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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|| |
Influenza haemagglutinin recombinant
|ATC codes|| |
|Date of decision|| |
12 May 2021
|Date of entry onto ARTG|| |
13 May 2021
|Original publication date|| |
21 May 2021
|ARTG numbers|| |
|Black Triangle Scheme|| |
Sanofi-Aventis Australia Pty Ltd
|Sponsor address|| |
12-24 Talavera Road, Macquarie Park NSW 2113 Australia
|Dose forms|| |
Solution for injection
180 µg (45 µg x 4) haemagglutinin /0.5 mL
|Other ingredients|| |
Sodium chloride, monobasic sodium phosphate, dibasic sodium phosphate, polysorbate 20 and water for injections
|Pack sizes|| |
1 or 10
|Routes of administration|| |
Given the variation of the influenza viruses and the duration of immunity provided by the vaccine, it is recommended to vaccinate against influenza every year.
Individuals 18 years of age and older receive a 0.5 mL single dose annually.
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 have not shown 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.
Flublok Quadrivalent (influenza haemagglutinin recombinant) was approved for the following therapeutic use:
Flublok Quadrivalent is indicated for active immunisation for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older.
Flublok Quadrivalent contains recombinant haemagglutinin (HA) proteins of the four strains of influenza virus specified by health authorities for inclusion in the annual seasonal vaccine.
Using the recombinant production technology, the HA in Flublok Quadrivalent has an identical primary structure to the HA in the wild type virus strains selected for seasonal vaccines without the mutations that may occur when the virus is adapted to grow in a culture matrix that is foreign to the wild-type strain. This assures the vaccine viral strains represent antigens that are an exact match to the World Health Organization (WHO) selected strains which induce the desired humoral immune response (as measured by hemagglutination inhibiting (HI) antibody that is known to protect against influenza infection).
Antibodies against one influenza virus type or subtype confer limited or no protection against another. Furthermore, antibodies to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual replacement of one or more influenza virus strains in each year's influenza vaccine. Therefore, influenza vaccines are standardised to contain the hemagglutinins of influenza virus strains (that is, typically two type A and two type B), representing the influenza viruses likely to be circulating in the upcoming season.
Annual influenza vaccination is recommended because immunity during the year after vaccination declines and because circulating strains of influenza virus change from year to year.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||2 December 2019|
|First round evaluation completed||30 April 2020|
|Sponsor provides responses on questions raised in first round evaluation||30 June 2020|
|Second round evaluation completed||12 August 2020|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||3 September 2020|
|Sponsor's pre-Advisory Committee response||14 September 2020|
|Advisory Committee meeting||30 September 2020|
|Registration decision (Outcome)||12 May 2021|
|Completion of administrative activities and registration on ARTG||13 May 2021|
|Number of working days from submission dossier acceptance to registration decision*||199|
*Statutory timeframe for standard applications is 255 working days
- The Flublok Quadrivalent European Union (EU)-risk management plan (RMP) (version 1.0, dated 12 October 2020, data lock point 15 January 2019), with Australian Specific Annex (version 1.1, dated December 2020), included with submission PM-2019-04824-1-2, 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 Therapeutic Goods Administration (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.
- The additional requested quality data should be provided to the TGA.
- Batch release testing and compliance
It is a condition of registration that all independent batches of Flublok Quadrivalent 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 email@example.com;
- complete summary protocols for manufacture and quality control (QC), including all steps in production;
- at least twenty doses of the first consignment of each batch of Flublok Quadrivalent with the Australian approved labels, Product Information (PI) and packaging;
- at least ten doses of any further consignment of each batch of Flublok Quadrivalent with the Australian approved labels, PI and packaging and at least twenty doses of any further consignment of each batch of Flublok Quadrivalent with the Australian approved labels, PI and packaging;
- certificate of Release from a regulatory agency acting for the country of origin such as an Official Medicines Control Laboratories (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.
- 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.
- For all injectable products the PI must be included with the product as a package insert.