Published: 6 June 2024

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Summary of Bexsero adverse events following immunisation

Published: 6 June 2024
Prescriber Update 45(2): 30–33
June 2024

Meningococcal disease is caused by the bacterium Neisseria meningitidis. In 2022, over 80 percent of meningococcal disease cases in New Zealand were caused by group B bacteria.^1,2

There are several vaccines available to protect against infection from different meningococcal groups. Bexsero is a multicomponent recombinant meningococcal group B vaccine. Bexsero was added to the New Zealand National Immunisation Schedule on 1 March 2023 for children at ages 3, 5 and 12 months, with a catch-up programme for those aged 12 to 59 months. It is also funded for eligible high-risk groups, including adolescents and young adults aged 13 to 25 years in communal living situations and those with certain medical conditions.³

This article provides a summary of the adverse events following immunisation (AEFI) reported with Bexsero in New Zealand between 1 March 2023 and 31 March 2024.

Bexsero indications and usage

Bexsero is indicated for active immunisation against invasive disease caused by N. meningitidis group B strains in individuals from 2 months of age and older. The use of this vaccine should be in accordance with official recommendations.⁴

There were 9,910 doses of Bexsero administered between 1 March 2023 and 31 March 2024. In line with the National Immunisation Schedule, the majority of these (7,186 doses) were administered to children aged under 5 years.

Overview of Bexsero AEFI reports

Between 1 March 2023 and 31 March 2024, Medsafe and the Centre for Adverse Reactions Monitoring (CARM) received 455 AEFI reports where Bexsero was reported to be the suspect medicine. Of these, 134 were considered serious by the reporter. In the majority of cases the reporter also indicated that the person had received other vaccines at the same time.

In line with the recommended immunisation schedule for Bexsero, the majority of reports were for children aged under 3 years (Figure 1). There were also three reports for adults aged 65 years and older. No additional safety concerns were identified from these reports in older adults.

Figure 1: Number of Bexsero adverse event reports by age group, 1 March 2023 to 31 March 2024

* There were 55 reports where age was unknown or not reported
Source: New Zealand Pharmacovigilance Database

Frequently reported AEFIs

For all reports, the most frequently reported AEFIs were injection site inflammation, pyrexia (fever), injection site erythema (redness) and injection site pain (Figure 2). For serious reports, pyrexia, injection site erythema and vomiting were the most frequently reported AEFIs (Figure 3). All of these AEFIs are listed in the Bexsero data sheet.⁴

Figure 2: All reports: Ten most frequently reported adverse event terms for Bexsero, 1 March 2023 to 31 March 2024

Source: New Zealand Pharmacovigilance Database

Figure 3: Serious reports: Ten most frequently reported event terms for Bexsero, 1 March 2023 to 31 March 2024

Source: New Zealand Pharmacovigilance Database

Adverse events of special interest

A review of serious reports identified 12 cases of seizures (including six cases of febrile convulsion) and five case of hypotonic-hyporesponsive episodes (HHE). Seizures, including febrile seizures, are listed in the Bexsero data sheet with a reporting frequency of ‘uncommon’ (≥1/1,000 to <1/100) and HHE is listed as a post-marketing adverse reaction.⁴ As with all vaccines, anaphylaxis is a potential risk with Bexsero. To date, no cases of anaphylaxis following Bexsero vaccination have been reported in New Zealand.

Summary and more information

Overall, Bexsero AEFIs reported in New Zealand are consistent with the known safety profile of the vaccine and are listed in the data sheet. The majority of reported AEFIs were for local and systemic reactions typically associated with immunisation. Medsafe’s review of these AEFI reports did not identify any new safety concerns.

The following links contain additional information about Bexsero and adverse events following immunisation.

• Bexsero data sheet
• Immunisation Advisory Centre: Bexsero
• Healthify: Bexsero
• Medsafe: Febrile seizures in children

References

1. Immunisation Advisory Centre. 2024. Meningococcal disease URL: www.immune.org.nz/diseases/meningococcal-disease (accessed 3 April 2024).
2. Immunisation Advisory Centre. 2023. Bexsero 27 February 2023. URL: www.immune.org.nz/vaccine/bexsero (accessed 3 April 2024).
3. Health New Zealand | Te Whatu Ora. 2024. Immunisation Handbook 2024 version 1. URL: www.tewhatuora.govt.nz/for-health-professionals/clinical-guidance/immunisation-handbook/ (accessed 17 April 2024).
4. GlaxoSmithKline NZ Limited. 2023. Bexsero New Zealand Data Sheet 2 March 2023. URL: www.medsafe.govt.nz/profs/datasheet/b/bexseroinj.pdf (accessed 12 March 2024).