This page is for healthcare professionals and other relevant decision makers in the UK. Information on this page is aligned to the Great Britain and Northern Ireland Summary of Product Characteristics.
 Information about adverse event reporting can be found towards the bottom of the page.

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Prescribing Information for COMIRNATY® JN.1▼ (bretovameran) for Great Britain and Northern Ireland and prescribing information for COMIRNATY® XBB.1.5▼ (raxtozinameran) for Great Britain is available here and at the bottom of the page. Adverse event reporting information can be found at the bottom of the page.

COMIRNATY JN.1▼ pre-filled syringe for COVID-19 vaccination of your private patients
Title
COMIRNATY JN.1 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older1
For queries regarding private supply of Pfizer COVID-19 vaccines, email [email protected] or call 01304 616161

COMIRNATY vaccines (in several different formulations) have been a familiar part of the UK COVID-19 vaccination programme since it began7

The COMIRNATY fridge-stable pre-filled syringe1 for use in the private market, targets the same variant as the COVID-19 vaccine used in the autumn National Immunisation Programme (NIP) Are you interested in COMIRNATY JN.1 in the private market or the NIP?

Pfizer/BioNTech COVID-19 vaccines have been available in the NIP since its inception, in a number of presentations. COMIRNATY JN.1 30mcg pre-filled syringes are now available for use in the private market for adults1 who are not eligible for vaccination as part of the NIP.

If you are looking for information related to the NIP, please click here

Mechanism of Action

The nonreplicating mRNA in COMIRNATY JN.1 stimulates immune responses to SARS-CoV-21

Made entirely in vitro1,3
COMIRNATY JN.1 formulations are made entirely by a cell-free in vitro transcription process.

Cannot cause COVID-194,5
COMIRNATY JN.1 does not contain a live virus and cannot cause COVID-19.

Does not enter nucleus3,5
COMIRNATY JN.1 does not integrate into the cell’s genome and cannot cause mutation of the DNA.

Transiently active5,6
The mRNA in COMIRNATY JN.1 is transiently active and degraded by normal metabolic pathways. After the piece of the spike protein is made, the cell breaks down the mRNA strand and removes it, leaving the body as waste.

Title
COMIRNATY JN.1 elicits both neutralising antibodies and cellular immune response to the spike (S) antigen, which may contribute to protection against COVID-191
MRNA vaccines can be updated in response to new SARS-CoV-2 variants2
Dosing & Administration1
  • COMIRNATY JN.1 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2.
  • The use of this vaccine should be in accordance with official recommendations and at least 3 months since the last prior COVID-19 Vaccine.
  • COMIRNATY JN.1 30 micrograms may be administered concomitantly with seasonal influenza vaccine.
Presentation Glass pre-filled syringe
Dosage 30 micrograms of bretovameran 
Injection Volume per Dose 0.3 mL
Dilution No dilution required
  • COMIRNATY JN.1 is administered intramuscularly into the deltoid muscle of the arm as a single dose of 0.3 mL, regardless of prior COVID-19 vaccination status.
  • Remove tip cap by slowly turning the cap counterclockwise. Do not shake. Attach a needle appropriate for intramuscular injection and administer the entire volume.
Storage1
  • For use in the private market, single dose pre-filled syringes are provided in packs of 10.
  • The vaccine can be stored at 2 °C to 8 °C for up to 8 months. This is refrigerated only. Do not freeze.
  • Prior to use, the pre-filled syringe can be stored for up to 12 hours at temperatures between 8 °C and 30 °C and can be handled in room light conditions.
Safety Profile1The safety of COMIRNATY JN.1 is inferred from safety data of the prior COMIRNATY vaccine, given as first, second or subsequent doses.

Adverse reactions observed during clinical studies are listed below according to the following frequency categories: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1 000 to < 1/100), Rare (≥ 1/10 000 to < 1/1 000), Very rare (< 1/10 000), Not known (cannot be estimated from the available data).

Example

In participants 5 years of age and older, a higher frequency of lymphadenopathy was reported after a booster (≤ 2.8%) dose than after primary (≤ 0.9%) doses of the vaccine.The frequency category for urticaria and angioedema was rare.Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or palsy) was reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.Adverse reaction determined post authorisation.Refers to vaccinated arm.A higher frequency of pyrexia was observed after the second dose compared to the first dose.Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post marketing phase.Most cases appeared to be non-serious and temporary in nature.Special Warnings1Hypersensitivity 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 just a few days after vaccination and have primarily occurred 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 professionals should consult guidance and/or specialists to diagnose and treat this condition.

For the most up to date safety profile information and guidance on the management of treatment related adverse events, please refer to the full Summary of Product Characteristics for COMIRNATY JN.1. Available here for Great Britain and here for Northern Ireland.

Now Available

COMIRNATY JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine Summary of Product Characteristics; Pfizer and BioNTech. Available at: https://www.medicines.org.uk/emc/product/15835 (Great Britain) https://www.emcmedicines.com/en-gb/northernireland/medicine?id=253ef3db-0fd1-4f25-9ebc-7cec2d0673e5&type=smpc (Northern Ireland)Pather S, Muik A, Rizzi R, Mensa F. Expert Rev Vaccines. 2023;22(1):650-661. DOI: 10.1080/14760584.2023.2232851

Established

COMIRNATY vaccines (in several different formulations) have been a familiar part of the UK COVID-19 Vaccination Programme since it began8

Established

COMIRNATY vaccines (in several different formulations) have been a familiar part of the UK COVID-19 Vaccination Programme since it began8

Established

COMIRNATY vaccines (in several different formulations) have been a familiar part of the UK COVID-19 Vaccination Programme since it began8

Background document on the mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19. 14 January 2021. World Health Organization. https://iris.who.int/bitstream/handle/10665/338671/WHO-2019-nCoV-vaccines-SAGE_recommendation-BNT162b2-background-2021.1-eng.pdf?sequence=1 (Last Accessed August 2024)Pardi N, Hogan MJ, Porter FW, Weissman. Nat Rev Drug Discov. D. 2018;17(4):261-279. doi: 10.1038/nrd.2017.243Centers for Disease Control and Prevention. COVID-19 Vaccine Basics. https://www.cdc.gov/covid/vaccines/how-they-work.html (Last Accessed August 2024)Schlake T, Thess A, Fotin-Mleczek M, Kallen KJ. RNA Biology. 2012;9(11):1319-30. doi: 10.4161/rna.22269Press release UK marks one year since deploying world's first COVID-19 vaccine. Department for Health and Social Care. Available at: https://www.gov.uk/government/news/uk-marks-one-year-since-deploying-worlds-first-covid-19-vaccine (Last Accessed August 2024)References:
PP-CMR-GBR-0653. October 2024

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.

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.

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Marketing Authorisation
Holder: BioNTech
Manufacturing GmbH

COMIRNATY JN.1 COVID-19 mRNA Vaccine, which is based on BioNTech proprietary mRNA technology, was developed by both BioNTech and Pfizer.


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.

 

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