NEJM: Study finds RSV Vaccine Demonstrated Efficacy Against Lower Respiratory Tract Disease in Older Adults Interview with:
Eleanor Wilson, M.D
Moderna, 200 Technology Sq.
Cambridge, MA 02139 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. 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. 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. 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.


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