(January 13, 2025 – Orlando, Florida) OneBlood, the not-for-profit blood center serving much of the southeastern United States, has become the first blood center in the country to be granted full FDA approval to provide licensed high titer plasma from people who have recovered from COVID-19 for use in individuals who are immunocompromised and unable to make their own antibodies to the virus.

To earn approval from the U.S. Food and Drug Administration (FDA), OneBlood, Johns Hopkins Medicine and the Johns Hopkins Bloomberg School of Public Health, the Mayo Clinic, the Association for the Advancement of Blood & Biotherapies (AABB), the COVID-19 Convalescent Plasma Project (CCPP19), and the COVID-19 Serologic Studies Consortium (CSSC-004) worked together to provide the necessary data to the FDA to prove that convalescent plasma is safe and effective for patients who are immunocompromised.

“A new era of treatment to protect the population who are immunocompromised has arrived. OneBlood is proud to be part of this significant accomplishment,” said George “Bud” Scholl, president and chief executive officer at OneBlood.

“The OneBlood team has been relentlessly refining processes and protocols to ensure the highest quality COVID-19 convalescent plasma that meets all FDA guidelines is available for patients in need,” said Rita Reik, M.D., chief medical officer at OneBlood.

“The AABB is committed to ensuring the safety of the blood supply, from donor to recipient,” said Claudia Cohn, M.D. PhD, chief medical officer at AABB. “During the COVID-19 pandemic, AABB played a leading role in developing guidelines for the use of COVID-19 convalescent plasma. CCP remains a safe and effective therapeutic option for patients who are immunosuppressed and have COVID-19. AABB commends OneBlood for obtaining licensure for this vital blood component, making it more accessible to patients in need.”

Three percent of the U.S. population (some 10 million people) is immunocompromised and accounts for 20% of COVID-19 hospitalized cases.  

"The immunocompromised want to live a life fully engaged in their communities, despite the fact that they remain at much higher risk for COVID progression to severe disease and even death. FDA approving a full license for CCP means that there is an effective antibody treatment added to the outpatient therapy toolbox in addition to inpatient to treat the immunocompromised. Knowing that lifesaving outpatient treatment is available greatly reduces the anxiety about getting COVID and enables the immunocompromised to more fully participate in the activities that give life meaning.  We are grateful to the physicians at Johns Hopkins and the Mayo Clinic who led the research which established the benefit of high titer CCP and to OneBlood for making this blood product reliably available to our community,” said Janet Handal, President and Co-founder of Transplant Recipients and Immunocompromised Patient Advocacy Group.

Having licensed, high titer COVID-19 convalescent plasma available provides physicians with a safe and effective resource to treat patients who are immunocompromised.

“The ability to provide COVID-19 convalescent plasma to people who are immunocompromised and unable to make sufficient antibodies against COVID-19, provides hope for those patients and a tangible blueprint for managing future infectious disease pandemics,” said David Sullivan, M.D., professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health.

“The COVID-19 convalescent plasma OneBlood is providing is the only antibody therapy that keeps up with the variants and mutations of the COVID-19 virus and is able to protect the large community of individuals who are immunocompromised in our country long into the future,” said Arturo Casadevall, M.D., Alfred and Jill Sommer Professor and Chair of the W. Harry Feinstone Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health.

“The Mayo convalescent plasma team is pleased by the landmark FDA approval of convalescent plasma to treat COVID-19 in patients who are immunocompromised,” said Michael Joyner, M.D., anesthesiologist at the Mayo Clinic. “The diligent and tireless work of our team along with our academic, governmental and not-for-profit collaborators laid the groundwork for this important therapeutic advance.”

Then and Now

• 2020: There were no FDA-approved drugs or vaccines against COVID-19. At that time, the FDA granted Emergency Use Authorization (EUA) of COVID-19 convalescent plasma to treat COVID-19 patients because it was reasonable to believe that virus-specific antibodies would be effective.
  
  
• 2022: The virus that causes COVID-19 had mutated. Some medicines used to treat or prevent serious illness no longer worked. The FDA authorized COVID-19 convalescent plasma for inpatient and outpatient use to lower the risk of developing serious illness in people who had weakened immune systems.
  
  
• December 2024: The FDA-approval of licensed high titer COVID-19 convalescent plasma marks the transition from Emergency Use Authorization for convalescent plasma, which requires a lower level of safety and efficacy proof during an emergency, to the higher level  of safety and efficacy required for an FDA-licensed product.
  
  
  • To obtain FDA approval, OneBlood submitted a Biologics License Application (BLA) to manufacture and distribute high titer COVID-19 convalescent plasma across state lines for use to treat immunocompromised patients. 
  • A BLA is typically submitted after extensive research and clinical studies have been completed under an Investigational New Drug (IND).
  • The BLA process ensures that biologic products meet stringent safety, purity, and potency standards, safeguarding public health.
  • The FDA approved OneBlood’s BLA in December 2024.

What is Licensed High Titer COVID-19 Convalescent Plasma?

People who have recovered from the coronavirus and/or who have been vaccinated for COVID-19 have developed antibodies to the virus that remain in the plasma portion of their blood. COVID-19 convalescent plasma from recovered patients with a high level of antibodies may be used to treat people diagnosed with COVID-19 who have a weakened immune system.

The high titer antibody levels are more than 20 times greater than the levels allowed previously under the Emergency Use Authorization.

COVID-19 convalescent plasma therapy is used to prevent or treat severe or life-threatening complications from COVID-19.  It helps by providing antibodies the immune system can’t make or can’t make fast enough.