NEW ORLEANS – The U.S. Food and Drug Administration (FDA) has approved Moderna’s mRESVIA® (mRNA-1345), a first-of-its-kind mRNA respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) in adults aged 60 and older. mRESVIA is Moderna’s second approved product and the first mRNA vaccine authorized for a disease other than COVID-19. Moderna’s innovation leverages its mRNA platform and introduces the only RSV vaccine available in single-dose pre-filled syringes. Marshall Morris, Partner at DelRicht Research, noted the approval as a breakthrough in preventive care for older adults and a testament to the promise of mRNA technology beyond COVID-19.

DelRicht Research contributed to this milestone through the work of Dr. Patrick Dennis, Principal Investigator at Touro Medical Center in New Orleans, LA, who supported Moderna’s pivotal ConquerRSV Phase 3 trial, a global study involving over 37,000 participants.

A Breakthrough in Protecting Older Adults from RSV

The ConquerRSV trial, which enrolled older adults across 22 countries, demonstrated vaccine efficacy of 83.7% against RSV-related LRTD, with results published in The New England Journal of Medicine. mRESVIA also maintained strong protection over 8.6 months of follow-up and showed a favorable safety profile. The most common side effects were mild-to-moderate and included injection site pain, fatigue, headache, and myalgia.

RSV poses a serious seasonal threat, especially to older adults, contributing to tens of thousands of hospitalizations and thousands of deaths each year in the U.S. alone. The ease of use provided by a pre-filled syringe format further enhances the vaccine’s accessibility and real-world impact.

Marshall Morris on a Promising New Chapter in mRNA Vaccines

What sets mRESVIA apart is its use of stabilized prefusion F glycoprotein mRNA, a key target for neutralizing antibodies across RSV subtypes. This marks an important advance in the application of mRNA vaccine technology beyond COVID-19, building on Moderna’s growing platform in infectious diseases. “We are proud to have contributed to the development of this important vaccine,” said Marshall Morris, Partner at DelRicht Research. “The approval of mRESVIA reflects our ongoing commitment to advancing mRNA innovation and protecting vulnerable populations through world-class clinical research.”

“We are proud to have contributed to the development of this important vaccine. The approval of mRESVIA reflects our ongoing commitment to advancing mRNA innovation and protecting vulnerable populations through world-class clinical research.”

— Marshall Morris, Partner at DelRicht Research

Innovation Through Local Research

mRESVIA’s approval showcases the power of public-private collaboration in addressing urgent health needs. The participation of Louisiana-based physician Dr. Patrick Dennis and the DelRicht network in a global pivotal trial reinforces the importance of regional research excellence in delivering solutions with national and global impact.

In conclusion, the FDA’s approval of mRESVIA for the prevention of RSV in older adults signals a major advancement in respiratory disease protection. With support from DelRicht Research and dedicated investigators like Dr. Dennis, Moderna’s second approved product further demonstrates the potential of mRNA science to transform public health.

Read the full press release from Moderna.