Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10853/1 |
| Trade Name | Dose Form | Strength | Identifier |
| Comirnaty | Suspension for injection | 0.1 mg/mL | (grey cap, do not dilute) 30 mcg/0.3 mL dose |
| Sponsor | Application date | Registration situation | Classification |
| Pfizer New Zealand Limited P O Box 3998 AUCKLAND 1140 | 12/11/2021 | Not available - Provisional consent Approval date: 16/12/2021 Expiry date: 3/11/2023 Notification date: 8/2/2022 Labelling exemption expires 03/11/2023 | Prescription |
Comirnaty (purple cap, dilute), original formulation, 0.5 mg/mL suspension for injection, 12 years of age and older (30 micrograms/dose)
Provisional consent is granted until 3 November 2023.
This consent is given subject to the following conditions:
The New Zealand Sponsor must fulfil the following obligations within the timelines specified, 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 independent batch certification, such as UK National Institute for Biological Standards and Control (NIBSC) certification, EU Official Control Authority Batch Release (OCABR) certification, Australian TGA batch release assessment, or any other certification agreed with Medsafe, on request for all batches distributed in New Zealand.
3) Provide any reports on the duration of efficacy and the requirement for booster doses within five working days of these being produced.
4) Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced.
5) Provide the final Clinical Study Reports for Study C4591001 and Study BNT162-01 within five working days of these being produced.
6) Provide Periodic Safety Update Reports according to the same schedule as required by the EMA.
7) Provide monthly safety reports, as well as all safety reviews they conduct or become aware of.
8) 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.
Comirnaty (grey cap, do not dilute), new formulation, 0.1 mg/mL suspension for injection, 12 years of age and older (30 micrograms/dose)
Provisional consent is granted until 3 November 2023.
This consent is given subject to the following conditions.
The New Zealand Sponsor must fulfil the following obligations within the timelines specified, 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 Certificates of Analysis to Medsafe for the first three batches of vaccine of each presentation intended to be distributed in New Zealand, prior to distribution.
3) Provide independent batch certification, such as UK National Institute for Biological Standards and Control (NIBSC) certification, EU Official Control Authority Batch Release (OCABR) certification, Australian TGA batch release assessment, or any other certification agreed with Medsafe, on request for all batches distributed in New Zealand.
4) Reassess and revise the finished product specifications acceptance limits for RNA and lipid content as further data becomes available. Due date: 31 December 2022.
5) Provide any reports on the duration of efficacy and the requirement for booster doses within five working days of these being produced.
6) Provide any reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, efficacy in population subgroups and results from post-marketing studies, within five working days of these being produced.
7) Provide the final Clinical Study Reports for Study C4591001 and Study BNT162-01 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, 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 |
| suspension for injection, New Formulation | Active | |
| Tozinameran 0.1 mg/mL equivalent to 30 µg/0.3mL dose | Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin Dublin 22 Ireland | |
| BioNTech Manufacturing Marburg GmbH Emil-von-Behring-Strasse 76 Marburg 35041 Germany | ||
| Wyeth Biopharma, Division of Wyeth Pharmaceuticals LLC One Burtt Road Andover Massachussetts 01810 United States of America | ||
| Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 Laupheim 88471 Germany | ||
| BioNTech Manufacturing GmbH An der Goldgrube 12 Mainz 55131 Germany | ||
| Excipient | ||
| 1,2-Distearoyl-sn-glycero-3-phosphocholine | ||
| ALC-0159 | ||
| ALC-0315 | ||
| Cholesterol | ||
| Sucrose | ||
| Trometamol | ||
| Trometamol hydrochloride | ||
| Water for injection |
Production
| Manufacturing step | Manufacturer |
| Finished Product Testing | Pfizer Ireland Pharmaceuticals Grange Castle Business Park Clondalkin Dublin 22 Ireland |
| Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs B-2870 Belgium | |
| Manufacture of Final Dose Form | Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs B-2870 Belgium |
| Packing | Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs B-2870 Belgium |
| Secondary Packaging | Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs B-2870 Belgium |
| NZ Site of Product Release | Pfizer New Zealand Limited Level 10, 11 Britomart Place Auckland CBD Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, multi-dose, (2.25 mL fill), closed with rubber stopper, aluminium overseal and grey flip-off plastic cap | 10 dose units | 12 months from date of manufacture stored in the freezer at -90°C to -60°C protect from light 24 hours unopened stored at or below 30°C. Applies to thawed vials. Do not refreeze. 10 weeks unopened stored at 2° to 8°C (Refrigerate, do not freeze). Applies to thawed vials within the 12 month shelf-life. Do not refreeze. 12 hours opened stored at or below 30°C |
| Vial, glass, multi-dose, (2.25 mL fill), closed with rubber stopper, aluminium overseal and grey flip-off plastic cap | 195 dose units | 12 months from date of manufacture stored in the freezer at -90°C to -60°C protect from light 24 hours unopened stored at or below 30°C. Applies to thawed vials. Do not refreeze. 10 weeks unopened stored at 2° to 8°C (Refrigerate, do not freeze). Applies to thawed vials within the 12 month shelf-life. Do not refreeze. 12 hours opened stored at or below 30°C |
Indications
Comirnaty has provisional consent for the indication below:
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 12 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 | Self-Assessable Change Notification | Active ingredient method of manufacture - Grade 3 (self-asessable) | Notified | 29/6/2022 | |
| 17/6/2022 | Self-Assessable Change Notification | Test methods and specifications - Grade 6 (Self assessable) | Notified | 29/6/2022 | |
| 15/6/2022 | Changed Medicine Notification | Finished product manufacturing site; Finished product testing site; Finished product manufacturing process - Grade 1; Administrative fee (CMN) | Initial evaluation | 29/6/2022 | |
| 10/6/2022 | Changed Medicine Notification | Active ingredient method of manufacture - Grade 1; Administrative fee (CMN) | Initial evaluation | 15/6/2022 | |
| 9/6/2022 | Self-Assessable Change Notification | Active ingredient method of manufacture - Grade 3 (self-asessable); Finished product manufacturing process - Grade 4 (self-assessable); Test methods and specifications - Grade 6 (Self assessable) | Notified | 22/6/2022 | |
| 6/6/2022 | Changed Medicine Notification | Finished product manufacturing site; Administrative fee (CMN) | Initial evaluation | 15/6/2022 | |
| 12/11/2021 | Provisional Consent (Section 23) | Additional dose form - higher-risk medicine - Grade 1 or 2 | Granted 16/12/2021 | 24/11/2021 |
