VAXZEVRIA Suspension for injection Ref.[11061] Active ingredients: SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden

Product name and form

Vaxzevria suspension for injection.

COVID-19 Vaccine (ChAdOx1-S [recombinant]).

Pharmaceutical Form

Suspension for injection (injection).

The suspension is colourless to slightly brown, clear to slightly opaque with a pH of 6.6.

Qualitative and quantitative composition

These are multidose vials which contain 8 doses or 10 doses of 0.5 ml per vial (see section 6.5).

One dose (0.5 ml) contains: Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)*, not less than 2.5 × 108 infectious units (Inf.U).

* Produced in genetically modified human embryonic kidney (HEK) 293 cells and by recombinant DNA technology.

This product contains genetically modified organisms (GMOs).

Excipient with known effect: Each dose (0.5 ml) contains approximately 2 mg of ethanol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)

SARS-CoV-2 Spike glycoprotein (ChAdOx1-S) is a monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2. The SARS-CoV-2 S immunogen in the vaccine is expressed in the trimeric pre-fusion conformation; the coding sequence has not been modified in order to stabilise the expressed S-protein in the pre-fusion conformation. Following administration, the S glycoprotein of SARS-CoV-2 is expressed locally stimulating neutralising antibody and cellular immune responses, which may contribute to protection to COVID-19.

List of Excipients

L-Histidine
L-Histidine hydrochloride monohydrate
Magnesium chloride hexahydrate
Polysorbate 80 (E433)
Ethanol
Sucrose
Sodium chloride
Disodium edetate (dihydrate)
Water for injections

Pack sizes and marketing

Multidose vial

8-dose vial: 4 mL of suspension in an 8-dose vial (clear type I glass) with stopper (elastomeric with aluminium overseal). Each vial contains 8 doses of 0.5 mL. Pack sizes of 10 multidose vials.

10-dose vial: 5 mL of suspension in a 10-dose vial (clear type I glass) with stopper (elastomeric with aluminium overseal). Each vial contains 10 doses of 0.5 mL. Pack sizes of 10 multidose vials.

Not all pack sizes may be marketed.

Marketing authorization holder

AstraZeneca AB, SE-151 85 Södertälje, Sweden

Marketing authorization dates and numbers

EU/1/21/1529/001 10 multidose vials (8 doses per vial)
EU/1/21/1529/002 10 multidose vials (10 doses per vial)

Date of first authorisation: 29 January 2021
Date of latest renewal: 9 November 2021

Drugs

Drug Countries
VAXZEVRIA Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania

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