First Blood Center Receives Full FDA Approval for Convalescent Plasma Treatment

Arturo Casadevall and David Sullivan, MD, from the Bloomberg School of Public Health, have been pivotal in advancing the use of COVID-19 convalescent plasma (CCP) since the pandemic's onset. Their efforts culminated in the FDA's full approval of CCP for immunocompromised patients, a first for convalescent plasma. This approval is based on their research, including a national multi-site randomized control trial published in the New England Journal of Medicine, which demonstrated CCP's safety and efficacy in reducing hospitalizations for early outpatient treatment.

High titer convalescent plasma, containing antibodies from recovered COVID-19 patients or those vaccinated, is crucial for immunocompromised individuals who cannot produce sufficient antibodies. The FDA's approval ensures the availability of high-quality CCP, which has antibody levels more than 20 times those allowed under the 2021 emergency use authorization.

This development is significant for the 10 million immunocompromised individuals in the U.S., representing 3% of the population, and 20% of all COVID-19 hospitalized cases. Unlike monoclonal antibodies, which have struggled against evolving variants, CCP's diverse antibodies offer broader protection.

The approval not only aids current COVID-19 treatment but also lays the groundwork for using convalescent plasma in future infectious disease outbreaks. The researchers advocate for the inclusion of CCP in public health preparedness plans, emphasizing the need for outpatient facilities ready to treat high-risk populations promptly.

OneBlood's achievement in receiving full FDA approval for CCP marks a milestone in medical treatment and pandemic preparedness, offering hope and a blueprint for combating future health crises.