FDA Issues EUA for Convalescent Plasma as Potential COVID-19 Treatment

©MohamadFaisal/stock.adobe.com

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for convalescent plasma for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized patients.

“Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing,” said the FDA in the August 23, 2020 press release.

The EUA was issued to the US Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response, and the FDA’s decision was based on available scientific evidence that showed convalescent plasma may be an effective COVID-19 treatment and, “that the known and potential benefits of the product outweigh the known and potential risks of the product,” noted the press release.

According to the FDA clinical memorandum requesting the EUA, convalescent plasma is human plasma collected by FDA-registered blood establishments from individuals whose plasma contains anti-SARS-CoV-2 antibodies, who meet all donor eligibility requirements, and are qualified. Current evidence suggests the largest clinical benefit is associated with high-titer units of convalescent plasma administered early in infected patients.

The clinical memorandum also explains that there are 4 lines of evidence to support that COVID-19 convalescent plasma may be effective in the treatment of patients hospitalized with COVID-19:

1. History of convalescent plasma for respiratory coronaviruses
2. Evidence of preclinical safety and efficacy in animal models
3. Published studies of the safety and efficacy of convalescent plasma
4. Data on safety and efficacy from the National Expanded Access Treatment Protocol sponsored by the Mayo Clinic

The EUA authorizes 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 hospitalized patients.

“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said FDA Commissioner Stephen M. Hahn, MD, in the press release.

The FDA will continue to work with researchers to conduct randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating COVID-19 patients, concluded Hahn.