COVID-19 vaccine guide for children: Vaccines available in Canada

Table 1. Comparison of the adult/youth and pediatric formulations of the Pfizer-BioNTech Comirnaty vaccine
Product specification	Adult or adolescent formulation	Pediatric formulation^{Table 1 Footnote a}
Age	12 years of age and over	5-11 years
Vial Cap Color	Purple	Orange
Diluent (Only use 0.9% Sodium Chloride Injection, USP as the diluent)	1.8 mL	1.3 mL
Dose	0.3 mL (30 micrograms)	0.2 mL (10 micrograms)
Doses per vial	6	10
Potential allergens	Polyethylene glycol (PEG)	Polyethylene glycol (PEG) Tromethamine (Tris, Trometamol)^{Table 1 Footnote b}
Post-dilution time Can be at room temperature	6 hours	12 hours
Ancillary supplies	Low dead volume needle/syringe	Low dead volume needle/syringe
Storage^{Table 1 Footnote c}^{Table 1 Footnote e}	Ultra-frozen until expiry date printed on the label^{Table 1 Footnote g} Frozen for up to 2 weeks^{Table 1 Footnote f}^{Table 1 Footnote g} Refrigerated^{Table 1 Footnote d} for up to 1 month Room temperature^{Table 1 Footnote d} for: up to 2 hours prior to dilution; up to 6 hours after dilution (i.e., post first puncture)	Ultra-frozen up to 6 months from the date of manufacture printed on the vial and cartons^{Table 1 Footnote a} Do not store frozen in a regular freezer (not at -25⁰C to -15⁰C) Refrigerated^{Table 1 Footnote d} for up to 10 weeks Room temperature^{Table 1 Footnote d} for: up to 12 hours prior to dilution; up to 12 hours after dilution (i.e., post first puncture)
Transport^{Table 1 Footnote c}^{Table 1 Footnote e}	Ultra-frozen full cartons containing vials^{Table 1 Footnote g} Frozen vials up to 2 weeks (included in 2-week limit for frozen storage)^{Table 1 Footnote f}^{Table 1 Footnote g} Refrigerated^{Table 1 Footnote d} thawed vials up to 12 hours (included in 1-month limit for refrigerated storage)	Ultra-frozen full cartons containing vials Refrigerated^{Table 1 Footnote d} full cartons or individual undiluted vials. Transport time as required and in keeping with other storage requirements (up to 10 weeks).
Footnotes Table 1 Footnote a Regardless of storage condition, vaccines should not be used after 6 months from the date of manufacture printed on the vial and cartons. Return to Footnote a referrer Table 1 Footnote b Tromethamine (Tris or trometamol) is used as a buffer in vaccines and medications, including those for use in children, to improve stability and prevent pH fluctuations in the solution. No safety concerns have been identified with tromethamine^{Footnote 1}. While tromethamine has been identified as a potential allergen, a review of existing evidence did not identify any cases of allergic reactions to tromethamine in children^{Footnote 2}. Return to Footnote b referrer Table 1 Footnote c Ultra Frozen is -90°C to -60°C; Frozen is -25°C to -15°C; Refrigerated is +2°C to +8°C; Room temperature is up to + 25°C. Return to Footnote c referrer Table 1 Footnote d Once vials are thawed, they should not be refrozen. Return to Footnote d referrer Table 1 Footnote e During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Return to Footnote e referrer Table 1 Footnote f Frozen vials stored for up to 2 weeks at -25°C to -15°C may be returned one time to ultra-frozen storage. Total cumulative time the vials are stored at -25°C to -15°C should not exceed 2 weeks. Return to Footnote f referrer Table 1 Footnote g Vials must be kept frozen and protected from light, in the original cartons, until ready to thaw. Return to Footnote g referrer

Adapted from the National Advisory Committee on Immunization Recommendation on the use of Pfizer-BioNTech COVID-19 vaccine (10 mcg) in children 5 to 11 years of age

References

Footnotes

Footnote 1

FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age [Internet]. Silver Spring (MD): United States Food and Drug Administration; 2021 Oct 29 [cited 2021 Nov 12]. Available from: https://www.fda.gov/news-events/press-announcements/fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use-children-5-through-11-years-age

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Footnote 2

Nilsson L, Csuth Á, Storsaeter J, Garvey LH, Jenmalm MC. Vaccine allergy: evidence to consider for COVID-19 vaccines. Curr Opin Allergy Clin Immunol. 2021 Aug 1;214:401,409. doi: 10.1097/ACI.0000000000000762.

Return to footnote 2 referrer

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Quick reference guide on use of COVID-19 vaccines for children 5 to 11 years of age: Available Pfizer-BioNTech Comirnaty product for children

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