Pfizer ready to file for FDA approval of RSV vaccine

Scientists have worked to develop a vaccine for respiratory syncytial virus (RSV) for over half a century, but there is no currently approved vaccine.

Today, US pharma giant Pfizer (NYSE: PFE) said it is one step closer to potentially helping address the substantial burden of RSV disease. The company has been advancing a novel vaccine candidate for the common respiratory virus and recently announced top-line results from its late-stage clinical trial for adults 60 years of age or older.

Based on these results, Pfizer plans to seek regulatory approval from the US Food and Drug Administration (FDA) this fall. If approved by the FDA, the bivalent vaccine candidate known as RSVpreF, has the potential to be the first bivalent vaccine candidate to help protect adults 60 years of age or older from RSV.