Publications

Revised: 13 May 2013

Timeline of actions during the approval process for the meningococcal B vaccine (MeNZB) application

Date Actions
2003  
5 February Discussions between Medsafe and Chiron regarding the format of the application. Medsafe accepted that data would be added to the submission in a rolling fashion as they became available.
6 June New Medicine Application received from Chiron seeking section 23 approval for the MeNZB vaccine.
25 November Update of manufacturing data received from Chiron.
2004  
24 January Manufacturing data delivered to the Medicines and Healthcare Products Regulatory Agency (MHRA) for evaluation (subsequently updated in February).
12 February Clinical overview of MeNZB studies sent to MHRA
24 February Clinical data sent to VSC evaluators for evaluation.
5 April Vaccine Sub-Committee (VSC) met and discussed clinical data. The VSC recommended provisional consent under section 23 of the Medicines Act 1981, for children 6 months and older, with certain conditions including that questions regarding manufacturing data be resolved.
27 April Initial evaluation of manufacturing data by MHRA completed and questions sent to Chiron.
10 May to 4 July Several rounds of questions were asked of Chiron and the answers evaluated by MHRA (with advice from NIBSC) and Medsafe. Agreement was reached that sufficient and suitable information and commitments had been presented by Chiron.
5 July The VSC met and discussed the manufacturing data and confirmed its earlier recommendation that provisional consent under section 23 of the Medicines Act 1981 was appropriate. The VSC recommended that minor questions regarding manufacturing be addressed on an ongoing basis by Chiron. (The bulk of these were actually addressed prior to the meeting).
6 July A teleconference was held with members of the Medicines Assessment Advisory Committee (MAAC) to ratify the VSC recommendation.
8 July A Gazette notice (approval) issued under section 23 of the Medicines Act 1981 for MeNZB with a condition that the vaccine is for use in individuals aged 6 months or older. This consent is valid for 2 years.
30 September Application received from Chiron to extend the use of MeNZB to children aged 6 weeks of age and over.
October Data from Chiron sent to VSC for evaluation.
21 December The VSC met and approved MeNZB for use in children aged 6 weeks and over, subject to Chiron clarifying the product datasheet.
23 December VSC recommendation to approve MeNZB for use in children aged 6 weeks and over, subject to Chiron clarifying the product datasheet ratified by the Chairman of the MAAC.
2005  
3 February A Gazette notice (approval) issued under section 23 of the Medicines Act 1981 for MeNZB with a condition that the vaccine is for use in individuals aged 6 weeks or older.
8 March VSC recommendation of indication for MeNZB for use in children aged 6 weeks and over, subject to Chiron clarifying the product datasheet. Ratified by the MAAC.
6 April Application received from Chiron to allow the administration of a fourth dose of MeNZB in certain cases.
5 June Name change for the Chiron sites in Sienna and Sovicille, Italy from Chiron SpA to Novartis Vaccines and Diagnostics S.r.l.
16 June Changed Medicine Notification proposed change of shelf life/storage conditions, proposed for Bulk Active and Finished product. During evaluation process, Bulk Active shelf life change subsequently withdrawn.
1 August Consent granted for extension of shelf life of Finished product from 12 months to 24 months from data of manufacture at 2° - 8°C. Refrigerate, Do not freeze.
1 August VSC met and deferred notification for the administration of a fourth dose of MeNZB in certain cases, pending additional data.
22 August VSC met and deferred notification for the administration of a fourth dose of MeNZB in certain cases, pending additional data.
17 October Changed Medicine Notification proposed change of shelf life/storage conditions of the Bulk Active.
1 November Novartis Vaccines and Diagnostics presented additional data to VSC on administration of a fourth dose.
06 December Consent granted for the extension of shelf life of the Bulk Active from 12 months to 24 months at 2° to 8°C. Refrigerate, Do not freeze.
15 December VSC met and made recommendation to approve indication for the administration of a 4th dose of the vaccine to infants who received the first dose when aged less than 6 months of age.
20 December VSC recommendation to approve indication for the administration of a 4th dose of the vaccine to infants who received the first dose when aged less than 6 months of age ratified by the Chairman of the MAAC.
23 December Director-General of Health accepted VSC recommendation regarding the administration of a 4th dose of the vaccine to infants who received the first dose when aged less than 6 months of age.
2006  
6 January Application received for consent pursuant to section 20 of the Medicines Act 1981
12 January Gazette notice (approval) for the administration of a 4th dose of the vaccine to infants who received the first dose when aged less than 6 months of age.
27 February Self-assessable Change Notification proposing change of NZ sponsor of the medicine to Medconsult Services Limited acknowledged.
09 March Updated data received for clinical evaluation.
28 March,
19 April
Clinical data supporting application under section 20 of the Medicines Act 1981 sent to VSC evaluators for evaluation.
26 May Company provide final version of the Effectiveness report of May 2006.
10 July Application for renewal of Provisional Consent under section 23 of the Medicines Act 1981
21 July Gazette notice (approval) issued for renewal of Provisional Consent under section 23 of the Medicines Act 1981, valid for 2 years from 8 July 2006.
28 August VSC meeting deferred application under section 20 of the Medicines Act 1981 pending receipt of more data.
5 September VSC recommendation to defer application under section 20 of the Medicines Act 1981 presented to the MAAC for information.
02 November Changed Medicine Notification proposing extension of the shelf life/storage conditions for both bulk active ingredient (purified OMV) and finished product submitted and subsequent data sheet update.
24 November Consent granted for the extension of the Shelf-lives of both the bulk active ingredient (purified OMV) and the finished product from 24 months to 36 months at 2° to 8°C, Refrigerate, Do not freeze.
Data sheet updated to include shelf life extension.
2007  
1 February
25 June VSC confirmed the current provisional consent under section 23 of the Medicines Act 1981 was still appropriate until acceptable long-term efficacy data were available.
11 September VSC confirmation that provisional consent under section 23 of the Medicines Act 1981 still appropriate presented to the MAAC for information.
2008  
10 July Gazette notice for renewal of provisional consent under section 23 of the Medicines Act 1981 issued, valid for two years from 10 July.