The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

  • LOG IN
  • BECOME A MEMBER
  • About
    • Mission & Activities
    • Directors and Officers
    • Marketing & Promotions
    • The Antibody Society’s Committees
      • Meetings Committee
      • AIRR Community Working Groups & Sub-Committees
    • Sponsors & Partners
  • Society meetings
    • Computational Antibody Discovery: State of the Art
      • Computational Antibody Discovery Symposium Participants
    • Harnessing Cytokines for Cancer Immunotherapy Symposium
    • Biopharmaceutical Informatics Symposium
    • Emerging Cancer Therapies Leveraging Gamma-Delta Effector T cells Symposium
    • Emerging Immunotherapeutics for Ovarian Cancer Symposium
    • AIRR Community Meetings
    • Antibody Engineering & Therapeutics (US) 2024
      • 2022 Antibody Engineering & Therapeutics
      • 2020 Antibody Engineering & Therapeutics
      • 2019 Antibody Engineering & Therapeutics
      • 2018 Antibody Engineering & Therapeutics
      • What is INN a Name?
        • INN issue updates
    • Antibody Engineering & Therapeutics Europe 10 – 12 June, 2025 | Congress Center, Basel Switzerland.
      • Scientific Advisors, Antibody Engineering & Therapeutics Europe
    • FOCIS Symposia
  • AIRR Community
    • AIRR Community News
    • AIRR Community Newsletter
    • AIRR Community Seminar Series
    • AIRR Community Meetings
      • Zooming into the Community III
      • AIRR Community Meeting VII – Learnings and Perspectives
      • AIRR Community Special Event 2023  – Zooming in to the Community II
      • AIRR Community Meeting VI: “Exploring New Frontiers”
      • AIRR Community Meeting V: “Zooming in to the AIRR Community”
      • AIRR Community Meeting V Pre-Meetings
        • AIRR-seq in the Pandemic
        • AIRR-seq Biological Standards and Workflows
      • AIRR Community Special Event: “Response to COVID-19”
      • AIRR Community Meeting IV: “Bridging the Gaps”
      • AIRR Community Meeting III
        • Day 1
        • Day 2
        • Day 3
        • Day 4
      • AIRR Community Meeting II
      • AIRR Community Meeting I
    • On AIRR – An AIRR Community Podcast
    • AIRR Data Commons
    • AIRR-C Germline Database Resources
    • AIRR Community Publications
    • AIRR Community Working Groups
      • Biological Resources Working Group
      • Common Repository Working Group
      • Diagnostics Working Group
      • Germline Database Working Group
      • Legal and Ethics Working Group
      • Software Working Group
      • Standards Working Group
    • AIRR Community Sub-Committees
      • Communications Sub-Committee
      • Executive Sub-Committee
      • Inferred Allele Review Committee
      • Meetings Sub-Committee
      • Strategic Planning Sub-Committee
    • AIRR Community Webinar Series
    • AIRR Community Calendar
    • AIRR Community Resources
  • Members only
    • Login
    • Note to members
    • Member discount codes
    • 2025 Calendar of Events
    • James S. Huston Antibody Science Talent Award
      • 2024 James S. Huston Antibody Science Talent Award Recipient
      • 2023 James S. Huston Antibody Science Talent Award Recipient
      • 2022 James S. Huston Antibody Science Talent Award Recipient
      • 2021 James S. Huston Antibody Science Talent Award Recipient
      • 2020 James S. Huston Antibody Science Talent Award Recipient
      • Huston Award submission guidelines
    • Research Competitions
      • Research Competition Winners
    • Science Writing Competition
      • Science Writing Competition Winners
    • Imaging Competition
      • Imaging Calendar Competition winners
        • The Antibody Society 2025 Calendar
        • The Antibody Society 2024 Calendar
    • Antibodies in early-stage studies
    • Presentations
  • Upcoming meetings in 2025
  • Web Resources
    • Society Publications
    • Antibody News
    • Antibody News Podcast
    • Antibody therapeutics approved or in regulatory review in the EU or US
      • Antibody therapeutics product data
    • Antibodies in late-stage clinical studies
    • Research Resources
    • Education Resources
  • Career Center
    • Career Shorts
  • Learning Center
    • Upcoming Webinars in 2025
    • The Antibody Series Lectures
    • Antibody Discovery & Development
    • Adaptive Immune Receptor Repertoires
    • Antibodies to Watch
    • Commercializing Antibody Therapeutics
    • Antibody Validation
      • 4th International Antibody Validation Meeting, Sep 2023
    • Snakebite antivenoms: Global challenges and progress toward recombinant antibody therapeutics
You are here: Home / COVID-19 / FDA issues Emergency Use Authorization for COVID-19 convalescent plasma

FDA issues Emergency Use Authorization for COVID-19 convalescent plasma

August 24, 2020 by Janice Reichert

On August 23, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for investigational COVID-19 convalescent plasma (CCP) for the treatment of COVID-19 in hospitalized patients. CCP is human plasma collected by FDA-registered blood establishments from individuals whose plasma contains anti SARS-CoV-2 antibodies, and who meet all donor eligibility requirements and are qualified. Titer levels of anti-SARS-CoV-2 antibodies are determined by the Ortho VITROS SARS-CoV-2 IgG test before units of CCP are released. Units found to have a signal-to-cutoff ratio of 12 or greater qualify as High Titer COVID-19 Convalescent Plasma.

Based on scientific evidence available, the FDA concluded CCP may be effective in treating COVID-19, and that the known and potential benefits of CCP outweigh the known and potential risks of the product. The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.

Data obtained from the ongoing National Convalescent Plasma Expanded Access Protocol (EAP) sponsored by the Mayo Clinic was included in FDA assessment. This uncontrolled, single-arm study was established in April 2020 to provide access to COVID-19 convalescent plasma in hospitalized subjects with severe or life-threatening COVID-19 or judged by the treating provider to be at high risk of progression to severe or life-threatening disease. As of August 13, 2020, over 90,000 patients have been enrolled. Data from the EAP posted online on August 12, 2020 reveals trends toward reduced mortality when patients receive CCP with higher antibody levels and at earlier time points. According to FDA’s decision memorandum:

  • In the subset of non-intubated patients, there was a 21% reduction in 7-day mortality (from 14% to 11%, p=0.03) in subjects transfused with high versus low titer CCP.
  • In the subgroup of patients less than 80 years of age who were not intubated and who were within 72 hours of diagnosis, a significant reduction in 7-day mortality from 11.3 to 6.3% (p = 0.0008) was observed when titers are binned to low versus high.
  • Survival trends observed at 7 days persisted over a longer time period, with significantly improved survival in non-intubated patients (p=0.032) and a larger benefit in the subset of patients not intubated at the time of treatment, less than 80 years of age, who were treated within 72 hours of diagnosis (p=0.0081)

However, there was no difference in 7-day survival in the overall population between subjects transfused with high versus low titer CCP, and there was no apparent association between neutralizing antibody titers and 7-day mortality in intubated subjects.

Information from the EUA and clinical studies of CCP may inform the development of other biologic COVID-19 interventions, such as recombinant anti-SARS-CoV-2 antibodies.  The Antibody Society is currently tracking 10 such antibodies in clinical studies or with clinical studies pending. We will report on the progress of these molecules and other COVID-19 interventions in the future.

Filed Under: COVID-19, Food and Drug Administration Tagged With: convalescent plasma, COVID-19, Food and Drug Administration

Share this post

  • LinkedIn

mabs

mabs

The Official Journal of The Antibody Society

Career Center

Our Career Center is a premier resource to connect highly qualified talent with matching career opportunities. Visit for details on over 800 jobs!

AIRR Community

AIRR Community

The Adaptive Immune Receptor Repertoire Community is a research-driven group organizing around the use of high-throughput sequencing technologies to study antibody/B-cell and T-cell receptor repertoires.

Recent Posts

  • Zooming into the Community III Starts Tomorrow! May 20, 2025
  • Exciting news – The AIRR Community is turning 10! 🎂 May 8, 2025
  • The Antibody Society (TAbS): Win a FREE Attendance Pass to AET Basel & Present A Poster: Call For Abstracts! March 26, 2025

Archives

Follow us online

  • Email
  • LinkedIn
  • Twitter
  • YouTube
  • Home
  • Privacy & Terms of Use
  • About
  • Directors and Officers
  • Advisors
  • Sponsors & Partners
  • Mission & Activities
  • Join the Society
  • Membership Levels
  • Members only
  • Login
  • Antibody therapeutics approved or in regulatory review in the EU or US
  • Meeting reports
  • Presentations
  • Contact

©2015 - scicomvisuals