Use of Comirnaty for 5- to 11-Year-Old Children - Important Information for Medical Doctors
The vaccine Comirnaty from BioNTech/Pfizer for children aged 5 to 11 years will soon be available in Germany. Doctors should urgently follow important instructions for use.
The paediatric vaccine Comirnaty from BioNTech/Pfizer for 5- to 11-year-olds differs in dosage and handling from the vaccine Comirnaty for people aged 12 years and older. The paediatric vaccine has a lower concentration and a lower injection volume. The thawed vial can be stored and transported at 2 to 8 degrees Celsius for ten weeks within its shelf life of 6 months.
Before vaccinating 5- to 11-year-olds, it is important to make sure that the vial indeed contains the vaccine for children aged 5 to 11: The cap colour of the vial containing the vaccine concentrate for children aged 5 to 11 years is orange, whereas that of the vaccine for 12 years and older is purple. Furthermore, it should be ensured that the dilution is carried out correctly according to the instructions and that a lower volume is injected for children aged 5-11 years. The concentrate in the multi-dose container for the paediatric vaccine (5-11 years) is diluted with 1.3 ml of a sodium chloride injection solution 9 mg/ml (0.9%) before use. Each vial contains 10 vaccine doses after dilution. For children aged 5 to 11 years, 0.2 ml (equivalent to a dose of 10 µg) is injected.
It should be expressly noted that a withdrawal of 0.1 ml of the vaccine for persons aged 12 years and older is not recommended to vaccinate children aged 5 to 11 years because the withdrawal volume is too low to ensure reliable vaccination with the required dose. It is also important to bear in mind that the vaccine has a different composition.
The most significant differences have been summarised by the National Association of Statutory Medical Doctors (Kassenärztliche Bundesvereinigung, KBV) in an information sheet on the storage and handling of both vaccines from BioNTech/Pfizer (see "Further information").
National Association of Statutory Medical Doctors (Kassenärztliche Bundesvereinigung, KBV): Vaccine from BioNTech / Pfizer for 5- to 11-year-old children and for persons 12 years and older - overview of differences (as of 1 December 2021, German only):
Product Information: Comirnaty