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Spikevax
Sponsor
Device/Product name
Spikevax
Active Ingredient
Elasomeran
Date of decision
Published
Submission type
New biological entity
ATC codes
Not yet assigned
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 Spikevax 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, to enable early evaluation of data as it comes to hand.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 24 June 2021 |
| First round evaluation completed | 8 July 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 5 August 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 23 July 2021 |
| Sponsor's pre-Advisory Committee response | 27 July 2021 |
| Advisory Committee meeting | 30 July 2021 |
| Registration decision (Outcome) | 9 August 2021 |
| Completion of administrative activities and registration on ARTG | 9 August 2021 |
| 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
Original publication date
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
0.2 mg/mL
Other ingredients
Heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate, cholesterol, distearoylphosphatidylcholine, 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 , trometamol, trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose and water for injections.
Containers
Vial
Pack sizes
10
Routes of administration
Intramuscular
Dosage
Spikevax is a vaccine intended to be administered as a course of 2 doses (0.5 mL each). It is recommended to administer the second dose 28 days after the first dose (see Section 4.4 Special warnings and precautions for use and Section 5.1 Pharmacodynamic properties in the Product Information).
There are no data available on the interchangeability of the Spikevax vaccine with other coronavirus disease 2019 (COVID-19) vaccines to complete the vaccination course. Individuals who have received the first dose of the Spikevax vaccine should receive the second dose of the Spikevax vaccine to complete the vaccination course.
For further information regarding dosage, refer to the Product Information.
Pregnancy category
B1Drugs 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
Spikevax (elasomeran) was approved for the following therapeutic use:
Spikevax (elasomeran) COVID-19 vaccine has provisional approval for the indication below:
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 efficacy 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
Spikevax contains messenger ribonucleic acid (mRNA) encapsulated in lipid nanoparticles. The mRNA encodes for the full-length severe acute respiratory syndrome coronavirus (SARS-CoV)-2 spike protein modified with 2 proline substitutions within the heptad repeat 1 domain (S-2P) to stabilise the spike protein into a prefusion conformation. After intramuscular injection, cells at the injection site and the draining lymph nodes take up the lipid nanoparticle, effectively delivering the mRNA sequence into cells for translation into viral spike protein. The delivered mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is expressed transiently mainly by dendritic cells and subcapsular sinus macrophages. The expressed, membrane-bound spike protein of SARS-CoV-2 is then recognised by immune cells as a foreign antigen. This elicits both T-cell and B-cell responses to generate neutralising antibodies, which may contribute to protection against coronavirus disease (COVID)-19.
What post-market commitments will the sponsor undertake
- 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.