This is Moderna's second mRNA vaccine approval and the first mRNA vaccine approved for an indication other than COVID-19.
Updated on May 31, 2024, at 12:30 pm.
The FDA has approved mRNA-1345 (mRESVIA; Moderna), the company’s mRNA respiratory syncytial virus (RSV) vaccine, for the protection of adults aged 60 years and older against lower respiratory tract disease (LRTD) caused by RSV infection, according to a news release. The approval was previously granted breakthrough therapy designation in February 2023 based on data from the ConquerRSV (NCT05127434) phase 3 trial.1,2
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"The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform," Stéphane Bancel, CEO of Moderna, said in the news release. "mRESVIA protects 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 administrative errors. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19."1
The approval was based on the ConquerRSV trial, which was a phase 2/3 randomized, observer-blind, placebo-controlled study divided into a Part A and Part B. Part A evaluated the safety and tolerability of the vaccine with a single dose compared with a placebo 14 days post-infection through 12 months, and Part 2 evaluated the safety, tolerability, and immunogenicity of a booster dose at 24 months after the initial dose.1,3
The trial included approximately 37,000 adults aged 60 years or older and found that the efficacy of the vaccine in preventing RSV-LRTD with 2 or more symptoms was 83.7% in the primary analysis. For RSV-LRTD with 3 or more symptoms, the efficacy was 82.4%. In a follow-up analysis performed during the FDA review, the results were consistent with the primary analysis, at 78.7% efficacy, which is included in the package insert. The longer-term analysis demonstrated protection over 8.6 moths, according to the news release.1,2
The study is still active, focusing on the older population and improved patient outcomes. Part A phase 2 included 2000 individuals who received a single injection of the vaccine or the placebo, while Part A phase 3 will include 35,000 individuals with the same regimen. In Part B, 15,000 individuals who received the dose of the vaccine will continue the study and randomly receive either a booster dose of the vaccine or the placebo.3
There were no serious safety concerns identified in the phase 3 trial, with the most commonly reported adverse effects (AEs) including injection site pain, fatigue, headache, myalgia, and arthralgia. The overall rate of severe solicited systemic AEs was 4% and 2.8% for the vaccine and the placebo, respectively.1,2
Trial Name: A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age
ClinicalTrials.gov Identifier: NCT05127434
Sponsor: ModernaTX Inc
Completion Date (Estimated): AUgust 2025
The company expects the vaccine to be available for the 2024 to 2025 RSV season and has filed for approval with other regulators worldwide. The initial results of the study were published in The New England Journal of Medicine and the trial is set to run from November 2021 to August 2025.1,3
The vaccine was also previously granted fast track designation by the FDA in August 2021.2
