Translation of a-t 2024; 55: 23
 

SIDE EFFECTS

RESPIRATORY SYNCYTIAL VIRUS VACCINES: POSSIBLE RISK OF GUILLAIN-BARRÉ SYNDROME?

Two vaccines have been available in Germany to prevent infection with respiratory syncytial virus (RSV) in adults aged 60 and over since autumn 2023: ABRYSVO and AREXVY. There is not yet a recommendation from the Standing Committee on Vaccination (Ständige Impfkommission, STIKO), so neither vaccine is currently covered by the statutory health insurance (a-t 2023; 54: 73-5).

Both vaccines have been approved in the US since May 2023, and since June 2023 they are recommended for people aged 60 and over on an individual basis following a joint decision with the doctor.¹ Assessments of safety data from routine use in older people were reported for the first time at a meeting of the US Advisory Committee on Immunization Practices (ACIP) in late February 2024. A possible risk signal for Guillain-Barré syndrome (GBS) was identified, which had already occurred in individual cases in the approval studies for both vaccines.^2,3 Up to 16 February 2024, the authorities documented 23 cases after reviewing confirmed spontaneous reports of GBS within 42 days of immunisation with ABRYSVO (15) or AREXVY (8). Verification is still pending for six further suspected reports. Those affected (14 men, 9 women) are a median of 71 years old and developed initial symptoms 1 to 22 days after the RSV vaccination (median of 9 days). The disease was fatal for one 70-year-old man vaccinated with AREXVY.²

A reporting rate of 4.6/1 million vaccine doses administered was calculated for a period of 21 to 42 days after vaccination for ABRYSVO* and for AREXVY a rate of 1.1 or 1.2/1 million. Based on this, since the estimated background activity of GBS in this age group is 2 to 5.2 diseases/1 million within 21 to 42 days, the demyelinating disease could occur more commonly than expected at least in patients receiving ABRYSVO.² Some further analyses based on health insurance data, however, indicate a possible increased risk for AREXVY too, which is overall used significantly more frequently.^2,3

The US authorities are classifying the data as provisional, so there are not currently any consequences of this. Active and passive monitoring of the two RSV vaccines for GBS will be continued,^2-4 –Ed.

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