FDA Letter of Authorization- Reissuance of Convalescent Plasma

Angie Szumlinski Health, Studies

On February 2, 2021, the U.S. Food and Drug Administration reissued an Emergency Use Authorization for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with Covid-19. This reissues the letter of authorization released on November 20, 2020, and also contained the following updates:

  1. Includes updates based on data from additional clinical trials.
  2. Clarifies that the authorization is limited to use of only high titer
  3. COVID-19 convalescent plasma in hospitalized patients early in the course of the disease and those hospitalized with impaired humoral immunity
  4. Adds the Abbott SARS-CoV-2 IgG test (ARCHITECT and Alinity i platforms), Beckman Coulter Access SARS-CoV-2 IgG test, EUROIMMUN Anti-SARS-CoV-2 ELISA (IgG) test, GenScript cPass SARS-CoV-2 Neutralization Antibody Detection Kit test, Kantaro COVID-SeroKlir test, Roche Elecsys AntiSARS-CoV-2 S test, and Siemens ADVIA Centaur SARS-CoV-2 IgG (COV2G) test as acceptable tests to be used for the purpose of qualifying high titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma.
  5. Changes the cutoff of the Ortho VITROS Anti-SARS-CoV-2 IgG test from S/C≥12.0 to S/C≥9.5 for the qualification of COVID-19 convalescent plasma as high titer.

Please read the full release below for more information.