Pfizer has announced its investigational novel COVID-19 oral antiviral candidate, Paxlovid?, significantly reduced hospitalisation and death, based on an interim analysis of the Phase II/III EPIC-HR randomised, double-blind study of non-hospitalised adult patients with COVID-19, who are at high risk of progressing to severe illness.

The scheduled interim analysis found that Paxlovid met its primary endpoint, showing an 89 percent reduction in risk of COVID-19-related hospitalisation or death from any cause compared to placebo in patients treated within three days of symptom onset. Furthermore, only 0.8 percent of patients who received Paxlovid were hospitalised through Day 28 following randomisation with no deaths, compared to 7.0 percent of patients who received placebo and were hospitalised or died. The statistical significance of these results was high.

Similar reductions in COVID-19-related hospitalisation or death were observed in patients treated within five days of symptom onset; 1.0 percent of patients who received Paxlovid were hospitalised through Day 28 following randomisation with no deaths, compared to 6.7 percent of patients who received a placebo and were hospitalised or died. In the overall study population through Day 28, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo.

According to Pfizer, Paxlovid would be the first specifically designed SARS-CoV-2-3CL protease inhibitor if approved or authorised. Upon successful completion of the remainder of the EPIC clinical development programme and subject to approval or authorisation, it could be prescribed more broadly as an at-home treatment to help reduce illness severity, hospitalisations, and deaths, as well as reduce the probability of infection following exposure, among adults. 

“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 authorised 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 hospitalisations,” commented Albert Bourla, Chairman and Chief Executive Officer at Pfizer. “Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”