To increase access to COVID-19 convalescent plasma (CCP) use, President Trump, in conjunction with the U.S. FDA, announced Emergency Use Authorization (EUA) for CCP on August 23, 2020. CCP has been available in the U.S. since early April through the Expanded Access Program (EAP)—a program sponsored by the U.S. government and organized by the Mayo Clinic. Since April, over 103,000 patients have requested CCP, and 72,461 have been infused through this program, which was disbanded at the same time the EUA was announced. Although some scientists and researchers are calling for more rigorous randomized controlled trials for CCP, the EUA comes on the heels of more evidence that CCP is safe and effective. Based on the initial three-months of CCP use transfused to 35,322 seriously ill patients through the EAP, both 7-day and 30-day mortality were lower in patients transfused with CCP within 3 days of diagnosis compared to patients transfused 4 or more days after diagnosis (P<0.001 for both). Furthermore, mortality was lower in patients transfused with CCP containing higher anti-SARS-CoV-2 IgG levels, and no adverse effects were observed. Randomized controlled trials are urgently needed to ensure the safety and efficacy of CCP; however, the feasibility to recruit patients is now in question given CCP availability through the EUA.
References:
- Joyner MJ, Senefeld JW, Klassen SA, Mills JR, et al. Effect of convalescent plasma on mortality among hospitalized patients with COVID-19: Initial three-month experience. MedRxIv 2020
- FDA News Release: FDA issues Emergency Use Authorization for convalescent plasma as potential promising COVID-19 treatment, another achievement in administration’s fight against pandemic.
- COVID-19 Expanded Access Program. Expanded Access Program for convalescent plasma discontinues enrollment as FDA authorizes its emergency use.
- S. Food and Drug Administration. Convalescent Plasma COVID-19 letter of authorization.
