The Food and Drug Administration on Wednesday issued an emergency use authorization for Pfizer’s COVID-19 pill, Paxlovid.
The pill is authorized to treat mild-to-moderate COVID-19 in people aged 12 and older who have tested positive for the viral infection and who are at high-risk of severe disease from the virus.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
Paxlovid is available by prescription only. It consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations. According to the FDA, the five-day, thirty pill regimen should be started “as soon as possible” after diagnosis of COVID-19 and within five days of symptom onset.
Health officials stress the pill is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.
READ MORE ABOUT IT: FDA website
