Translation of a-t 2025; 56: 80

New data on the RSV vaccine ABRYSVO in older adults

Since 2024, the Standing Committee on Vaccination in Germany (STIKO) has recommended that older adults have a one-off vaccination against respiratory syncytial virus (RSV), from the age of 75 as a standard vaccination and as an indicated vaccination for those aged 60 to 74 with a significantly increased risk of a severe RSV course (a-t 2024; 55: 82-4, 2025; 56: 60-1).¹ The goals the Committee is trying to achieve with this include reducing severe respiratory diseases associated with RSV and the resulting consequences such as hospital treatment and death, but no data was previously available from randomised, controlled studies. Now there is a large, open-label, randomised study² in the form of DAN-RSV from Denmark, which compared the protein-based, non-adjuvanted vaccine ABRYSVO in 131,276 adults from the age of 60 (average of 69 years, 50% women) with unvaccinated controls in the 2024/25 season. The randomisation was carried out individually, and the endpoints were recorded based on registers with ICD codes. The vaccine decreased the rate of hospitalisations for respiratory diseases associated with RSV from 0.66 to 0.11 per 1,000 patient years (PY; relative protective effect 83%; 95% confidence interval 43-97, primary endpoint). The most important secondary endpoints of inpatient admissions for lower respiratory diseases associated with RSV (0.04 compared to 0.44/1,000 PY; relative efficacy 92%) and for any respiratory diseases (10.42 compared to 12.29/1,000 PY; relative effect 15%) were recorded significantly more rarely. Over the study period, 1.7% of the participants in each group were tested for RSV, or around 23% of those treated as inpatients for a respiratory disease in each group. Tests for influenza were carried out three times as frequently in the season. The authors therefore assume an under-recording of RSV infections. This is supported, among other things, by the fact that the absolute reduction in hospitalisations for respiratory diseases of any cause is larger than that for hospitalisations with evidence of RSV (around 1.87 compared to 0.55/1,000 PY). Serious adverse events, defined as death or hospitalisation within six weeks of immunisation or planned visit to the study site (control group) occur with a similar level of frequency in both groups (2.1% compared to 2.4%). Guillain-Barré syndrome, a known risk of protein-based RSV vaccines, did not occur during this period. The total mortality is numerically higher in the vaccine group (5.34 compared to 4.39/1,000 PY).² The decrease in hospital treatments for a respiratory disease by an absolute 0.2% per year seems to us to come at a high cost, at EUR 100,000 per event prevented (10 doses of the ABRYSVO vaccine: EUR 2,061.91, list price), especially since the duration of the vaccine protection and the ability to administer a booster dose remain unclear for the RSV vaccines, –Ed.

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