COVID-19 S protein human adenovirus-vectored (Ad26.COV2.S) vaccine, recombinant

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

For moderately or severely immunocompromised patients: ≥18 years Primary vaccination: 50 billion viral particles/0.5 mL as a single dose. Thereafter, an additional (2nd) primary dose using a monovalent mRNA COVID-19 vaccine may be given ≥4 weeks (at least 28 days) after the 1st primary vaccination of Ad26.COV2.S vaccine, recombinant. Booster dose: 1st booster dose: 50 billion viral particles/0.5 mL as a single dose of Ad26.COV2.S vaccine, recombinant, or a bivalent mRNA COVID-19 vaccine may be administered at least 2 months after the completion of the additional (2nd) primary dose (using a monovalent mRNA COVID-19 vaccine). Refer to the specific product information of age-appropriate mRNA COVID-19 vaccines for the respective dosage recommendations.

For patients ≥18 years who have received the 1st dose of an mRNA COVID-19 vaccine but cannot complete the primary series with either the same or different mRNA COVID-19 vaccine (e.g. due to contraindication): The US Centres for Disease Control and Prevention (CDC) stated that in this limited and exceptional cases, 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 primary vaccination with Ad26.COV2.S vaccine, recombinant; these patients should not be considered to have received a mixed primary vaccination series.

History of severe hypersensitivity reaction (e.g. anaphylaxis) after a previous dose; known diagnosed allergy to any component of the formulation (e.g. polysorbate 80). History of thrombosis with thrombocytopenia syndrome after a previous dose of Ad26.COV2.S vaccine, recombinant or any other adenovirus vector COVID-19 vaccine; history of an episode of immune-mediated syndrome characterised by thrombosis and thrombocytopenia (e.g. spontaneous or classic heparin-induced thrombocytopenia); history of capillary leak syndrome; development of Guillain-Barre syndrome within 6 weeks after receipt of Ad26.COV2.S vaccine, recombinant.

Patient with history of bleeding disorder (e.g. thrombocytopenia, immune thrombocytopenia) or any coagulation disorder (e.g. haemophilia); those who are at increased risk for venous thromboembolism; autoimmune conditions; history of Guillain-Barre syndrome; history of non-severe, immediate (occurs within 4 hours) allergic reaction to a previous dose of Ad26.COV2.S vaccine, recombinant; history of immediate allergic reaction to any other non-COVID-19 vaccine or injectable therapies (excluding SC immunotherapy for allergies), and to polyethylene glycol; allergy-related contraindication to another type of COVID-19 vaccine (e.g. mRNA COVID-19 vaccine). Immunocompromised patients (e.g. those with HIV or receiving immunosuppressant treatment). Patients receiving aspirin or anticoagulant therapy. In patients with history of multisystem inflammatory syndrome (MIS), may consider delaying the vaccination until clinical recovery. Data on the safety of COVID-19 vaccination following MIS is limited; risks and benefits must be considered based on patient-specific factors (e.g. return to normal cardiac function, risk of COVID-19). Defer administration of vaccine in patients with moderate to severe acute illness (with or without fever); vaccination may be given 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 (primary or booster dose), until recovery from acute illness (if symptomatic) and no longer need isolation. Consider delaying the primary vaccination or booster dose by 3 months from symptom onset or positive test (if asymptomatic) in patients who recently had SARS-CoV-2 infection. Defer the administration of tixagevimab/cilgavimab as COVID-19 pre-expoure prophylaxis for at least 2 weeks after receiving a dose of COVID-19 vaccine. Not recommended for 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 breakthrough infection in fully vaccinated individuals.
- Ad26.COV2.S vaccine, recombinant may be available in some countries under an emergency use authorisation (EUA) or conditional approval scheme. Registration status and/or availability may vary between countries. Refer to your local regulatory agencies for more information.
- Administration of antipyretics, analgesics, or antihistamines 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 local/systemic post-vaccination symptoms (if medically appropriate).
- Individuals who have received a single dose of Ad26.COV2.S vaccine, recombinant are considered to have a complete, valid primary vaccination against COVID-19.
- Recommendations and approval of booster doses (particularly in individuals with co-morbidities) may vary between countries. Refer to specific country guidelines.
- 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 clearly to improve the traceability of biological medicinal products.
- To alleviate the risks of this unapproved drug during pandemic use, local regulatory agencies may require healthcare facilities and healthcare providers to comply with certain regulations for the transport, storage, and administration of Ad26.COV2.S vaccine, recombinant. Refer to country-specific recommendations for further information.

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; transient contralateral or ipsilateral lymphadenopathy. Very rarely, Guillain-Barre syndrome (mainly in males), transverse myelitis.
Blood and lymphatic system disorders: Rarely, lymphadenopathy.
Cardiac disorders: Myocarditis, pericarditis.
Immune system disorders: Angioedema (without respiratory distress).
Ear and labyrinth disorders: Tinnitus.
Gastrointestinal disorders: Nausea, diarrhoea. Rarely, vomiting.
General disorders and administration site conditions: Inj site pain, erythema or swelling; fatigue, asthenia, pyrexia, chills, malaise.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia, muscle weakness, pain in extremity, back pain.
Nervous system disorders: Headache, dizziness, tremor, paraesthesia, hypoaesthesia.
Respiratory, thoracic and mediastinal disorders: Cough, sneezing, oropharyngeal pain.
Skin and subcutaneous tissue disorders: Urticaria, rash, hyperhidrosis.
Vascular disorders: Cutaneous small vessel vasculitis.
Potentially Fatal: Very rarely, thrombosis with thrombocytopenia syndrome or a 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 in females; immune thrombocytopenia, capillary leak syndrome. Rarely, venous thromboembolism.

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 a few days after vaccination they develop the following: severe or persistent headaches, changes in mental status, 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.

Monitor for hypersensitivity reaction and syncope for at least 15 minutes post-vaccination. Observe patients for 30 minutes after vaccination for those with a history of anaphylaxis (due to any cause), history of an allergic reaction (regardless of severity) within 4 hours of receiving a non-COVID-19 vaccine or injectable therapy; history of non-severe, immediate (within 4 hours) allergic reaction after a previous dose of COVID-19 vaccine, 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. Closely monitor for signs and symptoms of thromboembolism and/or thrombocytopenia, Guillain-Barre syndrome, and transverse myelitis.

May cause bleeding or haematoma after IM administration in patients taking aspirin or anticoagulant therapy. Therapeutic effect may be diminished by immunosuppressants and tixagevimab/cilgavimab. Prophylactic use of antihistamines may mask the cutaneous signs of anaphylaxis which may lead to delayed diagnosis and management.

May cause false-positive rapid plasma reagin (RPR; nontreponemal [syphilis screening]) results for certain RPR tests for ≥5 months following vaccination. It is recommended to perform mammograms before vaccination to avoid possible misinterpretation of mammogram screening.

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 directed against the S antigen, which may contribute to protection against COVID-19 disease.
Synonym: COVID-19 vaccine (Ad26.COV2.S [recombinant]).

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 if not used immediately, store between 2-8°C for a single period of up to 11 months (not exceeding the original expiry date). Protect from light. Alternatively if needed immediately, thaw at room temperature (≤25°C) for approx 4 hours (for 10 vials/carton) or approx 1 hour (for 1 vial); vaccines are stable for up to 12 hours between 9-25°C. Do not refreeze thawed vials. Do not shake. Opened vials (after 1st 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.

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