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mRESVIA FDA Approval History

Last updated by Judith Stewart, BPharm on June 13, 2025.

FDA Approved: Yes (First approved May 31, 2024)
Brand name: mRESVIA
Generic name: respiratory syncytial virus vaccine, mRNA
Dosage form: Injection
Company: Moderna, Inc.
Treatment for: RSV Vaccination and Immunization

mRESVIA is a modified RNA vaccine for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).

Development timeline for mRESVIA

DateArticle
Jun 12, 2025Approval Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease
May 31, 2024Approval FDA Approves mRESVIA (respiratory syncytial virus vaccine) for Prevention of Lower Respiratory Tract Disease Caused by RSV
Jan 30, 2023Moderna Granted FDA Breakthrough Therapy Designation for mRNA-1345, An Investigational Respiratory Syncytial Virus (RSV) Vaccine Candidate
Jan 17, 2023Moderna Announces mRNA-1345, an Investigational Respiratory Syncytial Virus (RSV) Vaccine, Has Met Primary Efficacy Endpoints in Phase 3 Trial in Older Adults
Aug  3, 2021Moderna Receives FDA Fast Track Designation for Respiratory Syncytial Virus (RSV) Vaccine (mRNA-1345)

Further information

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