Pfizer has announced positive topline results from a phase 3 clinical trial investigating its bivalent respiratory syncytial virus (RSV) candidate, RSVpreF, in adults 60 years old and over.
There is currently no US approved vaccine for RSV, a contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can be dangerous, especially for infants and older adults, according to the Centers for Disease Control and Prevention (CDC).
In the US alone, it is estimated that RSV infections in older adults account for 177,000 hospitalisations and 14,000 deaths each year.
The phase 3 RENOIR trial is a global, randomised, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity and safety of a single dose of RSVpreF in adults 60 years old and over.
The study showed the vaccine was 85.7% effective among participants with three or more symptoms, and 66.7% for two or more symptoms, according to an interim analysis carried out by an external data monitoring panel. Moreover, the vaccine was well-tolerated and no safety concerns were observed.
Based on these results, Pfizer plans to submit a Biologics Licence Application (BLA) to the US Food and Drug Administration (FDA) for RSVpreF and to prepare submissions for other regulatory authorities in the coming months.
Commenting on the positive results, Annaliesa Anderson, senior vice president and chief scientific officer, vaccine research and development, Pfizer, said: “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.”
