Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 (Grey Cap, Grey Border)

≥ 12 years (15 mcg Original / 15 mcg Omicron BA.4/BA.5 per 0.3 mL)

Product Monograph   
Indication
  • Health Canada: Booster dose following COVID-19 primary series vaccination for individuals 12 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
  • Clinical information is based on the Pfizer-BioNTech Comirnaty® BA.1 Bivalent (30 mcg) candidate (which was not marketed). These results have been extrapolated to Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5.
  • Frequency and severity of adverse events of Pfizer-BioNTech Comirnaty® Original & Omicron BA.4/BA.5 are expected to be similar to those of Pfizer-BioNTech Comirnaty® original and Pfizer-BioNTech Comirnaty® BA.1 Bivalent when administered as a fourth dose.
  • Common adverse events (≥ 10%)
    • local reactions (pain, redness, swelling)
      • “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
    • chills
    • arthralgia
  • 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 second doses of monovalent mRNA COVID-19 vaccine and occurred more often in males, and in those 12 to 29 years of age.
      • There were no cases of myocarditis or pericarditis reported in the study. However, myocarditis and pericarditis are rare adverse events so would not be expected to be discovered in such a small study (n= 305). 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
      • 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
    • ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2- hexyldecanoate)
    • ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide
    • 1,2-distearoyl-sn-glycero-3-phosphocholine
    • cholesterol
    • sodium chloride
    • sucrose
    • tromethamine
    • tromethamine hydrochloride  
    • water for injection
  • Polyethylene glycol (PEG) and tromethamine are potentially allergenic ingredients
References
Last Updated

20 Oct 2022

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