Pfizer's COVID-19 Pill Fails To Prevent Symptomatic Infections

(RTTNews) - Pfizer Inc. (PFE) said Friday that results from phase 2/3 EPIC-PEP study, which evaluated Paxlovid for post-exposure prophylactic use, were not statistically significant. 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 in the study.

The analysis evaluated data from 2,957 adults. Enrolled adults had a negative SARS-CoV-2 rapid antigen test result and were asymptomatic household contacts with exposure within 96 hours to an individual who was symptomatic and recently tested positive for SARS-CoV-2. Each patient was randomized to receive orally twice daily one of the following: Paxlovid for five days followed by placebo for 5 days, Paxlovid for ten days or placebo for ten days.

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.

"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, " said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) 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.