You are here

COVID-19 Vaccine Janssen

25 June 2021

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summary

Summary of submission

Submission type
New biological entity
Product name
COVID-19 Vaccine Janssen
Active ingredients
Adenovirus serotype 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2.S)
ATC codes
J07BX03
Decision
Approved for provisional registration
Date of decision
25 June 2021
Date of entry onto ARTG
25 June 2021
Original publication date
25 June 2021
ARTG numbers
350150
Black Triangle Scheme
As a provisionally registered product, this medicine will remain in the Black Triangle Scheme for the duration of its provisional registration
Sponsor
Janssen-Cilag Pty Ltd
Sponsor address
1-5 Khartoum Road, Macquarie Park, NSW, 2113
Dose forms
Suspension for injection
Strength
5 x 1010 virus particles/0.5 mL
Other ingredients
Hydroxypropylbetadex, citric acid monohydrate, ethanol absolute, hydrochloric acid, polysorbate-80, sodium chloride, sodium hydroxide, sodium citrate dihydrate and water for injections
Containers
Multi-dose vial
Pack sizes
10 vials
Routes of administration
Intramuscular injection
Dosage

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.

Paediatric population

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.

Elderly

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.

Pregnancy category

B1

Drugs 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.

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?

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.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • 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 vaccines@health.gov.au.
    • 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) 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 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.

  • Clinical

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.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.