Drugs / mRNA-1345
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | mRESVIA | RSV-associated lower respiratory tract disease and acute respiratory disease | 2023-09-13 | “The Company has also initiated a rolling submission of a Biologics License Application to the U.S. Food and Drug Administration for mRNA-1345” q4web.com ↗ “Moderna filed for regulatory approval of mRNA-1345 for high-risk adults with the FDA using a priority review voucher in 2024.” q4web.com ↗ |
Trials 12
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2025-06-12 | ModernaTX, Inc. | Regulatory Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease q4web.com ↗
This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older. |
| 2025-03-31 | ModernaTX, Inc. | Regulatory Moderna Receives Australian Therapeutic Goods Administration Approval for RSV Vaccine for Older Adults q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the Australian Therapeutic Goods Administration (TGA) has granted approval for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older. |
| 2025-02-28 | ModernaTX, Inc. | Regulatory Moderna Receives Medicines and Healthcare Products Regulatory Agency Marketing Authorization in the UK for RSV Vaccine q4web.com ↗
With the MHRA decision, mRESVIA becomes Moderna's second approved product in the UK, further demonstrating the role of mRNA vaccines in helping to protect the public from respiratory diseases. |
| 2024-11-08 | ModernaTX, Inc. | Regulatory Moderna Receives Health Canada Approval for RSV Vaccine for Adults Aged 60 Years and Older q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced Health Canada has approved mRESVIA™ (Respiratory Syncytial Virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. |
| 2024-09-12 | ModernaTX, Inc. | Results Moderna R&D Day Highlights Progress and Strategic Priorities q4web.com ↗
In the trial, mRNA-1345 met all primary immunogenicity endpoints and the 50 µg dose, which is the same for the currently approved mRESVIA vaccine for adults 60 years and above, was well tolerated with no safety concerns identified. |
| 2024-08-23 | ModernaTX, Inc. | Regulatory Moderna Receives European Commission Approval for RSV Vaccine mRESVIA(R) q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. |
| 2024-06-28 | ModernaTX, Inc. | Regulatory EMA Committee For Medicinal Products For Human Use Adopts Positive Opinion Recommending Marketing Authorization Of Moderna’s RSV Vaccine, mRESVIA(R) q4web.com ↗
Following the CHMP's positive opinion, the European Commission will adopt a decision on the authorization of mRESVIA. |
| 2024-05-31 | ModernaTX, Inc. | Regulatory Moderna Receives U.S. FDA Approval for RSV Vaccine mRESVIA(R) q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. |
| 2024-05-10 | ModernaTX, Inc. | Regulatory Moderna Announces Update on Investigational RSV Vaccine q4web.com ↗
U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024 |
| 2024-02-08 | ModernaTX, Inc. | Results Statement on RSVVW Abstract on mRNA-1345 modernatx.com ↗
In this supplemental analysis, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% (95% CI: 48.7%, 73.7%) against RSV-LRTD including two or more symptoms. |
| 2023-12-14 | ModernaTX, Inc. | Results Moderna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data For MRNA-1345, The Company’s Investigational Respiratory Syncytial Virus (RSV) Vaccine q4web.com ↗
today announced the publication of positive Phase 3 clinical study results evaluating mRNA-1345, its vaccine candidate for respiratory syncytial virus (RSV), in The New England Journal of Medicine. |
| 2023-09-13 | ModernaTX, Inc. | Regulatory Moderna Expands the Field of mRNA Medicine with Positive Clinical Results Across Cancer, Rare Disease, and Infectious Disease q4web.com ↗
The Company filed for a Biologics License Application (BLA) with the FDA and used a Priority Review Voucher (PRV). |
| 2023-08-03 | ModernaTX, Inc. | Regulatory Moderna Reports Second Quarter 2023 Financial Results and Provides Business Updates q4web.com ↗
Moderna has submitted marketing authorization applications globally for mRNA-1345, a vaccine for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults aged 60 years or older. |
| 2023-07-05 | ModernaTX, Inc. | Regulatory Moderna Announces Global Regulatory Submissions For Its Respiratory Syncytial Virus (RSV) Vaccine, MRNA-1345 q4web.com ↗ |
| 2023-01-30 | ModernaTX, Inc. | Regulatory Moderna Granted FDA Breakthrough Therapy Designation for mRNA-1345, An Investigational Respiratory Syncytial Virus (RSV) Vaccine Candidate q4web.com ↗ |
| 2023-01-17 | ModernaTX, Inc. | Results Moderna Announces mRNA-1345, an Investigational Respiratory Syncytial Virus (RSV) Vaccine, Has Met Primary Efficacy Endpoints in Phase 3 Trial in Older Adults q4web.com ↗
Following review by an independent Data and Safety Monitoring Board (DSMB), the primary efficacy endpoints have been met, including vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms. |
| 2022-03-24 | ModernaTX, Inc. | Results Moderna Announces Clinical and Program Updates at 3rd Annual Vaccines Day q4web.com ↗
In an interim analysis, mRNA-1345 boosted RSV neutralizing antibodies and was well-tolerated at all dose levels in younger and older adults. |
| 2022-02-22 | ModernaTX, Inc. | Results Moderna Initiates Phase 3 Portion of Pivotal Trial for mRNA Respiratory Syncytial Virus (RSV) Vaccine Candidate, Following Independent Safety Review of Interim Data q4web.com ↗
The DSMB's endorsement comes after independent review of preliminary Phase 2 data, which suggest that the vaccine has an acceptable safety profile in older adults at the selected dose. |
| 2021-09-09 | ModernaTX, Inc. | Results Moderna Announces Significant Advances Across Industry-Leading mRNA Portfolio at 2021 R&D Day q4web.com ↗
Interim Phase 1 data from RSV vaccine candidate in older adults significantly boosted neutralizing antibody titers above baseline |
| 2021-08-03 | ModernaTX, Inc. | Regulatory Moderna Receives FDA Fast Track Designation for Respiratory Syncytial Virus (RSV) Vaccine (mRNA-1345) q4web.com ↗
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today 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. |
| 2021-04-14 | ModernaTX, Inc. | Results Moderna Announces Clinical Progress from its Industry-Leading mRNA Vaccine Franchise and Continues Investments to Accelerate Pipeline Development q4web.com ↗
The Company is also announcing new positive interim Phase 1 data from its Respiratory Syncytial Virus (RSV) vaccine candidate (mRNA-1345) and new 7-month interim Phase 2 data from its cytomegalovirus (CMV) vaccine candidate. |
| 2020-09-17 | ModernaTX, Inc. | Regulatory Moderna Announces Progress Across Broad Portfolio and all Three Clinical Stage Therapeutic Areas at 2020 R&D Day q4web.com ↗
The U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for the Company’s pediatric RSV vaccine (mRNA-1345) and allowed it to proceed to the clinic |
All press releases naming this drug 23 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-1345 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07117487 ↗ |
| Known as | mRESVIA | “mRNA-1345 (mRESVIA, Moderna, Inc.) is indicated in multiple countries for prevention of RSV-lower respiratory tract disease in adults.” PMID 42048601 ↗ Apr 2026 |
| Modality | Messenger RNA (mRNA) | “A lipid nanoparticle-encapsulated mRNA-based RSV vaccine (mRNA-1345) that encodes the membrane-anchored RSV prefusion-stabilized F glycoprotein” PMID 38298125 ↗ Sep 2024 |
| Route | Intramuscular | “Single injection of mRNA-1345 administered IM on BD Day 1.” NCT05330975 ↗ |