Revised: 31 May 2019
Medicines
Medsafe Product Detail | ![]() ![]() | |
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File ref: TT50-10877 |
Trade Name | Dose Form | Strength | Identifier |
Vaxzevria | Solution for injection | 5x10^10 VP/0.5mL | |
Sponsor | Application date | Registration situation | Classification |
AstraZeneca Limited P O Box 87453 Meadowbank Auckland 1742 | 29/1/2021 | Provisional consent Approval date: 29/7/2021 Expiry date: 29/4/2024 Labelling exemption expires 29/04/2024 | Prescription |
Provisional consent is granted for two years.
This consent is given subject to the following conditions:
This vaccine may only be sold to the New Zealand Government and distributed in accordance with the New Zealand Government's COVID-19 vaccine rollout or donated to other countries.
The New Zealand Sponsor must fulfil the following obligations within the timelines specified, the dates of which may be altered by mutual agreement with Medsafe:
1. The New Zealand site of batch release will only release batches for distribution in New Zealand once the sponsor has verified that the shipping temperature profile meets specifications.
2. Provide additional drug substance stability data and analysis to confirm the storage period at -90°C to -55°C, 2°C to 8°C, and 23°C to 27°C/55-65% RH storage conditions (for Process 3 and 4), for the pre-PPQ lots and three PPQ lots manufactured at each drug substance commercial site within five working days of submission to the EMA.
3. Provide additional finished product stability data to confirm the storage period with Process 4 batches from both the EU and the Amylin Ohio, US drug product manufacturing sites within five working days of submission to the EMA.
4. Report the recalculation of the average loss of infectivity rate during finished product storage at 2 to 8°C based on commercial process stability data within five working days of submission to the EMA. If needed the release specification should be changed in order to ensure that batches will remain within shelf life specification during storage and handling via submission of a Changed Medicine Notification.
5. Provide further efficacy and safety data from studies COV001, COV002, COV003 and COV005 including the final pooled analysis and Final Clinical Study reports within five working days of these being produced.
6. Provide any reports on the requirement for and timing of booster doses within five working days of these being produced.
7. Provide the Final Clinical Study report overview and summaries of Study D8110C0001 within five working days of these being produced.
8. Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
9. Provide monthly safety reports according to the same schedule as required by the EMA, as well as all safety reviews they conduct or become aware of.
10. Perform the required pharmacovigilance activities and interventions detailed in the agreed RMP and any agreed updates to the RMP. An RMP should be submitted at the request of Medsafe or whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important milestone being reached.
Composition
Component | Ingredient | Manufacturer |
solution for injection | Active | |
ChAdOx1-S 100 GVP/mL (GVP = Giga Viral Particles; equivalent to not less than to 5.0 x 10^8 infectious units per mL) | CSL Behring (Australia) Pty Ltd 189-209 Camp Road, Broadmeadows VIC 3047 Australia | |
Oxford Biomedical (UK) Limited Unit A, Plot 7000 Alec Issigonis Way Oxford OX4 2ZY United Kingdom | ||
Henogen SA Rue de la Marlette 14 Seneffe 7180 Belgium | ||
Catalent Maryland Inc Main Building (BWI) 7555 Harmans Road Harmans 21077 United States of America | ||
Excipient | ||
Disodium edetate dihydrate | ||
Ethanol | ||
Histidine | ||
Histidine hydrochloride monohydrate | ||
Magnesium chloride hexahydrate | ||
Polysorbate 80 | ||
Sodium chloride | ||
Sucrose | ||
Water for injection |
Production
Manufacturing step | Manufacturer |
Finished Product Testing | Amylin Ohio Inc 8814 Trade Port Drive West Chester Ohio 45071 United States of America |
Catalent Pharma Solutions LLC 160 Pharma Drive Morrisville North Carolina 27560 United States of America | |
Charles River Laboratories Germany GmbH Max-Planck-Strasse 15a Erkrath 40699 Germany | |
Charles River Laboratories Inc. 334 South Street Shrewsbury MA 01545 United States of America | |
Charles River Laboratories Inc. 466 Devon Park Drive Wayne PA 19087 United States of America | |
Charles River Laboratories Ireland Limited Carrentrila Ballina County Mayo Ireland | |
Quality Assistance SA Technoparc de Thudinie 2 Donstiennes B-6536 Belgium | |
Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 Australia | |
Manufacture of Final Dose Form | Amylin Ohio Inc 8814 Trade Port Drive West Chester Ohio 45071 United States of America |
Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 Australia | |
Packing | Amylin Ohio Inc 8814 Trade Port Drive West Chester Ohio 45071 United States of America |
Seqirus Pty Ltd 39-79 Poplar Road Parkville Victoria 3052 Australia | |
NZ Site of Product Release | Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics 58 Richard Pearse Drive Airport Oaks Mangere AUCKLAND 2022 |
Packaging
Package | Contents | Shelf Life |
Vial, glass, multi-dose, 10 x 5mL Type 1 borosilicate glass with rubber stopper | 100 dose units | 6 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 6 hours opened stored at or below 30°C 48 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) |
Indications
COVID-19 Vaccine AstraZeneca 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.
Latest Regulatory Activity
Application Date | Application Type | Change(s) | Status | Payment Date | Priority |
21/6/2022 | Changed Medicine Notification | Active ingredient method of manufacture - Grade 2; Finished product testing site; Test methods and specifications - Grade 3; Shelf life/storage conditions - Active ingredient and intermediate bulks | Initial evaluation | 23/6/2022 | |
21/3/2022 | CMN 24(5) | Indications/dosage - Grade 3; Contraindications, warnings and precautions; Data sheet - miscellaneous changes | Initial evaluation | 28/3/2022 | |
10/11/2021 | Self-Assessable Change Notification | Data sheet - miscellaneous changes (Self assessable) | Notified | 11/11/2021 | |
29/1/2021 | Provisional Consent (Section 23) | New higher-risk medicine containing one or more new active substances | Granted 29/7/2021 | 24/2/2021 | Y |