Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Not applicable.
COVID-19 mRNA Vaccine BNT162b2 concentrate for solution for injection.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for injection. The vaccine is a white to off-white frozen solution. |
This is a multidose vial and must be diluted before use. 1 vial (0.45 mL) contains 5 doses of 30 micrograms of BNT162b2 RNA (embedded in lipid nanoparticles).
COVID-19 mRNA Vaccine BNT162b2 is highly purified single-stranded, 5'-capped messenger RNA (mRNA) produced by cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2.
Excipients with known effect: 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 |
|---|
|
ALC-0315 = (4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate) |
Concentrate for solution for injection for 5 doses in a 2 mL clear vial (type I glass) with a stopper (bromobutyl) and a flip-off plastic cap with aluminium seal.
Pack size: 195 vials
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| 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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