USA – Convalescent Plasma: FDA Facilitating Emergency Access

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…