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Great BritainCOMIRNATY JN.1 30mcgCOMIRNATY JN.1 10mcgCOMIRNATY JN.1 3mcgNorthern Ireland

COMIRNATY JN.1 3 micrograms/dose concentrate for dispersion for injection 3-dose vial (dilute before use)

Full name: COMIRNATY JN.1 3 micrograms/dose concentrate for dispersion for injection 3-dose vial COVID-19 mRNA Vaccine1

Indication: indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years1

The use of this vaccine should be in accordance with official recommendations.1

How does the Pfizer/BioNTech Vaccine COMIRNATY JN.1 differ from Pfizer/BioNTech's pre-existing COMIRNATY Vaccines?
COMIRNATY JN.1 3 micrograms/dose concentrate for dispersion (dilute before use) is a monovalent vaccine adapted to target the JN.1 COVID-19 variant.

Posology:
The dose of COMIRNATY JN.1 is 0.3mL given intramuscularly.

There should be an interval of at least 3 months between administration of COMIRNATY JN.1 and the last prior dose of a COVID-19 vaccine.

Please refer to 4.2 of theSummary of Product Characteristics for more information.

Administration: administered intramuscularly. The preferred site is the deltoid muscle of the upper arm. Do not dilute prior to use.

Pack size: 10 x 3 dose vials1

Dilution status:  Dilute with 1.1mL of sodium chloride 9mg/mL (0.9%)  solution for injection.1

Posology:

Please refer to 4.2 of the Summary of Product Characteristics for more information.

Administration:administered intramuscularly after dilution. In infants from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle.1

Refrigerated storage (2°C to 8°C) once thawed: 10 weeks storage and transportation within the 18-month shelf life. Once thawed the vaccine should not be re-frozen.1

Vial: 3 dose vial1

Dose:  3 micrograms (0.3mL)1

Room temperature stability before use: the unopened vials can be stored for up to 12 hours at temperatures between 8oC and 30oC.1

Stability of opened vials: Chemical and physical in-use stability has been demonstrated for 12 hours at 2oC to 30oC, after dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, which includes up to 6 hours transportation time. 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. Discard any unused vaccine within 12 hours after dilution.1

Verification, handling & preparation of COMIRNATY JN.1 3 micrograms/dose concentrate (dilute before use)

Undesirable Effects:
The safety of COMIRNATY JN.1 is inferred from safety data of the prior COMIRNATY vaccine, given as first, second or subsequent doses.

The most common adverse reactions from COMIRNATY and COMIRNATY Original/Omicron BA.4-5 clinical trials and COMIRNATY post-authorisation experience in individuals 6 months of age and older were:

Irritability 
Diarrhoea
Headache
Drowsiness
Arthralgia/Myalgia
Injection site pain/tendernessⱡ/swelling
Pyrexia*
Chills
Fatigue

Irritability, injection site tenderness, and drowsiness pertain to participants 6 to 23 months of age

* a higher frequency of pyrexia was observed after a second dose compared to a first dose

Hypersensitivity and anaphylaxis:

  • Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
  • Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of COMIRNATY.

Myocarditis and pericarditis:

  • There is an increased risk of myocarditis and pericarditis following vaccination with COMIRNATY. These conditions can develop within a few days after vaccination and have primarily occured within 14 days. They have been observed more often after the second vaccination and more often in younger males. Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed. 
  • Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.
  • Healthcare professons should consult guidance and/or specialist to diagnose and treat this conditions. 


Before administering the vaccine, refer to the Summary of Product Characteristics for further details.

References: 

  1. Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection 3-dose vial children 6 months - 4 years COVID-19 mRNA Vaccine Summary of Product Characteristics, Great Britain.  Available at https://www.medicines.org.uk/emc/product/15837(accessed: August 2024)

PP-CMR-GBR-0648. August 2024

Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH

COMIRNATY, COMIRNATY JN.1, COMIRNATY Omicron XBB.1.5, which are based on BioNTech proprietary mRNA technology, were developed by both BioNTech and Pfizer.


©2024 Pfizer Inc. All rights reserved.PP-CMR-GBR-0711. November 2024

*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 products discussed may have different product labelling in other countries.​​​​​​​
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This website is not intended for patients or for members of the general public. The website contains promotional content.

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*** Great Britain includes England, Scotland and Wales.

PP-CMR-GBR-0400 June 2023