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Flucelvax Quad
Sponsor
ARTGs
341450, 319093
341450, 319093
Device/Product name
Flucelvax Quad
Active Ingredient
Quadrivalent influenza vaccine (surface antigen, inactivated)
Date of decision
Published
Submission type
New biological entity
ATC codes
J07BB02
Decision
Approved
What was the decision based on
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 Flucelvax Quad was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 31 July 2019 |
| First round evaluation completed | 14 January 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 6 March 2020 |
| Second round evaluation completed | 6 May 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 5 May 2020 |
| Sponsor's pre-Advisory Committee response | 14 May 2020 |
| Advisory Committee meeting | 3 June 2020 |
| Registration decision (Outcome) | 14 August 2020 |
| Completion of administrative activities and registration on ARTG | 1 September 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 198 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
No
Dose forms
Suspension for injection
Strength
60 µg (15 µg x 4) haemagglutinin/0.5 mL
Other ingredients
Sodium chloride, potassium chloride, magnesium chloride hexahydrate, dibase sodium phosphate dihydrate, dibase potassium phosphate, water for injection.
Containers
Syringe, syringe with attached needle.
Pack sizes
1, 10
Routes of administration
Intramuscular injection
Dosage
Adults and children from 9 year of age: a single 0.5 mL dose.
For further information refer to the Product Information.
Pregnancy category
B1Drugs 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.
What was approved
Flucelvax Quad (quadrivalent influenza vaccine, surface antigen, inactivated) was approved for the following therapeutic use:
For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine. The vaccine is indicated for use in adults and children 9 years of age and older.
For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.
What is this medicine and how does it work
Influenza illness and its complications follow infection with influenza viruses. Global surveillance and analysis of influenza virus isolates permits identification of yearly antigenic variants. Specific levels of haemagglutination inhibition (HI) antibody titres post-vaccination with inactivated influenza vaccine have not been correlated with protection from influenza virus. In some human studies, antibody titres of 1:40 or greater have been associated with protection from influenza illness in up to 50% of subjects. Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype.Annual revaccination with current influenza vaccines is recommended because immunity declines during the year after vaccination and circulating strains of influenza virus may change from year to year.
What post-market commitments will the sponsor undertake
- The Flucelvax Quad European Union (EU)-Risk Management Plan (RMP) (version 2.0, dated 25 September 2018, data lock point 30 May 2017), with Australian specific Annex (version1.1, dated 7 April 2020), included with submission PM-2019-02591-1-2, 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).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs 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.
- At least 45 working days before the submission of the first request under s.9D(3) of the Therapeutic Goods Act 1989 for a change to the strain composition of the vaccine, and not later than 31 October 2020, the additional requested quality data should be provided.
- Batch release testing and compliance with the certified product details conditions of registration for Flucelvax Quad Quadrivalent influenza vaccine.
It is a condition of registration that all independent batches of Flucelvax Quad imported into Australia are not released for sale until samples and the manufacturer's release data have been assessed and you have 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 quality control (QC), including all steps in production.
- At least 20 (twenty) doses of the first consignment of each batch of Flucelvax Quad with the Australian approved labels, PI and packaging.
- At least 10 (ten) doses of any further consignment of each batch of Flucelvax Quad with the Australian approved labels, PI and packaging and at least 20 (twenty) doses of any further consignment of each batch of Flucelvax 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 Official Medicines Control Laboratory (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.
- For all injectable products the Product Information must be included with the product as a package insert.