Fluzone High-Dose Quadrivalent
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 September 2019 |
| First round evaluation completed | 31 January 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 28 February 2020 |
| Second round evaluation completed | 14 April 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 5 May 2020 |
| Sponsor's pre-Advisory Committee response | 18 May 2020 |
| Advisory Committee meeting | 3 June 2020 |
| Registration decision (Outcome) | 30 July 2020 |
| Completion of administrative activities and registration on ARTG | 31 July 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 204 |
*Statutory timeframe for standard applications is 255 working days
Fluzone High-Dose Quadrivalent should be given in accordance with the national recommendation as per the current Immunisation Handbook.
The recommended dosage of Fluzone High-Dose Quadrivalent is 1 dose of 0.7 mL, annually, in persons 65 years of age and older.
For further information refer to the Product Information.
Fluzone High-Dose Quadrivalent (inactivated quadrivalent influenza vaccine (split virion) influenza virus haemagglutinin) was approved for the following therapeutic use:
Fluzone High-Dose Quadrivalent is indicated for active immunisation for the prevention of influenza disease. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.
The use of Fluzone High-Dose Quadrivalent should be based on official recommendations.
See Section 5.1 Clinical Trials for information of the effects on influenza associated complications.
- The Fluzone High-Dose Quadrivalent European Union (EU)-risk management plan (RMP) (version 1.0, dated 20 March 2019, data lock point 15 September 2018), with Australian specific Annex (version 1.0, dated 31 July 2019), included with submission PM-2019-03202-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- For all injectable products the Product Information (PI) must be included with the product as a package insert.
- The additional requested quality data should be provided prior to the lodgement of the Annual strain Update for the Southern Hemisphere (SH) 2021 Influenza season.
- Batch release testing and compliance with the Certified Product Details conditions of registration for Fluzone Quadrivalent
It is a condition of registration that all independent batches of Fluzone Quad imported into Australia are not released for sale until samples and the manufacturer's release data have been assessed and the sponsor has received notification acknowledging release from the Laboratories Branch, TGA.
For each independent batch of the product imported into Australia, the sponsor must supply the following:
- A completed Request for Release Form, available from vaccines@health.gov.au.
- Complete summary protocols for manufacture and QC, including all steps in production.
- At least 20 (twenty) doses of the first consignment of each batch of Fluzone Quadrivalent with the Australian approved labels, PI and packaging
- At least 10 (ten) doses of any further consignment of each batch of Fluzone Quadrivalent with the Australian approved labels, PI and packaging
- Certificate of Release from regulatory agency acting for the country of origin such as an OMCL (if available).
- Any reagents, reference material and standards required to undertake testing, as requested by Laboratories Branch, TGA.
Distribution of each shipment of each batch of vaccine is conditional upon fulfilment of these conditions and receipt of a letter from the Laboratories Branch acknowledging release.
- Certified Product Details
An electronic copy of the Certified Product Details (CPD) as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) should be provided upon registration of the therapeutic good. In addition, an updated CPD, for the above products incorporating the approved changes is to be provided within one month of the date of approval letter. A template for preparation of CPD for biological prescription medicines and Vaccines can be obtained from the TGA website. The CPD should be sent as a single bookmarked PDF document to vaccines@health.gov.au as soon as possible after registration/approval of the product or any subsequent changes as indicated above.
- The sponsor must conduct an enhanced safety surveillance study in Australia, if requested by TGA. A protocol for the proposed study will be required to be submitted with the annual strain update variation, if there is inadequate post-market safety data to demonstrate that the reactogenicity of that season's vaccine has been adequately characterised and the vaccine is not supplied on the National Immunisation Program in that season.