Convalescent Plasma: FDA Facilitating Emergency Access

Regulatory NewsRegulatory News | 24 March 2020 |  By 

One potential treatment for COVID-19, known as convalescent plasma, may be derived from patients who have already recovered from the disease, and the US Food and Drug Administration (FDA) said Tuesday that it will help to provide access to it for patients with serious or immediately life-threatening COVID-19 infections.

The idea behind the treatment is that plasma collected from patients recovering from COVID-19 may contain antibodies to the virus that might be effective against the infection. New York Gov. Andrew Cuomo (D) said yesterday that some critically ill patients would be able to access convalescent plasma in some cases.

Although FDA says it’s important to determine, via clinical trials, the safety and effectiveness of convalescent plasma before routinely administering it to patients with COVID-19, the agency said it will allow the use of single patient emergency Investigational New Drug Applications (eINDs) to obtain access to the investigational plasma. Such eINDs can be submitted to FDA via email and the agency says it can provide time-sensitive responses in four to eight hours.

At the White House last week, FDA Commissioner Stephen Hahn said the agency is “really pushing hard to try to accelerate” the use of convalescent plasma. He added: “If you’ve been exposed to coronavirus and you’re better and you don’t have the virus in your blood, we could collect the blood. Now, this is a possible treatment; this is not a proven treatment — just want to emphasize that. Collect the blood, concentrate that, and have the ability, once it’s pathogen-free — that is, virus-free — to be able to give that to other patients. And the immunoglobulins — the immune response — could potentially provide a benefit to patients.”

FDA also says that COVID-19 convalescent plasma must only be collected from recovered individuals (complete resolution of symptoms at least 14 days before a donation) and if they are eligible to donate blood. The required testing must be done, FDA says, while also outlining how it defines what “severe or immediately life-threatening COVID-19” means (see the link at the bottom for more details).

In addition, FDA is working with the National Institutes of Health and the Centers for Disease Control and Prevention to develop master protocols for use by multiple investigators in order to coordinate the collection and use of COVID-19 convalescent plasma.

The use of convalescent plasma was previously studied in other pandemics and epidemics, including the 2009-2010 H1N1 influenza virus pandemic, the 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic, FDA said.

A comment in the Lancet last month said that “several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma.”

Investigational COVID-19 Convalescent Plasma - Emergency INDs


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