RSV Vaccine Candidate Launches Phase 3 Study

New York-based Pfizer Inc. announced the initiation of RENOIR (RSV vaccine Efficacy study iNOlder adults Immunized against RSV disease), a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older.

The RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older.

The study's primary objectives will assess safety and efficacy for the prevention of moderate to severe lower respiratory tract illness (msLRTI-RSV) during the first RSV season.

RSV is a seasonal illness that commonly starts in the fall months, peaking in the winter when colds and other respiratory illnesses are more common, says the U.S. CDC.

“There is an important unmet medical need for an effective (RSV) vaccine that can help protect older adults against this highly contagious disease,” stated Kathrin U. Jansen, Ph.D., SVP, and Head of Vaccine Research & Development at Pfizer Inc., in a related press statement.

“The start of this (RSVpreF) Phase 3 study is an important step forward towards our goal of comprehensive immunization against RSV disease, which includes developing a potential first vaccine to help prevent RSV disease in adults as well as the ongoing efforts to help protect infants through maternal immunization, subject to regulatory approval of the candidate vaccine.”

Pfizer Inc. says 'Our purpose is grounded in our commitment to fund programs that provide public benefit, advance medical care, and improve patient outcomes. Our belief is that all people deserve to live healthy lives. This drives our desire to provide access to medicines that are safe, effective, and affordable.'