This brand name is authorized in Austria, Canada, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania
The drug SPIKEVAX contains one active pharmaceutical ingredient (API):
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1
mRNA-1273 SARS-CoV-2
UNII B6L4N5Z4GH - SARS-COV-2
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| MODERNA COVID-19 VACCINE CX-024414 Suspension for injection | FDA, National Drug Code (US) | MPI, US: SPL/PLR | |
| SPIKEVAX Dispersion for injection | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| J07BN01 | J Antiinfectives for systemic use → J07 Vaccines → J07B Viral vaccines → J07BN Covid-19 vaccines | |
This drug has been assigned below unique identifiers within the countries it is being marketed:
| Country | Identification scheme | Identifier(s) |
|---|---|---|
| Country: CA | Health Products and Food Branch | Identifier(s): 02510014 |
| Country: EE | Ravimiamet | Identifier(s): 1835085, 1887969, 1887970, 1888555 |
| Country: ES | Centro de información online de medicamentos de la AEMPS | Identifier(s): 1201507001 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 485348 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 66689795 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 9321 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 631341EA1038, 631341KA1026, 631341KA2022 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1091725 |
| Country: NL | Z-Index G-Standaard, PRK | Identifier(s): 206776 |
| Country: NZ | Medicines and Medical Devices Safety Authority | Identifier(s): 22951 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100444975 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W67772001 |
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