EBS - FDA Facilitating Use of Plasma From Recovered COVID-19 Patients to Treat Serious Cases
On Tuesday, the Food and Drug Administration said it's facilitating access to the blood plasma of patients who have recovered from COVID-19. Because those patients have fought off disease, their plasma should contain antibodies to SARS-CoV-2, which causes it.
The agency outlined eligibility rules for donors, including that they should have been free of symptoms for at least 14 days and test negative for COVID-19. The FDA would also like their plasma to be tested for neutralizing antibodies to the virus, but the agency realized that may not always be possible.
The agency is also approving emergency Investigational New Drug (IND) Applications for individual patients. It's shooting for getting those emergency INDs through the process in 4 to 8 hours via email, and is also offering verbal authorizations over the phone if doctors need a response more quickly.