COMIRNATY Original/Omicron BA.4-5

Product Overview

Type:                           COVID-19 mRNA Vaccine

INN:                            Tozinameran/Famtozinameran

Trade name:              COMIRNATY

EUL holder:               BioNTech Manufacturing GmbH

Country:                     Germany

Responsible NRA:    European Medicines Agency (EMA)

Country:                     The Netherlands


WHO EUL recommendation

Effective date:              11 November 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.

mibe GmbH Arzneimittel
Munchener Strasse 15. 06796 Brehna, Germany