Active ingredient
- COVID 19 Vaccine (ChAdOx1 S [recombinant])
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
COVID-19 Vaccine AstraZeneca Reg 174 Information for UK Recipients
REG 174 INFORMATION FOR UK RECIPIENTS
Package leaflet: Information for the recipient
COVID-19 Vaccine AstraZeneca solution for injection
COVID-19 Vaccine (ChAdOx1-S [recombinant])
This medicinal product has been given authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines & Healthcare products Regulatory Agency. It does not have a marketing authorisation, but this temporary authorisation grants permission for the medicine to be used for active immunisation of individuals aged 18 years and older for the prevention of coronavirus disease 2019 (COVID-19).
Reporting of side effects
As with any new medicine in the UK this product will be closely monitored to 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 the vaccine is given because it contains important information for you.
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 are given 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
1. What COVID-19 Vaccine AstraZeneca is and what it is used for
COVID-19 Vaccine AstraZeneca is a vaccine used for preventing COVID-19, caused by a virus called coronavirus (SARS-CoV-2).
COVID-19 Vaccine AstraZeneca is given to adults aged 18 years and older.
COVID-19 Vaccine AstraZeneca stimulates the body’s natural defences (immune system). It causes the body to produce its own protection (antibodies) against the virus. This will help to protect you against COVID-19 in the future. None of the ingredients in this vaccine can cause COVID-19.
2. What you need to know before you are given COVID-19 Vaccine AstraZeneca
Do not have the vaccine:
If you are not sure, talk to your doctor, pharmacist or nurse.
Warnings and precautions
Tell your doctor, pharmacist or nurse before vaccination:
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.
Blood disorders
Extremely rare cases of blood clots with low levels of blood platelets (thrombosis with thrombocytopenia syndrome) have been observed following vaccination with COVID-19 Vaccine AstraZeneca. This included some severe cases with blood clots in different or unusual locations and excessive clotting or bleeding throughout the body. The majority of these cases occurred within the first 3 weeks 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.
Blood clots in the brain, not associated with low level of blood platelets have been observed very rarely following vaccination with COVID-19 Vaccine AstraZeneca. The majority of these cases occurred within the first four weeks following vaccination. Some cases had a fatal outcome.
Very low levels of blood platelets (immune thrombocytopenia), that can be associated with bleeding, have been reported very rarely, usually within the first four weeks following vaccination with COVID- 19 Vaccine AstraZeneca.
If you experience any of the following from around 4 days after vaccination you should seek medical advice urgently:
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 the vaccine.
Capillary leak syndrome
Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine AstraZeneca. Some affected patients had a previous diagnosis of CLS. CLS is a serious, potentially fatal condition causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint (low blood pressure). Seek immediate medical attention if you develop these symptoms in the days following vaccination.
As with any vaccine, the 2-dose vaccination course of COVID-19 Vaccine AstraZeneca may not fully protect all those who receive it. It is not yet known how long you 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.
Neurological events
Seek immediate medical attention if you develop weakness and paralysis in the extremities that are persistent and can affect both sides of the body at the same time and can progress to the chest and face (Guillain-Barré Syndrome). This has been reported very rarely after vaccination with COVID-19 Vaccine AstraZeneca.
Children and adolescents
COVID-19 Vaccine AstraZeneca is not recommended for children aged below 18 years. 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, ask your doctor, pharmacist or nurse for advice before you receive this vaccine. 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
Some of the side effects listed in section 4 may temporarily reduce your ability to drive and use machines. If you feel unwell after vaccination, do not drive or use machines. Wait until any effects of the vaccine have worn off before you 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.
3. How COVID-19 Vaccine AstraZeneca is given
COVID-19 Vaccine AstraZeneca is given as an injection of 0.5 ml into a muscle (usually in the upper arm).
You will receive 2 injections. You will be told when you need to return for your second injection of COVID-19 Vaccine AstraZeneca.
The second injection can be given between 4 and 12 weeks after the first injection.
When COVID-19 Vaccine AstraZeneca is given for the first injection, the second injection to complete the vaccination course should also be with COVID-19 Vaccine AstraZeneca.
If you miss an appointment for your second injection of COVID-19 Vaccine AstraZeneca
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. If you miss a scheduled injection, you may not be fully protected against COVID-19.
A third injection may be given at least 8 weeks after the second injection if advised by your doctor.
4. Possible side effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Get urgent medical attention if you get symptoms of a severe allergic reaction. Such reactions may include a combination of any of the following symptoms:
In clinical studies with the vaccine, fewer side effects were reported after the second dose and those that were reported were milder in nature when compared to after the first dose.
If side effects such as pain and/or fever are troublesome, medicines containing paracetamol can be taken.
The following side effects may occur with COVID-19 Vaccine AstraZeneca:
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)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (cannot be estimated from the available data)
In clinical trials there were very rare reports of events associated with inflammation of the nervous system, which may cause numbness, pins and needles, and/or loss of feeling. However, it is not confirmed whether these events were due to the vaccine.
* Some people have reported a sudden feeling of cold with shivering/shaking accompanied by a rise in temperature, possibly with sweating, headache (including migraine-like headaches), nausea, muscle aches and feeling unwell, starting within a day of having the vaccine and usually lasting for a day or two.
If your fever is high and lasts longer than two or three days, or you have other persistent symptoms, this might not be due to side effects of the vaccine and you should follow appropriate advice according to your symptoms.
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.
5. How to store COVID-19 Vaccine AstraZeneca
Keep this medicine out of the sight and reach of children.
Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly.
Storage
Do not use COVID-19 Vaccine AstraZeneca after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Keep vials in outer carton to protect from light.
The vaccine does not contain any preservative and should be administered by a healthcare professional. After the first dose is withdrawn, the vaccine should be used as soon as practically possible and within 6 hours. During use it can be stored from 2°C to 25°C.
Disposal
COVID-19 Vaccine AstraZeneca contains genetically modified organisms (GMOs). Any unused vaccine or waste material should be disposed of in accordance with local requirements. Spills should be disinfected using agents with activity against adenovirus.
6. Contents of the pack and other information
What COVID-19 Vaccine AstraZeneca contains
One dose (0.5 ml) contains:
COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 1010 viral particles (vp)
*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 (E 433), sucrose, disodium edetate dihydrate, water for injections (see section 2 “COVID-19 Vaccine AstraZeneca contains sodium and alcohol”).
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.
Pack sizes (not all pack sizes may be marketed):
Manufacturer
For any information about this medicine, please contact:
This leaflet was last revised on 24/01/2022
Other sources of information
www.azcovid-19.com
2 Pancras Square, 8th Floor, London, N1C 4AG, UK
+44 (0)1582 838 000
+44 (0)1582 836 000
0800 783 0033
+44 (0)1582 838 003