Moderna Spikevax™ Bivalent (Royal Blue Cap, Green Border)

≥ 18 years (25 mcg Original / 25 mcg Omicron BA.1 per 0.5 mL)

Product Monograph   
Indication
  • Health Canada: Booster dose following COVID-19 primary series vaccination (with any COVID-19 vaccine) for individuals 18 years and older
    • The SK Ministry of Health supports permissive administration of this bivalent vaccine as a primary COVID-19 immunization series with informed consent if an individual requests to start or complete their COVID-19 primary series with this vaccine.
Dose
Adverse Events
  • Frequency and severity of adverse events of Moderna Spikevax™ Bivalent given as a second booster dose were similar or lower compared to Moderna Spikevax™ 100 mcg (2nd primary doses) and Moderna Spikevax™ 50 mcg (1st booster doses).
  • Common adverse events ( 10%)
    • local reactions (pain, axillary swelling/tenderness)
      • “COVID arm” is a local delayed (≥ 7 days) reaction with these symptoms; it is an expected reaction that resolves within 7 days. This does not need to be reported as an AEFI/AESI. 
    • fatigue
    • headache
    • myalgia
    • arthralgia
    • chills

  • Rare Adverse Events
    • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination with COVID-19 vaccines have been reported in a small number of people. Most cases followed vaccination with first doses of monovalent mRNA COVID-19 vaccine.
      • There were no cases of myocarditis or pericarditis reported in the studies. However, myocarditis and pericarditis are rare adverse events so would not be expected to be discovered in studies of < 1000 participants. Data suggest risk is lower following booster doses compared to the 2nd dose of a primary series. Monitoring real-world conditions will continue.
Drug Interactions
  • Anti-SARS-CoV-2 Monoclonal Antibodies
    • For treatment of COVID-19 (e.g. sotrovimab)
      • Based on Saskatchewan guidelines / recommendations, vaccination with COVID-19 vaccine should be delayed for at least 90 days after treatment with anti-SARS-CoV-2 monoclonal antibodies for treatment of COVID-19 infection, as this therapy may interfere with and delay response to the COVID-19 vaccine. The period of 90 days is based on the half-life of the therapy.
    • For pre-exposure prophylaxis of COVID-19
      • Evusheld™ (tixagevimab / cilgavimab)
        • NACI recommends delaying administration of Evusheld™ for at least 14 days following COVID-19 vaccination.
        • Information regarding effect of Evusheld™ on future COVID-19 vaccination is not available and NACI recommends timing be assessed on a case-by-case basis in consultation with clinical experts.
Vaccine Composition
  • Ingredients
    • acetic acid
    • cholesterol
    • DSPC (1,2-distearoyl-sn-glycero-3- phosphocholine)
    • Lipid SM-102
    • PEG2000-DMG (1,2-dimyristoyl-racglycerol,methoxy-polyethyleneglycol)
    • sodium acetate trihydrate
    • sucrose
    • trometamol
    • trometamol hydrochloride
    • water for injection
  • Polyethylene glycol (PEG) and trometamol (tromethamine) are potentially allergenic ingredients
References
Last Updated

20 Oct 2022