Great Britain | COMIRNATYEDUCATION.co.uk

Great Britain

COMIRNATY has been granted a conditional Marketing Authorisation in the UK for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older, and in individuals 5 to 11 years old.^1,2

Conditional Marketing Authorisation means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed at least every year and the product information will be updated as necessary.^{1, 2}

Therapeutic indications:

COMIRNATY 30 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA vaccine (nucleoside modified) is indicated for the active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.¹
COMIRNATY 10 micrograms/dose concentrate for dispersion for injection COVID-19 mRNA vaccine (nucleoside modified) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years.²

The use of this vaccine should be in accordance with official recommendations.^{1, 2}

Adverse Event Reporting

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via a Yellow card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and include the batch/Lot number if available.

Alternatively, adverse events of concern in association with COMIRNATY can be reported to Pfizer Medical Information on 01304 616161 or via www.pfizersafetyreporting.com.

Please do not report the same adverse event(s) to both systems as all reports will be shared between Pfizer and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates.

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	12 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-frozen¹	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, which includes up to 6 hours transportation time²
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 12-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:

Tozinameran is composed of a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates^{1, 2}
This mRNA encodes the full-length viral spike (S) protein of SARS-CoV-2^{1, 2}
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 antigen^{1, 2}
The vaccine elicits both neutralising antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19^{1, 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 older

The 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

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Adverse reactions – 12 years and older, Ready to Use

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Posology 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 old

The 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 intended for Healthcare Professionals and Other Relevant Decision Makers

References:

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: May 2022)
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: May 2022)
Pfizer Data on File. May 2022.

PP-CMR-GBR-0263 May 2022

*Healthcare Professionals ** Other Relevant Decision Makers

The product information provided in this site is intended only for Healthcare Professionals and Other Relevant Decision Makers resident in the United Kingdom.

This website is brought to you by Pfizer Limited, a company registered in England and Wales under No. 526209 with its registered office at Ramsgate Road, Sandwich, Kent CT13 9NJ, VAT registration number GB201048427.

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

Adverse Event Reporting

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

Vaccine Formulations Guide

Access

Summary of Product Characteristics

Patient Information Leaflet†

Patient Information Leaflet^†