Open letter to the FDA to permit access to COVID-19 convalescent plasma for outpatient use

This treatment may be critically important for immunocompromised patients.

Please provide us with all the help we need. We, the Immunocompromised community, are desperate and frightened.

Please allow!

my wife is high risk and we have no options left because the other treatments don't work on omicron. please let the doctors use this.

Please, make people understand this works--my mama was saved by it.

Please allow for people to have this much needed plasma during the pandemic

We have learned so much since 2020! Making CCP more accessible and given earlier in treatment - ideally as out-patient will be a game changer

an important product in our tool box for treating the emergence of new VOC that escape existing immunotherapeutics like omicron

Last year, my colleagues and I tried to convince immune globulin producers to prepare concentrated preparations of COVID-Immune Globulin from COVID-convalescent plasma that could be administered by local IM or SC injection without the need highly specialized medical personnel or time in a hospital or clinic. However, because more dilute immune globulin administered IV in hospital is much more profitable, the major immune globulin producers declined. Since such preparations would very likely be active against the prevalent SARS-CoV-2 variant without the delay and expense involved in producing variant-specific vaccines. Michael N. Oxman, MD, Professor of Medicine and Pathology (Emeritus), University of California, San Diego and Staff Physician, Infectious Diseases Section, VA San Diego Healthcare System.

We need every tool available to us in our response to Covid infections

Warren Alpert Medical School Brown University, Providence RI

Johns Hopkins Bloomberg School of Public Health

The Covid-19 pandemic is not over and treatment options for health care practitioners need to evolve as new variants such as omicron continue to emerge. COVID-19 Convalescent Plasma (CCP) evolves naturally as viral strains in circulation shift. CCP therapy therefore needs to be an available therapeutic option, since it naturally complements (rather than competes) with other therapeutic modalities such as vaccinations, monoclonal antibody and pharmacological treatment. I urge you to extend EUA for CCP therapy.

This is a well-evidenced treatment that could save lives and hospital beds.

Thank you Nigel!

Low risk and potentially high yield at a critical time.

Based on emergence of the Omicron variant, this would be an important tool to help reduce hospitalizations and save lives. The evidence is sufficiently strong and worthy of consideration of an EUA.

My initial skepticism has been overtaken by solid data.

In March of 2020 I contacted Covid 19 after 10 days on a vent, I was hours from death when they administered Convalesent Plasma. 4 days later I was extubated, sitting up and talking to my wife and kids on FaceTime. As the saying goes “the proof is in the pudding” stop wasting time!! https://www.google.com/amp/s/www.nytimes.com/2021/04/17/health/covid-convalescent-plasma.amp.html