US FDA Grants Emergency Approval for Plasma Therapy... Acceleration in Korea Too

FDA "Safety Confirmed for 20,000 out of 70,000 People"

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] The U.S. Food and Drug Administration (FDA) on the 23rd (local time) granted emergency approval for treatment using plasma from recovered COVID-19 patients, which is expected to accelerate the development of plasma therapies both domestically and internationally.

According to foreign media, the FDA stated that the mortality rate decreased and patients' conditions improved when COVID-19 plasma therapy was administered within three days of hospitalization. The FDA said that so far, 70,000 COVID-19 patients have been prescribed plasma therapy, and an analysis of 20,000 of these patients confirmed the safety of the treatment. In particular, the effect of plasma therapy was found to be greater in patients under 80 years old.

Plasma therapy is produced by collecting large amounts of plasma drawn from recovered patients and separating immune globulins containing neutralizing antibodies along with other plasma components (albumin, blood coagulation factors, etc.). Since it uses concentrated and processed antibodies and immune globulins contained in the blood of recovered patients, a large amount of blood is required.

With the FDA's emergency use approval of plasma therapy, the development of plasma therapies domestically and abroad is expected to gain momentum. The Ministry of Food and Drug Safety approved the phase 2 clinical trial plan (IND) for GC Green Cross's COVID-19 plasma therapy 'GC5131' on the 20th. In particular, from that day, GC Green Cross made it convenient for recovered COVID-19 patients to apply for plasma donation online. Previously, recovered patients could only inquire about plasma donation by phone, which was criticized for poor accessibility. The number of blood collection institutions has also increased significantly. Previously, plasma collection from recovered COVID-19 patients was only possible at four medical institutions: Korea University Ansan Hospital, Kyungpook National University Hospital in Daegu, Daegu Fatima Hospital, and Keimyung University Dongsan Hospital in Daegu. However, from that day, it expanded to 21 Blood Donation Centers in the Seoul metropolitan area and Gangwon Province, and from the 7th of next month, it will also be available at 24 Blood Donation Centers in Chungcheong, Gangwon, and Gyeongsang provinces.

A GC Green Cross official said, "More plasma donations are needed to produce plasma therapy, but there is a shortage," adding, "If accessibility for recovered patients to donate plasma improves, donations will increase, which will greatly aid the development of the therapy." Currently, 1,210 recovered patients in Korea have expressed willingness to donate plasma, and 895 of them have completed blood collection.

Meanwhile, amid the resurgence of COVID-19, countries such as the U.S., Japan, and Europe are rushing to develop plasma therapies and treatments, but some caution against excessive expectations. A medical industry official said, "Plasma therapy is a method of administering plasma from patients who have overcome an infectious disease to other patients to neutralize the causative virus. It should be regarded as one of the last resorts for treating new infectious diseases for which no treatment has yet been developed," adding, "Plasma therapy is a medical procedure, not a pharmaceutical product, administered like a blood transfusion. Since the neutralizing antibody levels in the plasma administered vary from person to person, its effectiveness may differ among individuals, and because there is no pharmaceutical formulation process, there may be some safety concerns."

A pharmaceutical industry official said, "Although plasma has long been used to treat infectious diseases such as Ebola, there is no rigorous clinical trial data proving how effective it is for COVID-19 treatment," adding, "The challenge is to verify safety and efficacy through clinical trials."

This content was produced with the assistance of AI translation services.