Moderna’s RSV mRNA Vaccine Gains Expanded FDA Approval for At-Risk Younger Adults
CAMBRIDGE, MA – June 12, 2025 – Moderna (NASDAQ:MRNA) announces FDA approval for mRESVIA® (mRNA-1345), their RSV vaccine, now cleared for individuals aged 18-59 years at increased risk of RSV disease. This expands its previous approval for adults 60+, marking a significant step forward in protecting more vulnerable populations.
Supported by robust Phase 3 data showing comparable immune responses to older adults, mRESVIA® utilizes mRNA technology encoding a prefusion F glycoprotein to induce strong neutralizing antibodies. It shares the same LNP platform as Moderna’s COVID-19 vaccines.
“RSV poses a serious health risk to adults with certain chronic conditions, and today’s approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,” said Stéphane Bancel, CEO of Moderna.
Moderna plans to have mRESVIA® available for both newly approved younger adults and older adults for the 2025-2026 respiratory virus season.
Source:
https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-RSV-Vaccine-mRESVIA-in-Adults-Aged-1859-at-Increased-Risk-for-RSV-Disease/default.aspx
About PackGene
PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.
