Moderna RSV Vaccine Gains Expanded FDA Approval for Younger Adults

Moderna Inc. (NASDAQ:MRNA) is one of the best mid cap growth stocks to invest in now. On June 12, the US FDA expanded the approval for Moderna’s respiratory syncytial virus/RSV vaccine, mRESVIA (mRNA-1345). The vaccine is now approved for the prevention of lower respiratory tract disease/LRTD caused by RSV in individuals aged 18 to 59 years who are at increased risk.

This builds upon its initial approval in May 2024 for adults aged 60 years and older, which makes mRESVIA the second approved product for Moderna in the US, alongside its COVID-19 vaccine, Spikevax. The expanded approval was supported by results from Moderna’s Phase 3 study, which evaluated the vaccine’s safety and immunogenicity in 1,150 adults aged 18 to 59 years with underlying health conditions.

Moderna RSV Vaccine Gains Expanded FDA Approval for Younger Adults

A scientist surrounded by vials and beakers in a modern laboratory, proudly displaying a vaccine.

Moderna intends to make mRESVIA available for both younger adults at increased risk (ages 18-59) and older adults (ages 60+) in the US in time for the 2025-2026 respiratory virus season, which typically begins around November. Despite FDA approval, inclusion in national immunization schedules is determined by the US Centers for Disease Control and Prevention’s/CDC Advisory Committee on Immunization Practices. The CDC currently recommends RSV vaccines for adults aged 75 and older, and for adults aged 60 to 74 who are at increased risk.

Moderna Inc. (NASDAQ:MRNA) is a biotechnology company that provides messenger RNA medicines internationally.

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Disclosure: None. This article is originally published at Insider Monkey.