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

Extract from Minutes of the Vaccine Sub-Committee Teleconference Meeting of 1 August 2005 relevant to MeNZB

Welcome and Apologies

The meeting opened at 9.30am.

Present: Associate Professor Richard Robson (Chair), Dr Tim Blackmore, Associate Professor David Holdaway, Dr Rod Ellis-Pegler, Dr Stewart Reid, Professor Jeff Weston, Alison MacDonald (Secretary) and Marie Prescott
Rob Allman and Stewart Jessamine attended part of the MeNZB discussion.

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

OBJECTIVE: To consider if the recommendation can be made to the Minister for Meningococcal B (MeNZB) Vaccine for an extension to introduce the possibility of administering a fourth dose of vaccine.

Conflict of interest statement

As with earlier applications for this vaccine Dr Reid stated a conflict of interest, as he has been a member of the Meningococcal B Vaccine Project Committee for the past five years. The committee noted his declaration and confirmed its earlier decision that Dr Reid could participate in the meeting by answering questions specifically asked by other committee members, but that Dr Reid would abstain from the decision making process.

The committee discussed the intention of the licensure of a 4th dose which is that:

• Infants and children aged greater than 6 months of age at first vaccination with MeNZB, would be offered a 4th booster dose if evidence becomes available indicating waning immunity at some point after completion of the initial vaccination programme.
• Infants aged less than 6 months at first vaccination with MeNZB would be routinely offered a 4th dose of MeNZB to increase their overall serological response rate to a level of that otherwise seen for older children.

The application consisted of the preliminary results of study V60P6. This study examined the ongoing serological response of a a subgroup of 45 infants who had previously completed a schedule of 3 vaccinations against MeNZB some 5 months previously. The study demonstrated that the serum bactericidal activity (SBA) had decreased over the five months since completion of the three-dose schedule. Assessment of the effect of administration of a fourth dose of MeNZB administered at that point in time demonstrated that 6 weeks following the booster dose the percentage of patients who mounted a 4-fold increase in SBA titre level rose to 69%.

The committee noted that following the fourth dose the response rate amongst infants under 6-month age at first vaccination increased to approximately the same rate as for other children over 6 months of age of 75%. The committee considered that the response to the fourth dose was brisk and potentially indicated that the earlier 3 doses had provoked a strong immunological memory against the epidemic strain even in the absence of high titres of SBA.

The committee considered that the study raised a number of complex issues relating to the vaccine. Contrary to their usual practice of reviewing evaluation reports from two of its members when considering an application, the committee requested that copies of study V60P6 and the data supplied in support of this application be distributed to all members of the VSC.

Committee recommendations:

That the application for MeNZB (Meningococcal B) vaccine for an extension to introduce the possibility of administering a fourth dose of vaccine be deferred.

The meeting closed at 10.45am