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Vaxelis
Sponsor
ARTGs
364413 and 363251
364413 and 363251
Device/Product name
Vaxelis
Active Ingredient
Diphtheria toxoid, Haemophilus influenza type B polyribose ribitol phosphate, hepatitis B surface antigen, Pertactin, Pertussis filamentous haemagglutinin, Pertussis fimbriae 2 + 3, Pertussis toxoid, Poliovirus and Tetanus toxoid
Date of decision
Published
Submission type
New biological entity
ATC codes
J07CA09
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 Vaxelis 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 | 1 June 2021 |
| First round evaluation completed | 26 October 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 25 November 2021 |
| Second round evaluation completed | 19 January 2022 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 24 January 2022 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 22 March 2022 |
| Completion of administrative activities and registration on ARTG | 23 March 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 158 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Dose forms
Suspension for injection
Strength
0.5 mL
Other ingredients
Sodium phosphate, aluminium and water for injections
Containers
Vial and prefilled syringe
Pack sizes
1 (prefilled syringe) and 10 (prefilled syringe and vial)
Routes of administration
Intramuscular
Dosage
Primary vaccination
The primary vaccination schedule consists of 2 or 3 doses, with an interval of at least 1 month between doses, and may be given from 6 weeks of age, in accordance with the official recommendations.
Where a dose of hepatitis B vaccine is given at birth, Vaxelis can be used for supplementary doses of hepatitis B vaccine from the age of 6 weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used. Vaxelis can be used for a mixed hexavalent/pentavalent/hexavalent combined vaccine immunisation schedule.
Booster vaccination
After a 3‑dose primary series vaccination with Vaxelis, a booster dose may be given. When giving a booster dose, this should be at least 6 months after the last priming dose. After a 2‑dose primary series vaccination with Vaxelis, a booster dose should be given at least 6 months after the last priming dose.
Booster doses should be given in accordance with the official recommendations.
For further information refer to the Product Information.
Pregnancy category
B2Drugs 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.
What was approved
Vaxelis (DTPa5 HB IPV Hib) was approved for the following therapeutic use:
Vaxelis (DTPa5 HB IPV Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).
The use of Vaxelis should be in accordance with official recommendations.
What is this medicine and how does it work
Vaxelis induces the production of antibodies against diphtheria, tetanus, pertussis, hepatitis B, poliovirus and invasive diseases caused by Haemophilus influenzae type b.
What post-market commitments will the sponsor undertake
- Vaxelis (Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliovirus (inactivated), and Haemophilus influenzae type b conjugate vaccine) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Vaxelis must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- 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 European Union (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 (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. - 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 portable document format (PDF) document to as soon as possible after registration/approval of the product or any subsequent changes as indicated above.
Quality Conditions
- Good manufacturing practice (GMP) clearance for listed manufacturers: all GMP clearances must be approved prior to registration and supply of product to Australia. A commitment is required from the sponsor that they maintain the validity of all manufacturer GMP clearances for the duration of product supply to Australia. Additionally, that adherence to the conditions of GMP clearance approval is upheld.
- Batch Release Testing and Compliance
It is a condition of registration that all independent batches of VAXELIS vaccine 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.
- Complete summary protocols for manufacture and quality control, including all steps in production in the agreed format.
- At least 20 vials (samples) of each manufacturing batch of Vaxelis vaccine with the Australian approved labels, PI and packaging (unless an exemption to supply these has been granted) representative of all batches of product seeking distribution in Australia.
- At least 5 vials (samples) of any further consignments of a manufacturing batch of Vaxelis vaccine with the Australian approved labels, PI and packaging (unless an exemption to supply these has been granted). Further consignments cover batches previously supplied to TGA for the purposes of batch release testing but are seeking to be supplied again.
- If the manufacturing batch has been released in Europe or United Kingdom a copy of the EU Official Control Authority Batch Release (OCABR) certificate (or equivalent from the UK) must be provided.
- Any reagents, reference material and standards required to undertake testing, as requested by Laboratories Branch, TGA.
Sponsors must provide all requested samples and data in sufficient time (at least 5 business days) prior to any distribution date to allow the TGA to perform testing and review. Distribution of each batch of vaccine is conditional upon fulfilment of these conditions and receipt of a letter from the Laboratories Branch acknowledging release.
Samples and data should be forwarded to the Biotherapeutics Section, Laboratories Branch before release of each batch and with sufficient lead time to allow for Laboratories Branch testing.
The shipments (including reagents) to TGA are the responsibility of the Australian sponsor/agent who will be required to facilitate the import and customs clearance process. - For all injectable products the Product Information must be included with the product as a package insert.