WHO recommendation BioNtech Tozinameran/US FDA - COVID-19 mRNA vaccine (nucleoside modified)

Pharmaceutical Form:                   Concentrate for dispersion for injection

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Dosage:                                            30 mcg

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Presentation:                                   2 mL Vial

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Number of doses:                            6 doses of 0.3 mL (after dilution)

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Route of administration:                Intramuscular

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Age indication:                                12 years and older

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

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Refrigeration Storage Time (2°C to 8°C):     10 weeks   

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Freezer Storage Time (-25°C to -15°C)​:       2 weeks within the 12 months shelf life

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Vaccine Vial monitor (VVM):        None

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Preservative:                                   None

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Adjuvant:                                        None

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Diluent:                                           Sodium Chloride Inj. USP 0.9%

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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.

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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)

 

 

Product information

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• WHO Summary of Product Characteristics
• WHO Package Leaflet

Pharmaceutical Form:                       Concentrate for dispersion for injection

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Dosage:                                                10 mcg

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Presentation:                                       2 mL Vial

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Number of doses:                                10 doses of 0.2 mL (after dilution)

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Route of administration:                    Intramuscular

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Age indication:                                    Children  from 5 to 11 years

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

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 Refrigeration Storage Time (2°C to 8°C):       10 weeks         

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Freezer Storage Time (-25 °C to -15°C):           DO NOT STORE

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Vaccine Vial monitor (VVM):             None

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Preservative:                                        None

---

Adjuvant:                                              None

---

Diluent:                                                 Sodium Chloride Inj USP 0.9%

---

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)

 

Product information

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• WHO Summary of Product Characteristics
• WHO Package Leaflet