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Safety Monitoring Following Menzbtm Immunisation

Safety Monitoring Following Menzbtm Immunisation

19 July 2004 – 27 February 2005

The Independent Safety Monitoring Board has considered safety data for

the first 32 weeks of the Meningococcal B Immunisation Programme. The

Board advises that it has no concerns in relation to vaccine safety.

The Independent Safety Monitoring Board was established by the Health

Research Council and is made up of international experts in vaccines,

paediatrics and epidemiology.

Data for the period 19 July 2004 to 27 February 2005 were considered. During that period, 526,827 doses of MeNZBTM were administered to 210,573 children and young people in the Auckland region.

A summary of the safety surveillance monitoring is presented below.

Hospital-based monitoring

From 19 July 2004, hospital-based monitoring for adverse events following immunisation has operated at Middlemore, Auckland City and Whangarei hospitals. The monitoring will continue throughout 2005.

All admissions and emergency department consultations for children and young people aged from four weeks to 20 years at Middlemore Hospital and Auckland City Hospital, and up to five years at Whangarei hospital, are monitored daily to detect a number of conditions, whether or not the person has been vaccinated.

The conditions monitored include any serious neurological illnesses such as encephalopathy and acute flaccid paralysis, any serious allergic reactions such as anaphylaxis, and less serious conditions such as febrile seizures, and petechial rashes. A check is then made to establish if any of the individuals have received MeNZBTM vaccine.

In addition, admissions and emergency department consultations in these hospitals are reviewed to detect unusual or unexpected events occurring in vaccine recipients.

Following review of the hospital-based monitoring data the Independent Safety Monitoring Board advises that it has no concerns in relation to vaccine safety.

Monitoring of deaths

All deaths in those aged under 21 years are identified whether or not the person has been vaccinated. The cause of death is reviewed in those who have received MeNZBTM vaccine in the previous 90 days. Deaths in hospital are identified through the hospital-based monitoring system and deaths outside hospital are identified from the national Child Youth and Mortality Review Committee database.

During the 32 week period there were no deaths attributed to MeNZBTM vaccine. Within this time period there were 26 deaths in people who had received MeNZBTM in the previous 90 days. However, the causes of death were trauma (mainly car accidents), or medical conditions, illnesses or infections that explained the death.

Spontaneous reports to the Centre for Adverse Reaction Monitoring (CARM)

Health professionals have continued to use the regular reporting system whereby they voluntarily report suspected adverse events following vaccination to CARM. In particular, they are asked to report health events following the MeNZBTM immunisation that are unexpected, serious in nature and that they are concerned about clinically. Parents and caregivers can also report suspected adverse events directly to CARM.

For the period 19 July 2004 to 27 February 2005, CARM received 429 reports of adverse events following MeNZBTM vaccination. Skin reactions, injection site reactions, fever and gastro-intestinal symptoms account for the majority of adverse reactions reported to CARM. The most frequent individual reactions reported are listed below.

Most frequent individual reactions spontaneously reported

to CARM following MeNZBTM vaccination*

Reactions Number of reports

Skin reactions (includes rash) 165
Injection site reactions 152
Fever 155
Vomiting 74
Irritability 30
Headache 27
Diarrhoea 22
Musculoskeletal 20

*Note: if an individual has more than one reaction they are counted for each type of reaction ie. they are counted multiple times

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