COVID-19 Vaccine Janssen
Consumer Medicine Information
This CMI provides important information about using COVID-19 Vaccine Janssen. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using COVID-19 Vaccine Janssen.
Where to find information in this CMI:
- Why am I receiving COVID-19 Vaccine Janssen?
- What should I know before I receive COVID-19 Vaccine Janssen?
- What if I am taking other medicines?
- How do I receive COVID-19 Vaccine Janssen?
- What should I know after receiving COVID-19 Vaccine Janssen?
- Are there any side effects?
- Product details
1. Why am I receiving COVID-19 Vaccine Janssen?
COVID-19 Vaccine Janssen contains the active ingredient Ad26.COV2.S.
COVID-19 Vaccine Janssen is a vaccine used for preventing COVID-19 caused by the SARS-CoV-2 virus.
COVID-19 Vaccine Janssen is given to adults aged 18 years and older.
COVID-19 Vaccine Janssen causes the immune system (the body’s natural defences) to produce antibodies and specialised white blood cells that work against the virus, so giving protection against COVID-19. None of the ingredients in this vaccine can cause COVID-19.
2. What should I know before I receive COVID-19 Vaccine Janssen?
Do not receive COVID-19 Vaccine Janssen if:
- you have previously had a severe allergic reaction to the active substance, or any of the ingredients listed at the end of this CMI. Always check the ingredients to make sure you can receive this vaccine
Talk to your doctor, pharmacist or nurse if:
- you have ever had a severe allergic reaction after injection of any other vaccine,
- you have previously had a blood clot in the brain (venous sinus thrombosis) with low platelets, blood cells that help your body stop bleeding (thrombocytopenia); or a history of heparin-induced thrombocytopenia (HIT)
- you have ever fainted following any needle injection,
- you have a severe infection with a high temperature (over 38°C). However, you can have your vaccination if you have a mild fever or upper airway infection like a cold,
- you have a problem with bleeding or bruising, or if you are taking an anticoagulant medicine (to prevent blood clots),
- 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)
- you have been given another injection or are taking any other medicines or vaccines (see Section 3).
If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given COVID-19 Vaccine Janssen.
As with all vaccines, vaccination with COVID-19 Vaccine Janssen may not fully protect all those who receive it. It is not known how long you will be protected.
After vaccination, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
A combination of blood clots and low levels of ‘platelets’ (cells that help blood to clot) in the blood has been observed very rarely following vaccination with COVID-19 Vaccine Janssen. This includes severe cases with blood clots, including in unusual locations, such as the brain, liver, bowel and spleen in some cases in combination with bleeding. These cases occurred within the first three weeks following vaccination, and occurred mostly in women below 60 years of age. Fatal outcome has been reported.
Seek immediate medical attention if you experience:
- severe or persistent headaches
- seizures (fits)
- mental status changes
- blurred vision
- unexplained skin bruising beyond the site of vaccination which appear a few days after vaccination
- pinpoint round spots beyond the site of vaccination
- shortness of breath
- chest pain
- leg pain
- leg swelling
- persistent abdominal pain
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor, pharmacist or nurse will discuss with you whether you can be given the vaccine.
Children and adolescents younger than 18 years of age
COVID-19 Vaccine Janssen is not recommended for children aged below 18 years.
No information is available on the use of COVID-19 Vaccine Janssen in children and adolescents younger than 18 years of age.
3. What if I am taking other medicines?
Tell your doctor if you have been given another injection or are taking any other medicines or vaccines, including any over-the counter (OTC) medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect COVID-19 Vaccine Janssen.
Published by MIMS August 2021