COVID-19 Vaccine (Temporary Authorisation – Review Product Information tab before reading)

Read all of this leaflet carefully before the vaccine is given because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What COVID-19 Vaccine AstraZeneca is and what it is used for
2. What you need to know before you receive COVID-19 Vaccine AstraZeneca
3. How COVID-19 Vaccine AstraZeneca is given
4. Possible side effects
5. How to store COVID-19 Vaccine AstraZeneca
6. Contents of the pack and other information

Do not have the vaccine:

• If you have ever had a severe allergic reaction to any of the active substances or any of the other ingredients listed in section 6. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away if you have an allergic reaction. It can be life-threatening.
• If you have ever had a major blood clot occurring at the same time as having low levels of platelets after receiving any COVID-19 vaccine.
• If you had ever had a condition known as heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2).

Warnings and precautions

Tell your doctor, pharmacist or nurse before vaccination:

• If you have ever had a severe allergic reaction (anaphylaxis) after any other vaccine injection;
• If you currently have a severe infection with a high temperature (over 38°C). However, a mild fever or infection, like a cold, are not reasons to delay vaccination;
• If you have a problem with bleeding or bruising, or if you are taking a blood thinning medicine (anticoagulant);
• If your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines);
• If you have ever had a blood clot in the sinus veins in the brain, or the autoimmune condition called antiphospholipid syndrome.

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before you are given the vaccine.

Extremely rare cases of blood clots with low levels of platelets have been observed following vaccination with COVID-19 Vaccine AstraZeneca. The majority of these cases occurred within the first 14 days following vaccination but some have also been reported after this period. Some cases were life-threatening or had a fatal outcome. It is important to remember the benefits of vaccination to give protection against COVID-19 still outweigh any potential risks.

If you experience any of the following from around 4 days after vaccination you should seek medical advice urgently:

• a severe headache that is not relieved with simple painkillers or is getting worse or feels worse when you lie down or bend over
• an unusual headache that may be accompanied by blurred vision, confusion, difficulty with speech, weakness, drowsiness or seizures (fits)
• rash that looks like small bruises or bleeding under the skin beyond the injection site
• shortness of breath, chest pain, leg swelling or persistent abdominal (tummy) pain.

Tell your doctor, pharmacist or nurse if you experienced a blood clot occurring at the same time as low levels of platelets after receiving a previous dose of a COVID-19 vaccine.

As with any vaccine, COVID-19 Vaccine AstraZeneca may not protect everyone who is vaccinated from COVID-19. It is not yet known how long people who receive the vaccine will be protected for. No data are currently available in individuals with a weakened immune system or who are taking chronic treatment that suppresses or prevents immune responses.

Children and adolescents

No data are currently available on the use of COVID-19 Vaccine AstraZeneca in children and adolescents younger than 18 years of age.

Other medicines and COVID-19 Vaccine AstraZeneca

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take, any other medicines or vaccines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, tell your doctor, pharmacist or nurse. There are limited data on the use of COVID-19 Vaccine AstraZeneca in pregnant or breastfeeding women. Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine.

Driving and using machines

COVID-19 Vaccine AstraZeneca has no known effect on the ability to drive and use machines. However, side effects listed in section 4 may impact your ability to drive and use machines. If you feel unwell, do not drive or use machines.

COVID-19 Vaccine AstraZeneca contains sodium and alcohol (ethanol)

This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 ml. This means that it is essentially ‘sodium-free’.

This medicine contains a very small amount of alcohol (2 mg of alcohol (ethanol) per dose of 0.5 ml).

This is not enough to cause any noticeable effects.

If you miss your second injection

If you forget to go back at the scheduled time, ask your doctor, pharmacist or nurse for advice. It is important that you return for your second injection of COVID-19 Vaccine AstraZeneca.

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 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.

What COVID-19 Vaccine AstraZeneca contains

One dose (0.5 ml) contains:

COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 10¹⁰ viral particles

*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.

This product contains genetically modified organisms (GMOs).

The other excipients are L-histidine, L-histidine hydrochloride monohydrate, magnesium chloride hexahydrate, polysorbate 80, ethanol, sucrose, sodium chloride, disodium edetate dihydrate, water for injections.

What COVID-19 Vaccine AstraZeneca looks like and contents of the pack

Solution for injection. The solution is colourless to slightly brown, clear to slightly opaque and particle free.

Pack sizes (not all pack sizes may be marketed):

• 10 dose vial (5 ml) in packs of 10 vials.
• 8 dose vial (4 ml) in packs of 10 vials.

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