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Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
What is in this leaflet:
COVID-19 mRNA Vaccine BNT162b2 is a vaccine used for active immunisation to prevent COVID19 disease caused by SARS-CoV-2 virus.
COVID-19 mRNA Vaccine BNT162b2 is given to adults and adolescents from 16 years.
The vaccine triggers the body’s natural production of antibodies and stimulates immune cells to protect against COVID-19 disease.
COVID-19 mRNA Vaccine BNT162b2 should not be given
Talk to your doctor, pharmacist or nurse before you are given the vaccine if you have:
As with any vaccine, COVID-19 mRNA Vaccine BNT162b2 may not fully protect all those who receive it. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.
COVID-19 mRNA Vaccine BNT162b2 is not recommended for children under 16 years.
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.
There is currently limited data available on the use of this vaccine in pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine. As a precaution, you should avoid becoming pregnant until at least 2 months after the vaccine.
COVID-19 mRNA Vaccine BNT162b2 has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4 ‘Possible side effects’ may temporarily affect the ability to drive or use machines. Do not drive or operate machinery until you are sure that you are not affected.
This vaccine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree’.
COVID-19 mRNA Vaccine BNT162b2 is given after dilution as an injection of 0.3 mL into a muscle of your upper arm.
You will receive 2 injections, given 21 days apart.
If you receive one dose of COVID-19 mRNA Vaccine BNT162b2, you should receive a second dose of the same vaccine 21 days later to complete the vaccination series. Protection against COVID-19 disease may not be effective until at least 7 days after the second dose.
If you have any further questions on the use of COVID-19 mRNA Vaccine BNT162b2, ask your doctor, pharmacist or nurse.
Like all vaccines, COVID-19 mRNA Vaccine BNT162b2 can cause side effects, although not everybody gets them.
Most side effects are mild or moderate and go away within a few days of appearing. If side effects such as pain and/or fever are troublesome, they can be treated by medicines for pain and fever such as paracetamol.
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Coronavirus Yellow Card reporting site or search for MHRA Yellow Card in the Google Play or Apple App Store and include the vaccine brand and batch/Lot number if available.
By reporting side effects, you can help provide more information on the safety of this vaccine.
Do not use this medicine after the expiry date which is stated on the box and label after EXP.
The expiry date refers to the last day of that month.
Store in freezer at -80 °C to -60 °C.
Store in the original package in order to protect from light.
After thawing, the vaccine should be diluted and administered by a healthcare professional and used within 6 hours. Any unused vaccine should be discarded.
What COVID-19 mRNA Vaccine BNT162b2 contains:
After dilution, the vial contains 5 doses, of 0.3 mL with 30 micrograms mRNA each.
The other ingredients are:
The vaccine is a white to off-white solution provided in a multidose vial of 5 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a flip-off plastic cap with aluminium seal.
Pack size: 195 vials
Manufacturer(s)
BioNTech Manufacturing GmbH
Kupferbergterrasse 17-19
55116 Mainz, Germany