Patient leaflet - Comirnaty JN.1 3 micrograms/dose concentrate for Dispersion for injection
1. What Comirnaty JN.1 is and what it is used for
Comirnaty JN.1 is a vaccine used for preventing COVID-19 caused by SARS-CoV-2.
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection is given to infants and children from 6 months to 4 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 JN.1 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.
2. What you need to know before your child receives Comirnaty JN.1
Comirnaty JN.1 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 JN.1 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 may be lower in people who are immunocompromised. If your child is immunocompromised, he/she may receive additional doses of Comirnaty. 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
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection is not recommended for children aged 5 years to 11 years.
There are paediatric formulations available for children 5 to 11 years of age. For details, please refer to the Package Leaflet for other formulations.
The vaccine is not recommended for infants aged under 6 months.
Other medicines and Comirnaty JN.1
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
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection is not intended for individuals older than 5 years of age.
For details for use in individuals older than 5 years of age, please refer to the Package Leaflet for those formulations.
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.
3. How Comirnaty JN.1 is given
If your infant is from 6 months to less than 12 months of age, he/she will be given Comirnaty JN.1 with a maroon cap after dilution as an injection of 0.2 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 JN.1 with a maroon cap after dilution as an injection of 0.2 mL into a muscle of the thigh or into a muscle of the upper arm.
If your child has not completed a COVID-19 primary vaccination course or has not been infected by COVID-19 in the past, your child will receive a maximum of 3 injections (the total number of doses required as primary course). It is recommended to receive the second dose 3 weeks after the first dose followed by a third dose at least 8 weeks after the second dose to complete the primary course.
If your child has previously completed a COVID-19 primary vaccination course or has had COVID-19, 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 JN.1 until at least 3 months after the most recent dose.
If your child turns 5 years old between their doses in the primary course, he/she should complete the primary course at the same 3 micrograms dose level.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty JN.1.
Interchangeability
Your child may receive any previous or current Comirnaty vaccine for the primary course. Your child should not receive more than the total number of doses needed as primary course. Your child should only be administered the primary course once.
If you have any further questions on the use of Comirnaty JN.1, ask your child’s doctor, pharmacist or nurse.
4. Possible side effects
Like all vaccines, Comirnaty JN.1 can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people
- irritability (6 months to less than 2 years)
- injection site: pain/tenderness, swelling
- tiredness, headache
- drowsiness (6 months to less than 2 years)
- 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 6 months to 11 years 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 6 months to less than 2 years) or itching
- decreased appetite (‘very common’ for 6 months to less than 2 years)
- 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.
5. How to store Comirnaty JN.1
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.
When stored frozen at -90 °C to -60 °C, 10-vial packs 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.
After dilution, store the vaccine at 2 °C to 30 °C and use within 12 hours, which includes up to 6 hours transportation time. Discard any unused vaccine.
Do not use this vaccine if you notice particulates in the dilution 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.
6. Contents of the pack and other information
What Comirnaty JN.1 contains
- The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is called bretovameran. After dilution, the vial with a maroon cap contains 10 doses of 0.2 mL with 3 micrograms bretovameran each.
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 JN.1 looks like and contents of the pack
The vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 10 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a maroon 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
service@biontech.de
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 04/2026.
Ref: bCY (JN.1) 3 mcg Conc 10 doses 5_0
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The following information is intended for healthcare professionals only:
If the child has not completed a COVID-19 primary vaccination course or does not have a history of prior SARS-CoV-2 infection, administer Comirnaty JN.1 with a maroon cap intramuscularly after dilution as a primary course of maximum 3 doses (the total number of doses required as primary course); the second dose administered 3 weeks after the first dose followed by a third dose at least 8 weeks after the second dose to complete the primary course.
If the child has completed a COVID-19 primary vaccination course or has a history of prior SARS-CoV-2 infection, administer Comirnaty JN.1 with a maroon cap intramuscularly after dilution a single dose of 0.2 mL. If the individual was previously vaccinated with a COVID-19 vaccine, the individual should receive a dose of Comirnaty JN.1 at least 3 months after the most recent dose.
Additional doses may be given to individuals who are severely immunocompromised.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Handling instructions prior to use
Verify that the vial has a maroon plastic cap and the product name is Comirnaty JN.1
3 micrograms/dose concentrate for dispersion for injection (infants and children 6 months to 4 years).
- If the vial has another product name on the label, or a different cap colour, please make reference to the Summary of Product Characteristics for that formulation.
- If the vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 10-vial pack may take 2 hours to thaw. Ensure vials are completely thawed prior to use.
- Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton.
- Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; not exceeding the printed expiry date (EXP).
- Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C.
Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.
Dilution for a vial with a maroon cap
- Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake.
- Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
The thawed vaccine must be diluted in its original vial with 2.2 mL sodium chloride 9 mg/mL
(0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques.
- Equalise vial pressure before removing the needle from the vial stopper by withdrawing 2.2 mL air into the empty diluent syringe.
- Gently invert the diluted dispersion 10 times. Do not shake.
- The diluted vaccine should present as a white to off-white dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present.
- The diluted vials should be marked with the appropriate discard date and time.
- After dilution, store at 2 ºC to 30 ºC and use within 12 hours.
- Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
Preparation of 0.2 mL doses using a vial with a maroon cap
- After dilution, the vial contains 2.6 mL from which 10 doses of 0.2 mL can be extracted.
- Using aseptic technique, cleanse the vial stopper with a single use antiseptic swab.
- Withdraw 0.2 mL of Comirnaty JN.1 for infants and children aged 6 months to 4 years.
- Low dead-volume syringes and/or needles should be used in order to extract 10 doses from a single vial. The low dead-volume syringe and needle combination should have a dead-volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract ten doses from a single vial.
- Each dose must contain 0.2 mL of vaccine.
- If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.
- Discard any unused vaccine within 12 hours after dilution.
Disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.