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Revised: 23 may 2013

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

Minutes of the Vaccine Sub-committee Teleconference 21 December 2004

NEW MEDICINE APPLICATIONS UNDER SECTION 23
MeNZB (Meningococcal B) injection suspension 25mcg/0.5mL TT50-7090
Welcome and Apologies:

The meeting opened at 9.20am.
Present: Associate Professor Richard Robson (Chair), Dr Tim Blackmore, Associate Professor David Holdaway, Dr Stewart Reid, Professor Jeff Weston, Alison MacDonald (Secretary).
Visitors: Rob Allman (Team Leader, Evaluation, Medsafe) and Marie Prescott (Advisor Science, Medsafe/MAAC Secretary)
Apologies: Dr Rod Ellis-Pegler

Objective: To consider if the recommendation can be made to the Minister for provisional consent for distribution of the Meningococcal B (MeNZB) Vaccine to children from the age of six weeks.

The Committee considered the clinical evaluation reports from Dr Tim Blackmore and David Holdaway of the Second Interim Study V60P6 of 264 infants who had completed Visit-4 6 weeks after the third dose of vaccine allowing an immunogenicity assessment.
The primary objective was to get at least 50% of recipients to have a 4-fold titre rise with the lower 98% CI to be greater than 40%. The data demonstrated that the response rate is 55% (47-63%) with the lower limit exceeding the 40% requirement.

The second interim study provided data that was acceptable to the clinical evaluators and VSC.

There was discussion re. the need for a fourth vaccine dose due to low immunogenicity responses of young infants and on the vaccines high reactogenicity.

Possible application next year to licence fourth dose, when data would be available from ongoing study.

Committee recommendations:

That the application for Meningococcal B (MeNZB) vaccine be approved under Section 23 of the Medicines Act 1981 for the primary immunisation against group B meningococci with the P1.7-b, 4 Por protein (New Zealand strain) in individuals aged 6 weeks or older. The population at risk should be vaccinated with MeNZB to prevent serious systemic disease (septicaemia and meningitis) caused by New Zealand strain serogroup B meningococci.

This approval is subject to the following: That the company be requested to clarify the reactogenicity data discrepancies between the Second Interim Study and the Data sheet.

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