Publications

Revised: 23 May 2013

Release of information relating to the approval process for the meningococcal B vaccine (MeNZB) application

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

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: