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);

*              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