Adult protection against respiratory infections strengthened – marketing authorisation granted for a new RSV vaccine

The European Commission, following a recommendation by the European Medicines Agency (EMA), has granted marketing authorisation for the new mRESVIA® vaccine for the prevention of RSV infection in adults aged 60 years and older. Respiratory syncytial virus, or RSV, can cause serious lower respiratory tract infections, often requiring hospital care, particularly in older adults and young infants during the autumn and winter seasons.

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RSV vaccines have become available with the help of studies conducted in Finland

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RSV vaccines have been developed and studied for a long time by FVR and its predecessors. Major progress was made last year, when the first vaccines for the prevention of RSV infections became available: Abrysvo® and Arexvy® for adults aged 60 years and older, and Abrysvo® administered during pregnancy to help prevent RSV infections in infants.

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Now, mRESVIA®, the first RSV vaccine based on mRNA technology, has received marketing authorisation. The vaccine is intended to protect adults aged 60 years and older. Monitoring of the vaccine’s effectiveness and safety is still ongoing.

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The marketing authorisation for mRESVIA® is based on positive results from the phase 3 study mRNA-1345-P301, published in The New England Journal of Medicine in December 2023. The study, conducted among adults aged 60 years and older, was carried out in 22 countries, including Finland, and involved more than 35,000 participants. The EMA states that mRESVIA received an EU-wide marketing authorisation on 22 August 2024.

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Based on the study results, mRESVIA® is highly effective in preventing RSV-associated lower respiratory tract disease in older adults. The vaccine prevented more than 80% of RSV lower respiratory tract disease cases in adults aged 60 years and older.

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RSV is one of the most common causes of respiratory infections in older adults. In Europe, the disease burden is substantial, including hospitalisations and mortality related to RSV infections.

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“Effective prevention of infections would significantly support the health and functional ability of older people. Thanks to successful vaccine studies, vaccines have now become available, making this possible,” says Arto Palmu, Chief Scientific Officer at FVR.

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EMA release 21.7.2023 >>

https://www.ema.europa.eu/en/medicines/human/EPAR/mresvia#authorisation-details

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More information

Arto Palmu

Chief Scientific Officer

arto.palmu (at) fvr.fi