FDA revises Recommendations on Investigational COVID-19 Covalescent Plasma

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

Viral safety plays a particularly important role in the collection and use of blood and plasma products. Which viral diseases can be transmitted via such products, which donors of blood and plasma pose a risk due to existing diseases and which do not. These questions arise particularly when new viral diseases emerge or when known diseases spread to new regions. These questions came up with the Zika virus, Ebola and, of course, Covid-19.

The FDA sees itself as playing a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases and seeks to provide timely support through guidance to affected facilities. 

The current Guidance

Recently, the FDA issued a guidance document entitled "Investigational COVID-19 Convalescent Plasma." It is intended to provide health care providers and researchers with recommendations for the use of COVID-19 convalescent plasma or convalescent plasma for research purposes during the pandemic. The document also includes recommendations for blood donation establishments. The document thus replaces the previous guidance documents of the same title from January 2021, November 2020, September 2020, May 2020 and April 2020. The revision of the guidance document aims to demonstrate and clarify that the Emergency Use Authorization (EUA) approves COVID-19 convalescent plasma with high titres of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or under immunosuppressive treatment in the outpatient or inpatient setting. In addition, it includes revised recommendations for COVID-19 convalescent plasma donors, who are now eligible as COVID-19 convalescent plasma donors 10 days after complete resolution of symptoms. It further addresses when individuals who have received a COVID-19 vaccine as a clinical trial participant or an approved or licensed COVID-19 vaccine are eligible as convalescent plasma donors. The section on FDA's interim policy on compliance and enforcement of IND requirements for the use of convalescent plasma for investigational purposes was deleted in the new version.

Further details can be found directly in the FDA's Guidance for Industry - Investigational COVID-19 Convalescent Plasma.