The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from public health threats including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to doing everything we can to provide timely response efforts to this pandemic and facilitate access to investigational drugs for use in patients with serious or immediately life-threatening COVID-19 infections.
One investigational treatment being explored for COVID-19 involves the use of convalescent plasma collected from recovered COVID-19 patients. It is possible that convalescent plasma that contains antibodies to SARS-CoV-2 (the virus that causes COVID-19) might be effective against the infection. Use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2009-2010 H1N1 influenza virus pandemic, 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic. Although promising, convalescent plasma has not been shown to be effective in every disease studied….
