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

Minutes of the Vaccine Sub-committee Meeting 28 August 2006

WELCOME

Associate Professor Richard Robson opened the meeting at 10.00.a.m. and welcomed members and guests to the meeting.

Present: Associate Professor R Robson (Chair), Dr T Blackmore, Associate Professor R Ellis-Pegler (by teleconference link), Dr D Holdaway, Dr S Reid, Dr J Weston and Mrs M Prescott (Acting Secretary).

Guests: Mr R Allman (Team Leader, Evaluation Team, Medsafe).

Objective: To consider if the New Medicine Application for Meningococcal B (MeNZB) Vaccine should receive the Minister’s Consent for distribution in New Zealand under Section 21.

CONFLICT OF INTEREST DECLARATIONS:

The following conflicts were noted:

• Dr Reid expressed a conflict of interest due to him previously being an advisor to the Meningococcal Management Team and having conducted one of the studies, V60P4 and its extension.
• Dr Blackmore expressed a conflict of interest due to him working at the Institute of Environmental Science and Research Ltd (ESR).
• Associate Professor Ellis-Pegler expressed a conflict of interest due to his role as a member of the Board of ESR.

The conflicts of interest were discussed but not considered to influence the discussions or decisions. All members therefore participated actively in the discussions.

NEW MEDICINE APPLICATIONS UNDER SECTION 21 PREVIOUSLY CONSIDERED UNDER SECTION 23.
MeNZB (Meningococcal B) injection suspension 25mcg/0.5mL. TT50-7090.

The Committee considered an application from Chiron for MeNZB (meningococcal B) vaccine for full consent.

MeNZB had been granted Provisional Consent under Section 23 on 8 July 2004. Provisional Consent had been renewed for a further two years on 8 July 2006.

The committee discussed additional data supplied by Chiron on 6 January 2006 to support the company’s application for full consent. The data presented contained details of clinical studies carried out with both the Norwegian vaccine and MeNZB. Most of these studies have previously been considered by the Vaccine Subcommittee.

The Committee noted that in the absence of Phase III data the discussion on efficacy had to be considered using surrogate markers, including national surveillance data. The evidence of efficacy largely consisted of models of treatment effect on background rates of disease using a Poisson regression model.

The Committee noted there was sufficient evidence to demonstrate that routine vaccines on the New Zealand immunisation schedule were not significantly inhibited when given with MeNZB. However the committee had questions about the methodology of the tests used to assess the possible interaction with the Hepatitis B antibody.

The Committee reviewed the Independent Safety Monitoring Board (ISMB) data and concluded the Committee had no concerns as to the safety of the vaccine. 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 recommendations:

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.

Meeting closed at 11.05a.m.