COVID-19 Vaccine Janssen
The following table summarises the key steps and dates for this application.
|Designation (Provisional)||16 November 2020|
|Submission dossier accepted||1 December 2020|
|Evaluation completed||16 June 2021|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||6 May 2021|
|Sponsor's pre-Advisory Committee response||21 May 2021|
|Advisory Committee meeting||26 May 2021|
|Registration decision (Outcome)||25 June 2021|
|Completion of administrative activities and registration on ARTG||25 June 2021|
|Number of working days from submission dossier acceptance to registration decision*||136|
*Statutory timeframe for standard applications is 255 working days
Hydroxypropylbetadex, citric acid monohydrate, ethanol absolute, hydrochloric acid, polysorbate-80, sodium chloride, sodium hydroxide, sodium citrate dihydrate and water for injections
Individuals 18 years of age and older
COVID-19 Vaccine Janssen is administered as a single-dose of 0.5 mL by intramuscular injection only.
The safety and efficacy of COVID-19 Vaccine Janssen in children and adolescents (less than 18 years of age) have not yet been established. No data are available.
No dose adjustment is required in elderly individuals ≥ 65 years of age. See also Sections 4.8 and 5.1 in the Product Information.
For further information refer to the Product Information.
COVID-19 Vaccine Janssen (Ad26.COV2.S) was provisionally approved for the following therapeutic use:
COVID-19 Vaccine Janssen has provisional approval for the indication:
COVID-19 Vaccine Janssen is indicated for active immunisation to prevent 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 is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
- COVID-19 Vaccine Janssen (Ad26.COV2.S) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for COVID-19 Vaccine Janssen must include the Black Triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
- The COVID-19 Vaccine Janssen European Union (EU)-risk management plan (RMP) (version 1.4, dated 12 March 2021, data lock point 22 January 2021), with Australian-Specific annex (version 4.0, dated 19 April 2021), included with Submission PM-2020-01673-1-2, to be revised to the satisfaction of 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 sponsor and the TGA, the first report must be submitted to TGA no later than six calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than six monthly 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, safety summary reports (including safety data for patients in Australia) are to be provided for the first six 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 batches of COVID-19 Vaccine Janssen (Ad26.COV2.S) vaccine imported into Australia are not released for sale until samples and the manufacturer's release data have been assessed and you [the 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 email@example.com.
- Complete summary protocols for manufacture and quality control, including all steps in production in the agreed format.
- At least 20 (twenty) vials (samples) of each manufacturing batch of COVID-19 Vaccine Janssen (Ad26.COV2.S) with the labels approved for Australian supply, Product Information (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 COVID-19 Vaccine Janssen (Ad26.COV2.S) with the labels approved for Australian supply, 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 United Kingdom (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 five 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 Certified product details (CPD) - Biological prescription medicines. 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.
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 six years that would start on the day that registration would commence) must be provided.
- Post approval quality commitments
As a provisionally registered medicine, extensive post-approval commitments will be required of the sponsor. The additional requested quality data and notifications to the TGA should be provided as post-approval commitments. This includes the following commitments:
- Commitment is required from the sponsor that they maintain the validity of all manufacturer Good Manufacturing Practice (GMP) clearances and adhere to the conditions of the GMP clearance approvals for the duration of product supply to Australia.
- The sponsor should inform TGA of any temperature deviation during shipment and not supply product that has been exposed to a temperature excursion outside of the approved storage conditions of -20±5°C (frozen) or 2 to 8°C (thawed/in use).
- To provide the requested additional data in relation to drug substance and drug product, including stability data.