The Ministry of Food and Drug Safety (MFDS) announced today (27th) that it has decided to approve the emergency use of Pfizer's edible Corona 19 treatment 'Paxrovid' in Korea.
This drug is an oral treatment for COVID-19 introduced for the first time in Korea, and the patient takes the pill for five days.
The Ministry of Food and Drug Safety's decision follows the request for emergency use authorization from the Korea Centers for Disease Control and Prevention on the 22nd.
Emergency use approval is a system in which manufacturers and importers supply unapproved medical products to Korea in order to properly respond to public health crises such as epidemics of infectious diseases. · As a result of the effectiveness review, it was revealed that this decision was made after comprehensive consideration of the results of the expert advisory meeting and deliberation by the 'Public Health Crisis Response Medical Product Safety Management and Supply Committee'.
At the advisory meeting, experts agreed that an emergency use authorization for Paxrovid is necessary in consideration of the domestic COVID-19 pandemic and clinical trial data.
In clinical trials, Paxrovid was found to significantly reduce the risk of hospitalization or death in high-risk mild and moderate COVID-19 patients.
Paxrobead is a treatment for COVID-19 that inhibits virus proliferation by preventing the production of proteins necessary for virus replication. Two tablets are packaged together and can be stored at room temperature.
This drug is indicated for patients with COVID-19 in mild to moderately ill adults and children 12 years of age and older who are at high risk of developing severe disease.
One dose of this medicine consists of 2 tablets of 'Nirmatrelvir' and 1 tablet of 'ritonavir'.
Patients only need to take two doses per day for five days.
After diagnosis of COVID-19, the drug should be administered as soon as possible within five days of the onset of symptoms.
However, pregnant women should administer it when the benefits outweigh the risks, and nursing mothers should stop breast-feeding after taking the drug.
The Ministry of Food and Drug Safety predicted that it would be effective for patients infected with various mutated Corona 19 viruses, including Omicron, due to the nature of Paxrobead, which inhibits virus proliferation in the body.
In vitro tests have already confirmed the antiviral effect on several mutated COVID-19 viruses except for Omicron, and Pfizer plans to submit the test results for the mutation of Omicron after approval for emergency use.
The Ministry of Food and Drug Safety (MFDS) said, "Paxrovid is a drug that diversifies treatment options according to the patient's situation along with the injection-type COVID-19 treatment currently in use in the field, and prevents patients who are admitted to a living treatment center or being treated at home from worsening to a serious condition," the ministry said. It will help,” he said.