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

Administration

Administered via intramuscular injection, preferably in the deltoid muscle.

Contraindications

Children under 18 years
History of capillary leak syndrome

Precautions and Warnings

Immunosuppression
Increased risk of cerebral venous and sinus thrombosis
Recent anticoagulant therapy
Severe febrile conditions
Antiphospholipid syndrome
Breastfeeding
Coagulopathy
History of cerebral venous sinus thrombosis
History of heparin-induced thrombocytopenia and thrombosis
History of immune thrombocytopenic purpura
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
Assess risk/monitor platelet count if history of immune thrombocytopenia
Avoid 2nd dose if symptoms of transverse myelitis occur with 1st dose
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 drugs or substances
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
Advise patient to contact a doctor if symptoms of thromboembolism develop
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

If anaphylaxis occurs following the first dose of the vaccine, do not administer the second dose.

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 approximately 3 weeks after the first dose. Individuals may not be fully protected until 15 days after the second dose is administered.

Pregnancy and Lactation

Pregnancy

Use COVID-19 vaccine (ChAdOx1-S recombinant) with caution during pregnancy.

The manufacturer does not recommend using COVID-19 vaccine (ChAdOx1-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 (ChAdOx1-S recombinant) with caution during breastfeeding.

The presence of COVID-19 vaccine (ChAdOx1-S recombinant) in human breast milk and the effects on exposed infants are unknown.

Side Effects

Abdominal pain
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Bruising at injection site
Capillary leak syndrome
Cerebrovascular venous and sinus thrombosis (CVST)
Chills
Decreased appetite
Diarrhoea
Dizziness
Erythema at injection site
Facial paralysis
Fatigue
Guillain-Barre syndrome
Headache
Hyperhidrosis
Hypersensitivity reactions
Idiopathic thrombocytopenic purpura (ITP)
Immunologically mediated thrombocytopenia
Induration (injection site)
Influenza-like syndrome
Lethargy
Local pain (injection site)
Lymphadenopathy
Malaise
Migraine
Muscle spasm
Myalgia
Nausea
Neuroinflammatory disorder
Painful extremities
Pruritus
Pyrexia
Rash
Rigors
Rise in body temperature
Sensation of warm and/or cold at injection site
Shivering
Somnolence
Swelling (injection site)
Tenderness (injection site)
Thrombocytopenia
Thrombosis
Thrombosis with thrombocytopenia syndrome
Transverse myelitis
Urticaria
Vomiting

Presentation

Vaccine containing COVID-19 (ChAdOx1-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

Administration

Administered via intramuscular injection, preferably in the deltoid muscle.

Contraindications

Children under 18 years
History of capillary leak syndrome

Precautions and Warnings

Immunosuppression
Increased risk of cerebral venous and sinus thrombosis
Recent anticoagulant therapy
Severe febrile conditions
Antiphospholipid syndrome
Breastfeeding
Coagulopathy
History of cerebral venous sinus thrombosis
History of heparin-induced thrombocytopenia and thrombosis
History of immune thrombocytopenic purpura
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
Assess risk/monitor platelet count if history of immune thrombocytopenia
Avoid 2nd dose if symptoms of transverse myelitis occur with 1st dose
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 drugs or substances
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
Advise patient to contact a doctor if symptoms of thromboembolism develop
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

If anaphylaxis occurs following the first dose of the vaccine, do not administer the second dose.

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 approximately 3 weeks after the first dose. Individuals may not be fully protected until 15 days after the second dose is administered.

Pregnancy and Lactation

Pregnancy

Use COVID-19 vaccine (ChAdOx1-S recombinant) with caution during pregnancy.

The manufacturer does not recommend using COVID-19 vaccine (ChAdOx1-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 (ChAdOx1-S recombinant) with caution during breastfeeding.

The presence of COVID-19 vaccine (ChAdOx1-S recombinant) in human breast milk and the effects on exposed infants are unknown.

Side Effects

Abdominal pain
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Bruising at injection site
Capillary leak syndrome
Cerebrovascular venous and sinus thrombosis (CVST)
Chills
Decreased appetite
Diarrhoea
Dizziness
Erythema at injection site
Facial paralysis
Fatigue
Guillain-Barre syndrome
Headache
Hyperhidrosis
Hypersensitivity reactions
Idiopathic thrombocytopenic purpura (ITP)
Immunologically mediated thrombocytopenia
Induration (injection site)
Influenza-like syndrome
Lethargy
Local pain (injection site)
Lymphadenopathy
Malaise
Migraine
Muscle spasm
Myalgia
Nausea
Neuroinflammatory disorder
Painful extremities
Pruritus
Pyrexia
Rash
Rigors
Rise in body temperature
Sensation of warm and/or cold at injection site
Shivering
Somnolence
Swelling (injection site)
Tenderness (injection site)
Thrombocytopenia
Thrombosis
Thrombosis with thrombocytopenia syndrome
Transverse myelitis
Urticaria
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: January 2022

Reference Sources

Summary of Product Characteristics: Vaxzevria suspension for injection. AstraZeneca UK Limited. Revised January 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: 26 January 2022

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 26 January 2022