Covid-19 vaccine (comirnaty original/omicron bivalent mrna)
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing COVID-19 (Comirnaty Original/Omicron mRNA).
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
Booster dose of COVID-19 Vaccine (Comirnaty Original-Omicron Bivalent mRNA) should be given at least 3 months after the completion of the primary series or booster COVID-19 vaccine.
Adults
1 dose (0.3ml).
Children
Children aged 12 years and older
1 dose (0.3ml).
Administration
Administered via intramuscular injection, preferably in the deltoid muscle.
Contraindications
Acute infection
Children under 12 years
Severe febrile conditions
Precautions and Warnings
Febrile disorder
Immunosuppression
Recent anticoagulant therapy
Coagulopathy
Immunodeficiency syndromes
Thrombocytopenia
Postpone immunisation if there is active or suspected infection
Avoid second dose if anaphylaxis occurs with first dose
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
Contains polyethylene glycol
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 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
Increased risk of myocarditis and pericarditis
Management of cases of shock should follow current medical standards
Follow national immunisation guidelines
Precautions should be in place to avoid injury from fainting should a psychogenic response occur from the needle injection.
Pregnancy and Lactation
Pregnancy
COVID-19 Vaccine (Comirnaty Original-Omicron Bivalent mRNA) is considered safe for use during pregnancy.
The manufacturer advises COVID-19 Vaccine (Comirnaty Original-Omicron Bivalent mRNA) may be used during pregnancy. At the time of writing there is limited published information regarding the use of COVID-19 Vaccine (Comirnaty Original-Omicron Bivalent mRNA) during pregnancy. Potential risks are unknown.
Lactation
COVID-19 Vaccine (Comirnaty Original-Omicron Bivalent mRNA) is considered safe for use during breastfeeding.
The manufacturer states COVID-19 Vaccine (Comirnaty Original-Omicron Bivalent mRNA) may be used safely during breastfeeding. The presence of COVID-19 Vaccine (Comirnaty Original-Omicron Bivalent mRNA) in breast milk is unknown. Effects on exposed infants are unknown.
Side Effects
Anaphylaxis
Angioedema
Arthralgia
Asthenia
Chills
Decreased appetite
Diarrhoea
Erythema multiforme
Facial paralysis
Facial swelling
Fatigue
Headache
Hyperhidrosis
Hypoaesthesia
Injection site reactions
Insomnia
Lethargy
Limb swelling
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Myocarditis
Nausea
Night sweats
Painful extremities
Paraesthesia
Pericarditis
Pruritus
Pyrexia
Rash
Swelling
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: September 2022
Reference Sources
Summary of Product Characteristics: Comirnaty Original/Omicron BA.1 (15/15 micrograms)/ dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified). Pfizer Ltd. 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: 16 September 2022
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