Convalescent Plasma and the US Expanded Access Program: A Personal Narrative.
Level 5 - mechanism / opinion, no new human data
Narrative review and personal reflection with no new primary data.
PubMed 38877204 · doi:10.1007/82_2024_269
What was done
The principal investigator provided a retrospective narrative describing the execution, key outcomes, and lessons from the FDA-authorized Expanded Access Program for COVID-19 convalescent plasma housed at the Mayo Clinic between early April and late August 2020. Clinicians nationwide registered hospitalized SARS-CoV-2 patients and submitted clinical data to participate.
What was found
Nearly 100,000 hospitalized patients received convalescent plasma across approximately 2,200 US hospitals in every state. Initial safety signals were identified in 5,000 recipients and supported by a subsequent analysis of 20,000 recipients. Prior published program analyses indicated that early administration of high-titer convalescent plasma lowered mortality by as much as one-third, which informed the August 2020 FDA Emergency Use Authorization.
Why it matters
The paper outlines the structure, historical timeline, and operational scale of a nationwide treatment access program deployed during the early phase of the pandemic.
Limits
This is a personal narrative reflection rather than a systematic review or prospective clinical trial. The underlying expanded access initiative was an open-label observational program designed for clinical access without randomized concurrent controls.
Cited by
- supports The FDA granted emergency use authorization for convalescent plasma for COVID-19 based on studies that lacked control groups.