www.fdanews.com/articles/192742-janssen-earns-breakthrough-therapy-designation-for-rsv-vaccine
Janssen Earns Breakthrough Therapy Designation for RSV Vaccine
September 16, 2019
The FDA granted Janssen breakthrough therapy designation for its investigational prophylactic vaccine to prevent spirator syncytial virus (RSV) in adults aged 60 or older.
The vaccine uses Janssen’s adenovector (AdVac) to deliver the genetic code for the antigen to the RSV virus.
The agency awarded the designation based on clinical data indicating the vaccine may offer substantial improvement compared to the available standard of care.