COVID-19 S protein human adenovirus-vectored (Ad26.COV2.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 as a single dose, injected preferably in the deltoid muscle. Efficacy and safety of giving Ad26.COV2.S vaccine, recombinant following mRNA COVID-19 vaccine has not been established. However, the US Centre for Disease Control and Prevention (CDC) stated that in limited and exceptional cases where the patient who received an mRNA COVID-19 vaccine as their 1st dose cannot complete the series with the same or different mRNA COVID-19 vaccine (e.g. due to contraindication), giving a single dose of Ad26.COV2.S vaccine, recombinant may be considered at a minimum interval of 28 days from the mRNA COVID-19 vaccine dose. Patients who receive Ad26.COV2.S vaccine, recombinant after a dose of mRNA COVID-19 vaccine under such exceptional cases must be considered to have received a valid single-dose vaccination with Ad26.COV2.S vaccine, recombinant; these patients should not be considered to have received a mixed vaccination series.
Child: <18 years Currently, the safety and efficacy of administering Ad26.COV2.S vaccine, recombinant in children and adolescents has not been established; until such data are available, vaccination in this age group is not recommended.
Elderly: No dosage adjustment required.
Contraindications
History of severe hypersensitivity reaction (e.g. anaphylaxis) or immediate allergic reaction (regardless of severity and occurs within 4 hours) after a previous dose; known allergy to any component of the formulation (e.g. polysorbate 80). History of capillary leak syndrome.
Special Precautions
Patient with history of bleeding disorder (e.g. thrombocytopenia) or any coagulation disorder (e.g. haemophilia); history of immune-mediated syndrome characterised by thrombosis and thrombocytopenia (e.g. heparin-induced thrombocytopenia); 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 the vaccination until illness resolution and for 90 days after diagnosis. 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 known current SARS-CoV-2 infection and those who develop SARS-CoV-2 infection prior to receiving any vaccine doses, until recovery from acute illness (if symptomatic) and no longer need isolation. Defer vaccination for at least 90 days in patients who have received COVID-19 convalescent plasma or anti-COVID-19 monoclonal antibody therapy. In vaccinated patients who subsequently develop COVID-19 infection, treatment decisions or timing of treatment should not be affected by prior receipt of a COVID-19 vaccine. 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 Ad26.COV2.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 ongoing to evaluate break-through infection in fully vaccinated individuals.
- Ad26.COV2.S vaccine, recombinant is available in some countries under an emergency use authorisation (EUA) or conditional approval scheme. Registration status or availability may vary between countries. Refer to your local regulatory agencies for more information.
- Administration of antipyretics, antihistamines, aspirin or anticoagulants prior to the administration of COVID-19 vaccines as prophylaxis for post-vaccination symptoms is not recommended. However, antipyretic/analgesic medications may be taken after vaccination to treat post-vaccination 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.
- Individuals who have received a single dose of Ad26.COV2.S vaccine, recombinant are considered to have a complete, valid vaccination series against COVID-19.
- Minimise any unnecessary co-medication whenever possible, given the lack of information about interaction risk.
- Record the vaccine name, batch or lot number, expiration date and other administration details to improve traceability of biological medicinal products.
- Local regulatory agencies may require healthcare facilities and healthcare providers to comply with certain regulations during transport, storage, and administration of Ad26.COV2.S vaccine, recombinant. Refer to country-specific recommendations.
Adverse Reactions
Significant: Severe allergic reactions (including anaphylaxis); anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress-related reactions; shoulder injury (e.g. shoulder bursitis or tendinopathy) due to vaccine administration; Bell’s palsy; transient contralateral or ipsilateral lymphadenopathy; immune thrombocytopenia. Very rarely, Guillain-Barre syndrome.
Ear and labyrinth disorders: Tinnitus.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Inj site pain, erythema or swelling; fatigue, pyrexia, chills.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Headache, dizziness.
Respiratory, thoracic and mediastinal disorders: Cough.
Potentially Fatal: Very rarely, combination of thrombosis and thrombocytopenia (accompanied by bleeding in some cases) including severe cases of venous thrombosis (e.g. cerebral venous sinus thrombosis, splanchnic vein thrombosis, arterial thrombosis), primarily among women; capillary leak syndrome.
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 after vaccination they develop the following: severe or persistent headaches, blurred vision, seizures, shortness of breath, chest pain, leg swelling or pain, persistent abdominal pain, or any unusual skin bruising and/or petechiae beyond the site of vaccination.
Monitoring Parameters
Monitor for hypersensitivity reaction and syncope for at least 15 minutes post-vaccination. Observe patients for 30 minutes after vaccination for those with 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. Actively investigate individuals diagnosed with thrombocytopenia within 3 weeks post-vaccination for signs of thrombosis. Additionally, patients who develop thrombosis within 3 weeks of vaccination must be assessed for thrombocytopenia. Monitor for signs and symptoms of thromboembolism and/or thrombocytopenia; Guillain-Barre syndrome.
Drug Interactions
May cause bleeding or bruising after IM administration in patients taking anticoagulant therapy. May diminish therapeutic effect with immunosuppressants. Prophylactic use of antihistamines may mask cutaneous signs and symptoms of anaphylaxis leading to delayed diagnosis and management.
Lab Interference
May cause a positive result in SARS-CoV-2 antibody test that detects antibody (IgG and/or IgM) to the SARS-CoV-2 spike protein.
Action
Description: COVID-19 S protein human adenovirus-vectored (Ad26.COV2.S) vaccine, recombinant is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 vector that expresses SARS-CoV-2 spike (S) antigen without the propagation of the virus. Once administered, the vaccine then stimulates neutralising antibodies and cellular immune response against the S antigen, which may contribute to protection against COVID-19 disease.
Synonym: COVID-19 vaccine (Ad26.COV2.S [recombinant]).
Storage
Vaccines are initially stored frozen by the manufacturer, then may be supplied either frozen between -25 to -15°C or thawed between 2-8°C. Intact vials: If received a thawed vaccine: Store between 2-8°C. Alternatively, may store between 9-25°C for up to 12 hours. Protect from light. Do not freeze. If received a frozen vaccine, thaw vials before administration: Thaw between 2-8°C for approx 13 hours (for 10 vials/carton) or approx 2 hours (for 1 vial), and store between 2-8°C for a single period of up to 3 months if not used immediately; or thaw at room temperature (≤25°C) for approx 4 hours (for 10 vials/carton) or approx 1 hour (for 1 vial) if needed immediately. Do not refreeze thawed vials. Do not shake. Opened vials (after first needle puncture): Store between 2-8°C for up to 6 hours or store at ≤25°C for up to 2 hours. This vaccine contains genetically modified organisms (GMO), follow applicable procedures for receiving, handling, administration, and disposal. Storage recommendations may vary among countries or between carton and vial labels of individual products. Refer to country- or product-specific guidelines.
References
Anon. COVID-19 Vaccine (Adenovirus Vector). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/08/2021.

Anon. COVID-19 Vaccine, Viral Vector (Janssen). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/08/2021.

COVID-19 Vaccine Janssen Suspension for Injection (Janssen-Cilag International NV). European Medicines Agency [online]. Accessed 18/08/2021.

COVID-19 Vaccine Janssen Suspension for Injection (Janssen-Cilag Ltd). MHRA. https://products.mhra.gov.uk. Accessed 02/08/2021.

COVID-19 Vaccine Safety Update (COVID-19 Vaccine Janssen) 11 August 2021. European Medicines Agency [online]. Accessed 23/08/2021.

Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) (Janssen Biotech, Inc.). U.S. FDA. https://www.fda.gov. Accessed 03/08/2021.

Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Centers for Disease Control and Prevention. https://www.cdc.gov. Accessed 19/08/2021.

Interim Recommendations for Use of the Janssen Ad26.COV2.S (COVID-19) Vaccine. World Health Organization. https://www.who.int. Accessed 19/08/2021.

Janssen COVID-19 Vaccine (Ad26.COV2.S) Injection, Suspension (Janssen Products, LP). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 18/08/2021.

Janssen-Cilag (New Zealand) Ltd. COVID-19 Vaccine Janssen Ad26.COV2.S data sheet 03 August 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 18/08/2021.

SARS-CoV-2 Virus (COVID-19) Adenovirus Vector Vaccine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 02/08/2021.

Disclaimer: This information is independently developed by MIMS based on COVID-19 S protein human adenovirus-vectored (Ad26.COV2.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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