As part of its COVID-19 response, the U.S. Food and Drug Administration in April launched a nationwide expanded access program to collect and provide convalescent plasma to patients in need across the country. Plasma from recovered COVID-19 patients contains antibodies that may help fight the disease.

Mayo Clinic is serving as the lead institution for the program, coordinating with other industry, academic and government organizations.

Dr. Michael Joyner, a Mayo Clinic physiologist researcher, is coordinating a national registry, known as USCovidPlasma.org, to increase availability of experimental convalescent plasma for patients in the hospital.

"We are pleased to work with colleagues and the federal government to fight this pandemic every way we can," said Joyner. "The collaboration of researchers across the nation is the key to realizing the full potential of convalescent plasma treatment."

Physicians across the nation are invited to register their COVID-19 patients' information at the registry site, which offers new guidance regarding units of convalescent plasma and transfusion rates, data collection, publication information for physicians and updated physician workflows to address transfusion and to report timing.

"We are pleased to work with colleagues and the federal government to fight this pandemic every way we can," said Joyner. "The collaboration of researchers across the nation is the key to realizing the full potential of convalescent plasma treatment."

The registry also supports collection of antibodies, critical to enabling research into which patients may be most at risk from the disease, he said.

To date, Mayo's Covid program has been live since April and has treated 12,000 patients. An Institutional Review Board registers hospitals, doctors and patients and uses collected data to track outcomes. 

The goal, according to Joyner, is to constantly be asking, "Are we safe?" So far, safety data is looking good, he said. "Now, the question is, has the work we've done made a difference? So far, it's too soon to tell."

Since January of 2020, FDA has been concerned with the medical-product supply chain and the need to avoid disruptions, which compelled the agency to get in touch with more than 180 makers of human drugs and evaluate their entire supply chain, according to FDA Commissioner Dr. Stephen Hahn.

Other FDA initiatives include:

• approved use of a new ventilator developed by NASA and tailored to treat COVID-19 patients
• improvements of critical infrastructure through data sharing and requiring more accurate supply assessment of critical infrastructure that includes the ability to recognize shortage signals
• establishment of reporting requirements for device-makers that include notifying FDA of an anticipated meaningful interruption in the supply of an essential device

Major blood centers across the nation accepting convalescent plasma donations include America's Blood Centers, American Red Cross, CoVIg-19 Plasma Alliance, and National COVID-19 Convalescent Plasma Project.

The plasma donation program further has received additional support as the Biomedical Advanced Research and Development Authority, known as BARDA, and part of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services, has awarded a $26 million contract to the Mayo Clinic to expand the plasma sharing program.

Email the writer: joe_goedert@yahoo.com
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