The pill, Paxlovid, showed an 88% decrease in hospitalization and death for those taking it 5 days after experiencing COVID-19 symptoms.
The long-awaited home remedy for one of the worst pandemics in history has just arrived. Well, it’s not exactly a remedy, but the US Food and Drug Administration (FDA) approved a pill by Pfizer that promises to head off the worst of COVID-19’s effects.
The FDA’s emergency use authorization (EUA) of the pill comes the same week that the Omicron variant of COVID-19 became the dominant variant in the United States, and President Joe Biden announced plans to help hospitals fighting off surges of both Delta and Omicron.
The timeliness of the announcement was not lost on Patrizia Cavazzoni, MD, 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,” she said in a statement.
Paxlovid is being touted as a faster and cheaper way to treat COVID-19 infections in their early stages. It’s the first therapy that can be taken orally; the previous therapies were administered through either IV or injection.
“It checks all the boxes,” said Gregory Poland, MD, who studies the immunogenetics of vaccine response in adults and children. Poland tells the Associated Press that those boxes include high efficiency and side effects that are low. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group—that’s stunning,” Poland tells the AP.
The FDA stresses that the pill is not to be seen as a substitute for vaccination or booster shots. “The FDA urges the public to get vaccinated and receive a booster if eligible,” the agency said in its statement.
Nirmatrelvir in Paxlovid inhibits the SARS-CoV-2 protein from replicating. Paxlovid also contains ritonavir, which helps nirmatrelvir stay in the body longer and 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,” the FDA statement says.
In a randomized, double-blind, placebo-controlled clinical trial, Paxlovid cut the percentage of people who had to be hospitalized or died from COVID-19 by 88% when compared to a placebo. The study was performed on people who were treated 5 days after getting COVID-19 symptoms and who did not get monoclonal antibody treatment.
“In this analysis, 1,039 patients had received Paxlovid, and 1,046 patients had received placebo and among these patients, 0.8% who received Paxlovid were hospitalized or died during 28 days of follow-up compared to 6% of the patients who received placebo,” the FDA said in its statement.
The AP reports that “the U.S. government has agreed to purchase enough Paxlovid to treat 10 million people. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other nations.”
In the FDA statement, Cavazzoni called Paxlovid’s approval “a major step forward in the fight against this global pandemic.”