MFDS Grants Emergency Use Authorization for Pfizer's COVID Pill 'Paxlovid' (Comprehensive)

"Expected Effectiveness Even Against Omicron"

Kim Gang-rip, Commissioner of the Ministry of Food and Drug Safety, is briefing on the emergency use authorization of the oral COVID-19 treatment 'Paxlovid' developed by Pfizer, USA, on the afternoon of the 27th at the MFDS briefing room in Cheongju, Chungbuk.
[Photo by Yonhap News]

[Asia Economy Reporter Kim Daehyun] The Ministry of Food and Drug Safety (MFDS) has decided to grant emergency use authorization for Pfizer's oral COVID-19 treatment, Paxlovid.

On the afternoon of the 27th, MFDS Commissioner Kim Gang-rip stated at a briefing room in Cheongju, Chungbuk, "Considering the increasing number of COVID-19 confirmed and critically ill patients, the necessity of introducing an oral treatment that patients can take themselves, the MFDS's review of safety and efficacy, and the results of expert advisory meetings, the decision was made after deliberation by the 'Public Health Crisis Response Medical Product Safety Management and Supply Committee."

"Effective in Preventing Severe Worsening in COVID-19 Patients"

Paxlovid is the first oral COVID-19 treatment introduced in Korea. It is a drug that inhibits viral replication by blocking the protease enzyme (3CL protease) necessary for producing proteins required for virus replication, and is expected to help prevent patients admitted to residential treatment centers or undergoing home treatment from worsening to severe conditions.

The target patients for Paxlovid are adults and children (aged 12 and older, weighing 40 kg or more) with mild to moderate COVID-19 who are at high risk of progressing to severe disease due to age, underlying conditions, etc. The regimen consists of taking two tablets of nirmatrelvir and one tablet of ritonavir twice daily (every 12 hours) for five days. Once diagnosed positive for COVID-19, the medication should be administered as soon as possible within five days of symptom onset.

Earlier, the Korea Disease Control and Prevention Agency (KDCA) requested the MFDS on the 22nd to grant emergency use authorization for Paxlovid due to the increasing need for oral COVID-19 treatments amid the phased return to normal life.

Emergency use authorization is a system that allows manufacturers or importers to supply medical products not yet approved domestically in response to public health crises such as infectious disease pandemics.

"Compensation Planned After Causality Assessment if Side Effects Occur"

The MFDS also announced that if side effects occur from taking Paxlovid, patients can report to the Korea Institute of Drug Safety & Risk Management and receive compensation.

Professor Choi Won-seok of the Department of Infectious Diseases at Korea University Ansan Hospital, who attended the briefing, explained, "Side effects that appeared more frequently in the treatment group compared to the placebo group included diarrhea, nausea, and taste disturbances. Most of these improved after the medication was completed and were generally mild."

For pregnant women, Paxlovid is administered only when the benefits outweigh the risks. Nursing mothers should stop breastfeeding during medication. Patients with severe liver or kidney impairment are not recommended to take the drug as it may affect metabolism.

Commissioner Kim said, "We will continuously analyze and evaluate safety information to promptly provide precautionary guidance, suspend use, recall if necessary, and prioritize patient safety by taking appropriate safety measures. If side effects occur, causality will be assessed and compensation provided."

"Expected to be Effective Against Omicron... MSD's Molnupiravir Also Under Emergency Use Review"

The MFDS expects Paxlovid to be effective against patients infected with various COVID-19 variants, including Omicron.

Commissioner Kim stated, "Clinical trial results confirmed that this drug is significantly effective against the Delta variant. In vitro tests also showed antiviral effects against other variants such as Alpha, Beta, Gamma, Delta, and Mu."

He added, "Although there is no in vitro test data yet for Omicron, based on expert opinions and discussions during advisory meetings, Paxlovid is expected to be effective against the Omicron variant because it works by inhibiting the protease enzyme necessary for viral protein replication."

Meanwhile, the MFDS is also reviewing emergency use authorization for Merck (MSD)'s oral treatment, Molnupiravir, which was applied for by the KDCA on the 17th of last month. Commissioner Kim said, "There is a need to proceed with additional verification regarding safety, especially efficacy data. The review has not yet been completed."

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