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For Prescribing Information on COMIRNATY®▼ vaccines available for use in the private market, please click here. Adverse event reporting information can be found at the bottom of the page.

COVID-19 National Immunisation ProgrammeTitle
Therpeutic indications:
  • COMIRNATY   XFG 30 micrograms/dose dispersion for injection in pre-filled syringe is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.
  • COMIRNATY   XFG 10 micrograms/dose dispersion for injection, single dose vial is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 11 years.
The use of the vaccines should be in accordance with the official recommendations.1,2

The autumn 2026 National Immunisation Programme:

The groups recommended by Joint Committee on Vaccination and Immunisation (JCVI) for vaccination in the NIP, continued from spring 2026 are:3,4

  1. Adults aged 75 years and over
  2. Residents in a care home for older adults
  3. Individuals aged 6 months and over who are immunosuppressed (as defined in the 'immunosuppression definition' box of the COVID-19 chapter of the green book here)
For prescribing information for COMIRNATY vaccines that can be used as part of the National Immunisation Programme, please click here

For information regarding private provision of COMIRNATY vaccines, please click here.

 

For more information relating to Pfizer's vaccines and relates therapy areas, including clinical publications and resources, as well as assets relating to particular at-risk groups, please click here.

COMIRNATY XFG Vaccine Formulation Quick Reference Guide
 COMIRNATY XFG 30 micrograms/dose dispersion for injection pre-filled syringe COVID-19 mRNA Vaccine1COMIRNATY XFG 10 micrograms/dose dispersion for injection single dose vial COVID-19 mRNA Vaccine2
Licensed age of use12 years and older6 months to 11 years
One dose contains30 micrograms mRNA encoding XFG10 micrograms mRNA encoding XFG
Dilution statusReady for use. Do not diluteReady for use. Do not dilute
Doses per vial/syringe1 dose of 0.3mL1 dose of 0.3mL
Dilution volumeDo not dilute prior to useDo not dilute prior to use.
PresentationSingle-use pre-filled syringeSingle dose vial
Refrigerated storage (2°C to 8 °C) once thawedReceived and stored at 2°C to 8 °C. 12 month shelf life when stored at 2°C to 8 °C. Store vaccine in the original packaging in order to protect from light.10 weeks storage and transportation at 2°C to 8 °C within the 18-month shelf life. Once thawed the vaccine should not be refrozen.

There should be an interval of at least 3 months between administration of COMIRNATY XFG and the last prior dose of COVID-19 vaccine.1,2Undesirable Effects1,2

The safety of COMIRNATY XFG is inferred from safety data of the prior COMIRNATY vaccines, given as first, second and subsequent doses.

The most common adverse reactions (classified as very common >1/10) from COMIRNATY clinical trials and post-authorisation experience were:

  • Diarrhoea
  • Headache
  • Arthralgia/Myalgia
  • Injection site pain/swelling/redness (redness only occured in immunocompromised participants <12 years)
  • Pyrexia*
  • Chills
  • Fatigue
Vomiting (only in pregnant women ages >18 years and immunocompromised participants from 5 to 18 years)
*a higher frequency of pyrexia was observed after a second dose compared to a first doseMechanism of Action1,2
  • mRNA encoding XFG is single-stranded, 5'-capped-messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (mRNA encoding XFG).
  • 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.
  • The vaccine elicits both neutralising antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19.

Hypersensitivity and anaphylaxis:1,2

  • 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:1,2
  • 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 professionals should consult guidance and/or specialists to diagnose and treat the conditions.
Before administering the vaccine, refer to the Summary of Product Characteristics for further details.
References
COMIRNATY XFG 30 micrograms/dose dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine Summary of Product Characteristics; Pfizer and BioNTech. Available at: https://medicines.org.uk/emc/product/102371COMIRNATY XFG 10 micrograms/dose dispersion for injection, single dose vial COVID-19 mRNA Vaccine Summary of Product Characteristics; Pfizer and BioNTech. Available at: https://medicines.org.uk/emc/product/102370UKHSA. COVID-19: the green book chapter. Available at: https://assets.publishing.service.gov.uk/media/69ba84f46b1db9df335fcb04/Green_Book_chapter_Covid_14a_17_3_26.pdfCOVID-19: the green book chapter [Accessed August 2026]GOV.UK. Advice accepted on autumn 2026 COVID-19 vaccination programme. Available at: https://www.gov.uk/government/news/advice-accepted-on-autumn-2026-covid-19-vaccination-programme [Accessed August 2026] 
PP-CMR-GBR-1081. August 2026

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 the 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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Holder: BioNTech
Manufacturing GmbH

COMIRNATY COVID-19 mRNA Vaccines, which are based on BioNTech proprietary mRNA technology, were developed by both BioNTech and Pfizer.


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