Revised: 31 May 2019
Medicines
Medsafe Product Detail |   | |
|---|---|---|
| File ref: TT50-10853 |
| Trade Name | Dose Form | Strength | Identifier |
| Comirnaty (COVID-19 mRNA vaccine) | Concentrate for injection | 0.5 mg/mL | Pfizer-BioNTech (delivers 30 µg/0.3mL dose) |
| Sponsor | Application date | Registration situation | Classification |
| Pfizer New Zealand Limited P O Box 3998 AUCKLAND 1140 | 13/11/2020 | Consent given Approval date: 15/11/2023 Labelling exemption expires 03/11/2025 | Prescription |
Composition
| Component | Ingredient | Manufacturer |
| concentrate for injection | Active | |
| Tozinameran 0.5 mg/mL equivalent to 30 µg/0.3mL dose | Rentschler 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 2021 | Active | |
| 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 step | Manufacturer |
| Finished Product Testing | Allergopharma 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 S.p.A 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-Sint-Amands 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 - Microbiological | Hospira 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 Form | Allergopharma 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 S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
| Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands 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 | |
| Packing | Baxter 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 S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
| Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands 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 Packaging | Baxter 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 S.p.A Viale G.B. Stucchi, 110 Monza Milan 20900 ITALY | |
| Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands 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 Release | Pfizer New Zealand Limited Level 10, 11 Britomart Place Auckland CBD Auckland 1010 |
Packaging
| Package | Contents | Shelf Life |
| Vial, glass, multi-dose, (Clear, Type I), 0.45 mL fill, closed with a rubber stopper, aluminium overseal and flip-off cap | 195 dose units | 24 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
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 |
| 28/7/2023 | Changed Medicine Notification | Shelf life/storage conditions - G2; Data sheet - G1; Administrative fee (CMN) | Granted 1/9/2023 | 9/8/2023 | |
| 20/6/2023 | New Higher-risk Medicine Application | Provisional to full approval (clinical need) higher-risk NCE | Granted 15/11/2023 | 23/8/2023 | |
| 13/11/2020 | Provisional Consent (Section 23) | New higher-risk medicine containing one or more new active substances | Granted 3/2/2021 | 25/11/2020 | Y |
