Nuvaxovid

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 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, 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 routine submission of the routine PSURs, expedited monthly Nuvaxovid COVID-19 Vaccine (adjuvanted) safety summary reports (including both global safety data and 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.

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

The following reports/data must be submitted to the TGA by the dates set out in the table below:

• The sponsor must investigate the need for a booster dose and submit data when available.
• The sponsor must perform investigations on identifying an immunological correlate of protection.
• The sponsor must investigate and provide results on the ability of the vaccine to neutralise emerging SARS-CoV-2 variants of concern.
• The sponsor must provide real world post market global/local efficacy data, when available.
• Studies addressing important safety concerns/important missing information (use in immunocompromised individual, pregnant women) must be submitted. However, this should be submitted as additional submissions, not as ‘conditions of original submission’.

• Medicine labels
  1. The medicines must not be supplied with labels other than the labels:
     1. that were considered and agreed to as part of the s.25 provisional registration decision, i.e. the labels referred to in the category 1 application and email from sponsor dated third quarter of 2021; or
     2. that are approved following a request to vary the entry in the Register under section 9D of the Act.
  2. The sponsor will develop Australian-specific labels for the medicines, that conform with all relevant Australian labelling requirements, and will take all reasonable steps to implement such labelling before the end of the provisional registration period for the medicine (noting that, consistent with paragraph 28(5)(aaa) of the Act, changes to such matters as labels that have been agreed to as part of an evaluation under section 25 of the Act may only occur following submission under section 9D of a 'variation' application and approval by the TGA).
  3. The sponsor will provide information to the TGA on the proposed strategies and planned timelines for Australian dedicated supplies, as soon as possible, and no later than first quarter of 2024.

The sponsor must provide updated statistical results of long-term stability data for process validation (PV) and clinical stability batches as they become available to further support 6 months storage at 2 to 8°C with real-time stability data.

NOTE: As per TGA guidelines, the sponsor should submit a formal (Category 3) application along with the supporting real-time (long-term) stability data for evaluation for any proposed extension to the shelf life post-provisional registration approval.

The sponsor must provide updated protein concentration results for clinical long-term stability batches [Information redacted] together with the investigation report into the observed atypical protein concentration results when the report became available.

The sponsor must provide commitment to review and update the stability testing parameters to include saponin integrity and particle size by dynamic light scattering (DLS).

Independent batches of Nuvaxovid (SARS-CoV-2 rS [NVX-CoV2373]) COVID-19 vaccine imported into Australia must not be released for sale until samples and the manufacturer’s release data have been assessed and sponsor 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 QC, including all steps in production in the agreed format.
• At least a 2 mL sample (as at least 4 × 500 μL aliquots) of each bulk drug substance batch used in the manufacture of the given drug product batch.
• At least 20 (twenty) vials (samples) of each manufacturing batch of Nuvaxovid (SARS-CoV-2 rS [NVX-CoV2373]) COVID-19 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 (five) vials (samples) of any further consignments of a manufacturing batch of Nuvaxovid (SARS-CoV-2 rS [NVX-CoV2373]) COVID-19 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.

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 PDF document to vaccines@health.gov.au as soon as possible after registration/approval of the product or any subsequent changes as indicated above.