Top-line results from phase II/III EPIC-PEP study of Paxlovid for post-exposure prophylactic use

In this trial, compared to placebo, Pfizer observed risk reductions of 32% and 37% in adults who received Paxlovid for five and ten days, respectively, to prevent infection. These results, however, were not statistically significant and, as such, the primary endpoint of reducing the risk of confirmed and symptomatic COVID-19 infection in adults who had been exposed to the virus through a household contact was not met.

Available safety data for Paxlovid has been generally consistent in more than 3,500 Paxlovid-treated participants across the EPIC-HR, EPIC-SR and EPIC-PEP studies, as well as in reported post-market safety experience. In EPIC-PEP, this safety profile remained generally consistent when Paxlovid was used for either five or ten days. Analyses of all secondary endpoints and sub-groups are ongoing, and results will be included in the publication or presentation of the final study results.

“We designed the clinical development program for PAXLOVID to be comprehensive and ambitious with the aim of being able to help combat COVID-19 in a very broad population of patients,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness, and we are pleased to see the growing global use of PAXLOVID in that population.”

Paxlovid is currently approved or authorized for conditional or emergency use in more than 60 countries across the globe to treat high-risk COVID-19 patients.