Covid-19 Vaccine Janssen *

4.8     Undesirable effects

Tabulated list of adverse reactions

Adverse drug reactions observed during study COV3001 or from post marketing sources are organised by MedDRA System Organ Class (SOC). Frequency categories are defined as follows:

Very common (≥ 1/10);

Common (≥ 1/100 to < 1/10);

Uncommon (≥ 1/1000 to < 1/100);

Rare (≥ 1/10000 to < 1/1000);

Very rare (< 1/10000);

Not known (cannot be estimated from the available data).

Table 1:          Adverse reactions reported following vaccination with COVID-19 Vaccine Janssen
System Organ Class	Very common (≥ 1/10)	Common (≥ 1/100 to < 1/10)	Uncommon (≥ 1/1000 to < 1/100)	Rare (≥ 1/10000 to < 1/1000)	Very Rare (< 1/10000)	Not known (cannot be estimated from the available data)
Blood and lymphatic system disorders				Lymph-adenopathy
Immune system disorders				Hypersensitivitya; urticaria		Anaphylaxisb
Nervous system disorders	Headache		Tremor; paraesthesia	Hypoaesthesia	Guillain-Barré syndrome	Capillary leak syndrome
Ear and labyrinth disorders				Tinnitus
Vascular disorders					Thrombosis in combination with thrombo-cytopeniac	Capillary leak syndrome
Respiratory, thoracic and mediastinal disorders		Cough	Sneezing; oropharyngeal pain
Gastrointestinal disorders	Nausea		Diarrhoea	Vomiting
Skin and subcutaneous tissue disorders			Rash; hyperhidrosis
Musculoskeletal and connective tissue disorders	Myalgia	Arthralgia	Muscular weakness; pain in extremity; back pain
General disorders and administration site conditions	Fatigue; injection site pain	Pyrexia; injection site erythema; injection site swelling; chills	Asthenia; malaise
a     Hypersensitivity refers to allergic reactions of the skin and subcutaneous tissue. b     Cases received from an ongoing open-label study in South Africa. c     Severe and very rare cases of thrombosis in combination with thrombocytopenia have been reported post‑marketing. These included venous thrombosis such as cerebral venous sinus thrombosis, splanchnic vein thrombosis, as well as arterial thrombosis (see section 4.4).

6.3       Shelf life

Opened vial (after first puncture of the vial)

Chemical and physical in-use stability of the vaccine has been demonstrated for 6 hours at 2°C to 25°C. From a microbiological point of view, the product should preferably be used immediately after first puncture of the vial; however, the product can be stored between 2°C to 8°C for a maximum of 6 hours or remain at room temperature (maximally 25°C) up to 3 hours after first puncture of the vial. Beyond these times, in-use storage is the responsibility of the user.

6.4       Special precautions for storage

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 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.

Once thawed, the vaccine cannot be re-frozen.

Keep the vials in the original carton in order to protect from light.

Unopened COVID-19 Vaccine Janssen is stable for a total of 12 hours at 9°C to 25°C. It is not a recommended storage or shipping condition but may guide decisions for use in case of temporary temperature excursions during the 3 month storage at 2°C to 8°C.

 

6.6     Special precautions for disposal and other handling

Handling instructions and administration

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

• 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.
• Do not re-freeze vaccine once thawed.
• Keep the vials in the original carton in order to protect from light and to record the expiry for the different storage conditions, if applicable.

 

a.       Storage upon receipt of vaccine
IF YOU RECEIVE YOUR VACCINE FROZEN AT -25°C to -15°C you may:
-25°C to -15°C	OR		2°C to 8°C
Store in a freezer The vaccine can be stored and transported frozen at -25°C to -15°C. The expiry date for storage is printed on the vial and outer carton after “EXP” (see section 6.4).		Store in a refrigerator The vaccine can also be stored and transported 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 a refrigerator at 2°C to 8°C, 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 crossed out (see section 6.4).
IF YOU RECEIVE YOUR VACCINE THAWED AT 2°C to 8°C you should store in a refrigerator:
2°C to 8°C
Do not re-freeze if the product is received already thawed at 2°C to 8°C.
Note: If the vaccine is received refrigerated at 2°C to 8°C, check that the expiry date has been updated by the local supplier upon receipt. If you cannot find the new EXP date, contact the local supplier to confirm the refrigerated EXP date. Write the new expiry date on the outer carton before the vaccine is stored in the refrigerator. The original expiry date should be made unreadable crossed out (see section 6.4).

2.       What you need to know before you are given COVID-19 Vaccine Janssen

Blood disorders

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 occurred mostly in women below 60 years of age. Fatal outcome has been reported.

4.         Possible side effects

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

 

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

5.         How to store COVID-19 Vaccine Janssen

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 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.

4.4     Special warnings and precautions for use

Capillary leak syndrome

Very rare cases of capillary leak syndrome (CLS) have been reported in the first days after vaccination with COVID Covid-19 vaccine Vaccine Janssen, in some cases with a fatal outcome. A history of CLS has been reported. CLS is a rare disorder characterised by acute episodes of oedema mainly affecting the limbs, hypotension, haemoconcentration and hypoalbuminaemia. Patients with an acute episode of CLS following vaccination require prompt recognition and treatment. Intensive supportive therapy is usually warranted. Individuals with a known history of CLS should not be vaccinated with this vaccine. See also section 4.3.

Guillain-Barré syndrome

Guillain-Barré syndrome (GBS) has been reported very rarely following vaccination with COVID-19 Vaccine Janssen. Healthcare professionals should be alert of GBS signs and symptoms to ensure correct diagnosis, in order to initiate adequate supportive care and treatment and to rule out other causes.

4.8     Undesirable effects

Table 1:          Adverse reactions reported following vaccination with COVID-19 Vaccine Janssen
System Organ Class	Very common (≥ 1/10)	Common (≥ 1/100 to < 1/10)	Uncommon (≥ 1/1 000 to < 1/100)	Rare (≥ 1/10 000 to < 1/1 000)	Very Rare (< 1/10 000)	Not known (cannot be estimated from the available data)
Immune system disorders				Hypersensitivitya; urticaria		Anaphylaxisb
Nervous system disorders	Headache		Tremor		Guillain-Barré syndrome
Vascular disorders					Thrombosis in combination with thrombo-cytopenia*	Capillary leak syndrome
Respiratory, thoracic and mediastinal disorders		Cough	Sneezing; oropharyngeal pain
Gastrointestinal disorders	Nausea
Skin and subcutaneous tissue disorders			Rash; hyperhidrosis
Musculoskeletal and connective tissue disorders	Myalgia	Arthralgia	Muscular weakness; pain in extremity; back pain
General disorders and administration site conditions	Fatigue; injection site pain	Pyrexia; injection site erythema; injection site swelling; chills	Asthenia; malaise
a     Hypersensitivity refers to allergic reactions of the skin and subcutaneous tissue. b     Cases received from an ongoing open-label study in South Africa. *    Severe and very rare cases of thrombosis in combination with thrombocytopenia have been reported post‑marketing. These included venous thrombosis such as cerebral venous sinus thrombosis, splanchnic vein thrombosis, as well as arterial thrombosis (see section 4.4)

6.3       Shelf life

Opened vial (after first puncture of the vial)

Chemical and physical in-use stability of the vaccine has been demonstrated for 6 hours at 2°C to 25°C. From a microbiological point of view, the product should preferably be used immediately after first puncture of the vial; however, the product can be stored between 2°C to 8°C for a maximum of 6 hours or remain at room temperature (maximally 25°C) up to 3 hours after first puncture of the vial. Beyond these times, in-use storage is the responsibility of the user.

6.4       Special precautions for storage

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 to 8°C as long as the appropriate storage conditions (temperature, time) are applied.

2. What you need to know before you are given COVID-19 Vaccine Janssen

Warnings and precautions

Capillary leak syndrome

Very rare cases of capillary leak syndrome (CLS) have been reported following vaccination with COVID 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.

Guillain-Barré syndrome

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

4.  Possible side effects

Very Rare: may affect up to 1 in 10 000 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-Barré syndrome (GBS))

2.       What you need to know before you are given COVID-19 Vaccine Janssen

Do not have the vaccine if

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

Warnings and precautions

 

Blood disorders

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.

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.

4.         Possible side effects

Unknown (cannot be estimated from the available data)

• capillary leak syndrome (a condition causing fluid leakage from small blood vessels).

4.3     Contraindications

Individuals who have previously experienced episodes of capillary leak syndrome (CLS) (see also section 4.4).

Thrombosis with thrombocytopenia syndrome

A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with COVID-19 Vaccine Janssen. This includes severe cases of venous thrombosis at unusual sites such as cerebral venous sinus thrombosis (CVST), splanchnic vein thrombosis as well as arterial thrombosis concomitant with thrombocytopenia. Fatal outcome has been reported. These cases occurred within the first three weeks following vaccination, and mostly in women under 60 years of age.

Capillary leak syndrome

Very rare cases of capillary leak syndrome (CLS) have been reported in the first days after vaccination with Covid-19 vaccine Janssen, in some cases with a fatal outcome. A history of CLS has been reported. CLS is a rare disorder characterised by acute episodes of oedema mainly affecting the limbs, hypotension, haemoconcentration and hypoalbuminaemia. Patients with an acute episode of CLS following vaccination require prompt recognition and treatment. Intensive supportive therapy is usually warranted. Individuals with a known history of CLS should not be vaccinated with this vaccine. See also section 4.3.

4.8     Undesirable effects

 

Table 1:          Adverse reactions reported following vaccination with COVID-19 Vaccine Janssen
System Organ Class	Very common (≥ 1/10)	Common (≥ 1/100 to < 1/10)	Uncommon (≥ 1/1 000 to < 1/100)	Rare (≥ 1/10 000 to < 1/1 000)	Very Rare (< 1/10 000)	Not known (cannot be estimated from the available data)
Immune system disorders				Hypersensitivitya; urticaria		Anaphylaxisb
Nervous system disorders	Headache		Tremor
Vascular disorders					Thrombosis in combination with thrombo-cytopenia*	Capillary leak syndrome
Respiratory, thoracic and mediastinal disorders		Cough	Sneezing; oropharyngeal pain
Gastrointestinal disorders	Nausea
Skin and subcutaneous tissue disorders			Rash; hyperhidrosis
Musculoskeletal and connective tissue disorders	Myalgia	Arthralgia	Muscular weakness; pain in extremity; back pain
General disorders and administration site conditions	Fatigue; injection site pain	Pyrexia; injection site erythema; injection site swelling; chills	Asthenia; malaise
a     Hypersensitivity refers to allergic reactions of the skin and subcutaneous tissue. b     Cases received from an ongoing open-label study in South Africa. *    Severe and very rare cases of thrombosis in combination with thrombocytopenia have been reported post‑marketing. These included venous thrombosis such as cerebral venous sinus thrombosis, splanchnic vein thrombosis, as well as arterial thrombosis (see section 4.4)

4.4     Special warnings and precautions for use

Thrombocytopenia Thrombosis and coagulation disorders with thrombocytopenia syndrome

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia. Those vaccinated should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg pain, leg swelling, or persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches, seizures, mental status changes or blurred vision after vaccination, or who experiences skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention.

Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.

Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with COVID-19 Vaccine Janssen should be actively investigated for signs of thrombosis. Similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia.

10.     DATE OF REVISION OF THE TEXT

0504/2021

2.       What you need to know before you are given COVID-19 Vaccine Janssen

Warnings and precautions

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

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.

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

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.

This leaflet was last revised in May 2021

The following information is intended for healthcare professionals only:

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia. Those vaccinated should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches or blurred vision after vaccination, or who experiences skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention. Thrombosis in combination with thrombocytopenia requires specialised

2.         What you need to know before you are given COVID-19 Vaccine Janssen

Warnings and precautions

Blood disorders

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 or blurred vision, unexplained skin bruising beyond the site of vaccination which appear a few days after vaccination, develop shortness of breath, chest pain, leg swelling, or persistent abdominal pain. Inform your healthcare provider that you have recently received COVID-19 Vaccine Janssen.

4.         Possible side effects

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

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

5.         How to store COVID-19 Vaccine Janssen

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 132hours 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 42 hours to thaw, and a single vial will take approximately 1 hour to thaw.

6.         Contents of the pack and other information

The other ingredients (excipients) are:

• 10 vial pack:  2hydroxypropyl-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).
• 20 vial pack:  2hydroxypropyl-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 or 20 multi-dose vials.

This leaflet was last revised in April March 2021

The following information is intended for healthcare professionals only:

• Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia. Those vaccinated should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches or blurred vision after vaccination, or who experiences skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention. Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition

 

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 132 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 42 hours to thaw, and a single vial will take approximately 1 hour to thaw.

2.       What you need to know before you are given COVID-19 Vaccine Janssen

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).

Blood disorders

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 or blurred vision, unexplained skin bruising beyond the site of vaccination which appear a few days after vaccination, develop shortness of breath, chest pain, leg swelling, or persistent abdominal pain. Inform your healthcare provider that you have recently received COVID-19 Vaccine Janssen.

4.         Possible side effects

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

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

 

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 132 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 20vials will take approximately 42 hours to thaw, and a single vial will take approximately 1 hour to thaw.

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:  2hydroxypropyl-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).
• 20 vial pack:  2hydroxypropyl-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  or 20 multi-dose vials.

This leaflet was last revised in MarchApril 2021

 

4.4     Special warnings and precautions for use

Thrombocytopenia and coagulation disorders

A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with COVID-19 Vaccine Janssen. This includes severe cases of venous thrombosis at unusual sites such as cerebral venous sinus thrombosis, splanchnic vein thrombosis as well as arterial thrombosis concomitant with thrombocytopenia. Fatal outcome has been reported. These cases occurred within the first three weeks following vaccination, and mostly in women under 60 years of age.

Healthcare professionals should be alert to the signs and symptoms of thromboembolism and/or thrombocytopenia. Those vaccinated should be instructed to seek immediate medical attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, or persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches or blurred vision after vaccination, or who experiences skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention.

Thrombosis in combination with thrombocytopenia requires specialised clinical management. Healthcare professionals should consult applicable guidance and/or consult specialists (e.g., haematologists, specialists in coagulation) to diagnose and treat this condition.

Risk of bleeding with intramuscular administration

As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.

4.8     Undesirable effects

Tabulated list of adverse reactions

Adverse drug reactions observed during study COV3001 are organised by MedDRA System Organ Class (SOC). Frequency categories are defined as follows:

Very common (≥ 1/10);

Common (≥ 1/100 to < 1/10);

Uncommon (≥ 1/1 000 to < 1/100);

Rare (≥ 1/10 000 to < 1/1 000);

Very rare (< 1/10 000);

System Organ Class

Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1/1 000 to <1/100)

Rare (≥1/10 000 to <1/1 000)

Very Rare (< 1/10 000)

Not known (cannot be estimated from the available data)

Vascular disorders

Thrombosis in combination with thrombo-cytopenia*

*              Severe and very rare cases of thrombosis in combination with thrombocytopenia have been reported post‑marketing. These included venous thrombosis such as cerebral venous sinus thrombosis, splanchnic vein thrombosis, as well as arterial thrombosis (see section 4.4)

 

6.       PHARMACEUTICAL PARTICULARS

 

6.1     List of excipients

10 vial pack

2-hydroxypropyl-β-cyclodextrin (HBCD)

Citric acid monohydrate

Ethanol

Hydrochloric acid

Polysorbate‑80

Sodium chloride

Sodium hydroxide

Trisodium citrate dihydrate

Water for injections

 

20 vial pack

2-hydroxypropyl-β-cyclodextrin (HBCD)

Citric acid monohydrate

Ethanol

Hydrochloric acid

Polysorbate‑80

Sodium chloride

Sodium hydroxide

Trisodium citrate dihydrate

Water for injections

 

6.4       Special precautions for storage

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”.

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 132 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 42 hours to thaw, and a single vial will take approximately 1 hour to thaw.

 

6.5     Nature and contents of container

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

Pack size of 10 or 20  multi-dose vials.

 

6.6     Special precautions for disposal and other handling

b.       If stored frozen, thaw vial(s) either in a refrigerator or at room temperature before administration
2°C to 8°C  Thaw for 132 hours	OR	Thaw for 42 hours Thaw for 1 hour Maximally 25°C
Thaw in refrigerator •    When stored frozen at -25°C to -15°C, a carton of 10 or 20 vials will take approximately 13 hours to thaw or individual vials will take approximately 2 hours to thaw at 2°C to 8°C. •    If the vaccine is not used immediately, refer to the instructions in section ‘Store in a refrigerator’. •    The vial must be kept in the original carton in order to protect from light and to record the expiry for the different storage conditions, if applicable. Do not re-freeze once thawed.		Thaw at room temperature •    When stored frozen at -25°C to -15°C, a carton of 10  or 20 vials or individual vials should be thawed at room temperature maximally 25°C. •    A carton of 10 or 20 vials will take approximately 42 hours to thaw. •    Individual vials will take approximately 1 hour to thaw. •    The vaccine is stable for a total of 12 hours at 9°C to 25°C. It is not a recommended storage or shipping condition but may guide decisions for use in case of temporary temperature excursions. •    If the vaccine is not used immediately, refer to the instructions in section Store in a refrigerator.  Do not re-freeze once thawed.

 

8.       MARKETING AUTHORISATION NUMBER(S)

EU/1/20/1525/001

EU/1/20/1525/002

10.     DATE OF REVISION OF THE TEXT

0403/2021