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Scheduling delegate's final decisions, June 2017

Scheduling medicines and poisons

29 June 2017

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4.4 Influenza virus haemagglutinin

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

New Chemical Entities – medicines for human therapeutic use

4.4 Influenza virus haemagglutinin

Scheduling proposal

The delegate considered an application from the Therapeutic Goods Administration (TGA) for the scheduling of influenza virus haemagglutinin, a new chemical entity (NCE) for a human therapeutic medicine.

Substance summary

Influenza virus haemagglutinin is a purified, inactivated influenza vaccine (surface antigen), containing the following four influenza strains recommended for the 2018 influenza season:

  • A/H1N1 – like strain
  • A/H3N2- like strain
  • B/Victoria lineage – like strain
  • B/Yamagata lineage – like strain

Influenza virus haemagglutinin is indicated for the prevention of influenza caused by influenza virus, types A and B. For full details regarding recommendations for influenza vaccination, please refer to the relevant National Immunisation Guidelines. Influenza virus haemagglutinin is indicated in adults (18 years of age and older).

Scheduling status

Influenza virus haemagglutinin is not specifically scheduled in the current Poisons Standard but is captured by the following group entry:

Schedule 4

INFLUENZA AND CORYZA VACCINES:

  1. for parenteral use; or
  2. for nasal administration.
International regulations

Influenza virus haemagglutinin is not specifically classed as a Prescription Medicine in New Zealand, Canada or the US, however, influenza vaccines are listed as Prescription Medicines in New Zealand, Schedule D – biological products in Canada, and are licensed products in the US.

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.
Delegate's final decision

The delegate's final decision is that influenza virus haemagglutinin does not require specific scheduling as it is captured by the Schedule 4 group entry for influenza and coryza vaccines.

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; (b) the purpose and the extent of use of a substance; (c) the toxicity 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:

  • Influenza virus haemagglutinin is a new vaccine with no clinical and marketing experience in Australia.
  • Influenza virus haemagglutinin is for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine and is captured by the group entry for influenza and coryza vaccines.
  • Adverse events may include sweating, pyrexia, myalgia, Headache, local injection site reactions.
  • Influenza virus haemagglutinin is contraindicated in people with hypersensitivity to the active substances, to any of the excipients and to residues of eggs (ovalbumin, chicken proteins), formaldehyde, cetrimonium bromide, polysorbate 80, or gentamicin. Immunisation should be postponed in patients with febrile illness or acute infection.
  • Influenza virus haemagglutinin should be administered by intramuscular or deep subcutaneous injection
  • The potential for abuse of Influenza virus haemagglutinin is unlikely.

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