Blood collectors across the United States have played a key role in helping to provide treatment for patients with COVID-19 until more advanced treatment options were available. AABB is proud of the contributions our Association’s member institutions have made during the pandemic and is pleased to support them in their heroic and essential work.
Blood collectors were called upon in the early months of the pandemic to begin collecting COVID-19 convalescent plasma (CCP) from people who had recovered from the infection. In April 2020, the FDA announced it was expanding access to investigational CCP for patients hospitalized with severe or life-threatening COVID-19. In support of the FDA’s treatment program, blood collection facilities throughout the country immediately began making updates to their facilities and processes to collect CCP and distribute it to hospitals where it could provide much-needed treatment for patients with COVID-19 who had limited treatment options.
The collection and transfusion of convalescent plasma as a treatment for patients with infectious diseases was first used in the 1890s. Convalescent plasma has a long history of helping to reduce the severity of infectious disease outbreaks prior to the development of antimicrobial therapy in the 1940s.
In the early 20th century, convalescent plasma treatment was used during outbreaks of various infectious diseases, including measles, mumps and influenza. More recently, it was used during the H1N1 influenza pandemic in 2009, and again in 2013 during the Ebola outbreak in West Africa.
FDA issued an initial emergency use authorization (EUA) for CPP in late August 2020, after publication of data from the Expanded Access Protocol, overseen by the Mayo Clinic, showed CCP transfusions to be safe and suggested a reduction in mortality among transfused patients. CCP remains an investigational treatment under emergency use authorization and is one of few first line treatment options for COVID patients.
Although initially regarded as a short-term bridge therapy, CCP has remained an important part of care for COVID patients for over a year, even as monoclonal antibody therapies and vaccines have been approved for use.
Since the early days of the pandemic, CCP has been the subject of multiple research studies to evaluate its safety and efficacy as a treatment for COVID-19. AABB has supported research to provide more information and has advocated for science to drive treatment guidelines.
More than a year after the pandemic began and following myriad scientific research, there is some evidence indicating that CCP may be an effective treatment for COVID-19 if it has a high concentration of antibodies and is given to certain patients early in the course of the infection.
Following a thorough review of the available scientific data, FDA announced a revision to its EUA for CCP on February 23, 2021. The revised EUA was further updated on March 9, 2021, and continues to limit CCP use to only high-titer CCP for the treatment of hospitalized patients early in the course of the disease course, as well as for hospitalized patients who have impaired humoral immunity and cannot produce an adequate antibody response.
In mid-February, AABB published a series of interim recommendations on the use of CCP as a treatment for COVID-19. The recommendations, based on evidence from published clinical research, are in line with FDA’s revised EUA and note that CCP is most efficacious when high-titer units are given early in the course of disease.
While additional studies on the efficacy of CCP are ongoing, the interim recommendations aim to address the present need for clinical guidance and serve as a valuable tool to guide current practice. AABB will continue to evaluate and revise these recommendations to reflect the latest peer-reviewed data and regulatory requirements as they become available.
In addition, AABB continues to provide resources and tools for both blood collectors and health care providers on CCP collection and treatment, including its Toolkit for CCP and its COVID-19 Resources page.
AABB supports continued research related to CCP and other therapies for patients with COVID-19. Additional data from clinical trials are needed to continue to fully assess the efficacy of CCP and to clarify which patients are most likely to benefit. AABB will also develop clinical practice guidelines for the use of CCP later this year.
AABB will continue to work with partners across the medical community to determine the role of CCP in the coming months as other treatment options become available.
The next critical question for the blood community will be whether CCP is a viable strategy to respond to new SARS-CoV-2 variants. Because CCP is collected from patients who have recovered from COVID-19, if variants are present in a region, the CCP collected in that region would potentially include antibodies that would be most effective against that variant. This could be critical if current therapies or vaccines prove less useful against new COVID variants.