Moderna RSV-Targeted mRNA Vaccine Candidate Gets Fast Track Tag In US
- The FDA granted Fast Track designation Moderna Inc's (NASDAQ: MRNA) mRNA-1345, its investigational single-dose mRNA vaccine against the respiratory syncytial virus (RSV) in adults older than 60 years of age.
- The respiratory syncytial virus is a common respiratory virus that generally causes cold-like symptoms.
- The vaccine is currently in Phase 1 study. All four cohorts of younger adults (ages 18-49 years) are fully enrolled. Dosing in the older adult cohort (ages 65-79 years) is ongoing.
- Moderna shared the first interim analysis of the Phase 1 study of mRNA-1345, through 1-month post-vaccination, of the younger adult cohorts.
- Results showed that the vaccine candidate generated a geometric mean rise in neutralizing antibodies relative to the baseline of at least 11-fold.
- Moderna 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.
- Price action: MRNA shares are up 1.12% at $350.79 during the market session on the last check Tuesday.
- Related content: Benzinga's Full FDA Calendar.
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