This helps to distinguish these vials from those with the higher dose. The vaccine vials with maroon caps and maroon border on the label are used to prepare the dose for individuals 6 months to less than 5 years of age. The vaccine vials with orange caps and an orange border on the label are used to prepare the dose for individuals 5 to less than 12 years of age. The gray caps and a gray label border and blue caps and blue label border have improved stability with a change in buffer and are the only vials that do not require dilution to make handling and administration easier.The currently available vaccine products with purple caps and a purple label border or gray caps with a gray label border are used to prepare the dose for individuals 12 years of age and older. If the child of less than 5 years of age has not been previously vaccinated, Comirnaty ® XBB.1.5 should be administered as a 3-dose regimen. Omicron XBB.1.5 subvariant vaccine doses (at least 6 months after previous dose) 12 years of age and older (30 micrograms).Booster doses (at least 6 months after previous dose) The interval between doses is determined by the child's age at the start of the vaccination series. 10 times the dose used for children 6 months to less than 5 years of age (3 micrograms).Ĭhildren aged 4 who will turn 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination.3 times the dose used for children 5 to 11 years of age (10 micrograms).The dose for individuals 12 years of age and older (30 micrograms) is: 6 months to 4 years (3 doses of 3 micrograms, the initial 2 doses are administered 21 days apart with the third dose at least 8 weeks after).5 to 11 years (2 doses of 10 micrograms, 21 days apart).12 years and older (2 doses of 30 micrograms, 21 days apart).The safety and effectiveness of the Pfizer-BioNTech Comirnaty ® Omicron XBB.1.5 subvariant, monovalent COVID-19 vaccine is based on studies of Comirnaty ® (Original, Original/Omicron BA.4/BA.5). The Pfizer-BioNTech Comirnaty ® Original and Omicron BA.1, bivalent COVID-19 vaccine was shown to increase the immune response against the Omicron BA.1 variant. The Pfizer-BioNTech Comirnaty ® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine was shown to increase the immune response against the Omicron BA.4/BA.5 variants. The data determined that the immune response to the vaccine for both age groups was comparable to the immune response of the older participants. 90.7% effective for those 5 to 11 years oldĮffectiveness data supporting the authorization in children ages 6 months to under 5 years are based on a comparison of immune responses in this age group to individuals ages 16 to 25 years.100% effective for those 12 to 15 years old.95% effective in protecting trial participants from COVID-19 for those 16 years and older.EffectivenessĬlinical trials showed that beginning 1 week after the second dose, the Pfizer-BioNTech Comirnaty ® COVID vaccine was about: Its safety and effectiveness in people younger than 6 months has not yet been established. The Pfizer-BioNTech Comirnaty ® Omicron XBB.1.5 subvariant, monovalent COVID-19 vaccine is approved for people who are 6 months of age and older. Pfizer-BioNTech Comirnaty ® Omicron XBB.1.5 subvariant, monovalent COVID-19 vaccine Its safety and effectiveness in younger people has not yet been established. The Pfizer-BioNTech Comirnaty ® Original and Omicron BA.1, bivalent COVID-19 vaccine is approved as a booster for people who are 12 years of age and older. Pfizer-BioNTech Comirnaty ® Original and Omicron BA.1, bivalent COVID-19 vaccine The Pfizer-BioNTech Comirnaty ® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine is approved as a primary series for people who are 6 months of age and older and as a booster for people who are 5 years of age and older. Pfizer-BioNTech Comirnaty ® Original and Omicron BA.4/BA.5, bivalent COVID-19 vaccine This vaccine is also approved as a booster for people age 5 to 11 years as well as 16 years and older. Its safety and effectiveness in people younger than 6 months of age have not yet been established. The vaccine is approved for people who are 6 months of age and older. Pfizer-BioNTech Comirnaty ® COVID-19 vaccine Vaccine review, approval and monitoring.Original and Omicron BA.1 (12 years and older).Original and Omicron BA.4/BA.5 (5 years and older).Original (5 to 11 years as well as 16 years and older).Primary series in individuals age 6 months and older:
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