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America's Blood Centers
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January 20, 2025

OneBlood FDA Approval for CCP for Immunocompromised Patients

By America's Blood Centers

OneBlood has announced that it has become the first blood center in the U.S. to be, β€œgranted full U.S. Food and Drug Administration (FDA) approval to provide licensed high titer COVID-19 convalescent plasma (CCP) 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.” This OneBlood FDA approval for CCP marks a significant milestone in combating COVID-19. A January 13th news release explained that OneBlood collaborated with 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) to, β€œprovide the necessary data to the FDA to prove that convalescent plasma is safe and effective for patients who are immunocompromised.”

OneBlood noted that individuals, β€œwho 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 in the licensed CCP are more than 20 times greater than the levels required previously under the Emergency Use Authorization.” The OneBlood FDA approval for CCP ensures that licensed high titer CCP is available for order to hospitals served by OneBlood (via BloodHub) and those not served by OneBlood (via: www.oneblood.org/ccp).

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  • About Us
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      • Stop the Bleed National Partnership
      • National Partnerships User Guide
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  • Advocacy
    • Advocacy Agenda
    • Priorities
      • Reducing Unnecessary Regulatory Burdens
      • Modernizing the Licensure Process
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