, Patrizio Caturegli, Rita Reik, Evan M. Bloch, Andrew Pekosz, Massimo Franchini, Marlene Pagan
article en

Abstract

With pandemic progression, the COVID-19 convalescent plasma safety and efficacy evidence quality increased. Ultimate regulatory approval required robust randomized control efficacy data. Future infectious disease outbreaks require randomized controlled trials in the convalescent plasma roadmap.

Expert Review of Anti-infective TherapyVol. 24(1)
Albert Einstein College of Medicine (US), Montefiore Medical Center (US), Johns Hopkins University (US), University of Illinois Urbana-Champaign (US), Johns Hopkins Medicine (US), WinnMed (US), OneBlood (US), Azienda Ospedaliera Carlo Poma (IT), Azienda Ospedaliera Universitaria Pisana (IT), Stanford University (US)
Good health and well-being
Openalex Percentile: Top 74%
SARS-CoV-2 and COVID-19 Research
DOIOpen Access PDFOpenAlex
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COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval — Daniel F. Hanley, Michael J. Joyner, et al. · Expert Review of Anti-infective Therapy (2026) | TGRS Research Map | TGRS