FDA Issues Emergency Use Of Convalescent Plasma For COVID–19 Treatment

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19.

The FDA was successful in determining that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients.

Patients who are below the age of 80 and are not on mechanical ventilation responded positively to the plasma therapy, provided they are treated within three days of the diagnosis.

“The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far. We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma,” - Alex Azar, Health and Human Services Secretary.

Political pundits believe the urgency in the matter from President Trump is directed towards reviving his political fortunes ahead of this week's Republican National Convention.

"The hope is that infusions of antibody-rich plasma from those who have recovered from Covid-19 can be injected into ill patients, kickstarting their immune system and allowing them to fight off the virus until they can generate their own antibodies," according to Stat News.

Stocks with exposure to the plasma space include Liminal BioSciences LMNL and Kamada Ltd KMDA.

Convalescent plasma is neither "major" nor "breakthrough"

It has already been given to >70,000 #COVID19 patients and this EUA won't significantly change standard of care.

Sadly we still don't convincing RCT data that demonstrate its effectiveness after >5M cases in US... https://t.co/AqHZDhob1l

— Andy Biotech (@AndyBiotech) August 23, 2020

Editor's note: A previous version of this article said Sonnet BioTherapeutics Holdings SONN has exposure to the plasma space. The company does not manufacture immunoglobulin products, but its fully human albumin-binding therapies bind to and attach to patient's endogenous human serum albumin for transport to target tissues.