Decision on Emergency Use of Oral COVID-19 Treatment to Be Made Within the Year

Newly Developed COVID-19 Treatment Molnupiravir by Merck, USA (AP=Yonhap News)

[Asia Economy Reporter Kim Heung-soon] The decision on the emergency use of oral COVID-19 treatments in South Korea will be made by next week.

On the 23rd, Kim Ok-su, head of the Resource Support Team at the Central Disease Control Headquarters (CDCH), stated at a regular briefing that "the Ministry of Food and Drug Safety (MFDS) is expected to review the emergency use approval of oral COVID-19 treatments by the end of this year." Accordingly, the domestic introduction date of the oral treatments is expected to be announced within this month.

The MFDS began reviewing the emergency use approval for Pfizer's oral COVID-19 treatment 'Paxlovid,' which has received emergency use authorization in the United States, as of the previous day. Additionally, the emergency use approval for Merck (MSD)'s oral COVID-19 treatment 'Molnupiravir' has been under review since mid-last month.

Regarding the possibility of Paxlovid's approval within this year, the MFDS stated, "We are swiftly and thoroughly reviewing whether Paxlovid has sufficiently secured safety and efficacy," adding, "The timing of approval may vary depending on Pfizer's data."

The decision on the supply of treatments will be based on the MFDS's data review results, expert advisory meetings, and discussions by the Public Health Crisis Response Medical Product Safety Management and Supply Committee.

Both Paxlovid and Molnupiravir are oral medications that inhibit viral replication by preventing the COVID-19 virus from replicating within the body, thereby suppressing virus proliferation. Oral treatments have the advantage of easily preventing the worsening of patients' conditions.

The health authorities announced that once oral COVID-19 treatments are introduced domestically, they plan to use them not only for high-risk, mild, and moderate patients but also for those receiving home treatment.

The CDCH previously announced that it had secured 404,000 doses of oral COVID-19 treatments through advance purchase last month and plans to introduce them gradually starting February next year.

Currently, the quantities under purchase agreements are 242,000 doses of Molnupiravir and 70,000 doses of Paxlovid. The purchase of the remaining 134,000 doses is under negotiation with MSD, Pfizer, and Swiss Roche. The health authorities are also pursuing plans to increase the purchase quantities additionally.

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