Skip to main content

MRESVIA FDA Approval History

Last updated by Carmen Pope, BPharm on June 4, 2024.

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

mRESVIA is a modified RNA vaccine that may protect adults aged 60 years and older from lower respiratory tract disease caused by an RSV infection.

mResvia is an injectable intramuscular vaccine that may be used to immunize adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV).

Development timeline for mRESVIA

DateArticle
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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.