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The safety and effectiveness of the Moderna Spikevax® Monovalent COVID-19 vaccine (Omicron XBB 1.5) is based on studies of Spikevax® (Original, Original/Omicron BA.1 & XBB.1.5). Dosage Primary series The mRNA sequence from Moderna Spikevax ® COVID-19 vaccine is also included in the Moderna Spikevax ®Bivalent COVID-19 vaccine (Original/Omicron BA.1). The bivalent booster also has an additional mRNA sequence that targets the Omicron BA.1 variant. A severe allergic (anaphylaxis) reaction is also rare. Signs and symptoms of anaphylaxis may include: Health care providers must report possible reactions following vaccination to their local public health authority. The public health authority then reports them to the Public Health Agency of Canada.Reported allergic reactions and side effects to COVID-19 vaccines are published weekly in our Reported side effects following COVID-19 vaccination report. Vaccine review, approval and monitoring

Find detailed technical information such as the product monograph and the regulatory decision summary: months to 4 years (25 micrograms at least 6 months after their previous dose). If the child has not been previously vaccinated, Spikevax XBB.1.5 should be administered a 2-dose regimen.Your province or territory decides when people receive their doses of the vaccine. These decisions are based on public health recommendations and the latest evidence. Clinical trials showed that beginning 2 weeks after the second dose, the Moderna Spikevax ® COVID vaccine was: Primary series in individuals age 6 months and older, or as a booster dose in individuals age 12 years and older: Moderna Spikevax ® Monovalent Omicron COVID-19 vaccine (Omicron XBB.1.5 subvariant) regulatory information

The Moderna Spikevax ®Bivalent COVID-19 vaccine (Original/Omicron BA.1) was shown to increase the immune response against the Omicron BA.1 variant. This means that the booster is expected to offer protection against this variant. The Moderna Spikevax®Monovalent COVID-19 vaccine(Omicron XBB.1.5 subvariant) is approved for people who are 6 months of age and older. It may be given to people who have been previously vaccinated or who have not been previously vaccinated. The bivalent Original/Omicron BA.4/5 0.1 mg/mL multi-dose vial has a royal blue plastic cap and grey label. years and older (50 micrograms at least 4 months after their previous dose) Moderna Spikevax ®COVID-19 vaccine, Moderna Spikevax ®Bivalent COVID-19 vaccine (Original/Omicron BA.1), Moderna Spikevax ®Bivalent COVID-19 vaccine (Original/Omicron BA.4/5) A different vaccine may be offered for your second dose. For example, you may have received Pfizer-BioNTech Comirnaty ® as your first dose and be offered Moderna Spikevax ® as your second. This is known as a mixed vaccine series.

Regulation

The safety and effectiveness of the Moderna Spikevax ® Bivalent COVID-19 vaccine(Original/Omicron BA. 4/5) is based on studies of Spikevax ® Bivalent (Original/Omicron BA.1). The Moderna Spikevax ® Bivalent COVID-19 vaccine (Original/Omicron BA.1) is approved as a booster for people who are 6 years of age and older. Its safety and effectiveness in younger people has not yet been established. Moderna Spikevax ®Bivalent COVID-19 vaccine (Original/Omicron BA.4/5) The Moderna Spikevax ® Bivalent COVID-19 vaccine (Original/Omicron BA.4/5) is approved as a booster for people who are 6 years of age and older. Its safety and effectiveness in younger people has not yet been established. Moderna Spikevax ®Monovalent COVID-19 vaccine (Omicron XBB.1.5 subvariant)

Dose volume depends on which series of the vaccine is being administered. The dose for people 12 years of age and older (100 micrograms) is: The bivalent Original/Omicron BA.1 0.1 mg/mL multi-dose vial has a royal blue plastic cap and green label. Health Canada's independent drug review process is recognized around the world for its high standards and rigor. Our decisions are based only on scientific and medical evidence showing that vaccines are safe and effective. The benefits must also outweigh any risks. The mRNA sequence from Moderna Spikevax ®COVID-19 vaccine is also included in the Moderna Spikevax ®Bivalent COVID-19 vaccine (Original/Omicron BA.4/5). The bivalent booster also has an additional mRNA sequence that targets the Omicron BA.4/5 variants. Other ingredients The National Advisory Committee on Immunization (NACI) recommends an mRNA vaccine (Pfizer-BioNTech Comirnaty ® or Moderna Spikevax ®) should be offered for your second dose.Its safety and effectiveness in people younger than 6 months has not yet been established. Effectiveness