On May 31, 2024 the FDA, under a breakthrough therapy designation, approved Moderna’s mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, marking the second disease targeted by the mRNA platform, plug and play technology, but the third RSV vaccine approved. The single dose vaccine is indicated “to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection”. [1, 2]. There was no press release by FDA, just a summary announcement. [3]
FDA approval of mRESVIA is based on a Phase 3 clinical trial ConquerRSV, a global study conducted in 35,541 adults ages 60 years or older in 22 countries”. Vaccine efficacy was determined to be 83.7% “against RSV lower respiratory tract disease (LRTD)” after “3.7 months of median follow-up”. Enrolments in the Phase 3 clinical trail (NCT05127434) started began November 17, 2021, where the placebo group were assigned a saline injection.
On May 03, 2023 FDA, under priority review designation, granted approval the very first RSV vaccine by GlaxoSmithKline. “Arexvy is approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older.” The apporval comes even though they are concerned about “serious risks for Guillain-Barré syndrome and ADEM” Pfizer’s Abrysvo is the second RSV vaccine approved by FDA.