SALT LAKE CITY, Utah (ABC4 News) – On Sunday, the U.S. Food and Drug Administration issued an emergency use authorization for the use of convalescent plasma or CCP to be used to treat patients.
According to the FDA the action followed, “an extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.”
Stephen M. Hahn, M.D., FDA Commissioner said “I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,”
Utah’s Intermountain Health Care has been one of the top participants in the national convalescent plasma treatment protocol, which is now being replaced by the emergency authorization.
Over 500 Intermountain Health Care patients with COVID-19 have received convalescent plasma, which is donated by patients who have recovered from the virus as part of the health care company’s participation in the FDA’s National Expanded Access Treatment Protocol.
According to a press release sent to ABC4 News, medical investigators from the Mayo Clinic lead the program. They recently released data suggesting convalescent plasma is safe and highlighting the need for plasma with high levels of antibodies.
The release states: “randomized controlled trials are underway to determine if the convalescent plasma is clinically beneficial for patients with COVID-19. So far, that has not been clinically established.”
According to the FDA’s clinical memorandum:
“There currently is no adequate, approved, and available alternative to CCP for treating COVID-19. The sponsor has pointed to four lines of evidence to support that CCP may be effective in the treatment of hospitalized patients with COVID-19:
- 1) History of convalescent plasma for respiratory coronaviruses;
- 2) Evidence of preclinical safety and efficacy in animal models;
- 3) Published studies of the safety and efficacy of CCP; and
- 4) Data on safety and efficacy from the National Expanded Access Treatment Protocol (EAP) sponsored by the Mayo Clinic.”
In Utah, IMC clinicians, including the chair of Intermountain’s COVID-19 therapeutics team, Dr. Brandon Webb, has lead the integrated efforts on COVID-19 treatment strategies.