Leading the Way: Stanford Blood Center Secures FDA Approval for COVID-19 Convalescent Plasma
Since the early days of the COVID-19 pandemic, at Stanford Blood Center (SBC) we have been committed to providing lifesaving treatments to patients in need. Last month, we reached a major milestone: the U.S. Food and Drug Administration (FDA) granted us approval to distribute COVID-19 Convalescent Plasma (CCP) nationwide for immunocompromised patients. With this approval, we are proud to be the first blood center in California, and only the second in the nation, to secure this authorization under a Biologics License Application (BLA).
CCP, plasma collected from individuals who have recovered from COVID-19, can help patients with weakened immune systems fight the virus. While the FDA previously allowed its use under an Emergency Use Authorization (EUA), that authorization ended in August 2025. Through our new BLA approval, we can ensure that high-titer CCP remains available to patients who continue to be vulnerable to severe COVID-19 illness.
“This FDA approval reaffirms our commitment to providing patients with what they need, when they need it,” said Harpreet Sandhu, our CEO. “By securing licensure, we are able to continue supporting immunocompromised patients across the nation who can benefit from convalescent plasma therapy.”
We have a long history with CCP, having been among the first blood centers in the country to collect plasma early in the pandemic. We’ve also been actively involved in research to optimize its use. “Data from multiple studies, including clinical trials, demonstrate a mortality benefit and clinical improvement when high-titer CCP is administered to COVID-19 patients with underlying immunosuppression in either the outpatient or inpatient setting,” said Dr. Suchi Pandey, SBC’s Chief Medical Officer.
With this approval, we can now manufacture CCP and distribute it throughout California and beyond, strengthening collaboration and patient care nationwide.
If you’ve recently recovered from COVID-19 and want to help make a difference, you can learn more about donating CCP by emailing support@stanfordbloodcenter.org.