Post-licensure observational safety study after meningococcal B vaccine 4CMenB (Bexsero) vaccination within the routine UK immunisation program

Gillian C Hall,Ian Douglas,Paul T Heath,Prab Prabhakar,Dominique Rosillon,Javeed Khan,Victoria Abbing-Karahagopian

doi:10.1016/j.vaccine.2021.02.065

Abstract

The study investigated the safety of 4-component meningococcal serogroup B vaccination (4CMenB) in routine care. 4CMenB exposure and seizures, febrile seizures and Kawasaki disease were identified from The Health Improvement Network (THIN) database of UK electronic primary healthcare records, 2015–2018. A self-controlled case series analysis was completed. Anaphylaxis, Guillain-Barré syndrome and acute disseminated encephalomyelitis were secondary outcomes.A total of 107,231 children aged 1–18 months received ≥1 doses of 4CMenB vaccination. Most 4CMenB exposure (93%) was on the same day as other vaccines within a complete national immunisation program stage. With day 0 as day of vaccination, 43 seizures occurred in days 0–6 after 239,505 doses, and 23 febrile seizures occurred in days 0–6, and 4 Kawasaki disease cases in days 1–28 after 194,929 4CMenB doses. Adjusted incidence rate ratios including all 4CMenB exposures were 1.43 (95%CI: 1.02–2.02) for seizures and 1.72 (95%CI: 1.08–2.75) for febrile seizures. There were insufficient cases to model Kawasaki disease, and no cases of the secondary outcomes in risk periods when they may be associated with the vaccination.This study shows few cases of the outcomes after vaccination including 4CMenB with an increased risk of seizures and febrile seizures. It is not possible to attribute the finding to one specific vaccination as the majority of 4CMenB was given with other vaccinations.Trial registration: NA.

Highlights

Meningococcal disease is caused by the bacterium Neisseria meningitidis and is associated with considerable mortality and morbidity [1] with young children and teenagers at highest risk of the disease [2]
Vaccine (4CMenB; Bexsero, GSK) was the first multicomponent meningococcal serogroup B vaccine and was included in the UK National Immunisation Programme (NIP) from September 2015 (Table 1) for infants born after July 2015 with a catch-up programme for children born from 1st May 2015 [2]
This study identified few cases of seizure, febrile seizure, and Kawasaki disease, and no cases of anaphylaxis, GBS, or ADEM, directly after routine vaccination which included 4CMenB

Summary

Introduction

Meningococcal disease is caused by the bacterium Neisseria meningitidis and is associated with considerable mortality and morbidity [1] with young children and teenagers at highest risk of the disease [2]. Vaccine (4CMenB; Bexsero, GSK) was the first multicomponent meningococcal serogroup B vaccine and was included in the UK National Immunisation Programme (NIP) from September 2015 (Table 1) for infants born after July 2015 with a catch-up programme for children born from 1st May 2015 [2]. Increased rates of fever [3] and cases of febrile seizures [4] after 4CMenB have been reported in some individual clinical trials or meta-analyses when compared to other vaccinations. Cases of possible or confirmed Kawasaki disease were reported in the 4CMenB clinical studies a relationship with the vaccination could not be established [5]

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