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Scheduling delegate's final decisions, March 2017

23 March 2017

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1.3 Meningococcal Group B Vaccine

Part B - Final decisions on matters not referred to an expert advisory committee

New Chemical Entities – medicines for human therapeutic use

1.3 Meningococcal Group B Vaccine

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of Neisseria Meningitidis Serogroup B Recombinant LP2086 (MnB rLP2086) Subfamily A Protein and Subfamily B Protein (Meningococcal Group B Vaccine), a new chemical entity (NCE) for a human therapeutic medicine.

Substance summary

Meningococcal Group B Vaccine consists of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B. fHBP.

Meningococcal Group B Vaccine is indicated for individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

ABN - Neisseria Meningitidis Serogroup B Recombinant LP2086 (MnB rLP2086) Subfamily A Protein and Subfamily B Protein (Meningococcal Group B Vaccine)

Scheduling status

Meningococcal Group B Vaccine is not specifically scheduled in the current Poisons Standard but is captured under the following group entry:

Schedule 4

MENINGOCOCCAL VACCINE.

International regulations

Meningococcal Group B Vaccine is not specifically classified in New Zealand. However, it would be classified under the group entry, MENINGOCOCCAL VACCINE, as a prescription medicine except when administered to a person 16 years of age or over by a registered pharmacist who has successfully completed a vaccinator training course approved by the Ministry of Health and who is complying with the immunisation standards of the Ministry of Health.

Delegate's consideration

The delegate decided to make a delegate-only decision. The Advisory Committee on Medicines Scheduling was not consulted.

The delegate considered the following in regards to this application for scheduling:

  • Subsection 52E(1) of the Therapeutic Goods Act 1989;
  • The Scheduling Policy Framework (2015) scheduling factors;
  • The TGA evaluation report; and
  • The new drug application.

The delegate noted that currently there are no issues of concern that require additional control other than by inclusion in Schedule 4.

Delegate's final decision

The delegate has made a final decision to amend the Poisons Standard to include Meningococcal Group B Vaccine in Schedule 4, with an implementation date of 1 June 2017.

The delegate has decided that the wording for the schedule and index entries will be as follows:

Schedule 4 - New Entry

MENINGOCOCCAL GROUP B VACCINE.

Index - New Entry

MENINGOCOCCAL GROUP B VACCINE
cross reference: Neisseria Meningitidis Serogroup B Recombinant LP2086 (MnB rLP2086) Subfamily A Protein and Subfamily B Protein

Schedule 4

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 is: (a) the risks and benefits of the use of a substance.

The delegate decided that the reasons for the final decision comprise the following:

  • Meningococcal Group B Vaccine is an NCE with no clinical and marketing experience in Australia;
  • The proposed indication is for individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B; and
  • The potential for abuse of Meningococcal Group B Vaccine is unlikely.

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