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Comirnaty original/Omicron BA.1 COVID-19 Vaccine

Device/Product name
Comirnaty original/Omicron BA.1 COVID-19 Vaccine
Active Ingredient
Tozinameran and riltozinameran
Date of decision
Published
Submission type
New biological entity/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.1 COVID-19 Vaccine 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.

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.

Description

Date

Determination (Provisional)

5 July 2022

Submission dossier accepted and first round evaluation commenced

30 August 2022

Evaluation completed

4 October 2022

Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice

23 September 2022

Sponsor’s pre-Advisory Committee response

29 September 2022

Advisory Committee meeting

5 October 2022

Registration decision (Outcome)

27 October 2022

Completion of administrative activities and registration on ARTG

28 October 2022

Number of working days from submission dossier acceptance to registration decision*

41

*Statutory timeframe for standard submissions 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
30 µg/0.3 mL (15 µg of tozinameran and 15 µg of riltozinameran)
Other ingredients

((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2-((polyethylene glycol)-2000)-N-N-ditetradecylacetamide, cholesterol, distearoylphosphatidylcholine, sucrose, trometamol hydrochloride, trometamol, water for injections

Containers
Multidose vial with grey cap
Pack sizes
10 vials, 195 vials
Routes of administration
Intramuscular injection
Dosage

Booster dose in individuals 18 years of age and older

A booster dose of Comirnaty original/Omicron BA.1 may be administered intramuscularly at least 5 months after the completion of a COVID-19 vaccine primary series in individuals 18 years of age and older.

Comirnaty original/Omicron BA.1 may also be given as a booster dose in individuals 18 years of age and older who have received a primary course comprised of another COVID-19 vaccine.

The decision when and for whom to implement a booster dose should be made based on available vaccine safety and effectiveness data (see Sections 4.4 Special warnings and precautions for use and 5.1 Pharmacodynamic properties), in accordance with official recommendations.

For further information 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.
What was approved

Comirnaty original/Omicron BA.1 COVID-19 Vaccine (tozinameran and riltozinameran) was approved for the following therapeutic use:

Comirnaty original/Omicron BA.1 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 18 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 (ribonucleic acid) 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 SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) spike (S) antigen. The mRNA (messenger ribonucleic acid) 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 COVID-19.
What post-market commitments will the sponsor undertake
  • Comirnaty original/Omicron BA.1 Vaccine (tozinameran/ riltozinameran) is to be included in the Black Triangle Scheme. The PI and Consumer Medicines Information (CMI) for Comirnaty original/Omicron BA.1 Vaccine must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.

The Comirnaty original/Omicron BA.1 Vaccine EU-RMP [risk management plan] (version 6.1, dated 24 August 2022, DLP [data lock point]; Module SIII: 5 April 2022 C4591031 Substudy E; 11 March 2022 (C4591031 Substudy D – Cohort 2). Module SVII.3. 5 April 2022 (Pfizer Clinical Database C4591031 Substudy E; 11 March 2022 (Pfizer Clinical Database C4591031 Substudy D – Cohort 2; 30 June 2022 (Pfizer safety Database)), with ASA [Australian specifi annex] (version 0.6, dated 6 September 2022), included with submission PM-2022-03551-1-2, 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 this 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 (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.

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 post registration, and thereafter at intervals specified by the TGA.

  • Batch Release Testing and Compliance

It is a condition of registration that all independent manufacturing batches of Comirnaty original/Omicron BA.1 tozinameran/riltozinameran 30 µg/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 sponsor 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, including all steps in production in the agreed format.
    • at least 10 (ten) vials (samples) of each manufacturing batch Comirnaty original/Omicron BA.1 tozinameran/riltozinameran 30 µg/ 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 5 (five) vials (samples) of any further consignments of a manufacturing batch of Comirnaty original/Omicron BA.1 tozinameran/riltozinameran 30 µg/ 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.

Clinical Conditions

  • Submit the final report for Sub studies E and D of the Study C4591031

Quality Conditions

  • Post-approval stability protocol and stability commitment: The sponsor is required to provide the results of the ongoing stability studies on the Omicron drug substance to confirm the shelf-life of 6 months when stored at the long-term storage condition of -20 ± 5 °C. The sponsor is required to provide commitment to continue the ongoing stability studies presented in the stability studies protocol. Additionally, one 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 sponsor should commit to communicate any out of specifications stability test results to the TGA.

Nonclinical Conditions

  • Levels of IL-2, TNF-α, IFN- γ and IL-4 or IL-10 producing CD4+ T cells in both naı̈ve and BNT162b2-immunised mice to support Th1 biased T cell responses (Study PRL-COVID-Ms-2022-01).
  • The kinetics of total spike-specific B cells and the strain-specific B-cell responses over time in spleen in both vaccine-naı̈ve and BNT162b2-experienced mice (Study PRL-COVID-Ms-2022-01).

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