The MeNZB vaccine will work

Jun 9 2005

The New Zealand Ministry of Health followed an internationally accepted process for licensing the MeNZB vaccine.

Director-General of Health Dr Karen Poutasi said today that the MeNZB vaccine, used in the Meningococcal B Immunisation Programme, has gone through the clinical trials required for such a vaccine.

New Zealand has followed a similar process for licensing its meningococcal vaccine that has been followed in the United Kingdom and the United States in licensing meningococcal vaccines in those countries.

Immunisation critics are trying to claim that phase III trials were required for this vaccine. Phase III trials were not required in New Zealand just like they were not required in the United Kingdom and the United States. Instead antibody results from phase I and II clinical trials were relied upon to give the required reassurance that the vaccine will be effective.

The Ministry sought advice from international experts including from the World Health Organization, the Centers for Communicable Disease Control in the United States and the medicine regulator in the United Kingdom.

All these international experts supported the licensing processes used in New Zealand.

The New Zealand regulatory body Medsafe assessed safety and quality data about the vaccine and sought international peer review of its findings before presenting its recommendation that the vaccine be distributed and administered.

The MeNZB vaccine is protective against the epidemic strain of meningococcal disease.

Evidence indicates about nine out of 10 people immunised with three doses of this vaccine will be protected against the epidemic strain of meningococcal disease.

We must not lose sight of the fact this is a horrific disease. The epidemic strain accounts for about 75 percent of cases in New Zealand. About 80 percent of meningococcal disease affects children and young people under the age of 20 years. This immunisation programme is offering a vaccine that offers protection to the majority of people immunised, to this most at risk age group.

Protection is necessary with this disease because treatment can come too late. The disease moves extremely quickly and can be difficult to diagnose.

The vaccine was licensed under The Medicines Act under Section 23.

This section enables a license under provisional consent where the data provided meets Medsafe requirements on both safety and protection grounds and there is a clinical need for the vaccine in New Zealand.

The Ministry worked with Medsafe to ensure the consent form and other information prepared for the public met all requirements for ensuring people had the information they required to enable them to make an informed choice about whether to vaccinate.

The Ministry recognises this is an important decision and is working with District Health Boards to ensure parents have sufficient time and all the information they require to make an informed decision.

The Ministry makes all information, including highly technical information prepared for doctors and nurses, available to the public through the www.immunise.moh.govt.nz website.