Breaking: FDA Approves Moderna’s mRNA RSV Vaccine, mRESVIA
mRESVIA is the first mRNA vaccine approved for a disease other than COVID-19.
The FDA has approved mRESVIA (mRNA-1345) an mRNA respiratory syncytial virus (RSV) vaccine for adults aged 60 years and older to protect against lower respiratory tract disease caused by RSV infection.1
The agency granted approval to mRESVIA under a breakthrough therapy designation.
Approval was based on positive data from the phase 3 ConquerRSV clinical trial (NCT05127434), a global study included approximately 37,000 adults from 22 countries aged 60 years and older. Study participants were randomly assigned 1:1 to receive either 1 dose of mRNA-1345 (50 µg) or placebo; primary efficacy endpoints included the prevention of RSV-associated lower respiratory tract disease with at least 2 signs or symptoms, and the prevention of RSV-associated lower respiratory tract disease with at least 3 signs or symptoms.
The initial results from this first phase of the study were published in the New England Journal of Medicine2 in December 2023, with primary analyses conducted with approximately 3.7 months of median follow-up. Investigators found that vaccine efficacy was 83.7% (95.88% CI, 66-92.2) against RSV-associated lower respiratory tract disease with at least 2 signs or symptoms, and 82.4% (96.36% CI, 34-8-95.3) against RSV-associated lower respiratory tract disease with at least 3 signs or symptoms. Efficacy was 68.4% (95% CI, 50.9-79.7) against RSV-associated acute respiratory disease.
READ MORE: RSV Vaccine Coverage Similar to Flu Could Reduce Illness, Cost Burden
During the FDA review, a follow-up analysis of the primary endpoint, inclusive of cases that began before the primary analysis cut-off date, was conducted. These results were consistent with the primary analysis: vaccine efficacy was 78.7% (95% CI, 62.9%-87.8%), and an additional longer-term analysis demonstrated continued protection from the vaccine against RSV-associated lower-respiratory tract disease over an 8.6 month median follow-up period.
The most common adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia. No serious safety concerns were reported.
“The FDA approval of our second [RSV] product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Stéphane Bancel, Moderna CEO, in a news release. “mRESVIA proctects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of t administrative errors.”
“This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19,” Bancel added.
Each year, RSV is responsible for between 60,000 and 160,000 hospitalizations among older adults; between 6000 and 10,000 die each year due to RSV infection.
Moderna anticipates availability of mRESVIA for eligible adults by the start of the 2024/2025 respiratory virus season. Once available, mRESVIA will join 2 other RSV vaccines currently available: GSK’s Arexvy, currently approved for use in adults aged 60 years and older3 and Pfizer’s Abrysvo, approved for use in adults aged 60 years and older4 and in pregnant women between 32- and 36-weeks’ gestational age.5 Earlier this year, GSK was assigned a PDFUA date of June 7 for an expanded indication of Arexvy, to include adults aged 50 to 59 years who are at increased risk for RSV infection.6
READ MORE: Respiratory Resource Center
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References
Moderna receives US FDA approval for RSV vaccine mRESVIA. News release. Moderna. May 31, 2024. Accessed May 31, 2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-U.S.-FDA-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx
Wilson E, Goswami J, Baqui AH, for the ConquerRSV Study Group. Efficacy and safety of an mRNA-based RSV PreF vaccine in older adults. N Engl J Med. 2023;389;2233-2244. doi:10.1056/NEJMoa2307079
Biscaldi L. Breaking: FDA approves first-ever RSV vaccine. Drug Topics. May 3, 2023. Accessed May 31, 2024. https://www.drugtopics.com/view/breaking-fda-approves-first-ever-rsv-vaccine
Biscaldi L. FDA: Pfizer RSV vaccine approved for use in older adults. Drug Topics. June 1, 2023. Accessed May 31, 2024. https://www.drugtopics.com/view/fda-pfizer-rsv-vaccine-approved-for-use-in-older-adults
Meara K. FDA approves Pfizer RSV vaccine for use during pregnancy to protect infants. Drug Topics. August 22, 2023. Accessed May 31, 2024. https://www.drugtopics.com/view/fda-approves-pfizer-rsv-vaccine-for-use-during-pregnancy-to-prevent-rsv-in-infants
FDA: PDUFA date assigned for Arexvy as RSV prevention in age 50 to 59. Formulary Watch. February 8, 2024. Accessed May 31, 2024. https://www.drugtopics.com/view/fda-action-date-assigned-for-arexvy-as-rsv-prevention-in-age-50-to-59
