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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New biological entity
|Product name|| |
|Active ingredients|| |
Inactivated quadrivalent influenza vaccine (surface antigen)
|ATC codes|| |
J07BB (Influenza vaccines)
|Date of decision|| |
24 September 2019
|Date of entry onto ARTG|| |
1 October 2019
|ARTG numbers|| |
|Black Triangle Scheme|| |
Seqirus Pty Ltd (Australia)
|Sponsor address|| |
63 Poplar Rd, Parkville VIC 3052
|Dose forms|| |
60 µg haemagglutinin (HA)/0.5 mL
|Other ingredients|| |
MF59C.1 (a proprietary adjuvant): containing squalene, polysorbate 80, sorbitan trioleate, sodium citrate dihydrate, citric acid monohydrate and water for injections and the following excipients; Sodium chloride, Potassium chloride, Monobasic potassium phosphate, Dibasic sodium phosphate dehydrate, Magnesium chloride hexahydrate, Calcium chloride dehydrate and Water for injections.
Prefilled syringe (needle free) and prefilled syringe (with attached needle)
|Pack sizes|| |
1 and 10
|Routes of administration|| |
A single 0.5 mL dose should be administered by intramuscular injection, preferably into the deltoid muscle of the upper arm.
Annual revaccination is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus change from year to year.
For further information refer to the Product Information.
|Pregnancy category|| |
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Fluad Quad (inactivated quadrivalent influenza vaccine (surface antigen)) was approved for the following therapeutic use:
Active immunisation against influenza in persons 65 years of age and older.
Fluad Quad provides active immunisation against four influenza virus strains (two A subtypes and two B types) contained in the vaccine. Fluad Quad has been shown to evoke antibody responses to the viral surface glycoproteins, haemagglutinin and neuraminidase. These antibodies provide protection against clinical illness in a high proportion of vaccine recipients.
The antibody response to Fluad Quad is similar to Fluad which is increased when compared to the response to vaccines without adjuvant, and is most pronounced for A/H3N2 influenza antigens. This increased response is even more pronounced in subjects 65 years of age and older. The inclusion of the second B strain in Fluad Quad also provides additional benefit compared to Fluad.
The adjuvant MF59 broadens the overall immune response allowing the vaccine to offer greater protection against heterologous strains of the virus. This may be important when there is a mismatch between the virus strains included in the vaccine and the strains circulating in the community. The antibody response is increased when compared to the response to non adjuvanted inactivated influenza vaccine. This increased response is seen particularly in elderly subjects with low pre-immunisation titres and/or with underlying diseases (diabetes, cardiovascular and respiratory diseases) who are at increased risk of complications of influenza infection.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Fluad Quad was considered favourable for the therapeutic use approved.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||1 March 2019|
|Evaluation completed||29 July 2019|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||31 July 2019|
|Sponsor's pre-Advisory Committee response||6 August 2019|
|Advisory Committee meeting||20 August 2019|
|Registration decision (Outcome)||24 September 2019|
|Completion of administrative activities and registration on ARTG||1 October 2019|
|Number of working days from submission dossier acceptance to registration decision*||123|
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.
- The Fluad Quad European Union (EU)-Risk Management Plan (RMP) (version 1.0, dated 9 January 2019, data lock point 31 October 2018), with Australian Specific Annex (version 1.0, dated 17 January 2019), included with submission PM-2019-00120-1-2, 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.
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.
- Batch Release Testing and Compliance with the Certified Product Details It is a condition of registration that all independent batches of Fluad 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 firstname.lastname@example.org.
- 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 Fluad Quad with the Australian approved labels, PI and packaging
- At least 10 (ten) doses of any further consignment of each batch of Fluad Quad with the Australian approved labels, PI and packaging
- Certificate of Release from a 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) https://www.tga.gov.au/guidance-7-certified-produc... 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 https://www.tga.gov.au/form/certified-product-deta.... The CPD should be sent as a single bookmarked PDF document to email@example.com as soon as possible after registration/approval of the product or any subsequent changes as indicated above.
- For all injectable products the Product Information must be included with the product as a package insert.