30 October 2007
Ministry welcomes Norwegian review
The Ministry of Health welcomes the key finding of a Norwegian review that the information provided to New Zealand about
Norway’s meningococcal B vaccine trials was adequate.
Two reports have recently been released by the Ministry’s Norwegian counterparts.
The first, interim report assessed whether all relevant information from the meningococcal B vaccine trials in Norway,
which began nearly 20 years ago, was made available to New Zealand via the vaccine manufacturer.
Ministry Immunisation spokesman Dr Pat Tuohy says the report concluded all relevant information from the Norwegian
trials of the vaccine was provided to Chiron (the manufacturer), which in turn provided it to Medsafe as part of the
Medicines Regulatory Approval process.
Dr Tuohy says information about common and expected adverse events was provided as part of the consent process prior to
receiving the vaccine.
As with all licensed medicinal products in New Zealand, possible rare adverse events are listed on the product datasheet
The full report from Norway, released this month, is primarily about the adequacy of the information given to the
Norwegian participants in the Norwegian trials and their subsequent treatment.
It found insufficient information about the vaccine risk was given to trial participants and that authorities did not
inform or support potential victims.
There was no concern about the information made available to vaccine recipients or their parents in New Zealand.
Dr Tuohy, says it is important to reiterate the vaccine used for New Zealand’s Meningococcal B programme is as safe as
any other comparable vaccine.
“The vaccines’ safety was very tightly monitored in New Zealand and the independent group monitoring the vaccine had no
concerns about its safety.’’
“The Ministry continues to urge parents to ensure that all children under five years of age are fully immunised against
the epidemic strain of Meningococcal B. For young babies who began their Meningococcal B vaccinations before they were
six months old, it is important that they have four doses."
For a copy of the interim report and a draft translation of the executive summary of the full report go to: http://www.immunise.moh.govt.nz/resources/healthprofessionals.html