What is a Patient Information Leaflet and why is it useful?

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.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00242/0742.


COVID-19 Vaccine Janssen suspension for injection

Package leaflet: Information for the user

COVID-19 Vaccine Janssen suspension for injection

COVID-19 vaccine (Ad26.COV2-S [recombinant])

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

1. What COVID-19 Vaccine Janssen is and what it is used for

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.

The vaccine 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 you need to know before you are given COVID-19 Vaccine Janssen

Do not have the vaccine if:

  • You are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given COVID-19 Vaccine Janssen if:

  • you have ever had a severe allergic reaction after injection of any other vaccine,
  • you have ever fainted following any needle injection,
  • you have ever had a condition known as heparin induced thrombocytopenia and thrombosis (HITT or HIT type 2),
  • 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).

As with any vaccine, 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.

Blood disorders

A combination of blood clots and low levels of ‘platelets’ (cells that help blood to clot) in the blood has been observed extremely 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 or 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, develop shortness of breath, chest pain, leg pain, leg swelling, or persistent abdominal pain. Inform your healthcare provider that you have recently received COVID-19 Vaccine Janssen.

Children and adolescents

COVID-19 Vaccine Janssen is not recommended for children aged below 18 years. Currently there is not enough information available on the use of COVID-19 Vaccine Janssen in children and adolescents younger than 18 years of age.

Other medicines and COVID-19 Vaccine Janssen

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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.

Driving and using machines

Some of the side effects of COVID-19 Vaccine Janssen listed 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.

COVID-19 Vaccine Janssen contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose of 0.5 mL, that is to say essentially ‘sodium-free’.

COVID-19 Vaccine Janssen contains ethanol

This medicine contains 2 mg of alcohol (ethanol) in each dose of 0.5 mL. The amount of ethanol in this medicine is equivalent to less than 1 mL beer or wine. The small amount of alcohol in this medicine will not have any noticeable effects.

3. How COVID-19 Vaccine Janssen is given

Your doctor, pharmacist or nurse will inject the vaccine into the muscle - usually in the upper arm.

How much vaccine will you receive

A single-dose (0.5 mL) of COVID-19 Vaccine Janssen is injected.

After the injection your doctor, pharmacist or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction.

If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all vaccines, COVID-19 Vaccine Janssen can cause side effects, although not everybody gets them. Most of the side effects occur in the 1 or 2 days of getting the vaccination.

Get medical attention immediately if within 3 weeks of vaccination you get any of the following symptoms:

  • experience severe or persistent headaches, blurred vision, mental status changes or seizures(fits);
  • develop shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain;
  • notice unusual skin bruising or pinpoint round spots beyond the site of vaccination.

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:

  • feeling faint or light-headed
  • changes in your heartbeat
  • shortness of breath
  • wheezing
  • swelling of your lips, face, or throat
  • hives or rash
  • nausea or vomiting
  • stomach pain.

The following side effects can happen with this vaccine.

Very common: may affect more than 1 in 10 people

  • headache
  • nausea
  • muscle aches
  • pain where the injection is given
  • feeling very tired

Common: may affect up to 1 in 10 people

  • redness where the injection is given
  • swelling where the injection is given
  • chills
  • joint pain
  • cough
  • fever

Uncommon: may affect up to 1 in 100 people

  • rash
  • muscle weakness
  • arm or leg pain
  • feeling weak
  • feeling generally unwell
  • sneezing
  • sore throat
  • back pain
  • tremor
  • excessive sweating

Rare: may affect up to 1 in 1 000 people

  • allergic reaction
  • hives

Very Rare: may affect up to 1 in 10 000 people

  • Following widespread use of the vaccine there have been extremely rare reports of blood clots in combination with low level of blood platelets. When these blood clots do occur, they may be in unusual or atypical locations (e.g. brain, liver, bowel, spleen).

Unknown (cannot be estimated from the available data)

  • severe allergic reaction

Tell your doctor, pharmacist or nurse if you have any side effects that bother you or do not go away.

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 COVID-19 Vaccine Janssen

Keep this vaccine out of the sight and reach of children.

Store vial in the original carton to protect from light.

Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly.

Store and transport frozen at -25°C to -15°C. The expiry date for storage at -25°C to -15°C is printed on the vial and outer carton after “EXP”.

The vaccine comes ready to use once thawed. The vaccine may be supplied frozen at- 25°C to -15°C or thawed at 2°C to 8°C.

When stored frozen at -25°C to -15°C, the vaccine can be thawed either at 2°C to 8°C or at room temperature:

  • at 2°C to 8°C: a carton of 10 vials will take approximately 12 hours to thaw, and a single vial will take approximately 2 hours to thaw.
  • at room temperature (maximally 25°C): a carton of 10 vials will take approximately 2 hours to thaw, and a single vial will take approximately 1 hour to thaw.

Do not re-freeze vaccine once thawed.

The vaccine can also be stored in a refrigerator at 2°C to 8°C for a single period of up to 3 months, not exceeding the original expiry date (EXP). Upon moving the product to 2°C to 8°C storage, the updated expiry date must be written on the outer carton and the vaccine should be used or discarded by the updated expiry date. The original expiry date should be made unreadable. The vaccine can also be transported at 2°C -8°C as long as the appropriate storage conditions (temperature, time) are applied.

6. Contents of the pack and other information

What COVID-19 Vaccine Janssen contains

  • The active substance is Adenovirus type 26 encoding the SARS-CoV-2 spike
    glycoprotein*(Ad26.COV2-S) not less than 8.92 log10 infectious units (Inf.U) in each 0.5 mL dose.
    * Produced in the PER.C6 TetR Cell Line and by recombinant DNA technology.
    This product contains genetically modified organisms (GMOs).
  • The other ingredients (excipients) are:
    2-hydroxypropyl-β-cyclodextrin (HBCD), citric acid monohydrate, ethanol, hydrochloric acid, polysorbate-80, sodium chloride, sodium hydroxide, trisodium citrate dihydrate, water for injections (see section 2 COVID-19 Vaccine Janssen contains sodium and COVID-19 Vaccine Janssen contains ethanol).

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

Suspension for injection (injection). The suspension is colorless to slightly yellow, clear to very opalescent suspension (pH 6-6.4).

2.5 mL suspension in a multi-dose vial (type I glass) with a rubber stopper, aluminium crimp and blue plastic cap. Each vial contains 5 doses of 0.5 mL.

COVID-19 Vaccine Janssen is available in a pack containing 10 multi-dose vials.

Marketing Authorisation Holder

Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
UK

Manufacturer

Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
The Netherlands

Janssen Pharmaceutica NV
Turnhoutseweg 30
2340 Beerse
Belgium

For information in large print, tape, CD or Braille, telephone +442076602872/0080056540088.

This leaflet was last revised in 05/2021

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 at least every year and this leaflet will be updated as necessary.

Scan the QR code below (also available on the carton and QR card) to get the package leaflet in different languages.

Or visit the URL: www.covid19vaccinejanssen.com