Oral Treatment Introduction 'Imminent'... Domestic Emergency Use Approval Possible as Early as Tomorrow

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

[Asia Economy Reporter Lee Chun-hee] The introduction of oral COVID-19 treatments, which the government plans to procure for more than 404,000 people, is imminent. The government is expected to announce as early as tomorrow whether it will grant emergency use authorization for the oral treatments domestically.

On the 26th, the Ministry of Food and Drug Safety (MFDS) announced that it will hold a briefing on the 27th afternoon at Osong MFDS regarding the results of the "Public Health Crisis Response Medical Products Safety Management and Supply Committee" meeting. Previously, the MFDS stated that it would thoroughly review clinical and quality data related to the oral treatments, confirm the safety and efficacy of the products through expert advisory meetings and the Safety Management and Supply Committee's deliberations, and then decide on emergency use authorization.

An MFDS official explained, "The Safety Management and Supply Committee is a deliberative body whose decisions are binding," adding, "If the review results are favorable, it is possible to proceed with the emergency use authorization decision."

Merck (MSD)'s oral COVID-19 treatment 'Molnupiravir'
[Image source=AP Yonhap News]

Currently, the MFDS is reviewing requests for emergency use authorization submitted by the Korea Disease Control and Prevention Agency for Merck (MSD)'s Molnupiravir and Pfizer's Paxlovid. These two oral COVID-19 treatments recently received emergency use authorization from the U.S. Food and Drug Administration (FDA).

Pfizer's Paxlovid is taken by combining two types of pills: the antiviral drug 'Nirmatrelvir' and 'Ritonavir.' One set consists of two 150 mg Nirmatrelvir pills and one 100 mg Ritonavir pill, totaling three pills, taken every 12 hours for five days. This amounts to 30 pills over five days, which constitutes one treatment course. Merck's Molnupiravir is taken as four pills twice a day, totaling 40 pills over five days for one treatment course.

According to currently available clinical results, Paxlovid showed an 89% effectiveness in preventing hospitalization and death in COVID-19 patients and maintained efficacy against the Omicron variant. However, controversy continues regarding the effectiveness of Molnupiravir. Merck announced clinical results indicating about a 50% reduction in hospitalization and death, but the FDA assessed the effectiveness at around 30%. The eligible age for administration is also a limitation for Molnupiravir. The FDA approved Paxlovid for use in patients aged 12 and older weighing at least 40 kg, while Molnupiravir was authorized only for those aged 18 and older due to concerns about its impact on growth.

The government has expressed its intention to secure as many oral treatments as possible. Although it initially aimed to pre-purchase treatments for 404,000 people, it is now aiming higher. Currently, the government has secured 242,000 treatment courses of Molnupiravir and 162,000 courses of Paxlovid, and is negotiating additional purchases considering the quarantine situation. On the 24th, Prime Minister Kim Boo-kyum stated, "We have been negotiating with Pfizer to purchase treatments for more than 300,000 people." However, actual introduction is expected to be possible no earlier than the end of next month.

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