Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Comirnaty XFG is a vaccine used for preventing COVID-19 caused by SARS-CoV-2.
Comirnaty XFG 10 micrograms/dose dispersion for injection, single dose vial is given to infants and children from 6 months to 11 years of age.
The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19.
As Comirnaty XFG does not contain the virus to produce immunity, it cannot give your child COVID−19.
The use of this vaccine should be in accordance with official recommendations.
Comirnaty XFG should not be given • if your child is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions Talk to your child’s doctor, pharmacist or nurse before your child is given the vaccine if your child:
• has ever had a severe allergic reaction or breathing problems after any other vaccine injection or after having been given this vaccine in the past.
• is feeling nervous about the vaccination process or has ever fainted following any needle injection.
• has a severe illness or infection with high fever. However, your child can have the vaccination if he/she has a mild fever or upper airway infection like a cold.
• has a bleeding problem, bruises easily or uses a medicine to prevent blood-clots.
• has a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects the immune system.
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Comirnaty (see section 4). 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. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years compared with ages 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required intensive care support and fatal cases have been seen. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.
As with any vaccine, Comirnaty XFG may not fully protect all those who receive it and it is not known how long your child will be protected.
The efficacy of Comirnaty XFG may be lower in people who are immunocompromised. If your child is immunocompromised, he/she may receive additional doses of Comirnaty XFG. In these cases, your child should continue to maintain physical precautions to help prevent COVID-19. In addition, your child’s close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your child’s doctor.
Children The vaccine is not recommended for infants aged under 6 months.
Other medicines and Comirnaty XFG Tell your child’s doctor or pharmacist if your child is using, has recently used or might use any other medicines or has recently received any other vaccine.
Pregnancy and breast-feeding If your child is pregnant, tell your child’s doctor, nurse or pharmacist before your child receives this vaccine.
No data are available yet regarding the use of Comirnaty XFG during pregnancy. However, a large amount of information from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.
Comirnaty XFG can be used during pregnancy.
No data are available yet regarding the use of Comirnaty XFG during breast-feeding. However, no effects on the breastfed newborn/infant are anticipated. Data from women who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty XFG can be used while breast-feeding.
Driving and using machines Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your child’s ability to use machines or undertake activities such as cycling. Wait until these effects have worn off before resuming activities that require your child’s full attention.
If your infant is from 6 months to less than 12 months of age, he/she will be given Comirnaty XFG as an injection of 0.3 mL into a muscle of the thigh. If your infant or child is 1 year of age or older, he/she will be given Comirnaty XFG as an injection of 0.3 mL into a muscle of the thigh or into a muscle of the upper arm.
Children 5 years to 11 years of age
Your child will receive 1 injection, regardless whether he/she has received a COVID-19 vaccine before.
If your child was previously vaccinated with a COVID-19 vaccine, he/she should not receive a dose of Comirnaty XFG until at least 3 months after the most recent dose.
Infants and children 6 months to 4 years of age
If your child has not received a COVID-19 vaccine in the past, your child will receive a maximum of 2 doses (the total number of doses required as a primary course). It is recommended to receive the second dose 8 weeks after the first dose to complete the primary course.
If your child turns 5 years old between their doses in the primary course, he/she should complete the primary course at the same 10 micrograms dose level.
If your child has previously completed a COVID-19 primary vaccination course, your child will receive 1 injection. If your child was previously vaccinated with a COVID-19 vaccine, your child should not receive a dose of Comirnaty XFG until at least 3 months after the most recent dose.
If your child has previously received 1 or 2 doses of the 3 micrograms 3-dose primary course but has not completed the COVID-19 primary vaccination course, he/she may receive additional doses of Comirnaty XFG 10 micrograms. The second dose may be administered 3 weeks after the first dose followed by a third dose at least 8 weeks after the second dose.
Immunocompromised infants and children 6 months to 11 years of age
If your child is immunocompromised, he/she may receive additional doses of Comirnaty XFG.
If you have any further questions on the use of Comirnaty XFG, ask your child’s doctor, pharmacist or nurse.
Like all vaccines, Comirnaty XFG can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people
• irritability (children 6 months to less than 2 years of age)
• injection site: pain/tenderness, swelling
• tiredness, headache
• drowsiness (children 6 months to less than 2 years of age)
• muscle pain, joint pain
• chills, fever
• diarrhoea
Common side effects: may affect up to 1 in 10 people
• nausea
• vomiting (‘very common’ in pregnant women 18 years of age and older and in immunocompromised individuals 2 to 18 years of age)
• injection site redness (‘very common’ in children 6 months to 11 years of age and in immunocompromised individuals 2 years of age and older)
• enlarged lymph nodes (more frequently observed after a booster dose)
Uncommon side effects: may affect up to 1 in 100 people
• feeling unwell, feeling weak or lack of energy/sleepy
• arm pain
• insomnia
• injection site itching
• allergic reactions such as rash (‘common’ for children 6 months to less than 2 years of age) or itching
• decreased appetite (‘very common’ for children 6 months to less than 2 years of age)
• dizziness
• excessive sweating, night sweats
Rare side effects: may affect up to 1 in 1 000 people
• temporary one sided facial drooping
• allergic reactions such as hives or swelling of the face
Very rare side effects: may affect up to 1 in 10 000 people
• inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain
Not known (cannot be estimated from the available data)
• severe allergic reaction
• extensive swelling of the vaccinated limb
• swelling of the face (swelling of the face may occur in patients who have had facial dermatological fillers)
• a skin reaction that causes red spots or patches on the skin, that may look like a target or “bulls-eye” with a dark red centre surrounded by paler red rings (erythema multiforme)
• unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
• decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)
Reporting of side effects If your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
The following information about storage, expiry and use and handling is intended for healthcare professionals.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
Store in freezer at -90 °C to -60 °C.
Store in the original package in order to protect from light.
The vaccine 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.
Single dose vials: When stored frozen at -90 °C to -60 °C, 10-vial packs of single dose vials of the vaccine can be thawed at 2 °C to 8 °C for 2 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Thawed (previously frozen) vials: Once removed from the freezer, the unopened vial may be stored and transported refrigerated at 2 °C to 8 °C for up to 10 weeks; not exceeding the printed expiry date (EXP). The outer carton should be marked with the new expiry date at 2 °C to 8 °C. Once thawed, the vaccine cannot be re-frozen.
Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and 30 °C.
Thawed vials can be handled in room light conditions.
Do not use this vaccine if you notice particulates or discolouration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Comirnaty XFG contains • The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is called mRNA encoding XFG. • A single dose vial contains 1 dose of 0.3 mL with 10 micrograms of mRNA encoding XFG per dose.
• The other ingredients are: • ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
• 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
• 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
• cholesterol
• trometamol
• trometamol hydrochloride
• sucrose
• water for injections
What Comirnaty XFG looks like and contents of the pack The vaccine is a clear to slightly opalescent dispersion (pH: 6.9 - 7.9) provided a single dose vial of 1 dose in a 2 mL clear vial (type I glass), with a rubber stopper and a blue flip-off plastic cap with aluminium seal.
Pack size: 10 vials
Marketing Authorisation Holder BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 E-mail: [email protected] Manufacturers BioNTech Manufacturing GmbH
An der Goldgrube 12
55131 Mainz
Germany
BioNTech Manufacturing GmbH
Kupferbergterrasse 17 - 19
55116 Mainz
Germany
Pfizer Manufacturing Belgium NV
Rijksweg 12
Puurs-Sint-Amands, 2870
Belgium
For any information about this medicine, please contact: Medical Information,
Pfizer Ltd
Walton Oaks
Dorking Road
Tadworth
Surrey
KT20 7NS
Telephone: 01304 616161 This leaflet was last revised in 08/2026.
Ref: bCY (XFG) 10 mcg SDV 1_0
2026-0102869
BioNTech - Pfizer
Address
An der Goldgrube 12, Mainz, 55131, Germany
WWW
https://biontech.de/
Telephone
+49 (0) 6131 90 84 0
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+44 (0)1304 616161
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www.pfizermedicalinformation.co.uk
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Comirnaty XFG 10 micrograms/dose dispersion for injection, single dose vial comes as injection containing 10 microgram. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Comirnaty XFG 10 micrograms/dose dispersion for injection, single dose vial is mrna encoding xfg.
This leaflet reproduces the patient information leaflet approved for Comirnaty XFG 10 micrograms/dose dispersion for injection, single dose vial, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
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 this vaccine should be in accordance with official recommendations.
Posology
Children 5 to 11 years of age (i.e. 5 to less than 12 years of age)
Comirnaty XFG 10 micrograms/dose dispersion for injection, single dose vial is administered intramuscularly as a single dose of 0.3 mL for children 5 to 11 years of age regardless of prior COVID-19 vaccination status (see sections 4.4 and 5.1).
For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty XFG should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Infants and children 6 months to 4 years of age who have not received a COVID-19 vaccine
Comirnaty XFG 10 micrograms/dose dispersion for injection is administered intramuscularly as a primary course of 2 doses. It is recommended to administer the second dose 8 weeks after the first dose (see sections 4.4 and 5.1).
If a child turns 5 years old between their doses in the primary course, he/she should complete the primary course at the same 10 micrograms dose level.
Infants and children 6 months to 4 years of age who have a history of completion of a COVID-19 vaccine primary course
Comirnaty XFG 10 micrograms/dose dispersion for injection is administered intramuscularly as a single dose.
For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty XFG should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Infants and children 6 months to 4 years of age who have received 1 or 2 doses of the 3 mcg 3-dose primary course
Additional doses of Comirnaty XFG 10 micrograms/dose may be administered to complete the 3−dose primary course. The second dose may be administered 3 weeks after the first dose followed by a third dose administered at least 8 weeks after the second dose (see sections 4.8 and 5.1).
Severely immunocompromised individuals
Additional doses may be administered to individuals who are severely immunocompromised in accordance with national recommendations (see section 4.4).
Interchangeability
The Comirnaty XFG 10 micrograms/dose primary course may consist of any previous or current Comirnaty vaccine but not exceeding the total number of doses required as primary course. The primary course should only be administered once.
The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers has not been established.
Paediatric population
The safety and efficacy of the vaccine in infants aged less than 6 months have not yet been established.
Method of administration
Comirnaty XFG 10 micrograms/dose dispersion for injection, single dose vial should be administered intramuscularly (see section 6.6). Do not dilute prior to use.
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 to 4 years of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. In individuals 5 years of age and older the preferred site is the deltoid muscle of the upper arm.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.
Single dose vials
Single dose vials of Comirnaty XFG contain 1 dose of 0.3 mL of vaccine.
• Withdraw a single 0.3 mL dose of Comirnaty XFG.
• Discard vial and any excess volume.
• Do not pool excess vaccine from multiple vials.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
No interaction studies have been performed.
Concomitant administration of Comirnaty XFG 10 micrograms/dose dispersion for injection, single dose vial with other vaccines has not been studied.
Pregnancy
No data are available yet regarding the use of Comirnaty XFG during pregnancy.
However, there are limited clinical study data (less than 300 pregnancy outcomes) from the use of Comirnaty in pregnant participants. A large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Based on data available with other vaccine variants, Comirnaty XFG can be used during pregnancy.
Breast-feeding
No data are available yet regarding the use of Comirnaty XFG during breast‑feeding.
However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast‑feeding woman to the vaccine is negligible. Observational data from women who were breast‑feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty XFG can be used during breast‑feeding.
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Comirnaty XFG has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
There have been reports of higher than recommended doses of Comirnaty in clinical trials and post-authorisation experience. In general, adverse events reported with overdoses have been similar to the known adverse reaction profile of Comirnaty.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Ask anything about Comirnaty XFG 10 micrograms/dose dispersion for injection, single dose vial. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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