FDA changes status of convalescent plasma program

New Emergency Use Authorization could make COVID-19 therapy more readily available to coronavirus patients
August 25, 2020

The Food and Drug Administration has changed the status of COVID-19 convalescent plasma therapy from a clinical trial to an Emergency Use Authorization.

The change should provide faster and easier access to the therapy by waiving some regulatory requirements before hospitalized patients with COVID-19 can receive transfusions of convalescent plasma.

Convalescent plasma is donated by those who have recovered from a COVID-19 infection and still have antibodies to COVID-19 in their blood. It is transfused to current patients, possibly providing passive immunity via anti-COVID antibodies.

The South Texas Blood & Tissue Center is the only organization in San Antonio collecting convalescent plasma donations and distributing them to local and area hospitals. The community blood center began collections as part of a clinical trial being conducted by the Mayo Clinic.

The FDA noted in its announcement on Sunday that convalescent plasma “may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.”

Carabin Shaw PC and Wyatt Law Firm PLLC are sponsoring a program to give convalescent plasma donors with STBTC a $50 Visa gift card for donating. The cards are being supplied by the firms and are not funded by the South Texas Blood & Tissue Center, a subsidiary of BioBridge Global. The cards will be distributed while supplies last.

Anyone interested in donating convalescent plasma can contact the South Texas Blood & Tissue Center at COVID19@SouthTexasBlood.org or visit SouthTexasBlood.org.

STBTC is taking donations by appointment only at the Donor Pavilion in San Antonio and its donor room in Victoria.

Plasma donors also must meet all other requirements to give blood.

The Emergency Use Authorization allows the distribution of convalescent plasma for its use by health care providers to treat suspected or laboratory-confirmed COVID-19 patients.

The Mayo Clinic recently reported data from 35,000 patients treated with convalescent plasma in its clinical trial. The report said there were fewer deaths among people given plasma within three days of diagnosis as well as those given plasma with the highest levels of antibodies.

The FDA’s Emergency Use Authorization authorizes the use of COVID-19 convalescent plasma, but its use has not been fully approved or licensed by the FDA.

The Emergency Use Authorization allows its use “only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic,” under federal law, the FDA stated, “unless the authorization is terminated or revoked sooner.”