Spikevax

• Risk management plan

Spikevax (elasomeran) COVID-19 vaccine is to be included in the Black Triangle Scheme. The PI and CMI for Spikevax must include the black triangle symbol and mandatory accompanying text for the period of provisional registration.

The Spikevax EU-RMP (version 2.1, dated 15 July 2021; DLP 31 May 2021), with Australian Specific annex (version 0.2, dated 22 July 2021), included with submission PM-2021-02994-1-2, 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 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 EMA’s Guideline on Good Pharmacovigilance Practices 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 routine submission of the routine PSURs, expedited monthly, Spikevax safety summary 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.

• Clinical

The following reports/data will have to be submitted before a definitive authorisation can be considered:

• Submit safety analysis at 6 months post Dose 2 from Phase I, II Study when the analysis is available
• Submit the clinical study report for Study 301 (Phase III) and Study 201 (Phase II) when ready. Please also submit the final report for these studies with 24 months follow up duration when it became available.
• Submit the immunogenicity data for Study 301
• When available, please provide:
• Further data relating to vaccine efficacy against asymptomatic disease, efficacy against SARS-CoV-2 transmission, vaccine efficacy in immunocompromised subjects, efficacy in subjects with autoimmune conditions, efficacy against variants of concern, pregnant women, lactating mothers, and information relating to post-market safety and effectiveness studies should be provided to the TGA to update the PI.
• Please also provide real world post market global/local efficacy data, when available.

• Confirmatory trial data (as identified in the sponsor’s plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years that would start on the day that registration would commence) must be provided.
• Quality

Batch release testing and compliance

Batch release testing and compliance with the certified product details conditions of provisional registration for Spikevax.

It is a condition of registration that all independent batches of Spikevax elasomeran COVID-19 vaccine 0.2 mg/mL suspension for injection vial imported into Australia are not released for supply by or on behalf of the sponsor 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, including all steps in production in the agreed format.
• At least 10 (ten) vials (samples) of each manufacturing batch of Spikevax elasomeran 0.2 mg/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 Spikevax elasomeran 0.2 mg/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 UK a copy of the EU-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.

Certified Product Details

An electronic copy of the CPD as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines 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-prescriptionmedicines. 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.

• Post approval commitments:

Drug substance

• Sponsor to provide:
• real time stability data within 3 months of provisional registration
• additional data on the clinical safety and efficacy of the product
• additional data on shipping and holding time of drug substance
• additional data on comparative batch analysis
• additional data on validation of analytical procedures
• additional data on batch analysis
• additional data on container closure system
• additional stability data, protocol and commitment
• additional stability data

Drug product

• Sponsor to provide:
• real time stability data within 3 months of provisional registration
• additional data on process validation
• additional data on control of excipients
• additional data on batch analysis
• additional data on stability
• additional data on microbiology
• For all injectable products the PI must be included with the product as a package insert.