Industry call for COVID‐19 convalescent plasma collections

Abstract

The treatment of COVID-19 patients, especially in severe conditions, presents a challenge to medical professionals. Plasma from recovered COVID-19 patients is a potential and promising therapeutic option, and efforts are underway at different levels to encourage convalescent plasma donations [1, 2]. Convalescent plasma obtained by apheresis from the blood of healthy people who overcame the disease contains specific antibodies against coronavirus SARS-CoV-2. It can be used for immediate transfusion and/or for the manufacture of purified antibodies in the form of polyclonal hyperimmune immunoglobulins. The latter process is lengthy (at least 6 months) and requires large volumes of plasma (at least one thousand litres) for production. Global manufacturers are already working on SARS-CoV-2-specific hyperimmune immunoglobulin therapy options [2]. The success of these efforts requires a sufficient number of donations from willing and eligible patients recovered from COVID-19. It is essential to establish the efficacy of both therapies, as curative and prophylactic treatments in well-thought clinical trials, some of which are already underway [1, 3]. Although the literature on convalescent plasma treatment of COVID-19 is scarce, a few recent publications described positive outcomes in a small number of patients (27 total cases), mainly in critical conditions, who received convalescent plasma from COVID-19 recovered persons [4-8]. Despite limitations, these studies provide supporting evidence for evaluating COVID-19 convalescent plasma in more rigorous investigations. Convalescent plasma is a long-standing therapy that has been used in other infectious and respiratory diseases, including SARS [9]. A large study based on a systematic review and exploratory meta-analysis found that the treatment of SARS patients with convalescent plasma or serum appears to be safe and may reduce mortality rates, especially when administered soon after the disease onset [10]. The U.S. Food and Drug Administration has established a pathway to allow the use of COVID-19 convalescent plasma during the public health emergency [https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma]. The European Commission runs a programme for COVID-19 convalescent plasma collection and transfusion [https://ec.europa.eu/health/blood_tissues_organs/covid-19_en]. However, both activities are limited and do not consider other uses. We posit that COVID-19 convalescent plasma should be collected for immediate transfusions and the manufacturing of hyperimmune immunoglobulin therapies. In addition to COVID-19 survivors who can donate plasma 14 days after complete resolution of symptoms, plasma donation should be encouraged in individuals who tested positive for the SARS-CoV-2 but did not develop COVID-19 after a 14-day incubation period [https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/updated-information-blood-establishments-regarding-novel-coronavirus-covid-19-outbreak]. These asymptomatic individuals, even in the absence of significant knowledge about the levels of SARS-CoV-2 neutralizing antibodies in their blood, may represent a substantial proportion of the infected population and could contribute significantly to the COVID-19 convalescent plasma supply. Once vaccines are developed against SARS-CoV-2 infection, the plasma of vaccinated individuals can be used to produce hyperimmune immunoglobulin therapies of high specificities and titres. Both COVID-19 convalescent plasma and especially hyperimmune immunoglobulin should be considered for pre- and post-exposure treatment for individuals at higher risk for severe illness due to age, poor health and/or other medical conditions, for example abnormalities associated with the immune system function, serious lung pathologies or coagulation disorders. Prophylactic interventions for selected frontline workers with high exposure to infection may allow them to perform critical activities without becoming sick. Medical professionals play an important role in building awareness about the significance of blood and plasma donation as an essential component of the broad healthcare infrastructure. It is highly important to continue informing wide networks about the critical and ongoing need for donations throughout the COVID-19 pandemic and beyond. The need for blood and plasma is greater than ever. On behalf of the standard-setting and global advocacy organization that represents plasma donation centres and manufacturers of plasma protein therapies including human normal and hyperimmune immunoglobulins, we support these efforts with great enthusiasm and appreciation. All authors contributed equally to the writing of this manuscript and approved the final version. Authors report no conflict of interest for this article. Amy Chevalier Efantis, a full-time PPTA employee, declares no funding sources associated with the writing of this manuscript. Brenna Raines, a full-time PPTA employee, declares no funding sources associated with the writing of this manuscript. Larisa Cervenakova, a full-time PPTA employee, declares no funding sources associated with the writing of this manuscript.