Patient Leaflet Updated 20-Apr-2026 | BioNTech - Pfizer
Comirnaty JN.1 30 micrograms/dose dispersion for injection Adults and adolescents from 12 years COVID-19 mRNA Vaccine
Comirnaty JN.1 30 micrograms/dose dispersion for injection (frozen vials)
Adults and adolescents from 12 years
COVID-19 mRNA Vaccine
bretovameran
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Comirnaty JN.1 is and what it is used for
2. What you need to know before you receive 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
Comirnaty JN.1 is a vaccine used for preventing COVID-19 caused by SARS-CoV-2.
Comirnaty JN.1 30 micrograms/dose dispersion for injection is given to adults and adolescents from 12 years of age and older.
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 you COVID-19.
The use of this vaccine should be in accordance with official recommendations.
Talk to your doctor, pharmacist or nurse before you are given the vaccine if:
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 you will be protected.
The efficacy of Comirnaty JN.1 may be lower in people who are immunocompromised. If you are immunocompromised, you may receive additional doses of Comirnaty JN.1. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.
Comirnaty JN.1 30 micrograms/dose dispersion for injection is not recommended for children aged under 12 years.
There are paediatric formulations available for infants aged 6 months and above and children below 12 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.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine.
Comirnaty JN.1 may be given at the same time as a flu vaccine.
In adults 18 years of age and older, Comirnaty JN.1 may be given at the same time as a pneumococcal conjugated vaccine (PCV).
In adults 18 years of age and older, Comirnaty JN.1 may be given at the same time as a respiratory syncytial virus (RSV) vaccine.
In older adults 65 years of age and older, Comirnaty JN.1 may be given at the same time as a high dose flu and an RSV vaccine.
If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive 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 ability to drive or use machines. Wait until these effects have worn off before you drive or use machines.
Comirnaty JN.1 is given as an injection of 0.3 mL into a muscle of your upper arm.
You will receive 1 injection, regardless whether you have received a COVID-19 vaccine before.
If you were previously vaccinated with a COVID-19 vaccine, you should not receive a dose of Comirnaty JN.1 until at least 3 months after the most recent dose.
If you are immunocompromised, you may receive additional doses of Comirnaty JN.1.
If you have any further questions on the use of Comirnaty JN.1, ask your doctor, pharmacist or nurse.
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
Some of these side effects were slightly more frequent in adolescents 12 to 15 years than in adults.
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. 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 (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.
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 white to off-white dispersion (pH: 6.9 - 7.9) provided in a multidose vial of 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a grey flip-off plastic cap with aluminium seal.
Pack size: 10 vials
For any information about this medicine, please contact: Medical Information,
This leaflet was last revised in 04/2026.
Ref: bCY (JN.1) 30 mcg MDV 7_0
2026-0102218
An der Goldgrube 12, Mainz, 55131, Germany
+49 (0) 6131 90 84 0
www.pfizermedicalinformation.co.uk
https://biontech.de/
+44 (0)1304 616161
