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Covid-19 vaccine (spikevax original-omicron bivalent mrna)

Updated 2 Feb 2023 | Coronavirus vaccine


Vaccine containing COVID-19 (Spikevax Original/Omicron mRNA).

Drugs List

  • COVID-19 SPIKEVAX VACCINE BIVALENT ORIGINAL/OMICRON MRNA dispersion for injection multidose vial
  • GENERIC COVID-19 SPIKEVAX BIVALENT ORIGINAL OMICRON VACCINE dispersion for injection multidose vial
  • Therapeutic Indications


    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


    Booster dose of COVID-19 Vaccine (Spikevax Original-Omicron Bivalent mRNA) should be given at least 3 months after the completion of the primary series or booster COVID-19 vaccine.


    1 dose (0.5ml).


    Administered via intramuscular injection, preferably in the deltoid muscle.


    Acute infection
    Children under 18 years
    Severe febrile conditions

    Precautions and Warnings

    Febrile disorder
    Recent anticoagulant therapy
    Immunodeficiency syndromes

    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
    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 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.

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

    Pregnancy and Lactation


    COVID-19 Vaccine (Spikevax Original-Omicron Bivalent mRNA) is considered safe for use during pregnancy.

    The manufacturer advises COVID-19 Vaccine (Spikevax Original-Omicron Bivalent mRNA) may be used safely during pregnancy. Available reports indicate no increased risk of teratogenic or developmental effects.


    COVID-19 Vaccine (Spikevax Original-Omicron Bivalent mRNA) is considered safe for use during breastfeeding.

    The manufacturer states COVID-19 Vaccine (Spikevax Original-Omicron Bivalent mRNA) may be used safely during breastfeeding. The presence of COVID-19 Vaccine (Spikevax Original-Omicron Bivalent mRNA) in breastmilk is unknown. Studies of breastfed infants exposed to COVID-19 Vaccine (Spikevax Original-Omicron Bivalent mRNA) have shown no adverse effects.

    Side Effects

    Abdominal pain
    Delayed injection site reaction
    Erythema at injection site
    Erythema multiforme
    Facial paralysis
    Facial swelling
    Hypersensitivity reactions
    Local pain (injection site)
    Rash at injection site
    Swelling (injection site)


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2022.

    Reference Sources

    Summary of Product Characteristics: Spikevax bivalent Original/Omicron 0.1mg/ml dispersion for injection. Moderna. Revised August 2022.

    Immunisation against infectious disease - The Green Book.
    Available at
    Last accessed: 30 August 2022.

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