FDA allows investigational use of COVID-19 convalescent plasma
The US Food and Drug Administration (FDA) released a statement on March 24 stating that investigators can request to use plasma from COVID-19 survivors to deliver antibodies to seriously ill patients, under an emergency investigational new drug (IND) protocol.
To bring the treatment up to modern standards, plasma donations from people who have recovered from COVID-19 infection would be processed and purified, creating a serum to transfuse into critically ill patients.
In January, Casadevall and Liise-anne Pirofski of New York’s Montefiore Health System wrote in the Journal of Clinical Investigation that convalescent therapy could be used to curb COVID-19. They note that attempts to use convalescent therapies during outbreaks over the last 25 years, including the H1N1 pandemic in 2009 and 2013 Ebola epidemic, were met with varying levels of success, possibly due to the plasma being administered when the patient was too far gone for it to help. Casadevall’s team recently received funding from Johns Hopkins, with a goal of performing these convalescent transfusions at the university’s Baltimore campus within a month.
While an eventual vaccine would ideally provide long-lasting immunity by spurring the recipient to create their own antibodies, receiving antibodies via the convalescent treatment would only form a temporary immunity, so multiple treatments would be required over the course of the illness.
There are still details that need to be figured out in using convalescent plasma for COVID-19 treatment, including determining an effective dosing size. In its statement announcing the emergency IND access protocols, the FDA outlined standards for donor and recipient eligibility.
Plasma transfusions are commonplace, with patients receiving millions of donated units every year, but they are not without risks. Severe lung injury or allergic reactions can occur after receiving donor plasma.
To achieve similar results to transferring plasma with potentially fewer downsides, some biotech companies are developing antibodies to combat SARS-CoV-2. Vir Biotechnology in San Francisco is focusing its efforts on one particular antibody, with modifications to make the antibodies last longer in the body. Vir reports that its drug might be ready for clinical trials as soon as this summer.
Read more from The Scientist: https://www.the-scientist.com/news-opinion/fda-to-allow-for-plasma-thera...
Read the FDA statement on investigational use: https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-in...
Read the Montefiore study here: https://www.jci.org/articles/view/138003