March 3, 2026Open Access

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

Key Points

Safety and efficacy of convalescent plasma have improved with better evidence quality over time, in response to COVID-19.
Increased regulatory approval requires robust randomized controlled trial data to support efficacy.
Analysis focuses on the roadmap for future infectious disease outbreaks and the role of convalescent plasma.
Highlights the urgency of conducting randomized controlled trials to validate convalescent plasma's effectiveness.

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.

Connected Papers

Building similarity graph...

Analyzing shared references across papers

Discussion

Authors

David J. Sullivan

Rita Reik

Alicia Prichard

Journals

Expert Review of Anti-infective Therapy

Actions

Institutions

Stanford University

Johns Hopkins University

University of Illinois Urbana-Champaign

References and Citations

Connected Papers

Building similarity graph...

Analyzing shared references across papers

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

Key Points

Abstract

Citation Network

Connected Papers

Discussion

Authors

Journals

Actions

Institutions

References and Citations

Citation Network

Connected Papers

Discussion

Cite this study