Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10853
Trade NameDose FormStrengthIdentifier
Comirnaty (COVID-19 mRNA vaccine)Concentrate for injection0.5 mg/mLPfizer-BioNTech (delivers 30 µg/0.3mL dose)
SponsorApplication dateRegistration situationClassification
Pfizer New Zealand Limited
P O Box 3998
AUCKLAND 1140
13/11/2020Provisional consent
Approval date: 3/2/2021
Expiry date: 3/11/2023
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

ComponentIngredientManufacturer
concentrate for injectionActive 
 Tozinameran 0.5 mg/mL equivalent to 30 µg/0.3mL doseRentschler Biopharma SE
Erwin-Rentschler-Strasse 21
Laupheim 88471
Germany
  Wyeth Biopharma, Division of Wyeth Pharmaceuticals LLC
One Burtt Road
Andover
Massachussetts 01810
United States of America
  BioNTech Manufacturing Marburg GmbH
Emil-von-Behring-Strasse 76
Marburg 35041
Germany
  Pfizer Ireland Pharmaceuticals
Grange Castle Business Park
Clondalkin
Dublin 22
Ireland
  BioNTech Manufacturing GmbH
An der Goldgrube 12
Mainz 55131
Germany
 Excipient 
 1,2-Distearoyl-sn-glycero-3-phosphocholine
 ALC-0159
 ALC-0315
 Cholesterol
 Dibasic sodium phosphate dihydrate
 Monobasic potassium phosphate
 Potassium chloride
 Sodium chloride
 Sucrose
 Water for injection
concentrate for injection, available from December 2021Active 
 Tozinameran 0.5 mg/mL equivalent to 30 µg/0.3 mL dose
 Excipient 
 1,2-Distearoyl-sn-glycero-3-phosphocholine
 ALC-0159
 ALC-0315
 Cholesterol
 Dibasic sodium phosphate dihydrate
 Hydrochloric acid
 Monobasic potassium phosphate
 Potassium chloride
 Sodium chloride
 Sodium hydroxide
 Sucrose
 Water for injection

Production

Manufacturing stepManufacturer
Finished Product TestingAllergopharma GmbH & Co. KG
Hermann-Koerner-Strasse 52
Reinbek 21465
Germany
 Baxter Oncology GmbH
Kantstrasse 2
Halle-Kunsebeck Westfalen D-33790
Germany
 BioNTech Innovative Manufacturing Services GmbH
Vollmersbachstrasse 66
Idar-Oberstein 55743
Germany
 BioNTech Manufacturing GmbH
An der Goldgrube 12
Mainz 55131
Germany
 BioNTech Manufacturing Marburg GmbH
Emil-von-Behring-Strasse 76
Marburg 35041
Germany
 Catalent Anagni SRL
Localita Fontana del Ceraso
SP Casilina
Anagni 41 03012
Italy
 Delpharm Saint Remy
Rue de l'Isle
Saint Remy Sur Avre 28380
France
 Eurofins Pharma Quality Control
16 rue Clement Ader
Sainte Croix en Plaine 68127
France
 Eurofins Pharma Quality Control
9 Avenue de Laponie
ZI de Courtaboeuf
Les Ulis 91940
France
 Mibe GmbH Arzneimittel
Munchener Strasse 15
Brehna 06796
Germany
 Novartis Pharma Stein AG
Schaffhauserstrasse
Stein 4332
Switzerland
 Patheon Italia SpA
Viale G.B. Stucchi, 110
Monza
Milan 20900
Italy
 Pfizer Inc
875 Chesterfield Parkway West
Chesterfield
MO 63017-1732
United States of America
 Pfizer Ireland Pharmaceuticals
Grange Castle Business Park
Clondalkin
Dublin 22
Ireland
 Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs B-2870
Belgium
 Sanofi-Aventis Deutschland GmbH
Industriepark Hochst
Bruningstrasse 50
Frankfurt am Main 65926
Germany
 Siegfried Hameln GmbH
Langes Feld 13
Hameln 31789
Germany
 Wyeth Biopharma, Division of Wyeth Pharmaceuticals LLC
One Burtt Road
Andover
Massachussetts 01810
United States of America
Finished Product Testing - MicrobiologicalHospira Zagreb d.o.o.
Prudnicka cesta 60
Prigorje Brdovecko 10291
Croatia
 Labor LS SE & Co.KG
Mangelsfeld 4
Bad Bocklet
Grossenbrach 97708
Germany
 SGS Lab Simon SA
Vieux Chemin du Poete 10
Wavre B-1301
Belgium
Manufacture of Final Dose FormAllergopharma GmbH & Co. KG
Hermann-Koerner-Strasse 52
Reinbek 21465
Germany
 Baxter Oncology GmbH
Kantstrasse 2
Halle-Kunsebeck Westfalen D-33790
Germany
 BioNTech Manufacturing Marburg GmbH
Emil-von-Behring-Strasse 76
Marburg 35041
Germany
 Catalent Anagni SRL
Localita Fontana del Ceraso
SP Casilina
Anagni 41 03012
Italy
 Delpharm Saint Remy
Rue de l'Isle
Saint Remy Sur Avre 28380
France
 Mibe GmbH Arzneimittel
Munchener Strasse 15
Brehna 06796
Germany
 Novartis Pharma Stein AG
Schaffhauserstrasse
Stein 4332
Switzerland
 Patheon Italia SpA
Viale G.B. Stucchi, 110
Monza
Milan 20900
Italy
 Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs B-2870
Belgium
 Polymun Scientific Immunobiologische Forschung GmbH
Donaustrasse 99
Klosterneuburg 3400
Austria
 Sanofi-Aventis Deutschland GmbH
Industriepark Hochst
Bruningstrasse 50
Frankfurt am Main 65926
Germany
 Siegfried Hameln GmbH
Langes Feld 13
Hameln 31789
Germany
PackingBaxter Oncology GmbH
Kantstrasse 2
Halle-Kunsebeck Westfalen D-33790
Germany
 Catalent Anagni SRL
Localita Fontana del Ceraso
SP Casilina
Anagni 41 03012
Italy
 Delpharm Saint Remy
Rue de l'Isle
Saint Remy Sur Avre 28380
France
 Mibe GmbH Arzneimittel
Munchener Strasse 15
Brehna 06796
Germany
 Novartis Pharma Stein AG
Schaffhauserstrasse
Stein 4332
Switzerland
 Patheon Italia SpA
Viale G.B. Stucchi, 110
Monza
Milan 20900
Italy
 Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs B-2870
Belgium
 Sanofi-Aventis Deutschland GmbH
Industriepark Hochst
Bruningstrasse 50
Frankfurt am Main 65926
Germany
 Siegfried Hameln GmbH
Langes Feld 13
Hameln 31789
Germany
Secondary PackagingBaxter Oncology GmbH
Kantstrasse 2
Halle-Kunsebeck Westfalen D-33790
Germany
 Catalent Anagni SRL
Localita Fontana del Ceraso
SP Casilina
Anagni 41 03012
Italy
 Delpharm Saint Remy
Rue de l'Isle
Saint Remy Sur Avre 28380
France
 Mibe GmbH Arzneimittel
Munchener Strasse 15
Brehna 06796
Germany
 Novartis Pharma Stein AG
Schaffhauserstrasse
Stein 4332
Switzerland
 Patheon Italia SpA
Viale G.B. Stucchi, 110
Monza
Milan 20900
Italy
 Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs B-2870
Belgium
 Sanofi-Aventis Deutschland GmbH
Industriepark Hochst
Bruningstrasse 50
Frankfurt am Main 65926
Germany
 Siegfried Hameln GmbH
Langes Feld 13
Hameln 31789
Germany
NZ Site of Product ReleasePfizer New Zealand Limited
Level 10, 11 Britomart Place
Auckland CBD
Auckland 1010

Packaging

PackageContentsShelf Life
Vial, glass, multi-dose, (Clear, Type I), 0.45 mL fill, closed with a rubber stopper, aluminium overseal and flip-off cap195 dose units12 months from date of manufacture stored in the freezer at -90°C to -60°C protect from light
2 hours unopened stored at or below 30°C. Applies to undiluted or thawed vials. Do not refreeze thawed vials.
1 months unopened stored at 2° to 8°C (Refrigerate, do not freeze). Applies to undiluted or thawed vials. Do not refreeze thawed vials.
6 hours diluted stored at or below 30°C. Do not refreeze diluted vials.
2 weeks unopened stored in the freezer at -25°C to -15°C protect from light

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 DateApplication TypeChange(s)StatusPayment DatePriority
21/6/2022Self-Assessable Change NotificationActive ingredient method of manufacture - Grade 3 (self-asessable)Awaiting payment  
17/6/2022Self-Assessable Change NotificationTest methods and specifications - Grade 6 (Self assessable)Awaiting payment  
10/6/2022Changed Medicine NotificationActive ingredient method of manufacture - Grade 1; Administrative fee (CMN)Initial evaluation15/6/2022 
9/6/2022Self-Assessable Change NotificationActive ingredient method of manufacture - Grade 3 (self-asessable); Finished product manufacturing process - Grade 4 (self-assessable); Test methods and specifications - Grade 6 (Self assessable)Notified22/6/2022 
8/6/2022Changed Medicine NotificationFinished product manufacturing process - Grade 1Initial evaluation15/6/2022 
13/11/2020Provisional Consent (Section 23)New higher-risk medicine containing one or more new active substancesGranted 3/2/202125/11/2020Y
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