COVID-19 Vaccine Janssen - patient leaflet, side effects, dosage

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).
• You have had a blood clot occurring at the same time as having low levels of blood platelets

(thrombosis with thrombocytopenia syndrome, TTS) after receiving any COVID-19 vaccine.

• You have a previous diagnosis of capillary leak syndrome, (a condition causing fluid leakage from small blood vessels).

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 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 risk factors for blood clots in your veins (venous thromboembolism (VTE)).

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

• Venous thromboembolism: Blood clots in veins (venous thromboembolism (VTE)) have been

observed rarely following vaccination with COVID-19 Vaccine Janssen.

• Thrombosis with thrombocytopenia syndrome: A combination of blood clots and low levels of

‘platelets’ 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 mostly occurred within the first three weeks following vaccination and in individuals below 60 years of age. Fatal outcome has been reported.

• Immune thrombocytopenia: 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 Janssen.

Seek immediate medical attention, if you experience symptoms that may be signs of blood disorders: severe or persistent headaches, seizures (fits), mental status changes or blurred vision, unexplained bleeding, 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.

Capillary leak syndrome

Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID-19 Vaccine Janssen. At least one affected patient 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.

Neurological disorders

• Guillain-Barre syndrome

Seek immediate medical attention if you develop weakness and paralysis in the extremities that can progress to the chest and face (Guillain-Barre syndrome, GBS). This has been reported very rarely after vaccination with COVID-19 Vaccine Janssen.

• Inflammation of the spinal cord (transverse myelitis)

Seek immediate medical attention if you develop weakness in the arms or legs, sensory symptoms (such as tingling, numbness, pain or loss of pain sensation) or problems with bladder or bowel function. This has been reported very rarely after vaccination with COVID-19 Vaccine Janssen.

Risk of very rare events after a booster dose

The risk of very rare events (such as blood disorders including thrombosis with thrombocytopenia syndrome, CLS and GBS) after a booster dose of COVID-19 Vaccine Janssen is unknown.

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 primary vaccination (0.5 mL) of COVID-19 Vaccine Janssen is injected.

A booster dose (second dose) of COVID-19 Vaccine Janssen may be given at least 2 months after the primary vaccination in individuals 18 years of age and older.

COVID-19 Vaccine Janssen may be administered as a single booster dose to eligible individuals who have completed primary vaccination with an approved mRNA COVID-19 vaccine. The dosing interval for the booster dose is the same as that authorised for a booster dose of the vaccine used for primary vaccination.

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
• unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
• diarrhoea
• dizziness

Rare: may affect up to 1 in 1000 people

• allergic reaction
• hives
• swollen lymph nodes (lymphadenopathy)
• decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• persistent ringing in the ears (tinnitus)
• vomiting
• blood clots in veins (venous thromboembolism (VTE))

Very Rare: may affect up to 1 in 10000 people

• blood clots often in unusual locations (e.g., brain, liver, bowel, spleen) in combination with low

level of blood platelets

• serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain-Barre

syndrome (GBS))

Unknown (cannot be estimated from the available data)

• severe allergic reaction
• capillary leak syndrome (a condition causing fluid leakage from small blood vessels)
• low levels of blood platelets (immune thrombocytopenia) that can be associated with bleeding

(see section 2, ‘Blood Disorders’)

• inflammation of the spinal cord

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. You can also report side effects directly via the national reporting system listed in Appendix V 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 or 20 vials will take approximately 13 hours to thaw, and a single

vial will take approximately 2 hours to thaw.

• at room temperature (maximally 25°C): a carton of 10 or 20 vials will take approximately

• 4 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 or transported at 2°C to 8°C for a single period of up to 11 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 crossed out. The vaccine can also be transported at 2°C to 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:

• – 10 vial pack: 2—hydroxypropyl—P—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).

• – 20 vial pack: 2-hydroxypropyl-P-cyclodextrin (HBCD), citric acid monohydrate, ethanol,

hydrochloric acid, polysorbate-80, sodium chloride, sodium hydroxide, 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 or 20 multi-dose vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Janssen-Cilag International NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Manufacturer

Janssen Biologics B.V.

Einsteinweg 101

2333 CB Leiden

The Netherlands

Janssen Pharmaceutica NV

Turnhoutseweg 30

2340 Beerse

Belgium

For the specific manufacturer of the vaccine you have received, check the Lot number on the carton or vial and please contact the local representative of the Marketing Authorisation Holder.

For any additional information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Janssen-Cilag NV Tel/Tél: +3233939323/0­080056540088	Lietuva UAB “JOHNSON & JOHNSON” Tel: +37052142002/­0080056540088
Efc^rapufl	Luxembourg/Lu­xemburg
„^■/KOHCbH & ^’/KOHCbH Ebnrapua” EOOfl	Janssen-Cilag NV
Ten.: +35928008028/­080018192	Tél/Tel: +35227302815/­0080056540088

This leaflet was last revised in

This vaccine has been given ‘conditional approval’. This means that there is more evidence to come about this vaccine.

The European Medicines Agency will review new information on this vaccine 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:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

The following information is intended for healthcare professionals only:

• As with all injectable vaccines, appropriate medical treatment and supervision must always be

readily available in the event of an anaphylactic reaction following the administration of COVID-19 Vaccine Janssen. Individuals should be monitored by a healthcare professional after vaccination for at least 15 minutes.

• COVID-19 Vaccine Janssen must not be mixed with other medicinal products or diluted in the

same syringe.

• COVID-19 Vaccine Janssen must not be administered by intravascular, intravenous,

subcutaneous or intradermal injection under any circumstances.

• Immunisation should be carried out by intramuscular injection only, preferably in the deltoid

muscle of the upper arm.

• Syncope (fainting) may occur with any injection, including COVID-19 Vaccine Janssen.

Procedures should be in place to prevent injury from falling and to manage syncopal reactions.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Instructions for administration and handling

This vaccine should be handled by a healthcare professional using aseptic technique to ensure the sterility of each dose.

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 or 20 vials will take approximately 13 hours to thaw, and a single

vial will take approximately 2 hours to thaw.

• at room temperature (maximally 25°C): a carton of 10 or 20 vials will take approximately