Media Release

3 October 2006

Vaccine safety monitoring praised

A panel of international and New Zealand experts charged with monitoring the safety of the Meningococcal B Immunisation Programme is satisfied that there was an "outstanding programme of sensitive and objective safety monitoring" throughout the rollout of the MeNZB™ vaccine.

The Independent Safety Monitoring Board (ISMB), established by the Health Research Council of New Zealand (HRC), reviewed safety data throughout the programme until the end of June, 2006. The ISMB has advised that it found no evidence of any significant adverse health event associated with the vaccine.

With the end of the mass immunisation campaign, the monitoring of adverse events following MeNZB™ is now the same as for other vaccines.

Health professionals will continue to report any adverse events to the Centre for Adverse Reactions Monitoring (CARM) which monitors MeNZB™ and routine schedule vaccinations.

Findings from the safety monitoring programme will be submitted for publication in peer reviewed scientific journals.

The safety monitoring broke new ground in terms of the scope and intensity of its monitoring and reporting systems, says Meningococcal B Immunisation Programme Director Jane O'Hallahan.

As with other vaccines, MeNZB™ was subject to passive safety surveillance - where doctors and nurses voluntarily report possible adverse events to the CARM - but the programme also had extra checks which included daily and weekly monitoring in hospitals for adverse events. All these steps are outlined in the Meningococcal B Vaccine (MeNZB™) Safety Monitoring Plan.

It was important to have a comprehensive safety surveillance system to identify serious adverse events that could be truly related to vaccination and to ensure that allegations relating to vaccine safety could be rapidly investigated.

"This was crucial as mistakenly linking a serious adverse event to the vaccine could have had disastrous consequences if parents decided not to immunise their children or the programme ended prematurely, leaving the meningococcal B epidemic to continue unabated," Dr O'Hallahan says.

The Meningococcal B Vaccine (MeNZB™) Safety Monitoring Plan includes an outline for additional investigations that may be required over time. These include investigations of conditions not previously identified as being related to vaccination, conditions that may appear some years after vaccination or conditions that may not in the first instance be diagnosed at a hospital.

The plan also gives consideration to investigation of events for which there have been high profile allegations of an association with vaccination, despite lack of supporting scientific evidence, for example, autism, chronic fatigue syndrome, attention deficit hyperactivity disorder. None of these conditions have been linked to MeNZB™.

The key to investigations of events that take a long time to develop is the ability to identify everyone who has received the vaccine. New Zealand is well placed to do this as the NZ Meningococcal B Immunisation Programme requires that all MeNZB™ vaccinations are recorded on the National Immunisation Register.

For more information please see the Meningococcal B Vaccine (MeNZB™) Safety Monitoring Plan (PDF, 349 KB). This plan was used to guide the implementation of several complementary monitoring systems, analysis of data generated from these checks and assessment of data by the ISMB.

For further information please contact Michelle Quirke, Media Advisor, Ministry of Health, (04) 496 2265 or 027 434 6878.

For ISMB chairman Professor Terry Nolan please contact 61+3+8344 9350. For the Health Research Council of New Zealand please contact the Council's Chief Executive, Dr Bruce Scoggins (09) 303 5203.