We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine
Sponsor
Device/Product name
Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine
Active Ingredient
Tozinameran and famtozinameran
Date of decision
Published
Submission type
New biological entity and new combination of active ingredients
ATC codes
J07BX03
Decision
Approved for provisional registration
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 Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Data were provided as a rolling submission. Under normal circumstances, TGA's assessment (for both provisional and general registration) begins once all information to support registration is available. As part of the Department of Health's response to the pandemic, the TGA has agreed to accept rolling data for COVID-19 vaccines and treatments, to enable early evaluation of data as it becomes available.
Registration timeline
| Description | Date |
|---|---|
| Determination (Provisional) | 15 November 2022 |
| Submission dossier accepted and first round evaluation commenced | 13 December 2022 |
| Evaluation completed | 19 January 2023 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 12 January 2023 |
| Sponsor’s pre-Advisory Committee response | 16 January 2023 |
| Advisory Committee meeting | 18 January 2023 |
| Registration decision (Outcome) | 20 January 2023 |
| Completion of administrative activities and registration on ARTG | 23 January 2023 |
| Number of working days from submission dossier acceptance to registration decision* | 23 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Yes. As a provisionally registered product, this medicine will remain in the Black Triangle Scheme for the duration of its provisional registration
Dose forms
Suspension for injection
Strength
15 µg of tozinameran and 15 µg of famtozinameran/0.3 mL
Other ingredients
((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315), 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159), distearoylphosphatidylcholine (DSPC), cholesterol, trometamol, trometamol hydrochloride, sucrose, and water for injections
Containers
Multidose vial
Pack sizes
10 vials and 195 vials
Routes of administration
Intramuscular
Dosage
Booster dose in individuals 12 years of age and older
A booster dose of Comirnaty Original/Omicron BA.4-5 may be administered intramuscularly at least 3 months after the completion of a COVID-19 vaccine primary series in individuals 12 years of age and older.
Comirnaty Original/Omicron BA.4-5 may be administered to individuals 12 years of age and older at least 3 months after a previous booster dose of any COVID 19 vaccine.
The decision when and for whom to implement a booster dose should be made based on available vaccine safety and immunogenicity data (see Sections 4.4 Special warnings and precautions for use and 5.1 Pharmacodynamic properties of the Product Information), in accordance with official recommendations.
For further information regarding dosage, refer to the Product Information.
Pregnancy category
B1
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.
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.
What was approved
Comirnaty Original/Omicron BA.4-5 COVID-19 vaccine (tozinameran and famtozinameran) was approved for the following therapeutic use:
Comirnaty Original/Omicron BA.4-5 vaccine has provisional approval for the indication below:
As a booster dose for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
The decision has been made on the basis of short term immunogenicity and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
What is this medicine and how does it work
The nucleoside-modified messenger RNA in the vaccine is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) antigen. The messenger RNA (mRNA) codes for membrane-anchored, full-length S with two point mutations within the central helix. Mutation of these two amino acids to proline locks S in an antigenically preferred prefusion conformation. The vaccine elicits both neutralising antibody and cellular immune responses to the antigen, which may contribute to protection against coronavirus disease 2019 (COVID-19).
What post-market commitments will the sponsor undertake
- Comirnaty Original/Omicron BA.4-5 is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for that Comirnaty Original/Omicron BA.4-5 must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
The Comirnaty Original/Omicron BA.4-5 EU- RMP [European Union- risk management plan] (version 9, dated 4 November 2023) with ASA [Australia specific index] (version 0.7 dated December 2022), 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, or the entire period of provisional registration, whichever is longer.
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. Each report must have been prepared within ninety calendar days of the data lock point for that report.
Additional to the submission of routine PSURs, expedited monthly summary safety reports (including safety data for patients in Australia) are to be provided for the first 6 months from the date of first supply in Australia, and thereafter at intervals specified by the TGA.
Any changes to which the sponsor has agreed should be included in a revised RMP and ASA. However, irrespective of whether or not they are included in the currently available version of the RMP document, the agreed changes become part of the risk management system.
Clinical Conditions
- An update of the Australian PI via a future submission is required for inclusion of adolescent immunogenicity data in 12 to17 years old age group based on the Study C4591044. This may be undertaken after Clinical Evaluation Report (Round 2) by the TGA for the current submission PM-2022-05306-1-2 has been issued to the sponsor.
- Final Clinical Study Report for the Study C4591044 is to be provided to the TGA when it becomes available to the sponsor.
Quality Conditions
- GMP [Good Manufacturing Practices] clearance for listed manufacturers: All relevant manufacturing sites require approved and current GMP clearances prior to Australian supply. 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.
- Post-approval stability protocol and stability commitment: The manufacturer has provided commitment to continue the ongoing stability studies presented in the stability studies protocol. Additionally, 1 batch of drug product per year for all relevant products will be placed on long term stability program and on accelerated stability testing where significant changes are made to the manufacturing process. The manufacturer has committed to communicate any out of specifications stability test results to the TGA.
Batch Release Testing and Compliance
It is a condition of registration that all independent manufacturing batches of Comirnaty Original/Omicron BA.4-5 (tozinameran/famtozinameran) COVID-19 Vaccine 15/15 micrograms/0.3 mL suspension for injection vial to be supplied in Australia are not released for supply by or on behalf of the sponsor until the manufacturer’s release data have been assessed by, and you have received notification acknowledging authorisation to release from, the Laboratories Branch, TGA.
In complying with the above, the sponsor must supply the following for each independent batch of the product imported or proposed to be imported into Australia:
- a completed Request for Release Form, available from vaccines@health.gov.au; and
- complete summary protocols for manufacture and QC [Quality Control], including all steps in production in the agreed format
- at least ten (10) vials (samples) of each manufacturing batch of Comirnaty Original/Omicron BA.4-5 (tozinameran/famtozinameran) COVID-19 Vaccine 15/15 micrograms/0.3 mL suspension for injection vial 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 five (5) vials (Samples) of any further consignments of a manufacturing batch of Comirnaty Original/Omicron BA.4-5 (tozinameran/famtozinameran) COVID-19 Vaccine 15/15 micrograms/0.3 mL suspension for injection vial 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 also be provided; and
- 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.
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-product-details 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-details-cpd-biological-prescription-medicines]. 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.