Posology : מינונים

4.2    Posology and method of administration
Posology

Individuals 12 years of age and older
Comirnaty is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose (see sections 4.4 and 5.1).

Interchangeability
The interchangeability of Comirnaty with other COVID-19 vaccines from other manufacturers to complete the vaccination course has not been established. Individuals who have received 1 dose of Comirnaty should receive a second dose of Comirnaty to complete the vaccination course.

Doses of Comirnaty (supplied in a vial with a purple cap) and Comirnaty TRIS 30 (supplied in a vial with a grey cap) are considered interchangeable.


Paediatric population
There is a paediatric formulation available for individuals 5 to 11 years of age (i.e. 5 to less than 12 years of age). For details, please refer to Comirnaty TRIS 10 label.

The safety and efficacy of Comirnaty in infants aged less than 5 years have not yet been established.

Elderly population
No dosage adjustment is required in elderly individuals ≥ 65 years of age.
Method of administration

Comirnaty should be administered intramuscularly after dilution (see section 6.6).

After dilution, vials of Comirnaty 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.
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.

The preferred site is the deltoid muscle of the upper arm.

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 section 4.4.

For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.