Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: MODERNA BIOTECH SPAIN, S.L., Calle Monte Esquinza 30, 28010 Madrid, Spain
Spikevax dispersion for injection.
COVID-19 mRNA Vaccine (nucleoside modified).
| Pharmaceutical Form |
|---|
|
Dispersion for injection. White to off white dispersion (pH: 7.0–8.0). |
This is a multidose vial which contains 10 doses of 0.5 mL.
One dose (0.5 mL) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles).
One dose (0.25 mL) contains 50 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles).
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 | |
|---|---|---|
| mRNA-1273 |
mRNA-1273 is COVID-19 mRNA encapsulated in lipid nanoparticles. The mRNA encodes for the full-length SARS-CoV-2 spike protein modified with 2 proline substitutions within the heptad repeat 1 domain (S-2P) to stabilise the spike protein into a prefusion conformation. After intramuscular injection, cells at the injection site and the draining lymph nodes take up the lipid nanoparticle, effectively delivering the mRNA sequence into cells for translation into viral protein. The delivered mRNA does not enter the cellular nucleus or interact with the genome, is nonreplicating, and is expressed transiently mainly by dendritic cells and subcapsular sinus macrophages. The expressed, membrane-bound spike protein of SARS-CoV-2 is then recognised by immune cells as a foreign antigen. This elicits both T-cell and B-cell responses to generate neutralising antibodies, which may contribute to protection against COVID-19. |
| List of Excipients |
|---|
|
Lipid SM-102 (heptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino}octanoate) |
5 mL dispersion in a vial (type 1 or type 1 equivalent glass) with a stopper (chlorobutyl rubber) and a flip-off plastic cap with seal (aluminium seal).
Each vial contains 5 mL.
Pack size: 10 multidose vials.
MODERNA BIOTECH SPAIN, S.L., Calle Monte Esquinza 30, 28010 Madrid, Spain
EU/1/20/1507/001
Date of first authorisation: 06 January 2021
Date of latest renewal: 04 October 2021
| Drug | Countries | |
|---|---|---|
| SPIKEVAX | Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania |
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