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.

Contraindications

Children under 6 years

Precautions and Warnings

Immunosuppression
Recent anticoagulant therapy
Severe febrile conditions
Coagulopathy
History of capillary leak syndrome
Immunodeficiency syndromes
Thrombocytopenia

Postpone immunisation if there is active or suspected infection
Advise ability to drive/operate machinery may be affected by side effects
Avoid second dose if anaphylaxis occurs with first 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
Contains polyethylene glycol
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
Monitor for symptoms of Capillary Leak Syndrome
Monitor patient for at least 15 minutes after vaccination
Advise patient to inform their physician if dyspnoea/chest pain occur
Advise patient to report signs or symptoms of myocarditis and pericarditis
Advise patient to seek medical attention if new onset of heart palpitations
Management of cases of shock should follow current medical standards
Follow national immunisation guidelines

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

Healthcare professionals should consult specialists to diagnose and treat myocarditis and pericarditis. Very rare cases of myocarditis and pericarditis have been observed following vaccination with Spikevax Covid-19 vaccine. These cases have primarily occurred within 14 days following vaccination, more often the second vaccination, and more often in younger men.

Precautions should be in place to avoid injury from fainting should a psychogenic response occur from the needle injection.

If administering more than one non live vaccine at the same time, administer into different injection sites and preferably in different limbs. If more than one injection is administered in the same limb, separate by at least 2.5cm. Some live vaccines require further caution or time separation, see specific product literature.

Capillary leak syndrome (CLS) has been reported within first days of administration of Spikevax Covid-19 vaccine, monitoring for signs and symptoms of CLS is recommended. In Patients with a history of CLS, the use of Spikevax Covid-19 vaccine should be used with caution.

Pregnancy and Lactation

Pregnancy

Spikevax Covid-19 vaccine is considered safe for use during pregnancy.

The manufacturer advises Spikevax Covid-19 vaccine may be used safely during pregnancy.

Pregnant women should follow national guidance which suggests Spikevax Covid-19 vaccine is one of the preferred vaccine during pregnancy.

Lactation

Spikevax Covid-19 vaccine is considered safe for use during breastfeeding.

The manufacturer states Spikevax Covid-19 vaccine may be used safely when breastfeeding.

Side Effects

Abdominal pain
Anaphylaxis
Arthralgia
Chills
Delayed injection site reaction
Diarrhoea
Dizziness
Erythema at injection site
Erythema multiforme
Facial paralysis
Facial swelling
Fatigue
Headache
Hypersensitivity reactions
Hypoaesthesia
Itching (injection site)
Local pain (injection site)
Localised urticaria
Lymphadenopathy
Myalgia
Myocarditis
Nausea
Paraesthesia
Pericarditis
Pyrexia
Rash
Swelling (injection site)
Vomiting

Presentation

Vaccine containing COVID-19 mRNA (embedded in SM-102 lipid nanoparticles).

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

Children

Administration

Administered via intramuscular injection.

Contraindications

Children under 6 years

Precautions and Warnings

Immunosuppression
Recent anticoagulant therapy
Severe febrile conditions
Coagulopathy
History of capillary leak syndrome
Immunodeficiency syndromes
Thrombocytopenia

Postpone immunisation if there is active or suspected infection
Advise ability to drive/operate machinery may be affected by side effects
Avoid second dose if anaphylaxis occurs with first 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
Contains polyethylene glycol
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
Monitor for symptoms of Capillary Leak Syndrome
Monitor patient for at least 15 minutes after vaccination
Advise patient to inform their physician if dyspnoea/chest pain occur
Advise patient to report signs or symptoms of myocarditis and pericarditis
Advise patient to seek medical attention if new onset of heart palpitations
Management of cases of shock should follow current medical standards
Follow national immunisation guidelines

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

Healthcare professionals should consult specialists to diagnose and treat myocarditis and pericarditis. Very rare cases of myocarditis and pericarditis have been observed following vaccination with Spikevax Covid-19 vaccine. These cases have primarily occurred within 14 days following vaccination, more often the second vaccination, and more often in younger men.

Precautions should be in place to avoid injury from fainting should a psychogenic response occur from the needle injection.

If administering more than one non live vaccine at the same time, administer into different injection sites and preferably in different limbs. If more than one injection is administered in the same limb, separate by at least 2.5cm. Some live vaccines require further caution or time separation, see specific product literature.

Capillary leak syndrome (CLS) has been reported within first days of administration of Spikevax Covid-19 vaccine, monitoring for signs and symptoms of CLS is recommended. In Patients with a history of CLS, the use of Spikevax Covid-19 vaccine should be used with caution.

Pregnancy and Lactation

Pregnancy

Spikevax Covid-19 vaccine is considered safe for use during pregnancy.

The manufacturer advises Spikevax Covid-19 vaccine may be used safely during pregnancy.

Pregnant women should follow national guidance which suggests Spikevax Covid-19 vaccine is one of the preferred vaccine during pregnancy.

Lactation

Spikevax Covid-19 vaccine is considered safe for use during breastfeeding.

The manufacturer states Spikevax Covid-19 vaccine may be used safely when breastfeeding.

Side Effects

Abdominal pain
Anaphylaxis
Arthralgia
Chills
Delayed injection site reaction
Diarrhoea
Dizziness
Erythema at injection site
Erythema multiforme
Facial paralysis
Facial swelling
Fatigue
Headache
Hypersensitivity reactions
Hypoaesthesia
Itching (injection site)
Local pain (injection site)
Localised urticaria
Lymphadenopathy
Myalgia
Myocarditis
Nausea
Paraesthesia
Pericarditis
Pyrexia
Rash
Swelling (injection site)
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: November 2021

Reference Sources

Summary of Product Characteristics: Spikevax dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified). Moderna Biotech. Revised September 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: 24 January 2022

The Joint Committee on Vaccination and Immunisation (JCVI)
Available at: https://www.gov.uk/government/news/jcvi-issues-updated-advice-on-covid-19-booster-vaccination Last accessed: 22 November 2021