VIDPREVTYN BETA Solution and emulsion for emulsion for injection Ref.[50347] Active ingredients: SARS-CoV-2 spike glycoprotein (B.1 strains)

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Sanofi Pasteur, 14 Espace Henry Vallรฉe, 69007 Lyon, France

Product name and form

VidPrevtyn Beta solution and emulsion for emulsion for injection.

COVID-19 vaccine (recombinant, adjuvanted).

Pharmaceutical Form

Solution and emulsion for emulsion for injection.

The antigen solution is a colourless, clear liquid.

The adjuvant emulsion is a whitish to yellowish homogeneous milky liquid.

Qualitative and quantitative composition

These are two multidose vials (antigen vial and adjuvant vial) that must be mixed before use. After mixing, the vaccine vial contains 10 doses of 0.5 mL.

One dose (0.5 mL) contains 5 micrograms of SARS-CoV-2 spike protein (B.1.351 strain) produced by recombinant DNA technology using a baculovirus expression system in an insect cell line that is derived from Sf9 cells of the fall armyworm, Spodoptera frugiperda.

AS03 adjuvant is composed of squalene (10.69 milligrams), DL-ฮฑ-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams).

VidPrevtyn Beta may contain traces of octylphenol ethoxylate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
SARS-CoV-2 spike glycoprotein (B.1 strains)
List of Excipients

Antigen vial:

Sodium dihydrogen phosphate monohydrate
Disodium phosphate dodecahydrate
Sodium chloride
Polysorbate 20
Water for injections

Adjuvant vial:

Sodium chloride
Disodium hydrogen phosphate
Potassium dihydrogen phosphate
Potassium chloride
Water for injections

For adjuvant, see section 2.

Pack sizes and marketing

VidPrevtyn Beta is presented as:

  • 2.5 mL antigen solution in a multidose vial (type 1 glass) with a stopper (chlorobutyl) and an aluminium seal with a green plastic flip-off cap;
  • 2.5 mL adjuvant emulsion in a multidose vial (type 1 glass) with a stopper (chlorobutyl) and an aluminium seal with a yellow plastic flip-off cap.

Each pack contains 10 multidose antigen vials and 10 multidose adjuvant vials.

Marketing authorization holder

Sanofi Pasteur, 14 Espace Henry Vallรฉe, 69007 Lyon, France

Marketing authorization dates and numbers

EU/1/21/1580/001

Drugs

Drug Countries
VIDPREVTYN BETA Spain, Lithuania, Poland
 
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