Assessing the risk of Guillain-Barré syndrome in older adults after bivalent RSV pre-F vaccination in England

An elevated risk of Guillain-Barré syndrome following respiratory syncytial virus vaccination in older adults was reported from the United States in the first year of their programme. This national study assesses the risk of Guillain-Barré syndrome (GBS) following vaccination against respiratory syncytial virus (RSV) using bivalent pre-F (Abrysvo, Pfizer) vaccine in England's programme for 2.5 million 75-79 year olds. The vaccination campaign began in September 2024, with initial risk assessed three months later using the intravenous immunoglobulin registry for the target age group. This ecological analysis used historical data and case-coverage comparisons linking to the national RSV vaccine register. A final six-month analysis combined the intravenous immunoglobulin and GBS-coded hospital discharge data, using both case-coverage and the planned self-controlled case-series method, focusing on the 0-42 day post-vaccination risk window. The initial analysis showed a significant increased risk of GBS after RSV vaccination, confirmed by both ecological and case-coverage methods. Final results were consistent, with the self-controlled case-series estimating a relative incidence of 3.34 (95% CI: 2.12-5.28) and an attributable risk of 23 (95% CI: 17-26) cases per million doses. Here, we show a small risk of GBS following RSV vaccination with the bivalent pre-F in England's older adults' programme, but this is at a level that is far exceeded by the vaccine benefits.