Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has authorized the emergency use of PAXLOVID™ tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 88 lbs) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The treatment is specifically designed to block the activity of an enzyme that the coronavirus needs to replicate.
“Today’s authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Pfizer stands ready to begin delivery in the U.S. immediately to help get PAXLOVID into the hands of appropriate patients as quickly as possible.”
Trials undertaken by Pfizer demonstrated an 89% reduction in the risk of COVID-19-related hospitalization or death from any cause in adults treated with PAXLOVID within three days of symptom onset. No deaths occurred in the treatment group. Similar results were seen in those treated within five days of symptom onset, with an 88% reduction in risk and no deaths observed in the treatment group.
“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic in an interview with the Associated Press. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”
The challenge with the new drug will be availability. Because of the nature of drug, manufacturing is relatively slow. Pfizer has announced that there are currently only 180,000 dosages of PAXLOID available currently, with approximately 60,000 of those allocated to the United States. The company expects to have 250,000 available by the end of January.
In November 2021, Pfizer announced an agreement with the U.S. government to supply 10 million treatment courses of PAXLOVID, with delivery fulfillment expected to be completed in 2022.
Unlike prior treatments for COVID, PAXLOID is taken in pill form, which greatly enhances accessibility for even at-home treatment, thus ultimately relieving stress on medical facilities in high-exposure areas.