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Publications

Published: November 2004
ADR update

Surveillance of Adverse Events Following MeNZB™ Immunistation

Prescriber Update 25(2): 19
November 2004

Ministry of Health Meningococcal B Immunisation Programme

In the first two months of the roll-out of the Meningococcal B Immunisation Programme, from 19 July to 19 September 2004, more than 140,000 doses of MeNZB™ were administered.  The Independent Safety Monitoring Board, established by the Health Research Council, has considered safety data for this period and advises that it has no particular issues of concern in relation to the safety of the MeNZB™ vaccine.

As of 24 September 2004, 88 reports of adverse events following MeNZB™ vaccination were reported to the Centre for Adverse Reactions Monitoring (CARM) in Dunedin. CARM notes that the number of reactions reported suggests that the rate of post-vaccination adverse events of clinical concern is low for MeNZB™. The most frequent individual reactions reported are listed in the following table.

Most frequent individual reactions reported to CARM following MeNZB™ vaccination

Reactions Number of reports* received Proportion of all
reports received
Injection Site Reactions 26 30%
Rash 26 30%
Fever 21 24%
Vomiting 18 20%

* It should be noted that each report may include more than one reaction.

Whilst 30% of submitted reports identified localised reactions, systemic reactions (such as gastrointestinal events, fever, headache and musculoskeletal events) were reported in 44 (50%) of the reports. Six reports documented vasovagal/syncopal-type episodes, all of which occurred in teenage girls in the context of the school-based immunisation programme, and were subsequently categorised as anxiety-related injection reactions. No life threatening or unexpected events have been reported.

Health professionals are asked to continue reporting to CARM any health events following MeNZB™ immunisation that are unexpected, serious in nature or of clinical concern. Reporting forms are available on both the Medsafe and CARM web sites.

Further information about the surveillance of MeNZB™ adverse events is available on the Ministry of Health web site: www.immunise.moh.govt.nz/documents/surveillanceofadverseevents.pdf

Other information about the Meningococcal B Immunisation Programme can be found at: www.immunise.moh.govt.nz

 

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