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Covid-19 vaccine (comirnaty original/omicron ba 4-5 mrna vaccine)

Updated 2 Feb 2023 | Coronavirus vaccine

Presentation

Vaccine containing COVID-19 (Comirnaty Original/Omicron BA 4-5 MRNA).

Drugs List

  • COMIRNATY COVID-19 VACCINE ORIGINAL/OMICRON BA 4-5 MRNA dispersion for inj multidose vial
  • GENERIC COMIRNATY COVID-19 VACCINE ORIGINAL/OMICRON BA 4-5 dispersion for injection multidose vial
  • 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

    COVID-19 Vaccine (Comirnaty Original/Omicron BA 4-5 MRNA vaccine) is indicated for individuals who have previously received at least a primary vaccination course against COVID-19.

    Adults

    1 dose (0.3ml).

    Children

    Children aged 12 years and older
    1 dose (0.3ml).

    Administration

    Administered via intramuscular injection, preferably into 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
    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

    Myocarditits and pericarditis can develop with a few days after vaccination, and have occurred primarily within 14 days, and observed more often after the second vaccination and in younger males.

    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.

    Pregnancy and Lactation

    Pregnancy

    COVID-19 Vaccine (Comirnaty Original-Omicron BA 4-5 MRNA) is considered safe for use during pregnancy.

    The manufacturer advises COVID-19 Vaccine (Comirnaty Original-Omicron BA 4-5 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 BA 4-5 MRNA) during pregnancy. Potential risks are unknown.

    Lactation

    COVID-19 Vaccine (Comirnaty Original-Omicron BA 4-5 MRNA) is considered safe for use during breastfeeding.

    The manufacturer states COVID-19 Vaccine (Comirnaty Original-Omicron BA 4-5 MRNA) may be used safely during breastfeeding. The presence of COVID-19 Vaccine (Comirnaty Original-Omicron BA 4-5 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: January 2023

    Reference Sources

    Summary of Product Characteristics: Comirnaty Original/Omicron BA. 4-5 (15/15 micrograms)/ dose dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified). Pfizer Ltd. Revised November 2022.

    Immunisation against infectious disease (The Green Book).
    Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
    Last revised: 05 September 2022
    Last accessed: 30 January 2023

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