US FDA authorizes Pfizer's Covid-19 antiviral pill for people aged 12

The US Food and Drug Administration (FDA) on Wednesday (local time) authorized Pfizer's Paxlovid COVID-19 pill for high-risk people aged 12 and over to treat coronavirus disease (COVID-19).

"The US Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death," US Food and Drug said in a statement.

"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.

Cavazzoni added, "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 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. Paxlovid is administered as three tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken together orally twice daily for five days, for a total of 30 tablets. Paxlovid is not authorized for use for longer than five consecutive days, said the statement.