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. 2025 Dec 11;16(1):11496.
doi: 10.1038/s41467-025-66280-z.

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

Julia Stowe  1   2 , Conall H Watson  3 , Mary E Ramsay  3 , Nick J Andrews  3   4
Affiliations

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

Julia Stowe et al. Nat Commun. .

Abstract

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.

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Conflict of interest statement

Competing interests: The Immunisation and Vaccine Preventable Diseases Department at UKHSA has provided vaccine manufactures with post-marketing surveillance reports, which the Marketing Authorization Holders are required to submit to the UK Licensing authority in compliance with their Risk Management Strategy. A cost recovery charge is made for these reports. The authors declare no other competing interests.

Figures

Fig. 1
Fig. 1. Ecological assessment of IVIG case numbers in 74–79 year olds in England by quarter from March 2021 to November 2024.
Orange bar shows the post vaccine introduction period and the dashed line is the trend in case numbers prior to vaccination (prior to September 2024) fitted using Poisson regression to predict the expected cases for September-November 2024.
Fig. 2
Fig. 2
Data flow chart of the 173 individuals in the final analysis.
Fig. 3
Fig. 3. RSV vaccine coverage in 74-79 year olds in England.
Using data from the Immunisation Information System (IIS) by age at September 1st 2024, sex and week number.
Fig. 4
Fig. 4
Distribution of GBS cases by days from RSV vaccination in the 10 weeks after vaccination.
See this image and copyright information in PMC

References

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