Research & Development

Data from a Phase III clinical trial has shown that the Respiratory Syncytial Virus (RSV) vaccine is 85.7% effective when administered to patients 60 years and older, burgeoning hopes for a first bivalent RSV vaccine candidate.

The Phase III RENOIR study is a global, randomised, double-blind, placebo-controlled trial designed to assess the efficacy, immunogenicity, and safety of a single dose of RSVpreF in adults over 60. Approximately 37,000 patients have been enrolled, with enrolment continuing in the Southern Hemisphere of up to 40,000 patients.

An external Data Monitoring Committee conducted an interim analysis of the study, where they assessed the vaccine’s protection levels against RSV-associated lower respiratory tract illness (LRTI-RSV), defined by two or more symptoms, and the primary endpoint of LRTI-RSV, defined by three or more symptoms. For the weaker strain, the efficacy was 66.7%, however the vaccine efficacy against the more serious strain was 85.7%. No safety concerns regarding the investigational vaccine were recorded.

Annaliesa Anderson, Senior Vice President and Chief Scientific Officer of Vaccine Research and Development at Pfizer 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 adults.”

In March, RSVpreF was awarded Breakthrough Therapy Designation by the FDA for the prevention of RSV-associated lower respiratory tract disease caused by RSV in babies aged from birth to six months, by active immunisation of pregnant women.