This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 53632/0032.
Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)
Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection
Children 5 to 11 years
COVID-19 mRNA Vaccine (nucleoside modified)
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects your child may get. See the end of section 4 for how to report side effects.
1. What Comirnaty Omicron XBB.1.5 is and what it is used for
2. What you need to know before your child receives Comirnaty Omicron XBB.1.5
3. How Comirnaty Omicron XBB.1.5 is given
4. Possible side effects
5. How to store Comirnaty Omicron XBB.1.5
6. Contents of the pack and other information
Comirnaty Omicron XBB.1.5 is a vaccine used for preventing COVID-19 caused by SARS-CoV-2.
Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection is given to children from 5 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 Omicron XBB.1.5 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.
Talk to your child’s doctor, pharmacist or nurse before your child is given the vaccine if your child:
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 Omicron XBB.1.5 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 Omicron XBB.1.5 may be lower in people who are immunocompromised. If your child is immunocompromised, he/she may receive additional doses of Comirnaty Omicron XBB.1.5. 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 Omicron XBB.1.5 10 micrograms/dose dispersion for injection 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 Omicron XBB.1.5 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 Omicron XBB.1.5 can be used during pregnancy.
No data are available yet regarding the use of Comirnaty Omicron XBB.1.5 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 Omicron XBB.1.5 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.
Comirnaty Omicron XBB.1.5 is given as an injection of 0.3 mL into a muscle of your child’s upper arm.
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 Omicron XBB.1.5 until at least 3 months after the most recent dose.
If your child is immunocompromised, he/she may receive additional doses of Comirnaty Omicron XBB.1.5.
If you have any further questions on the use of Comirnaty Omicron XBB.1.5, ask your child’s doctor, pharmacist or nurse.
Like all vaccines, Comirnaty Omicron XBB.1.5 can cause side effects, although not everybody gets them.
Very common side effects: may affect more than 1 in 10 people
Common side effects: may affect up to 1 in 10 people
Uncommon side effects: may affect up to 1 in 100 people
Rare side effects: may affect up to 1 in 1 000 people
Very rare side effects: may affect up to 1 in 10 000 people
Not known (cannot be estimated from the available data)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
If you are concerned about a side-effect it can be reported directly via the Coronavirus Yellow Card reporting site https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store and include batch/Lot number if available. 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.
Multidose vials: 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 6 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Thawed 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 discard 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.
Opened vials: After first puncture, 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 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.
The vaccine is a clear to slightly opalescent dispersion (pH: 6.9 - 7.9) provided in:
Multidose vial pack size: 10 vials
Not all pack sizes may be marketed.
For any information about this medicine, please contact:
This leaflet was last revised in 09/2023.
Ref: bCY (XBB.1.5) 10 mcg MDV 1_0