MFDS Begins Review for Emergency Use Authorization of Pfizer Oral Treatment 'Paxlovid'

Pfizer's oral COVID-19 treatment 'Paxlovid' is being produced at the Ascoli factory in Italy. [Image source=Reuters Yonhap News]

[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety (MFDS) has begun reviewing the emergency use authorization for Pfizer's oral COVID-19 treatment, Paxlovid.

On the 22nd, the MFDS announced that it started the review following the Korea Disease Control and Prevention Agency's request for emergency use authorization of Pfizer's oral COVID-19 treatment, Paxlovid. Previously, the importer, Pfizer Korea, had applied for a preliminary review of Paxlovid to the MFDS on the 10th of last month. Since then, the MFDS had been reviewing related data and has now received the request for emergency use authorization.

The MFDS plans to thoroughly examine the submitted clinical and quality data, hold expert advisory meetings, and conduct deliberations through the ‘Public Health Crisis Response Medical Products Safety Management and Supply Committee’ to verify the product's safety and efficacy before deciding on the emergency use authorization.

Paxlovid is a treatment that inhibits the coronavirus's protein protease (3CL protease), blocking the production of proteins necessary for viral replication, thereby suppressing the virus's proliferation.

Earlier, on the 17th of last month, the MFDS also announced that it would begin reviewing the emergency use authorization request from the Disease Control Agency for Merck (MSD)'s oral COVID-19 treatment, Molnupiravir.

These two oral COVID-19 treatments are expected to receive emergency use authorization from the U.S. Food and Drug Administration (FDA) as early as the 22nd.

The government is pushing forward with advance purchase contracts for 404,000 doses of oral COVID-19 treatments. Previously, it signed purchase contracts for 200,000 doses of Molnupiravir in September and 70,000 doses of Paxlovid last month. The government is also negotiating advance purchase contracts for the remaining 134,000 doses with Pfizer, Merck, and Roche. Starting January next year, the government plans to provide oral treatments to elderly patients undergoing home care.

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