Moderna receives FDA fast track designation for RSV vaccine

Aug. 6, 2021

Moderna 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.

“We are pursuing an mRNA RSV vaccine to protect the most vulnerable populations — young children and older adults,” said Stéphane Bancel, Chief Executive Officer of Moderna.

RSV is a common respiratory virus that generally causes cold-like symptoms. RSV is the most common cause of bronchiolitis and pneumonia in children younger than one year of age in the United States and can result in pneumonia and respiratory distress in older adults.

The Phase 1 study of mRNA-1345 to evaluate the tolerability and reactogenicity of mRNA-1345 in younger adults, older adults and children is ongoing. 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. The age range of toddlers in this de-escalation Phase 1 study is 12-59 months.

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