Markets
EBS

FDA Authorizes Plasma Antibodies as a COVID-19 Treatment

The Food and Drug Administration (FDA) issued an emergency use authorization yesterday for the utilization of convalescent plasma as a treatment for COVID-19. Convalescent plasma contains antibodies against the novel coronavirus that causes COVID-19. The plasma is harvested from patients who have recovered from the disease.

"The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients," the agency said in a press release announcing the decision.

If "reasonable" doesn't sound like a ringing endorsement, that's because it isn't. The authorization is based on two small randomized clinical trials -- neither of which reached statistical significance. The authorization also included data from nonrandomized studies and data on patients treated under an expanded access program, both of which don't have a control group, making the data hard to interpret.

This is an emergency use authorization rather than a full approval because the FDA believes "COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence." The agency encouraged clinical trials testing convalescent plasma to continue unaltered, to gain better evidence on whether the treatment actually helps patients.

Doctors in personal protective equipment talking to a patient

Image source: Getty Images.

Over 70,000 patients have been treated with convalescent plasma, so it seems reasonable that the agency has enough data to conclude that the treatment is relatively safe. Nevertheless, there are still some risks associated with plasma transfusion, including acute lung injury, cardiac overload, reactions to the treatment, and infections from the donors.

A consortium of biotechs and pharmaceutical companies, including CSL Behring (OTC: CSLLY) and Takeda Pharmaceutical (NYSE: TAK), is working on a commercial plasma-derived antibody treatment, as is Emergent BioSolutions (NYSE: EBS).

10 stocks we like better than Emergent BioSolutions
When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.*

David and Tom just revealed what they believe are the ten best stocks for investors to buy right now... and Emergent BioSolutions wasn't one of them! That's right -- they think these 10 stocks are even better buys.

See the 10 stocks

 

*Stock Advisor returns as of August 1, 2020

 

Brian Orelli, PhD has no position in any of the stocks mentioned. The Motley Fool owns shares of and recommends Emergent BioSolutions. The Motley Fool has a disclosure policy.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story

EBS TAK

Latest Markets Videos

The Motley Fool

Founded in 1993 in Alexandria, VA., by brothers David and Tom Gardner, The Motley Fool is a multimedia financial-services company dedicated to building the world's greatest investment community. Reaching millions of people each month through its website, books, newspaper column, radio show, television appearances, and subscription newsletter services, The Motley Fool champions shareholder values and advocates tirelessly for the individual investor. The company's name was taken from Shakespeare, whose wise fools both instructed and amused, and could speak the truth to the king -- without getting their heads lopped off.

Learn More