COMIRNATY Concentrate for dispersion for injection Ref.[10433] Active ingredients: Tozinameran

Source: European Medicines Agency (EU)  Revision Year: 2021  Publisher: BioNTech Manufacturing GmbH, An der Goldgrube 12, 55131 Mainz, Germany Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 service@biontech.de

Product name and form

Comirnaty 30 micrograms/dose concentrate for dispersion for injection.

COVID-19 mRNA Vaccine (nucleoside modified).

Pharmaceutical Form

Concentrate for dispersion for injection (sterile concentrate).

The vaccine is a white to off-white frozen dispersion (pH: 6.9-7.9).

Qualitative and quantitative composition

This is a multidose vial and must be diluted before use.

One vial (0.45 mL) contains 6 doses of 0.3 mL after dilution, see sections 4.2 and 6.6.

One dose (0.3 mL) contains 30 micrograms of tozinameran, a COVID-19 mRNA Vaccine (embedded in lipid nanoparticles).

Tozinameran is a single-stranded, 5'-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tozinameran

The nucleoside-modified messenger RNA in COVID-19 mRNA Vaccine BNT162b2 is formulated in lipid nanoparticles, which enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the spike (S) antigen, which may contribute to protection against COVID-19 disease.

List of Excipients

((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315)
2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159)
1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC)
Cholesterol
Potassium chloride
Potassium dihydrogen phosphate
Sodium chloride
Disodium phosphate dihydrate
Sucrose
Water for injections
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)

Pack sizes and marketing

0.45 mL concentrate in a 2 mL clear multidose vial (type I glass) with a stopper (synthetic bromobutyl rubber) and a purple flip-off plastic cap with aluminium seal. Each vial contains 6 doses, see section 6.6.

Pack size: 195 vials.

Marketing authorization holder

BioNTech Manufacturing GmbH, An der Goldgrube 12, 55131 Mainz, Germany

Phone: +49 6131 9084-0
Fax: +49 6131 9084-2121
service@biontech.de

Marketing authorization dates and numbers

EU/1/20/1528/001

Date of first authorisation: 21 December 2020
Date of latest renewal: 03 November 2021

Drugs

Drug Countries
COMIRNATY Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Tunisia, United Kingdom, United States, South Africa

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