Paxlovid, a Pfizer’s coronavirus disease (COVID-19) pill, is seen manufactured in Freiburg, Germany, in this undated handout photo obtained by Reuters on November 16, 2021. Pfizer/Handout via REUTERS (Reuters)
FDA calls emergency authorization a ‘major step forward in the fight against this global pandemic’The Food and Drug Administration authorized the first oral antiviral treatment for COVID-19, Pfizer’s Paxlovid drug.
Emergency use authorization was granted Wednesday for Pfizer’s Paxlovid – nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use – for the treatment of mild-to-moderate coronavirus disease in adults and children 12 years of age or older weighing at least 40 kilograms or about 88 pounds.
It applies only to those who meet those qualifications, have tested positive for SARS-CoV-2 testing and “who are at high risk for progression to severe COVID-19, including hospitalization or death,” the FDA said.
Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.