COVID-19 S protein chimpanzee adenovirus-vectored (ChAdOx1-S) vaccine, recombinant

Intramuscular
Active immunisation against coronavirus disease 2019 (COVID-19)

History of severe hypersensitivity reaction (e.g. anaphylaxis) after a previous dose; known allergy to any component of the formulation (e.g. polysorbate 80). History of thrombosis with thrombocytopenia syndrome (TTS) after the previous dose of ChAdOx1-S vaccine, recombinant. History of capillary leak syndrome.

Patient with history of bleeding disorder (e.g. thrombocytopenia) or any coagulation disorder (e.g. haemophilia), history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2) or cerebral venous sinus thrombosis; autoimmune conditions. Immunocompromised patients (e.g. HIV or receiving immunosuppressant treatment). Patients receiving aspirin or anticoagulant therapy. In patients with history of multisystem inflammatory syndrome, may consider delaying vaccination until illness resolution. Schedule IM injection shortly after administration of antihaemophilia or other similar therapy. Defer administration of vaccine in patients with acute severe febrile illness or acute infection; may give vaccination in patients with minor infection and/or low-grade fever. Defer vaccine administration in patients with current SARS-CoV-2 infection, patients who develop SARS-CoV-2 infection prior to receiving any vaccine doses or those who develop infection post-1st dose but prior 2nd dose, until recovery from acute illness and no longer need isolation. Not recommended for outbreak management or postexposure prophylaxis. Pregnancy and lactation.

It should be noted that:

- Refer to your local health authority for the most up-to-date therapeutic drug monitoring protocol when prescribing ChAdOx1-S vaccine, recombinant.
- The duration of protection against COVID-19 after a complete vaccination course has not been fully evaluated. Clinical trials and epidemiologic surveillance are on-going to evaluate break-through infection in fully vaccinated individuals.
- ChAdOx1-S vaccine, recombinant is available in some countries under an emergency use listing or authorisation. Registration status or availability may vary between countries. Refer to your local regulatory agencies for more information.
- There is currently no data on interchangeability of ChAdOx1-S vaccine, recombinant with other COVID-19 vaccines to complete the vaccination course. The same brand of vaccine should be used to complete the vaccination course.
- Administration of antipyretics or analgesics is not recommended as a prophylaxis for post-vaccination symptoms. However, antipyretic or analgesic may be taken after vaccination to treat symptoms such as local pain or fever.
- It is recommended to use a low-dead volume syringe and needle during administration of the vaccine. Care should be taken to ensure a full 0.5 mL dose is administered.
- Minimise any unnecessary co-medication whenever possible, given the lack of information about drug-drug interaction risk.
- Record the vaccine name, batch or lot number, expiration date and other administration details to improve traceability.
- Local regulatory agencies may require healthcare facilities and healthcare providers to comply with certain regulations during transport, storage, and administration of ChAdOx1-S vaccine, recombinant. Refer to country-specific recommendations.

Significant: Shoulder injury (e.g. shoulder bursitis or tendinopathy); hypersensitivity reaction (e.g. anaphylaxis, angioedema); anxiety-related reactions (e.g. vasovagal reactions [syncope], hyperventilation, stress-related reactions); temporary contralateral or ipsilateral lymphadenopathy. Very rarely, Guillain-Barre syndrome, transverse myelitis.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Inj site tenderness, pain, warmth, pruritus, bruising, erythema, swelling or induration; asthenia, fatigue, malaise, feverishness, pyrexia, chills, influenza-like illness.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, pain in extremity.
Nervous system disorders: Headache.
Potentially Fatal: Very rarely, thrombosis with thrombocytopenia syndrome (accompanied by bleeding in some cases) presenting as venous thrombosis (e.g. cerebral venous sinus thrombosis, splanchnic vein thrombosis, arterial thrombosis); thrombocytopenia (including immune thrombocytopenia); capillary leak syndrome; cerebrovascular venous and sinus thrombosis (CVST) without thrombocytopenia.

Fully vaccinated recipients should continue to observe effective prevention measures (e.g. wearing a mask, social distancing). Refer to specific country guidelines. Vaccinated individuals should seek immediate medical attention if few days following vaccination, they develop any of the following: severe or persistent headaches with blurred vision that do not respond to painkillers; confusion, seizures, shortness of breath, chest pain, leg swelling or pain, persistent abdominal pain, any unusual skin bruising and/or petechiae.

Monitor for hypersensitivity reaction and syncope for at least 15 minutes post-vaccination. Observe for 30 minutes post-vaccination for those patients with the following conditions: history of anaphylaxis (due to any cause), history of an allergic reaction (regardless of severity) within 4 hours of receiving a vaccine or injectable therapy, or with contraindication to a different type of COVID-19 vaccine. In patients diagnosed with thrombocytopenia within 3 weeks post-vaccination, actively investigate for signs of thrombosis. Additionally, in patients who develop thrombosis within 3 weeks of vaccination, assess for thrombocytopenia.

May cause bleeding or bruising after IM administration to patients taking anticoagulant therapy. May diminish therapeutic effect with immunosuppressants.

It is recommended to perform mammograms before vaccination or 4-6 weeks after the administration of 2nd dose to avoid possible misinterpretation.

Description: COVID-19 S protein chimpanzee adenovirus-vectored (ChAdOx1-S) vaccine, recombinant is a monovalent vaccine composed of a single recombinant, replication-incompetent chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2. Once administered, the SARS-CoV-2 S glycoprotein is expressed locally stimulating neutralising antibody and cellular immune responses, which may contribute as protection against COVID-19 disease.
Synonym: COVID-19 vaccine (ChAdOx1-S [recombinant]).
Onset: Protection may start approx 3 weeks after 1st dose.

Store between 2-8°C. Do not freeze or shake. Protect from light. Opened vials (first needle puncture): Store between 2-8°C for up to 48 hours, or store below 30°C for up to 6 hours. This vaccine contains genetically modified organisms (GMO), follow applicable procedures for receiving, handling, administration, and disposal. Storage recommendations may vary among countries or individual products or preparations. Refer to country- or product-specific recommendations.

Vaccines, Antisera & Immunologicals

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Joint Formulary Committee. COVID-19 Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/09/2022.

Vaxzevria Suspension for Injection (AstraZeneca AB). European Medicines Agency [online]. Accessed 08/09/2022.