Revised: 31 May 2019

Medicines

 

Medsafe Product Detail

Data SheetCMI
File ref: TT50-10853/1
Trade NameDose FormStrengthIdentifier
ComirnatySuspension for injection0.1 mg/mL(grey cap, do not dilute) 30 mcg/0.3 mL dose
SponsorApplication dateRegistration situationClassification
Pfizer New Zealand Limited
P O Box 3998
AUCKLAND 1140
12/11/2021Not 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

ComponentIngredientManufacturer
suspension for injection, New FormulationActive 
 Tozinameran 0.1 mg/mL equivalent to 30 µg/0.3mL dosePfizer 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 stepManufacturer
Finished Product TestingPfizer Ireland Pharmaceuticals
Grange Castle Business Park
Clondalkin
Dublin 22
Ireland
 Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs B-2870
Belgium
Manufacture of Final Dose FormPfizer Manufacturing Belgium NV
Rijksweg 12
Puurs B-2870
Belgium
PackingPfizer Manufacturing Belgium NV
Rijksweg 12
Puurs B-2870
Belgium
Secondary PackagingPfizer Manufacturing Belgium NV
Rijksweg 12
Puurs B-2870
Belgium
NZ Site of Product ReleasePfizer New Zealand Limited
Level 10, 11 Britomart Place
Auckland CBD
Auckland 1010

Packaging

PackageContentsShelf Life
Vial, glass, multi-dose, (2.25 mL fill), closed with rubber stopper, aluminium overseal and grey flip-off plastic cap10 dose units12 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 cap195 dose units12 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 DateApplication TypeChange(s)StatusPayment DatePriority
21/6/2022Self-Assessable Change NotificationActive ingredient method of manufacture - Grade 3 (self-asessable)Notified29/6/2022 
17/6/2022Self-Assessable Change NotificationTest methods and specifications - Grade 6 (Self assessable)Notified29/6/2022 
15/6/2022Changed Medicine NotificationFinished product manufacturing site; Finished product testing site; Finished product manufacturing process - Grade 1; Administrative fee (CMN)Initial evaluation29/6/2022 
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 
6/6/2022Changed Medicine NotificationFinished product manufacturing site; Administrative fee (CMN)Initial evaluation15/6/2022 
12/11/2021Provisional Consent (Section 23)Additional dose form - higher-risk medicine - Grade 1 or 2Granted 16/12/202124/11/2021 
Hide menus
Show menus
0 1 2 4 5 6 7 9 [ /