Covid-19 vaccine (ad26.cov2-s recombinant)
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing COVID-19 (AD26.COV2-S recombinant).
Drugs List
Therapeutic Indications
Uses
Coronavirus disease 2019 (COVID-19): Prophylaxis
For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
Available at https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Dosage
Adults
1 dose (0.5ml).
A booster dose (second dose) of 0.5ml may be administered intramuscularly at least 2 months after the primary vaccination.
Administration
Administered via intramuscular injection, preferably in the deltoid muscle.
Contraindications
Children under 18 years
History of capillary leak syndrome
Precautions and Warnings
Acute infection
Immunosuppression
Recent anticoagulant therapy
Severe febrile conditions
Breastfeeding
Coagulopathy
History of heparin-induced thrombocytopenia and thrombosis
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia
Postpone immunisation if there is active or suspected infection
Advise ability to drive/operate machinery may be affected by side effects
Avoid 2nd dose if thrombosis with thrombocytopenia occurs with 1st dose
Avoid within 90 days after casirivimab and imdevimab therapy
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
Different brands may not be interchangeable
Do not mix with other vaccines in the same syringe
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Evaluate for thrombocytopenia if thrombosis occurs within 3 weeks of dose
Exclude thrombosis if thrombocytopenia occurs within 3 weeks of dose
Monitor for signs and symptoms of Guillain-Barre syndrome
Monitor for signs and symptoms of thromboembolism and/or thrombocytopenia
Monitor patient for at least 15 minutes after vaccination
Advise patient to contact a doctor if symptoms of thrombocytopenia develop
Advise patient to contact a doctor if symptoms of thromboembolism develop
Advise patient to report signs and symptoms of immune thrombocytopenia
Advise patient to report sudden severe headache and visual disturbances
Advise pt. to seek medical attention if sudden abdominal,chest or back pain
Management of cases of shock should follow current medical standards
Seek urgent medical attention if symptoms of Capillary Leak Syndrome occur
Follow national immunisation guidelines
Precautions should be in place to avoid injury from fainting should a psychogenic response occur from the needle injection.
Consult specialist to diagnose and treat thrombosis with thrombocytopenia syndrome (TTS).
The duration of protection provided by the vaccine is unknown. Protection starts from around 14 days after vaccination.
Pregnancy and Lactation
Pregnancy
Use COVID-19 vaccine (AD26.COV2-S recombinant) with caution during pregnancy.
The manufacturer does not recommend using COVID-19 vaccine (AD26.COV2-S recombinant) during pregnancy unless the potential benefits outweigh any potential risks to the mother or foetus. Animal studies indicate there are no harmful effects during pregnancy. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Use COVID-19 vaccine (AD26.COV2-S recombinant) with caution during breastfeeding.
The presence of COVID-19 vaccine (AD26.COV2-S recombinant) in human breast milk and the effects on exposed infants are unknown.
Side Effects
Anaphylaxis
Arthralgia
Asthenia
Back pain
Bell's palsy
Capillary leak syndrome
Cerebrovascular venous and sinus thrombosis (CVST)
Chills
Cough
Cutaneous vasculitis
Diarrhoea
Dizziness
Erythema at injection site
Facial paralysis
Fatigue
Guillain-Barre syndrome
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypoaesthesia
Local pain (injection site)
Lymphadenopathy
Malaise
Muscle weakness
Myalgia
Nausea
Oropharyngeal pain
Painful extremities
Paraesthesia
Pyrexia
Rash
Sneezing
Splanchnic vein thrombosis
Swelling (injection site)
Thrombocytopenia
Thromboembolism
Thrombosis
Thrombosis with thrombocytopenia syndrome
Tinnitus
Transverse myelitis
Tremor
Urticaria
Venous thrombosis
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: February 2022
Reference Sources
Summary of Product Characteristics: COVID-19 Vaccine Janssen suspension for injection. Janssen-Cilag Ltd. Revised December 2022.
Immunisation against infectious disease - The Green Book.
Available at https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last accessed: 01 February 2022
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 01 February 2022
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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