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How to handle & prepare COMIRNATY 30mcg/dose concentrate - 12 years and older

A guide to product handling, preparation and administration of COMIRNATY at your vaccination site.

Training for Healthcare Professionals and Other Relevant Decision Makers in Great Britain.

Vaccine Formulations Guide


​​​​​​​Refer to the information outlined below to understand the differences across age groups and formulations.

Formulation

Formulation

Formulation

30mcg/dose concentrate -
12 years and older1

Ready to Use,
12 years and older

10mcg/dose concentrate -
​​​​​​​5 to 11 years old2

Name

Name

Name

COMIRNATY 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA vaccine (nucleoside modified)1

COMIRNATY 30 micrograms/dose dispersion for injection COVID-19 mRNA vaccine (nucleoside modified)

COMIRNATY 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA vaccine (nucleoside modified)2

Indication

Indication

Indication

Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.1

Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.

Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years.2

Licensed age of use

Licensed age of use

Licensed age of use

12 years of age and older1

12 years of age and older

Children 5 to 11 years old2

Vial Cap Colour

Vial Cap Colour

Vial Cap Colour

Summary of Product Characteristics

Summary of Product Characteristics

Summary of Product Characteristics

Handling & Administration Poster

Handling & Administration Poster

Handling & Administration Poster

Download Now Download Now Download Now

Pack Size

Package Size

Pack Size

195 multidose vials1

10 multidose vials

10 multidose vials2

Vial

Vial

Vial

Multi-dose vial1

Multi-dose vial

Multi-dose vial2

Requires Dilution before use?

Requires Dilution before use?

Requires Dilution before use?

YES1

NO

YES2

Doses per Vial

Doses per Vial

Doses per Vial

6 doses after dilution1

6 doses

10 doses after dilution2

Dose

Dosage

Dose

30 micrograms1

30 micrograms

10 micrograms2

Amount of diluent required per vial

Amount of diluent needed per vial

Amount of diluent required per vial

1.8 mL of sodium chloride 9 mg/mL (0.9%) solution for injection1

DO NOT DILUTE

1.3 mL of sodium chloride 9 mg/mL (0.9%) solution for injection2

Injection volume per dose

Injection volume per dose

Injection volume per dose

0.3mL1

0.3mL

0.2mL2

Storage 
This is an overview of the storage requirements for COMIRNATY – for full information on handling and preparation of this vaccine please refer to the relevant Summary of Product Characteristics.

Formulation

Formulation

Formulation

30mcg/dose concentrate - 12 years and older1

12 years and older, Ready to Use

10mcg/dose concentrate - 5 to 11 years old2

Storage of frozen unopened vials

Shelf life when stored at -90 °C to -60 °C

Shelf Life when stored at -90 °C to -60 °C

Shelf life when stored at -90 °C to -60 °C


​​​​​​​12 months1
​​​​

6 months

9 months2

Shelf life when stored at​​​​ -25 °C to -15 °C

DO NOT STORE

Storage of thawing or thawed unopened vials

Conditions required to thaw frozen vials

Conditions required to thaw frozen vials

Conditions required to thaw frozen vials

195 vials: 3 hours at 2-8 °C, or individual vials: 30 mins at temperatures up to
​​​​​​​ 30 °C1
Once thawed, the vaccine should not be re-frozen​​​​​​​1

10 vials: 6 hours at 2-8 °C or individual vials: 30 mins at 30 °C

10 vials: 4 hours at 2-8 °C or individual vials: 30 mins at temperatures up to
​​​​​​​30 °C2
Once thawed, the vaccine should not be re-frozen2

Shelf life of thawed unopened vials at ​​​​​​2 °C to 8 °C

Shelf life of thawed vials at ​​​​​​2 °C to 8 °C

Shelf life of thawed unopened vials at ​​​​​​2 °C to 8 °C

1 month1

10 weeks

10 weeks2

Stability of thawed unopened vials prior to use

Shelf life of thawed vials prior to use

Stability of thawed unopened vials prior to use

Up to 2 hours at temperatures up to 30 °C1

Up to 12 hours between 8 °C-30 °C

Up to 12 hours between 8 °C-30 °C2

Transportation

10 weeks storage and transportation at 2 °C to 8 °C within the 6-month shelf life.

Storage of diluted vials
​​​​​​​
From a microbiological point of view, unless the method of dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.​​​​​​​1,2

Stability of diluted vials

Shelf life of opened vials

Stability of diluted vials

After dilution, store at 2 °C to 30 °C and use within 6 hours, including any transportation time.1

DO NOT DILUTE
Chemical and physical in-use stability has been demonstrated for 12 hours at 2 °C to 30 °C.

After dilution, chemical and physical in-use stability has been demonstrated for 12 hours at 2 °C to 30 °C.2

Discard times of unused vaccine

Discard times of unused vaccine

Discard times of unused vaccine

Discard within 6 hours after dilution1

Discard within 12 hours post first puncture

Discard any unused vaccine within 12 hours after dilution2

Transportation

30mcg/dose concentrate - 12 years and older

12 years and older, ready to use formulation

10mcg/dose concentrate - 5 to 11 years old

  • ​​​​​​​​Frozen vials: within the 12-month shelf-life unopened vials may be stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C to -60 °C.1
  • Thawed unopened vials: within the 1-month shelf-life at 2 °C to 8 °C, up to 12 hours may be used for transportation.​​​​​​​1
  • For thawed opened vials that have been diluted, store at 2 °C to 30 °C and use within 6 hours, including any transportation time.1

Frozen vials must be transported at -90 °C to -60 °C. Thawed vials can be stored or transported for up to 10 weeks at 2 °C to 8 °C within the 6-month shelf life.

  • Frozen vials will be received frozen at -90 °C to -60 °C. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt.​​​​​​​2
  • For thawed unopened vials: 10 weeks storage and transportation at 2 °C to 8 °C within the 9-month shelf life.2
  • There are no data available within the 10mcg/dose concentrate regarding transportation of thawed, opened vials.3
Mechanism of Action and Composition:
  1. Tozinameran is composed of a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates1, 2
  2. This mRNA encodes the full-length viral spike (S) protein of SARS-CoV-21, 2
  3. The nucleoside-modified mRNA in COMIRNATY is formulated in lipid nanoparticles, which enable delivery of the non-replicating RNA into host cells to direct transient expression of the SARS-CoV-2 S antigen1, 2
  4. The vaccine elicits both neutralising antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-191, 2
Posology and administration - 30mcg/dose concentrate - 12 years and older COMIRNATY (tozinameran) 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) is supplied in a multidose vial which must be diluted before use. The thawed vaccine must be diluted in its original vial with 1.8 mL of sodium chloride 9mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.1

One vial (0.45 mL) of COMIRNATY contains 6 doses of 0.3 mL vaccine after dilution. In order to extract six doses from a single vial, low dead-volume syringes and/or needles should be used.1

Primary vaccination course

Individuals 12 years of age and older
​COMIRNATY is administered intramuscularly after dilution as a primary course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose. The use of this vaccine should be in accordance with official recommendations.1

Severely immunocompromised aged 12 years and older
A third primary course dose may be administered intramuscularly at least 28 days after the second dose to individuals who are severely immunocompromised.
 
Booster dose 

Booster dose in individuals 12 years of age and older
A booster dose of COMIRNATY may be administered intramuscularly at least 6 months after the second dose in individuals 12 years of age and older. The decision when and for whom to implement a booster dose of COMIRNATY should be made based on available vaccine effectiveness and safety data.

For further information on Posology and vaccine administration, please refer to the Summary of Product Characteristics​​​​​​​
Adverse reactions - 30mcg/dose concentrate - 12 years and olderThe safety of COMIRNATY was evaluated in participants 12 years of age and older in 2 clinical studies that included 23,205 participants (comprised of 22,074 participants 16 years of age and older and 1,131 adolescents 12 to 15 years of age) that have received at least one dose of COMIRNATY.1

The overall safety profile of COMIRNATY in adolescents 12 to 15 years of age was similar to that seen in participants 16 years of age and older.​​​​​​​1

Additionally, 306 existing Phase 3 participants 18 to 55 years of age received a booster dose of Comirnaty approximately 6 months after the second dose in the non-placebo-controlled booster dose portion of Study 2.1 The overall safety profile for the booster dose was similar to that seen after 2 doses.1

In Study 4, a placebo-controlled booster study, 5,081 participants 16 years of age and older were recruited from Study 2 to receive a booster dose of Comirnaty at least 6 months after the second dose. No new adverse reactions of Comirnaty were identified.1

​​​​​​​The most frequent adverse reactions in participants 16 years of age and older that received two doses were1:
  • Injection site pain (>80%),
  • Fatigue (>60%),​​​​​​​
  • Headache (>50%),
  • Myalgia (>40%),
  • Chills (>30%),
  • Arthralgia (>20%),
  • Pyrexia (>10%),
  • Injection site swelling (>10%)

These reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.​​​​​​​​​​​​​​1

The most frequent adverse reactions in adolescents 12 to 15 years of age that received two doses were1: 
  • Injection site pain (>90%),

  • Fatigue (>70%),

  • Headache (>70%),​​​​​​​

  • Myalgia (>40%),

  • Chills (>40%),

  • Arthralgia (>20%),

  • Pyrexia (>20%)

​​​​​​​For further information on the COMIRNATY safety profile, please refer to the Summary of Product Characteristics.
Posology and administration – 12 years and older, Ready to Use Dummy Text Adverse reactions – 12 years and older, Ready to UseDummy TextPosology and administration - 10mcg/dose concentrate - 5 to 11 years old COMIRNATY (tozinameran) 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified) is supplied in a multidose vial which must be diluted before use. The thawed vaccine must be diluted in its original vial with 1.3 mL of sodium chloride 9mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.2

One vial (1.3 mL) of COMIRNATY contains 10 doses of 0.2 mL vaccine after dilution. In order to extract ten doses from a single vial, low dead-volume syringes and/or needles should be used.2

Children 5 to 11 years of age (i.e. 5 to less than 12 years of age)
​COMIRNATY is administered intramuscularly after dilution as a primary course of 2 doses (0.2 mL each). It is recommended to administer the second dose 3 weeks after the first dose. The use of this vaccine should be in accordance with official recommendations.2

Severely immunocompromised aged 5 years and older
A third primary course dose may be administered intramuscularly at least 28 days after the second dose to individuals who are severely immunocompromised.2 
​​​​​​​
Comirnaty 10 micrograms/dose should be used only for children 5 to 11 years of age.

For further information on Posology and vaccine administration, please refer to the Summary of Product Characteristics 
Adverse reactions - 10mcg/dose concentrate - 5 to 11 years oldThe safety of COMIRNATY was evaluated in participants 5 years of age and older in 3 clinical studies that included 24,675 participants (comprised of 22,026 participants 16 years of age and older, 1,131 adolescents 12 to 15 years of age, and 3,109 children 5 to 11 years of age) that have received at least one dose of COMIRNATY.2

The overall safety profile of COMIRNATY in participants 5 to 15 years of age was similar to that seen in participants 16 years of age and older.2

The most frequent adverse reactions in children 5 to 11 years of age that received two doses were2:
  • Injection site pain (>80%),

  • Fatigue (>50%),​​​​​​​

  • Headache (>30%),

  • Injection site redness and swelling (>20%)

  • Myalgia (>10%),

  • Chills (>10%)

​​​​​​​For further information on the COMIRNATY safety profile, please refer to the Summary of Product Characteristics.

Summary of Product Characteristics

30mcg/dose concentrate - 12 years and older 12 years and older, Ready to Use 10mcg/dose concentrate - 5 to 11 years old

Patient Information Leaflet

30mcg/dose concentrate - 12 years and older 12 years and older, Ready to Use 10mcg/dose concentrate - 5 to 11 years old


​​​​​​​If this material is shared with patients it must be downloaded and NOT shown directly to patients from this website which is inten​​​​​​​ded for Healthcare Professionals and Other Relevant Decision Makers

References:

  1. COMIRNATY (tozinameran) 30 micrograms/dose 12+ years COVID-19 mRNA Vaccine (nucleoside modified) Summary of Product Characteristics, Great Britain. Available at: www.medicines.org.uk/emc/product/12740/smpc (accessed: April 2022)

  2. COMIRNATY (tozinameran) 10 micrograms/dose Children 5 to 11 years COVID-19 mRNA Vaccine (nucleoside modified) Summary of Product Characteristics, Great Britain. Available at: www.medicines.org.uk/emc/product/13134/smpc (accessed: April 2022)

  3. ​​​​​​​Pfizer Data on File. April 2022.

PP-CMR-GBR-0250 April 2022

Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH
​​​​​​​

COMIRNATY COVID-19 mRNA Vaccine (nucleoside modified) which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.

©2022 Pfizer Inc. All rights reserved. PP-CMR-GBR-0251 April 2022

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The product discussed may have different product labelling in other countries.​​​​​​​
​​​​​​​

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