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Independent Safety Monitoring Board Q&As


New Zealand Group B Meningococcal Vaccine Independent Safety Monitoring Board (ISMB)

Questions and Answers

Q. When was the New Zealand Group B Meningococcal Vaccine Independent Safety Monitoring Board (ISMB) set up?

A. The ISMB was established by the Health Research Council of New Zealand in February 2004.

Q. What is the role of the ISMB?

A. The role of the ISMB is to provide objective, independent monitoring of the Meningococcal B Immunisation Programme in New Zealand with MeNZB™. Specifically, the ISMB is to be an independent monitor of roll out and is to ensure that the roll out remains scientifically and ethically sound throughout.

Data and safety monitoring committees are used internationally and have become international best practice in monitoring programmes such as the Meningococcal Vaccine Programme in New Zealand. The Health Research Council of New Zealand has another committee that monitors clinical trials in New Zealand.

Q. How will the ISMB achieve its aims?

A. The ISMB will monitor serious adverse events throughout the Programme and will provide advice on the safety of the Programme to the Ministry of Health and Medsafe.

Q. How is membership of the board structured?

A. The ISMB has 5 members, from New Zealand and overseas, whose skills and experience include:

• Statistics

• Vaccine trials experience

• Epidemiology

• Clinical paediatrics

• Expertise in meningococcal disease

• A member with expertise in advising on the safety and effectiveness aspects relating to Maori

-More -


2.

Q. Why is the vaccination programme important?

A. New Zealand is continuing to experience an epidemic of group B meningococcal disease. A vaccine for the particular strain of group B meningococcal disease that is most common in New Zealand is now available and is being offered free to all New Zealanders under 20 years of age. This group accounts for 80 per cent of cases of type B meningococcal disease in New Zealand.


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