The Food and Drug Administration (FDA) approved the Pfizer COVID-19 pill for emergency use Wednesday. The video above shows clips of the White House COVID-19 Response Team discussing the approval. This marks the first time U.S. health regulators have approved an at-home treatment for COVID-19 since the pandemic began.
“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,” FDA Center for Drug Evaluation and Research Director Dr. Patrizia Cavazzoni said in a news release.
The pill, called Paxlovid, is approved for adults and children ages 12 and older with a positive COVID-19 test “and who are at high risk for progression to severe COVID-19, including hospitalization or death.” The weight minimum for kids getting the Pfizer COVID-19 pill is 88 lbs. According to the release, it’s available “by prescription only” and it should only be taken “within five days of symptom onset.”
“If you go outside that window of time I fully expect the effectiveness of this drug is going to fall,” Johns Hopkins University virologist Andrew Pekosz warned. In the FDA release, officials provided their own warnings regarding the Pfizer COVID-19 pill.
“Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19,” the FDA wrote. “Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”
Pfizer currently has 180,000 treatment courses available worldwide. Roughly 60,000-70,000 of those are allocated to the U.S. Federal health officials are expected to ration early shipments to the hardest hit parts of the country.
An antiviral pill from Merck is also expected to soon win authorization. However, Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness. It was shown to reduce hospitalizations and deaths among patients most likely to get severe disease by nearly 90%.
“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” Dr. Gregory Poland of the Mayo Clinic said. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”