COMIRNATY Original/Omicron BA.1



Product Overview


Type:                           COVID-19 mRNA Vaccine


INN:                            Tozinameran/Riltozinameran


Trade name:              COMIRNATY


EUL holder:               BioNTech Manufacturing GmbH


Country:                     Germany


Responsible NRA:    European Medicines Agency (EMA)


Country:                     The Netherlands


 

WHO EUL recommendation


Effective date:             19 October 2022


 

Product description


Pharmaceutical Form:                   Sterile dispersion for injection


Dosage:                                            15/15 mcg


Presentation:                                   2.25 mL Vial


Number of doses:                            6 doses of 0.3 mL


Route of administration:                Intramuscular


Age indication:                                12 years and older


Shelf – life:                                       12 months     Storage temperature:   -90°C to -60°C      


Refrigeration Storage Time (2°C to 8°C):     10 weeks within the 12 months shelf life


Vaccine Vial monitor (VVM):        None


Preservative:                                    None


Adjuvant:                                          None


Diluent:                                              None


Handling of opened multi-dose vials: 

WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.


 

Packaging description

Secondary Packaging:    Carton holding 195 vials (1170 doses). Dimensions: 22.9 x 22.9 x 4.0 cm
Tertiary Packaging: Insulated box containing 5 secondary cartons with a total of 975 vials (5850 doses). Dimensions: 40 x 40 x 56 cm
Cold Chain Volume:  1.8 cm3/dose      (in secondary packaging)

 

Drug product - Manufacturing sites


Pfizer Manufacturing Belgium NV
Rijksweg 12, 2870 Puurs, Belgium.

Sanofi-Aventis Deutschland GmbH
Brueningstrasse 50 (H500, H590, H600, H750, H785, H790), 65926 Frankfurt am Main, Germany.