The FDA said on Tuesday it has developed guidelines to take plasma from coronavirus survivors to treat patients who are critically ill from the virus.
The FDA said on Tuesday that It is possible that convalescent plasma contains antibodies to the coronavirus and might be effective against the infection. The FDA said that although the announcement is promising, convalescent plasma has not been shown to be effective in every disease studied.
The FDA is not approving using plasma as a treatment, instead using it as a clinical trial and for the treatment of those who are critically ill.
"Given the public health emergency that the expanding COVID-19 outbreak presents, while clinical trials are being conducted, FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections," the FDA said.
The plasma will be collected from recovered individuals only if they are eligible to donate blood.
The FDA said on Sunday that it was altering its guidelines on Risk Evaluation and Mitigation Strategy (REMS)-required testing, which allows healthcare providers to weigh the benefits of an experimental drug over its risks.
“The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Under these circumstances, undergoing testing or imaging studies in order to obtain a drug that is subject to a REMS can put patients and others at risk for transmission of the coronavirus. We will continue to work with sponsors to ensure that patients have appropriate access to the medications they need.”
