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Spikevax
COVID-19 Vaccine, mRNA
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Spikevax
Proper name
COVID-19 Vaccine, mRNA
Licence type
351(a)
BLA number
125752
Applicant
ModernaTX, Inc.
Center
CBER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100UG | Injection | Intramuscular | Multi-Dose Vial | Disc | January 31, 2022 |
| 25UG/0.25mL | Injection | Intramuscular | Pre-Filled Syringe | Rx | July 9, 2025 |
| 50UG | Injection | Intramuscular | Single-Dose Vial | Disc | September 11, 2023 |
| 50UG | Injection | Intramuscular | Multi-Dose Vial | Disc | September 11, 2023 |
| 50UG/0.5mL | Injection | Intramuscular | Pre-Filled Syringe | Rx | September 11, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |