FDA to allow COVID-19 treatments with blood from survivors

The FDA unlocked the use of convalescent plasma—derived from the donated blood of people that have recovered from COVID-19 and which may contain helpful antibodies—as an investigational treatment for patients with severe cases of the disease.

The method has been used for decades to treat infectious diseases, with the goal of transferring newly acquired immunity from one person to another. More recently, it has been studied in the H1N1 swine flu, Ebola, SARS and MERS epidemics—as well as against the novel coronavirus in China—however, it is currently unknown how well it will perform.

“Although promising, convalescent plasma has not been shown to be effective in every disease studied,” the FDA said in its announcement. “It is therefore important to determine through clinical trials, before routinely administering convalescent plasma to patients with COVID-19, that it is safe and effective to do so.”

The agency said that although widespread clinical testing may not be feasible for evaluating this specific and scarce donated plasma, it would also allow physicians to proceed on a case-by-case basis for patients with serious or life-threatening infections outside of larger research studies.

Plasma donors must have had a COVID-19 diagnosis confirmed by a lab test and been completely symptom-free for at least two weeks before donating.

That process includes filing for a single-patient, emergency investigational new drug application, or eIND. Physicians can obtain authorization over email or receive verbal, over-the-phone confirmations in emergency and time-sensitive cases.

The FDA also said it is working with the National Institutes of Health and the Centers for Disease Control and Prevention to develop larger protocols for use by multiple researchers to coordinate the collection and use of COVID-19 plasma.

Elsewhere, New York Governor Andrew Cuomo said this week that the state department of health would be conducting its own trial of convalescent plasma. As of March 24, New York has confirmed more than 25,000 cases statewide, nearly half of the over 55,000 cases reported in the U.S.