SARS-CoV-2 Spike glycoprotein (ChAdOx1-S) Other names: AZD1222 ChAdOx1 nCoV-19 COVID-19 Vaccine AstraZeneca

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 (ChAdOx1-S) vaccine 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 event following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of SARS-CoV-2 Spike glycoprotein (ChAdOx1-S).

• Thrombosis with thrombocytopenia syndrome: Thrombosis with thrombocytopenia syndrome (TTS), in some cases accompanied by bleeding, has been observed very rarely following vaccination with SARS-CoV-2 Spike glycoprotein (ChAdOx1-S). This includes severe cases presenting as venous thrombosis, including unusual sites such as cerebral venous sinus thrombosis, splanchnic vein thrombosis, as well as arterial thrombosis, concomitant with thrombocytopenia. Some cases had a fatal outcome. The majority of these cases occurred within the first three weeks following vaccination. TTS 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.
• Cerebrovascular venous and sinus thrombosis: Events of cerebrovascular venous and sinus thrombosis without thrombocytopenia have been observed very rarely following vaccination with SARS-CoV-2 Spike glycoprotein (ChAdOx1-S). Some cases had a fatal outcome. The majority of these cases occurred within the first four weeks following vaccination. This information should be considered for individuals at increased risk for cerebrovascular venous and sinus thrombosis. These events may require different treatment approaches than TTS and healthcare professionals should consult applicable guidance.
• Thrombocytopenia: Cases of thrombocytopenia, including immune thrombocytopenia (ITP), have been reported after receiving SARS-CoV-2 Spike glycoprotein (ChAdOx1-S), typically within the first four weeks after vaccination. Very rarely, these presented with very low platelet levels (<20,000 per µL) and/or were associated with bleeding. Some of these cases occurred in individuals with a history of immune thrombocytopenia. Cases with fatal outcome have been reported. If an individual has a history of a thrombocytopenic disorder, such as immune thrombocytopenia, the risk of developing low platelet levels should be considered before administering the vaccine 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 swelling, leg pain, persistent abdominal pain following vaccination. Additionally, anyone with neurological symptoms including severe or persistent headaches, blurred vision, confusion or seizures 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 three weeks after vaccination with SARS-CoV-2 Spike glycoprotein (ChAdOx1-S), should be actively investigated for signs of thrombosis. Similarly, individuals who present with thrombosis within three 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 (ChAdOx1-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.

Very rare cases of capillary leak syndrome (CLS) have been reported in the first days after vaccination with SARS-CoV-2 Spike glycoprotein (ChAdOx1-S). A history of CLS was apparent in some of the cases. Fatal outcome 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.