Comirnaty Dosage/Direction for Use

Posology: For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty JN.1 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Severely immunocompromised aged 6 months to 4 years (3 mcg) or 5 years and older (10 mcg) or 12 years and older (30 mcg): Additional doses may be administered to individuals who are severely immunocompromised in accordance with national recommendations (see Precautions).
Paediatric population: There are paediatric formulations available for infants aged 6 months and above and children below 12 years of age. For details, please refer to the monograph for other formulations.
The safety and efficacy of the vaccine in infants aged less than 6 months have not yet been established.
3 mcg: Infants and children 6 months to 4 years of age without history of completion of a COVID-19 primary course or prior SARS-CoV-2 infection: Comirnaty JN.1 (3 micrograms)/dose with yellow cap is administered intramuscularly after dilution as a primary course of 3 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose followed by a third dose administered at least 8 weeks after the second dose (see Precautions and Pharmacology: Pharmacodynamics under Actions).
If a child turns 5 years old between their doses in the primary course, he/she should complete the primary course at the same 3 micrograms dose level.
Infants and children 6 months to 4 years of age with history of completion of a COVID-19 primary course or prior SARS CoV-2 infection: Comirnaty JN.1 (3 micrograms)/dose with yellow cap is administered intramuscularly after dilution as a single dose of 0.3 mL for infants and children 6 months to 4 years of age.
Interchangeability: The primary course may consist of either Comirnaty, Comirnaty Original/Omicron BA.4-5, Comirnaty Omicron XBB.1.5 or Comirnaty JN.1 (or a combination) but not exceeding the total number of doses required as primary course. The primary course should only be administered once.
The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers has not been established.
10 mcg: Children 5 to 11 years of age (i.e. 5 to less than 12 years of age): Comirnaty JN.1 (10 micrograms)/dose dispersion for injection is administered intramuscularly as a single dose of 0.3 mL for children 5 to 11 years of age regardless of prior COVID-19 vaccination status (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Comirnaty JN.1 (10 micrograms)/dose should be used only for children 5 to 11 years of age.
30 mcg: Individuals 12 years of age and older: Comirnaty JN.1 (30 micrograms)/dose is administered intramuscularly as a single dose of 0.3 mL for individuals 12 years of age and older regardless of prior COVID-19 vaccination status (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Elderly population: No dose adjustment is required in elderly individuals ≥65 years of age.
Method of administration: Do not inject the vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
For precautions to be taken before administering the vaccine, see Precautions.
For instructions regarding thawing, dilution, handling and disposal of the vaccine, see Special Precautions for Disposal and Other Handling under Cautions for Usage.
Irrespective of the type of syringe and needle: Each dose must contain 0.3 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Do not pool excess vaccine from multiple vials (3 mcg & 30 mcg only).
3 mcg: Comirnaty JN.1 (3 micrograms)/dose concentrate for dispersion for injection should be administered intramuscularly after dilution (see Special Precautions for Disposal and Other Handling under Cautions for Usage).
After dilution, vials with a yellow cap of Comirnaty JN.1 contain 3 doses of 0.3 mL of vaccine. Standard syringes and needles can be used to extract 3 doses from a single vial.
In infants from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle.
10 mcg/30 mcg: Comirnaty JN.1 (10 or 30 micrograms)/dose dispersion for injection should be administered intramuscularly (see Special Precautions for Disposal and Other Handling under Cautions for Usage). Do not dilute prior to use.
The preferred site is the deltoid muscle of the upper arm (see Special Precautions for Disposal and Other Handling under Cautions for Usage).
Single dose vials: Single dose vials of Comirnaty JN.1 contain 1 dose of 0.3 mL of vaccine.
Withdraw a single 0.3 mL dose of Comirnaty JN.1.
Discard vial and any excess volume.
Do not pool excess vaccine from multiple vials (30 mcg only).
30 mcg: Multidose vials: Multidose vials of Comirnaty JN.1 contain 6 doses of 0.3 mL of vaccine. In order to extract 6 doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial.
Pre-filled syringes: Each single dose pre-filled syringe of Comirnaty JN.1 contains 1 dose of 0.3 mL of vaccine.
Attach a needle appropriate for intramuscular injection and administer the entire volume.