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Scheduling delegate's final decisions, March 2017

23 March 2017

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1.6 Dengue Vaccine (Live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4))

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

New Chemical Entities - medicines for human therapeutic use

1.6 Dengue Vaccine
(Live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4))

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4) (Dengue Vaccine), a new chemical entity (NCE) for a human therapeutic medicine.

Substance summary

Live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4) is a live attenuated tetravalent vaccine, composed of four live recombinant, attenuated vaccines (CYD-1-4) based on a well-characterized Yellow Fever virus strain 17D (YFV 17D) genomic backbone modified to express the pre-membrane and envelope genes of one of the four Dengue virus serotypes.

Live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4) is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 through 60 years of age living in endemic areas.

Scheduling status

The Dengue vaccine (live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4) is not specifically scheduled and is not captured by any entry in the current Poisons Standard.

International regulations

Live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4) (Dengue vaccine) is not classified in New Zealand.

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;
  • 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 live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4) (Dengue Vaccine) in Schedule 4, with an implementation date of 1 June 2017.

The delegate has decided that the wording for the schedule entry will be as follows:

Schedule 4 - New Entry

DENGUE VACCINE.

Index - New Entry

DENGUE VACCINE
crosses reference: LIVE ATTENUATED CHIMERIC DENGUE VIRUS (SEROTYPES 1, 2, 3 & 4)

Schedule 4

The delegate decided that the relevant matters under subsection 52E(1) of the Therapeutic Goods Act 1989 are: (a) the risks and benefits of the use of a substance; and (d) the dosage, formulation, labelling, packaging and presentation of a substance.

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

  • It is an NCE with no marketing experience in Australia;
  • The proposed indication for the CYD dengue vaccine is for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 through 60 years of age living in endemic areas. Living in endemic areas would require medical assessment;
  • The approved dose is as a suspension for injection; and
  • The potential for abuse of live attenuated chimeric dengue virus (serotypes 1, 2, 3 & 4) is unlikely.

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