31 Jan US FDA grants breakthrough therapy designation for Moderna’s RSV vaccine
The FDA’s decision was based on the positive results obtained from the Phase III ConquerRSV trial.
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Moderna’s investigational mRNA vaccine candidate, mRNA-1345, for respiratory syncytial virus (RSV) in adult patients.
The vaccine candidate is indicated to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in people aged 60 years or above.
It contains a single mRNA sequence encoding for a stabilised prefusion F glycoprotein.
The investigational mRNA-1345 vaccine uses the same lipid nanoparticles (LNPs) that are also used in the Moderna Covid-19 vaccines.
Moderna CEO Stéphane Bancel said: “The FDA’s breakthrough designation for mRNA-1345 further emphasises the significant health impact of RSV in older adults and the high unmet need.
“With this designation, we look forward to productive conversations with the FDA in the hopes of bringing our RSV vaccine candidate for older adults to the market safely and quickly.
“Moderna’s mRNA platform has now demonstrated two positive Phase III infectious disease trial results and we continue to advance a portfolio of respiratory mRNA vaccines targeting the most serious diseases.”
The regulatory agency’s decision was based on the positive data obtained from the Phase III ConquerRSV trial, which is assessing the vaccine’s efficacy against RSV-LRTD. Read more …