RSV Vaccine Candidate for Seniors Seeks Approval
Moderna, Inc. announced positive topline data from its ConquerRSV Phase 3 pivotal efficacy trial of mRNA-1345, an mRNA vaccine candidate targeting respiratory syncytial virus (RSV) in older adults.
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 as defined by two or more symptoms.
Based on these results, Moderna stated on January 17, 2023, it intends to submit for regulatory approval for mRNA-1345 in the first half of 2023.
"RSV significantly affects the health of older and high-risk adults, particularly those with comorbidities," commented Abdullah Baqui, a principal investigator for the study sites in Bangladesh and Professor, Department of International Health, Director, International Center for Maternal and Newborn Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, in a related press release.
"This trial will help to understand the role of severe acute respiratory infections in older adult populations and inform the future implementation of vaccines in adults in lower-resource areas."
A concurrent review of available safety data was also conducted by the DSMB.
mRNA-1345 was well tolerated, with no safety concerns identified. To date, most solicited adverse reactions were mild or moderate, and the most commonly reported solicited adverse reactions in the mRNA-1345 group were injection site pain, fatigue, headache, myalgia, and arthralgia.
The overall rate of severe (Grade 3 or greater) solicited systemic adverse reactions was 4.0% for mRNA-1345 and 2.8% for placebo.
The overall rate of Grade 3 or greater solicited local adverse reactions was 3.2% for mRNA-1345 and 1.7% for placebo.
The study is ongoing, and an updated analysis of safety and tolerability will be provided at the time of regulatory submission.