Patient Leaflet Updated 25-Apr-2022 | BioNTech - Pfizer
Comirnaty 30 micrograms/dose concentrate for dispersion for injection 12+ years COVID-19 mRNA Vaccine (nucleoside modified)
Package leaflet: Information for the user
Comirnaty 30 micrograms/dose concentrate for dispersion for injection
Adults and adolescents from 12 yearsCOVID-19 mRNA Vaccine (nucleoside modified)
tozinameran
▼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.
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
What is in this leaflet
1. What Comirnaty is and what it is used for
2. What you need to know before you receive Comirnaty
3. How Comirnaty is given
4. Possible side effects
5. How to store Comirnaty
6. Contents of the pack and other information
1. What Comirnaty is and what it is used for
Comirnaty is a vaccine used for preventing COVID-19 caused by SARS-CoV-2 virus.
Comirnaty 30 micrograms/dose concentrate for 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 does not contain the virus to produce immunity, it cannot give you COVID-19.
2. What you need to know before you receive Comirnaty
Comirnaty should not be given
Warnings and precautions
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. 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 may not fully protect all those who receive it and it is not known how long you will be protected.
You may receive a third dose of Comirnaty. The efficacy of Comirnaty, even after a third dose, may be lower in people who are immunocompromised. 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.
Children
Comirnaty 30 micrograms/dose concentrate for dispersion for injection is not recommended for children aged under 12 years.
There is a paediatric presentation available for children 5 to 11 years of age. For details, please refer to the Package Leaflet for Comirnaty 10 micrograms/dose concentrate for dispersion for injection.
Other medicines and Comirnaty
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.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine.
Comirnaty can be used during pregnancy. A large amount of information from pregnant women vaccinated with Comirnaty 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 can be given during breast-feeding.
Driving and using machines
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 contains potassium and sodium
This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium-free’.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How Comirnaty is given
Comirnaty is given after dilution as an injection of 0.3 mL into a muscle of your upper arm.
You will receive 2 injections.
It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination course.
If you are immunocompromised, you may receive a third dose of Comirnaty at least 28 days after the second dose.
A booster dose of Comirnaty may be given at least 6 months after the second dose in individuals 12 years of age and older.
If you have any further questions on the use of Comirnaty, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all vaccines, Comirnaty 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)
Reporting of side effects
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.
5. How to store Comirnaty
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. Unopened vials may be stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C to -60 °C; not exceeding the printed expiry date (EXP).
Store in the original package in order to protect from light.
When stored frozen at -90 °C to -60 °C, 195-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
Transfers of frozen vials stored at ultra-low temperature (< -60 °C)
Transfers of frozen vials stored at -25 °C to -15 °C
Once a vial is removed from the vial tray, it should be thawed for use.
After thawing, the vaccine should be diluted and used immediately. However, in-use stability data have demonstrated that once removed from freezer, the undiluted vaccine can be stored for up to 1 month at 2 °C to 8 °C; not exceeding the printed expiry date (EXP).. Within the 1-month shelf life at 2 °C to 8 °C, up to 12 hours may be used for transportation. Prior to use, the unopened vaccine can be stored for up to 2 hours at temperatures up to 30 °C.
Thawed vials can be handled in room light conditions.
After dilution, store and transport the vaccine at 2 °C to 30 °C and use within 6 hours. Discard any unused vaccine.
Once removed from the freezer and diluted, the vials should be marked with the new discard date and time. Once thawed, the vaccine cannot be re-frozen.
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 contains
What Comirnaty 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 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a purple flip-off plastic cap with aluminium seal.
Pack size: 195 vials
Marketing Authorisation Holder
Manufacturer(s)
For any information about this medicine, please contact: Medical Information,
This leaflet was last revised in 04/2022.
This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited. New information on this medicinal product will be reviewed at least every year and this leaflet will be updated as necessary.
Ref: bCY 15_0
Pfleet no:
2021-0072678, 2021-0073908, 2022-0075536, 2022-0075537, 2022-0075548
An der Goldgrube 12, Mainz, 55131, Germany
+49 (0) 6131 90 84 0
www.pfizermedicalinformation.co.uk
https://biontech.de/
+44 (0)1304 616161
