[Q&A] 'Pfizer Pills' 30 Tablets Over 5 Days... For Ages 12 and Above 40kg

Pfizer's COVID-19 treatment pill 'Paxlovid' approved by the US FDA.
[Source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] The oral COVID-19 treatment 'Paxlovid' is expected to mark a turning point in quarantine measures as it is set to be introduced domestically by mid-next month. With 29,057 patients under home treatment as of midnight on the 28th, the distribution of this treatment could help reduce the number of severe and critical cases. However, there are limitations as no treatment is yet available for children under 12 years old, and research data on certain groups such as pregnant women remain limited.

Q. Who are the candidates for Paxlovid administration?

A. The target patients are adults and children aged 12 and above (weighing 40 kg or more) with mild to moderate symptoms who are at high risk of progressing to severe COVID-19 due to age, underlying conditions, etc. Pregnant women may receive the treatment if the benefits outweigh the risks, and breastfeeding mothers should stop breastfeeding during treatment. Patients with severe liver or kidney impairment are not recommended to take it. For patients with moderate kidney impairment, the dose of nirmatrelvir should be reduced by half. The Ministry of Food and Drug Safety explained, "It is important to review concomitant medications when using Paxlovid," adding, "If co-administered drugs can decrease or increase the drug levels in the body, contraindications or precautions apply, so relevant information must be checked."

Q. Is it effective against variant viruses?

A. In a clinical trial involving 2,246 high-risk non-hospitalized patients with mild to moderate symptoms, administration within 5 days of symptom onset reduced hospitalization and death rates by 88%. Antiviral effects have been confirmed against various variants including Omicron, Alpha, Beta, Gamma, Delta, and Mu. 98% of the trial participants were infected with the Delta variant, and the hospitalization and death rate in the Paxlovid group decreased by 88%. The Ministry of Food and Drug Safety stated, "Considering the mechanism of action of Paxlovid, it is expected to be effective against the Omicron variant as well." Pfizer plans to submit trial results regarding the Omicron variant following emergency use authorization.

Q. How long should it be taken?

A. Take nirmatrelvir 300 mg (two 150 mg tablets) and ritonavir 100 mg (one 100 mg tablet) twice daily every 12 hours. A total of 30 tablets (6 tablets per day for 5 days) should be taken. Treatment should begin as soon as possible within 5 days of symptom onset after testing positive for COVID-19. If less than 8 hours have passed since the last dose, take the dose as soon as possible, and then continue with the regular schedule. If more than 8 hours have passed, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Q. Are there any side effects?

A. Major side effects observed in clinical trials included taste disturbances, diarrhea, increased blood pressure, and muscle pain, but most were mild. If side effects occur, manufacturers, medical institutions, and patients can report them to the Korea Institute of Drug Safety & Risk Management and receive counseling related to side effects. Compensation may be available depending on the recognition of causality if side effects occur after taking the medication.

Q. How does it differ from Celltrion's antibody treatment 'Rekkirona'?

A. Both Rekkirona and Paxlovid target high-risk mild to moderate patients, but their administration methods differ. Rekkirona is administered via a 60-minute intravenous infusion at a hospital, whereas Paxlovid can be self-administered by patients during home treatment. Storage methods also differ: Rekkirona must be refrigerated (2?8°C) and protected from light, while Paxlovid can be stored at room temperature (15?30°C).

Q. What is the specific quantity to be introduced?

A. The government is pursuing contracts for a total of 1,004,000 courses of oral treatment. Pre-purchase contracts have been completed for 242,000 courses from Merck (MSD) and 362,000 courses from Pfizer, totaling 604,000 courses. The exact quantity of Pfizer's oral treatment to be introduced by mid-next month has not yet been disclosed. The government is currently negotiating with pharmaceutical companies to increase initial supply and shorten delivery schedules. In preparation for the spread of Omicron and phased recovery of daily life, the government is also negotiating additional purchase contracts separately from existing agreements and plans to finalize and announce the contracts early next month. Professor Jeong Ki-seok of Hallym University Sacred Heart Hospital emphasized, "To avoid repeating the vaccine shortage crisis, thorough calculation and preparation regarding the quantity and timing of oral treatment introduction are necessary."

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