Pfizer Outlines Positive Topline Data From Late-Stage Respiratory Syncytial Virus (RSV) Vaccine Study

Pfizer Inc. PFE announced positive top-line data from the Phase 3 clinical trial RENOIR investigating its bivalent RSV prefusion F vaccine candidate, RSVpreF, when administered to adults 60 years of age or older.

The Phase 3 RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease) trial is a global study designed to assess the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults 60 years of age and older.

The bivalent vaccine candidate is composed of two preF proteins selected to optimize protection against RSV A and B strains.

This positive results from the late-stage study enabled Pfizer to look at the more severe disease primary endpoint of LRTI-RSV defined by three or more symptoms, where vaccine efficacy of 85.7% was observed.

Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, commented: “We are delighted that this first bivalent RSV vaccine candidate, RSVpreF, was observed to be efficacious in our clinical trial against this disease, which is associated with high levels of morbidity and mortality in older adult. we look forward to working with the FDA and other regulatory agencies to make this vaccine candidate available to help address the substantial burden of RSV disease in older adults."

RSV disease is distinguished by several respiratory symptoms varying from mild to more severe disease, with more severe disease having more symptoms.

Pfizer expects to present results of this interim analysis at a future medical congress and will submit the results for peer-review in a scientific journal.

The company plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for RSVpreF and to prepare submissions for other regulatory authorities in the coming months.

Price Action : Pfizer shares closed Wednesday’s trading down 1 percent at $47.43.