FDA Moves Back the PDUFA Date for Moderna’s RSV Vaccine


The federal agency said that due to administrative constraints, they will not complete the review of mRNA-1345 by the PDUFA date of May 12.

FDA logo Image credit: FDA

The federal agency is planning to have a decision the vaccine by the end of this month.

Image credit: FDA

This morning, Moderna announced the FDA is moving back its PDUFA review of the company’s mRNA-1345 RSV vaccine, which was initially scheduled to be completed by Sunday, May 12. FDA did not specify a new date, but said it will have the review completed by the end of May.1 "Moderna is very grateful to the FDA for their continued efforts and diligence," said Stephen Hoge, MD, president of Moderna.1

Moderna’s mRNA-1345 vaccine was developed for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) for seniors.1

The Data

Data from the phase 3 ConquerRSV trial (NCT05127434) was a randomized, double-blind, placebo-controlled study of approximately 37,000 adults who are 60 years or older across 22 countries. The investigators based their primary efficacy endpoints around 2 definitions of RSV-LRTD defined as either 2 or more symptoms, or 3 or more symptoms of disease.2

The interim analysis was based on 64 cases of RSV-LRTD with 2 or more symptoms, of which 55 occurred in the placebo group and 9 occurred in the mRNA-1345 group, and 20 cases of RSV-LRTD with three or more symptoms, of which 17 cases were observed in the placebo group compared with three cases observed in the mRNA-1345 group. The other primary efficacy endpoint against RSV-LRTD defined by three or more symptoms was also met, with a vaccine efficacy (VE) of 82.4% (96.36% CI, 34.8%–95.3%; P = .0078).3

A subsequent analysis from the ConquerRSV study with a longer median follow-up duration of 8.6 months (versus 3.7 months in the primary analysis), with a range of 15 days to 530 days, and including subjects from the Northern and Southern Hemispheres was recently presented at the RSVVW'24 conference. In this supplemental analysis, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% (95.88% CI, 48.7%–73.7%) against RSV-LRTD including 2 or more symptoms. VE was 74.6% (95% CI, 50.7%–86.9%) against RSV-LRTD with ≥2 symptoms, including shortness of breath, and 63.0% (95% CI, 37.3%–78.2%) against RSV-LRTD including three of more symptoms.4

What's Next

Although the FDA decision was moved back, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) meeting, on June 26 to 27, is still scheduled to discuss mRNA-1345. This meeting and review of the vaccine's data is a necessary step in the approval process.

"We look forward to helping the agency complete the review of our application, and to the June ACIP meeting," Hoge said.

1. Moderna Announces Update on Investigational RSV Vaccine. Moderna. News release. May 10, 2024. Accessed May 10, 2024.
2. Parkinson J. Moderna RSV Vaccine Granted FDA Breakthrough Therapy Status. Contagion. January 31, 2023. Accessed April 4, 2024 https://www.contagionlive.com/view/moderna-rsv-vaccine-granted-fda-breakthrough-therapy-status
3. Moderna Announces mRNA-1345, an Investigational Respiratory Syncytial Virus (RSV) Vaccine, Has Met Primary Efficacy Endpoints in Phase 3 Trial in Older Adults. Moderna. News release. January 17, 2023. Accessed April 4, 2024. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-mRNA-1345-an-Investigational-Respiratory-Syncytial-Virus-RSV-Vaccine-Has-Met-Primary-Efficacy-Endpoints-in-Phase-3-Trial-in-Older-Adults/default.aspx
4. Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials. Moderna. News release. March 27, 2023. Accessed April 4, 2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Advances-Multiple-Vaccine-Programs-to-Late-Stage-Clinical-Trials/default.aspx
Related Videos
© 2024 MJH Life Sciences

All rights reserved.