Pfizer’s COVID-19 Treatment Reduces Hospitalization by 89%

Pfizer recently announced that its COVID-19 treatment, PAXLOVID, reduced hospitalization and death in high-risk adults with coronavirus by 89 percent compared to placebo. 

In the Phase 2/3 EPIC-HR study, patients were randomized to receive PAXLOVID or placebo. In the study, about one percent of patients who received PAXLOVID were hospitalized through Day 28 following randomization, compared to 6.7 percent of patients who received placebo.

Similar reductions in COVID-19-related hospitalizations or death were observed in patients treated within five days of symptom onset. 

Specifically, about 0.8 percent of patients who received PAXLOVID were hospitalized through Day 28 compared to seven percent of patients who received placebo and were hospitalized or died. 

Overall, researchers reported no deaths in the PAXLOVID group and ten deaths in the placebo group. 

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” Albert Bourla, chairman and chief executive officer of Pfizer, said in the announcement. 

Pfizer will stop further enrollment into the study due to the efficacy demonstrated in the trial results. The company also plans to submit the data as part of its ongoing rolling submission to FDA for emergency use authorization. 

If approved or authorized, PAXLOVID will be the first oral SARS-CoV-3CL protease inhibitor. In addition, the drug could be prescribed more broadly as an at-home treatment to reduce illness severity, hospitalizations, and death in adults. 

The EPIC-HR study began enrollment in July 2021. The Phase 2/3 EPIC-SR and EPIC-PEP studies began in August and September 2021, respectively. The trials were not included in the interim analysis and are currently ongoing.

“We’re thankful to all of the patients, investigators, and sites around the world who participated in this clinical trial, all with the common goal of bringing forth a breakthrough oral therapy to help combat COVID-19,” said Mikael Dolsten, MD, PhD, chief scientific officer and president of worldwide research, development, and medical at Pfizer.