04 August 2021 | News
There is no approved vaccine available today for RSV
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US-based Moderna, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults older than 60 years of age.
Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and that fill an unmet medical need.
Respiratory syncytial virus is a common respiratory virus that generally causes cold-like symptoms.
There is no approved vaccine available today for RSV. The Phase 1 study of mRNA-1345 to evaluate the tolerability and reactogenicity in younger adults, older adults and children is ongoing.
The company also intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults.
mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state.