Comirnaty JN.1 10 micrograms/dose dispersion for injection - single dose vial

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your child’s doctor, pharmacist or nurse.
• 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. See section 4.

1. What Comirnaty JN.1 is and what it is used for
2. What you need to know before your child receives Comirnaty JN.1
3. How Comirnaty JN.1 is given
4. Possible side effects
5. How to store Comirnaty JN.1
6. Contents of the pack and other information

• if your child is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)

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 JN.1 may be lower in people who are immunocompromised. If your child is immunocompromised, he/she may receive additional doses of Comirnaty JN.1. 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.

Comirnaty JN.1 10 micrograms/dose dispersion for injection, single dose vial is not recommended for children aged under 5 years.

There are paediatric formulations available for infants and children aged 6 months to 4 years. For details, please refer to the Package Leaflet for other formulations.

The vaccine is not recommended for infants aged under 6 months.

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.

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 JN.1 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 JN.1 can be used during pregnancy.

No data are available yet regarding the use of Comirnaty JN.1 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 JN.1 can be used while breast-feeding.

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 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.

• The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is called bretovameran.
  • A single dose vial contains 1 dose of 0.3 mL with 10 micrograms of bretovameran 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

The vaccine is a clear to slightly opalescent dispersion (pH: 6.9 - 7.9) provided in 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

For any information about this medicine, please contact: Medical Information,