Comirnaty original/Omicron BA.1 COVID-19 Vaccine

• Comirnaty original/Omicron BA.1 Vaccine (tozinameran/ riltozinameran) is to be included in the Black Triangle Scheme. The PI and Consumer Medicine 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:

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  • 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).