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COVID-19 Vaccine AstraZeneca
Sponsor
ARTGs
349072
Device/Product name
COVID-19 Vaccine AstraZeneca
Active Ingredient
ChAdOx1-S (Provisional Australian Biological Name)
Date of decision
Published
Submission type
New biological entity
ATC codes
J07BX
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 COVID-19 vaccine Astra Zeneca 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 |
|---|---|
| Designation (Provisional) | 9 October 2020 |
| Submission dossier accepted and first round evaluation commenced | 1 December 2020 |
| Evaluation completed | 28 January 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 28 January 2021 |
| Sponsor's pre-Advisory Committee response | 1 February 2021 |
| Advisory Committee meeting | 3 February 2021 |
| Registration decision (Outcome) | 15 February 2021 |
| Completion of administrative activities and registration on ARTG | 16 February 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 48 |
*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
Solution for injection
Strength
1 x 1011 viral particles (vp)/mL
Other ingredients
Histidine, histidine hydrochloride, monohydrate, sodium chloride, magnesium chloride hexahydrate, disodium edetate (EDTA), sucrose, ethanol absolute, polysorbate 80 and water for injections.
Containers
Multi dose vial
Pack sizes
10 vials
Routes of administration
Intramuscular
Dosage
The COVID-19 Vaccine AstraZeneca vaccination course consists of two separate doses of 0.5 mL each. The second dose should be administered between 4 and 12 weeks after the first dose.
It is recommended that individuals who receive a first dose of COVID-19 Vaccine AstraZeneca complete the vaccination course with COVID-19 Vaccine AstraZeneca.
For further information refer to the Product Information.
Pregnancy category
B2Drugs 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 are inadequate or may be lacking, but available data show no 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
COVID-19 Vaccine AstraZeneca (ChAdOx1-S) was approved for the following therapeutic use:
COVID-19 Vaccine AstraZeneca has provisional approval for the indication:
Active immunisation of individuals ≥ 18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
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
The COVID-19 Vaccine AstraZeneca is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of severe acute respiratory syndrome coronavirus 2 (SARS-COV-2). Following administration, the S glycoprotein of SARS-COV-2 is expressed locally stimulating neutralising antibody and cellular immune responses.
What post-market commitments will the sponsor undertake
- COVID-19 Vaccine AstraZeneca is to be included in the Black Triangle Scheme. The PI and CMI for COVID-19 Vaccine AstraZeneca must include the black triangle symbol and mandatory accompanying text for the products entire period of provisional registration.
- The COVID-19 Vaccine AstraZeneca EU-RMP (Version 1.0 Succession 5, dated 2 February 2021, data lock point 4 November 2020), with Australian Specific Annex (Version 1.0 Succession 4, dated 4 February 2021), included with submission PM‑2020-06115-1-2 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 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 6 months post registration, and thereafter at intervals specified by the TGA.
- Clinical
- The sponsor provide the full study reports of Studies COV001, COV002, COV003 and COV005 when available in 2022 as a Category 1 Type J or Type F application.
- The sponsor should provide the interim data from Study D811C00001 when available to provide further evidence in support of efficacy, safety, use in the elderly, and use with co-morbidities. This would be a Category 1 Type J or Type F application, depending upon the PI changes proposed.
- The sponsor provide updates to the TGA in relation to additional information relevant to efficacy of COVID-19 Vaccine AstraZeneca against new and emerging variants of COVID-19.
- The sponsor provide further information to the TGA in relation to use of the COVID-19 vaccine with influenza vaccines when available.
- The sponsor to provide the TGA with updates of the studies in the pharmacovigilance plan in relation to the safety of the vaccine in pregnancy, the elderly, the immunosuppressed and those with co-morbidities with the PSUR every 6 months.
- Nonclinical
The sponsor should submit the following studies for review by the TGA when they are available. The submission type would be a Category 1 Type H were no update to the PI is required, or Category 1 Type J where an update to the PI is required.
- Biodistribution study
- Developmental and reproductive toxicity final report
- Medicine labels
Unless otherwise agreed to by the Secretary following an application under section 9D of the Act, the product must only be supplied with the following labels:
- the international label, referred to here as the 'EU labels' for 10 doses per vial as follows:
- EU Anangi carton label
- EU Anangi vial label
- EU Catalent Stickers
The sponsor will develop Australian-specific labels for the product, 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 referred to in subsection 29(3) of the Act (being the period of 2 years starting on the day specified in the ARTG certificate of registration) (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).
- the international label, referred to here as the 'EU labels' for 10 doses per vial as follows:
- Batch release testing and compliance
It is a condition of registration that all independent batches of COVID-19 Vaccine AstraZeneca (ChAdOx1-S) vaccine imported into Australia are not supplied for distribution by or on behalf of the sponsor until samples and the manufacturer's release data have been assessed and the sponsor has 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 (QC), including all steps in production in the agreed format.
- At least 10 (ten) vials (samples) of each manufacturing batch of COVID-19 Vaccine AstraZeneca (ChAdOx1-S) 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 COVID‑19 Vaccine AstraZeneca (ChAdOx1-S) 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.
- 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 at 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.
- 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:
- Additional data should be provided in relation to drug substance and drug product stability.
- Additional information should be provided in relation to the test for transgene expression of the spike protein.
- The requested leachables study data should be provided.
- The additional data related to validation of analytical procedures for endotoxin testing should be provided.