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Investigational COVID-19 convalescent plasma
Investigational COVID-19 convalescent plasma
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Biologics Evaluation and Research, January 7, 2022
- Language(s):
- English
- Format:
- Text
- Subject(s):
- COVID-19 -- therapy
Immunization, Passive
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. On August 23, 2020, FDA issued an Emergency Use Authorization (EUA)0F 1 for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA has subsequently reissued this EUA with revisions. Most recently, FDA revised the EUA to limit authorization to the use of COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting.1F 2 FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the authorization, COVID-19 convalescent plasma may also be used under an investigational new drug application (IND). For the purposes of this guidance, the term “COVID-19 convalescent plasma” refers to the convalescent plasma authorized under the EUA, while the term “investigational convalescent plasma” refers to convalescent plasma that does not meet all the conditions of the EUA and/or is being used under an IND. FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency. The guidance also provides recommendations to blood establishments on collection. This document supersedes the guidance of the same title issued in February 2021 (previous versions January 2021, November 2020, September 2020, May 2020, and April 2020). We have revised the guidance to reflect that the EUA authorizes COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. In addition, we have revised certain recommendations pertaining to COVID-19 convalescent plasma donors. In sections III.B.1 and III.C.1, we now recommend that individuals qualify as COVID-19 convalescent plasma donors 10 days following complete resolution of symptoms. We also have revised the recommendations in section III.B.1 that address when individuals who have received an investigational COVID-19 vaccine as a participant in a clinical trial or received an authorized or licensed COVID-19 vaccine, qualify as convalescent plasma donors. Also, the section on FDA’s interim compliance and enforcement policy regarding the IND requirements for the use of investigational convalescent plasma has been removed because the period of enforcement discretion ended on May 31, 2021.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (i, 13 pages)).
- NLM Unique ID:
- 9918351274506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351274506676