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Booster dose Individuals 18 years of age and olderĪ booster dose (0.25 mL, containing 50 micrograms mRNA, which is half of the primary dose) of Spikevax may be administered intramuscularly at least 6 months after the second dose in individuals 18 years of age and older. Severely immunocompromised aged 6 years and olderĪ third dose may be given at least 28 days after the second dose to individuals 12 years of age and older (0.5 mL, 100 micrograms) and children 6 through 11 years (0.25 mL, 50 micrograms) who are severely immunocompromised (see section 4.4). It is recommended to administer the second dose 28 days after the first dose (see sections 4.4 and 5.1). Spikevax is administered as a course of 2 (two) 50 microgram doses (0.25 mL each, containing 50 micrograms mRNA, which is half of the primary dose for individuals 12 years and older). Spikevax is administered as a course of 2 (two) 100 microgram doses (0.5mL each). 4.2 Posology and method of administration Posology Primary series Individuals 12 years of age and older

The use of this vaccine should be in accordance with official recommendations. Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older. Clinical particulars 4.1 Therapeutic indications White to off white dispersion (pH: 7.0 – 8.0). One dose (0.25 mL) contains 50 micrograms of of elasomeran, a COVID-19 mRNA Vaccine (embedded in SM-102 lipid nanoparticles).Įlasomeran is a single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.įor the full list of excipients, see section 6.1. One dose (0.5 mL) contains 100 micrograms of elasomeran, a COVID-19 mRNA Vaccine (embedded in SM-102 lipid nanoparticles). This is a multidose vial that contains 10 doses of 0.5 mL each or a maximum of 20 doses of 0.25mL each. Name of medicinal productĬOVID-19 mRNA Vaccine (nucleoside modified) 2. See section 4.8 for how to report adverse reactions. Healthcare professionals are asked to report any suspected adverse reactions. This will allow quick identification of new safety information. This medicinal product is subject to additional monitoring.