13 Dec NEJM: Study finds RSV Vaccine Demonstrated Efficacy Against Lower Respiratory Tract Disease in Older Adults
MedicalResearch.com Interview with:
Eleanor Wilson, M.D
Moderna, 200 Technology Sq.
Cambridge, MA 02139
MedicalResearch.com: What is the background for this study? What are the main findings and side effects (if any)?
Response: The ConquerRSV trial is a randomized, double-blind, placebo-controlled study of approximately 37,000 adults 60 years or older in 22 countries. The primary efficacy endpoints were based on two definitions of RSV-associated lower respiratory tract disease (RSV-LRTD) defined as either two or more symptoms, or three or more symptoms of disease.
Vaccine efficacy was 83.7% (95.88% confidence interval [CI], 66.0 to 92.2) against RSV-associated lower respiratory tract disease with at least two signs or symptoms and 82.4% (96.36% CI, 34.8 to 95.3) against the disease with at least three signs or symptoms. Most adverse reactions were mild to moderate in severity and included injection site pain, fatigue, headache, myalgia, and arthralgia.
MedicalResearch.com: What should readers take away from your report?
Response: We want readers to understand that our investigational vaccine against RSV demonstrated vaccine efficacy against RSV-associated lower respiratory tract disease, representing an important step forward in potentially preventing lower respiratory disease due to RSV in adults 60 years of age and older.
MedicalResearch.com: Are there are patient demographics, ie younger immuncompromised patients, cystic fibrosis, asthma patients etc. consider taking the vaccine?
Response: This research indicates that mRNA-1345 may be effective against RSV-LRTD in adults 60 years of age and older. RSV significantly affects the health of older and high-risk adults, particularly those with comorbidities – an RSV infection can exacerbate underlying medical conditions such as asthma and COPD and can result in acute myocardial infarction, stroke, and long-term decline of respiratory functions.
This data found our vaccine was well-tolerated among this population, meaning it may provide an additional option for older, at-risk adults seeking protection. All patients should consult with their health care provider prior to taking a vaccine.
MedicalResearch.com: Is there anything else you would like to add? Any disclosures?
Response: Moderna is committed to developing a portfolio of respiratory mRNA vaccines to target the most significant viruses causing respiratory disease. These data represent the second demonstration of positive phase 3 trial results from our mRNA infectious disease vaccine platform.
Citation:
Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults
Eleanor Wilson, M.D., Jaya Goswami, M.D., Abdullah H. Baqui, M.B., B.S., M.P.H., Dr.P.H., Pablo A. Doreski, M.D., Gonzalo Perez-Marc, M.D., Khalequ Zaman, M.B., B.S., Ph.D., Jorge Monroy, M.D., Christopher J.A. Duncan, M.B., Ch.B., D.Phil., Mugen Ujiie, M.D., M.T.M., Ph.D., Mika Rämet, M.D., Ph.D., Lina Pérez-Breva, M.D., Ph.D.,
Ann R. Falsey, M.D., et al., for the Conquer RSV Study Group*
December 14, 2023
N Engl J Med 2023; 389:2233-2244
DOI: 10.1056/NEJMoa2307079
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Last Updated on December 13, 2023 by Marie Benz MD FAAD