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


Generic Medicine Info
Indications and Dosage
Intramuscular
Active immunisation against coronavirus disease 2019 (COVID-19)
Adult: 50 billion viral particles/0.5 mL dose, for 2 doses to be given 4-12 weeks (28-84 days) apart, injected preferably in the deltoid muscle. World Health Organization (WHO) recommends an interval of 8-12 weeks (56-84 days) between doses since an increased efficacy and immunogenicity has been observed with a longer dose interval. If the 2nd dose is unintentionally administered earlier (<28 days post-1st dose), the dose does not need to be repeated.
Elderly: No dosage adjustment required.
Contraindications
History of severe hypersensitivity reaction (e.g. anaphylaxis) or immediate hypersensitivity reaction (regardless of severity and within 4 hours of occurrence) after a previous dose; known allergy to any component of the formulation (e.g. polysorbate 80). History of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2). Do not administer 2nd dose if the patient developed major venous and/or arterial thrombosis.
Special Precautions
Patients with history of bleeding disorder (e.g. thrombocytopenia) or any coagulation disorder (e.g. haemophilia), autoimmune conditions, significant co-morbidities. Patients receiving anticoagulant therapy. Immunocompromised patients (e.g. HIV or receiving immunosuppressant treatment). Defer administration of vaccine in patients with moderate to severe acute illness (with or without fever); may give vaccination in patients with mild acute illness (with or without 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. Defer vaccine administration for at least 90 days after receiving COVID-19 convalescent plasma or anti-COVID-19 monoclonal antibody therapy. Not recommended for outbreak management or postexposure prophylaxis. Do not administer concomitantly with other vaccines; allow a minimum interval of 14 days between other vaccines. 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.
- COVID-19 vaccines are not interchangeable. The same brand of vaccine should be used to complete the vaccination course.
- Administration of antipyretic or antihistamines is not recommended as a prophylaxis for post-vaccination symptoms. However, antipyretic/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.
- There are no specific drug-drug interaction data available. Minimise any unnecessary co-medication whenever possible.
- 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.
Adverse Reactions
Significant: Shoulder injury (e.g. shoulder bursitis or tendinopathy), syncope.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea.
General disorders and administration site conditions: Inj site tenderness, pain, warmth, pruritus, bruising, erythema, swelling; fatigue, malaise, pyrexia, chills.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
Nervous system disorders: Headache.
Potentially Fatal: Rarely, thrombosis and thrombocytopenia (accompanied by bleeding in some cases) presenting as venous thrombosis (e.g. cerebral venous sinus thrombosis, mesenteric vein thrombosis, arterial thrombosis).
Patient Counseling Information
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 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, or any unusual skin bruising and/or petechiae.
Monitoring Parameters
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. Monitor for signs of thrombosis and actively investigate if patient developed thrombocytopenia within 3 weeks. Patients who developed thrombosis within 3 weeks of vaccination should be monitored for thrombocytopenia.
Drug Interactions
May cause bleeding or bruising after IM administration to patients taking anticoagulant therapy. May diminish therapeutic effect with immunosuppressants or COVID-19-directed monoclonal antibodies. Prophylactic use of antihistamine may mask signs and symptoms of anaphylaxis leading to delayed diagnosis and management.
Action
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 a protection against COVID-19 disease.
Synonym: vaccine, COVID-19 (adenovirus vector).
Storage
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.
References
Allergy, Immunodeficiency, Autoimmunity and COVID-19 Vaccination Frequently Asked Questions. Australian Society of Clinical Immunology and Allergy (ASCIA). https://www.allergy.org.au. Accessed 19/03/2021.

Anon. COVID-19 Vaccine (Adenovirus Vector). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 19/03/2021.

AZD1222 Injection, Suspension (AstraZeneca Pharmaceuticals LP). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 19/03/2021.

Background Document on the AZD1222 Vaccine Against COVID-19 Developed by Oxford University and AstraZeneca. World Health Organization. http://www.who.int. Accessed 19/03/2021.

COVID-19 Vaccine AstraZeneca Suspension for Injection (AstraZeneca AB). European Medicines Agency [online]. Accessed 19/03/2021.

Joint Formulary Committee. COVID-19 Vaccine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/03/2021.

Vaxzevria Suspension for Injection (AstraZeneca AB). European Medicines Agency [online]. Accessed 27/05/2021.

Disclaimer: This information is independently developed by MIMS based on COVID-19 S protein chimpanzee adenovirus-vectored (ChAdOx1-S) vaccine, recombinant from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by MIMS.com
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