FDA authorizes Paxlovid, the first oral antiviral for COVID-19
The FDA issued an emergency use authorization for Pfizer's Paxlovid (nirmatrelvir/ritonavir) for mild-to-moderate COVID-19 in high-risk patients 12 and older, to be started within five days of symptom onset. Authorization rested on the EPIC-HR randomized, placebo-controlled trial in unvaccinated high-risk adults, which found 0.8% of Paxlovid recipients were hospitalized or died within 28 days versus 6% on placebo — an 88% relative risk reduction. It was the first at-home pill authorized for COVID-19 treatment, arriving as the Omicron variant spread; initial supply was very limited.
Primary quotes
“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.”
Patrizia Cavazzoni, FDA Center for Drug Evaluation and Research
Linked sources
Related contentions
Unresolved. The efficacy question for ivermectin in COVID-19 is largely settled against benefit in the major RCTs, but the dispute over the tone and legality of the FDA's messaging — and over whether early dismissal distorted research and prescribing — remains contested in court (Apter v. HHS, revived by the Fifth Circuit in 2023 and later settled with the FDA removing the posts) and in public debate.