The Food and Drug Administration (FDA) has granted Fast Track designation to mRNA-1345, an investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults over 60 years of age.

mRNA-1345 is a vaccine candidate against RSV that utilizes the same lipid nanoparticle as Moderna’s authorized COVID-19 vaccine. The vaccine encodes for a prefusion F glycoprotein eliciting a superior neutralizing antibody response compared with the postfusion state.

The Company is evaluating the safety, reactogenicity, and immunogenicity of mRNA-1345 in healthy younger adults aged 18 to 49 years, women of child-bearing potential aged 18 to 40 years, healthy older adults aged 65 to 79 years, and RSV-seropositive children aged 12 to 59 months in an ongoing phase 1 study (ClinicalTrials.gov Identifier: NCT04528719).

Data from an interim analysis at 1 month postvaccination showed that the vaccine candidate elicited a geometric mean rise in neutralizing antibodies of at least 11-fold from baseline in younger adults.


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“We are pursuing an mRNA RSV vaccine to protect the most vulnerable populations – young children and older adults,” said Stéphane Bancel, Chief Executive Officer of Moderna.Stéphane Bancel, CEO of Moderna. “The Fast Track designation for older adults underscores the urgent need for a vaccine against RSV.”

The FDA’s Fast Track designation allows for expedited review of therapies that are meant to treat serious or life-threatening conditions. Generally, the designation is granted to therapies that are expected to have an impact on factors such as survival and daily functioning.

Reference

Moderna receives FDA Fast Track designation for respiratory syncytial virus (RSV) vaccine (mRNA-1345). News release. Moderna, Inc. Accessed August 3, 2021. https://www.businesswire.com/news/home/20210803005702/en/Moderna-Receives-FDA-Fast-Track-Designation-for-Respiratory-Syncytial-Virus-RSV-Vaccine-mRNA-1345