FDA issues emergency use authorisation for COVID-19 convalescent plasma
The emergency use authorisation (EUA) allows the distribution and administration of COVID-19 convalescent plasma to hospitalised patients in the US.
The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for convalescent plasma as a treatment of COVID-19 in hospitalised patients. The authorisation was based on evidence that the product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks, as well as the determination that there are no adequate, approved and available alternative treatments.
The EUA authorises the distribution of COVID-19 convalescent plasma in the US and its administration by health care providers to treat suspected or laboratory-confirmed COVID-19 in hospitalised patients.
The FDA Commissioner, Dr Stephen Hahn said: “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We are encouraged by the early promising data that we have seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who have recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus. At the same time, we will continue to work with researchers to continue randomised clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”
The EUA is not intended to replace randomised clinical trials, which will be critically important to definitive demonstration the safety and efficacy of COVID-19 convalescent plasma. The FDA said it recommends that the designs of ongoing randomised clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care.
Terms of EUA
The EUA requires that patients and health care providers are provided access to fact sheets detailing important information about using COVID-19 convalescent plasma in treating COVID-19, including dosing instructions and potential side-effects. These side-effects include allergic reactions, transfusion-associated circulatory overload and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.
The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined that it no longer meets the statutory criteria for issuance.