SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S)

The efficacy, safety and immunogenicity of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S) may be lower in immunosuppressed individuals.

Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination.

• Thrombosis with thrombocytopenia syndrome: A combination of thrombosis and thrombocytopenia, in some cases accompanied by bleeding, has been observed very rarely following vaccination with SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S). 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. 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 who have experienced thrombosis with thrombocytopenia syndrome following vaccination with any COVID-19 vaccine should not receive SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S).
• Venous thromboembolism: Venous thromboembolism (VTE) has been observed rarely following vaccination with SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S). This should be considered for individuals at increased risk for VTE.
• Immune thrombocytopenia: Cases of immune thrombocytopenia with very low platelet levels (<20000 per μL) have been reported very rarely after vaccination with COVID-19 vaccine, usually within the first four weeks after receiving SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S). This included cases with bleeding and cases with fatal outcome. Some of these cases occurred in individuals with a history of immune thrombocytopenia (ITP). If an individual has a history of ITP, the risks of developing low platelet levels should be considered before vaccination, and platelet monitoring is recommended after vaccination.

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 spontaneous bleeding, skin bruising (petechia) beyond the site of vaccination after a few days, should seek prompt medical attention.

Individuals diagnosed with thrombocytopenia within 3 weeks after vaccination with SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S) should be actively investigated for signs of thrombosis. Similarly, individuals who present with thrombosis within 3 weeks of vaccination should be evaluated for thrombocytopenia.

Guillain-Barré syndrome (GBS) has been reported very rarely following vaccination with SARS-CoV-2 Spike glycoprotein (Ad26.COV2-S). 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.

Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. However, the presence of a minor infection and/or low-grade fever should not delay vaccination.

Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.