Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10877
Trade NameDose FormStrengthIdentifier
VaxzevriaSolution for injection5x10^10 VP/0.5mL
SponsorApplication dateRegistration situationClassification
AstraZeneca Limited
P O Box 87453
Meadowbank
Auckland 1742
29/1/2021Provisional 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

ComponentIngredientManufacturer
solution for injectionActive 
 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 stepManufacturer
Finished Product TestingAmylin 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 FormAmylin 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
PackingAmylin 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 ReleasePharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks
Mangere
AUCKLAND 2022

Packaging

PackageContentsShelf Life
Vial, glass, multi-dose, 10 x 5mL Type 1 borosilicate glass with rubber stopper100 dose units6 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 DateApplication TypeChange(s)StatusPayment DatePriority
21/6/2022Changed Medicine NotificationActive ingredient method of manufacture - Grade 2; Finished product testing site; Test methods and specifications - Grade 3; Shelf life/storage conditions - Active ingredient and intermediate bulksInitial evaluation23/6/2022 
21/3/2022CMN 24(5)Indications/dosage - Grade 3; Contraindications, warnings and precautions; Data sheet - miscellaneous changesInitial evaluation28/3/2022 
10/11/2021Self-Assessable Change NotificationData sheet - miscellaneous changes (Self assessable)Notified11/11/2021 
29/1/2021Provisional Consent (Section 23)New higher-risk medicine containing one or more new active substancesGranted 29/7/202124/2/2021Y
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