FDA Issues Emergency Use Authorization for Convalescent Plasma Treatment for Patients With COVID-19

The FDA has issued an emergency use authorization (EUA) for the use of convalescent plasma in the treatment of coronavirus disease 2019 (COVID-19). Although there is currently a lack of data from randomized control trials, the FDA stated that the potential benefits of the treatment outweigh any potential risks.¹

Prior research has demonstrated that infusing COVID-19 patients with plasma from those who have recovered from the disease was beneficial, such as a study conducted by the Mayo Clinic and the National Institutes of Health (NIH) and a study conducted at Houston Methodist.^2,3

In the study conducted by the Mayo Clinic and the NIH, researchers found that plasma treatments had a small but significant effect on the mortality of patients with COVID-19 who received infusions within 3 days of the onset of symptoms, compared with those who received an infusion later. However, the lack of a placebo group in the study remained a problem in determining the overall benefit of the treatment.²

In the study conducted at Houston Methodist, researchers observed similar results, finding that treating critically ill COVID-19 patients with a transfusion of high antibody plasma within 3 days of hospitalization proved the most effective method of reducing mortality rates. This study included data from 300 COVID-19 patients treated with convalescent plasma therapy.²

Houston Methodist was the first hospital to begin infusing critically ill COVID-19 patients with donated plasma from recovered patients, as they started the practice on March 28. In a study published in The American Journal of Pathology, the authors explained that they tracked patients admitted to a location within the Houston Methodist hospital system between March 28 and July 6. These patients were then tracked for 28 days following the transfusion, with the results compared with a similar control group who did not receive the therapy.³

"Our studies to date show the treatment is safe and, in a promising number of patients, effective,” said co-author James M. Musser, MD, chair of the Department of Pathology and Genomic Medicine at Houston Methodist, in a press release. “While convalescent plasma therapy remains experimental and we have more research to do and data to collect, we now have more evidence than ever that this century-old plasma therapy has merit, is safe and can help reduce the death rate from this virus.”³

However, the decision by the FDA to issue an EUA for the use of convalescent plasma to treat COVID-19 was made following a rare intervention by the NIH to stop the FDA from doing so. Three NIH officials involved in the intervention—Francis S. Collins, MD, PhD, the director of the NIH; Anthony S. Fauci, MD, the government’s top infectious disease expert; and H. Clifford Lane, MD, the clinical director at the National Institute of Allergy and Infectious Diseases—cited the problem being that data from randomized control trials were still lacking.⁴

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” said Lane in an interview with the New York Times.⁴

In a press conference, President Donald Trump cited politics as a potential source of a delay in the FDA’s granting an EUA for the experimental drug treatment.⁵

“I hear great things about it ... that’s all I can tell you,” Trump said during a White House press briefing referring to convalescent plasma therapy, according to a CNBC article. “It could be a political decision because you have a lot of people over there who don’t want to rush things because they want to do it after November 3, and you’ve heard that one before.”⁵

Although an EUA has been released by the FDA for the plasma treatment, an EUA is not the same as an FDA approval. According to the FDA, the organization only issues EUAs when it has reason to believe a treatment’s efficacy and benefits outweigh its potential risks.¹

However, the FDA noted in their statement that an EUA is not intended to replace randomized clinical trials, as the enrollment of patients into ongoing randomized clinical trials is critically important to definitively determine the safety and efficacy of convalescent plasma for the treatment of COVID-19.¹

“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 statement from the FDA.¹

REFERENCE

1. FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID—19 Treatment, Another Achievement in Administration’s Fight Against Pandemic. U.S. Food and Drug Administration; August 23, 2020. fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment. Accessed August 24, 2020.

2. Garde, D. Large study suggests convalescent plasma can help treat Covid-19, but experts have doubts. STAT. August 13, 2020. statnews.com/2020/08/13/large-study-suggests-convalescent-plasma-can-help-treat-covid-19-with-caveats/. Accessed August 24, 2020.

3. Preliminary study of 300-plus COVID-19 patients suggests convalescent plasma therapy effective. Houston, TX: Houston Methodist; August 12, 2020. sciencedaily.com/releases/2020/08/200812201325.htm. Accessed August 24, 2020.

4. Weiland N, LaFraniere S, Fink S. F.D.A.’s Emergency Approval of Blood Plasma Is Now on Hold. New York Times. August 19, 2020. nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html. Accessed August 24, 2020.

5. Huggins-Dunn N, Farr C. Trump says FDA hold on blood treatment therapy use for coronavirus patients ‘could be a political decision.’ CNBC. August 19, 2020. cnbc.com/2020/08/19/trump-says-fda-hold-on-blood-treatment-therapy-use-for-coronavirus-patients-could-be-a-political-decision.html. Accessed August 24, 2020.