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Relevant extract from
Minutes of the Medicines Assessment Advisory Committee Meeting
5^th September 2006
Meeting Minutes

With correction of grammatical and typographical error.

ITEMS FOR INFORMATION

7.1 Vaccine Subcommittee Business

7.1.1 MeNZB (meningococcal B) vaccine. TT50-7090.

The Vaccine Subcommittee met on the 28 August 2006, to consider an application for full consent for MeNZB (meningococcal B) injection suspension. The application was gazetted under section 23 of the Medicines Act 1981 on 8 July 2004 and provisional consent was renewed on 8 July 2006. The VSC discussed additional data supplied by Chiron.

The Committee noted that sufficient evidence to demonstrate that routine vaccines on the New Zealand immunization schedule were not significantly inhibited when given with MeNZB. The Committee reviewed the Independent Safety Monitoring Board data and concluded the Committee had no concerns as to the safety of the vaccine.

The Committee had questions about the methodology of the tests used to assess the possible interaction with the Hepatitis B antibody,

The Committee were not satisfied that the summary data from the regression model presented was sufficient to demonstrate efficacy to allow it to recommend full consent. Particular areas of concern were how the model assessed efficacy in the community, managed the increased rates of microbiological confirmation, the differences in confirmation between ethnic groups and changes in the background frequency of the disease.

Committee recommendation:

That the application for full consent for MeNZB (meningococcal B) injection suspension be deferred pending a satisfactory response to the following:

• The company is to provide a full reworking and an independent analysis of the Poisson model using an independent evaluator. This should include modelling of the effect of improved rates of microbiological confirmation since the MeNZB programme began. This should also examine confirmation rates in different ethnic groups.
• The Committee seeks further information on the justification and validation of the test methodology used to determine the Hepatitis B/MeNZB interaction data.