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Comirnaty
COVID-19 Vaccine, mRNA
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Comirnaty
Proper name
COVID-19 Vaccine, mRNA
Licence type
351(a)
BLA number
125742
Applicant
BioNTech Manufacturing GmbH
Center
CBER
Presentations
6
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 10UG/0.3ML | For Injection | Intramuscular | Single-Dose Vial | Rx | August 27, 2025 |
| 30UG/0.3ML | For Injection | Intramuscular | Multi-Dose Vial | Disc | August 23, 2021 |
| 30UG/0.3ML | For Injection | Intramuscular | Multi-Dose Vial | Disc | December 16, 2021 |
| 30UG/0.3ML | For Injection | Intramuscular | Single-Dose Vial | Disc | August 25, 2022 |
| 30UG/0.3ML | For Injection | Intramuscular | Pre-Filled Syringe | Disc | August 23, 2023 |
| 30UG/0.3ML | For Injection | Intramuscular | Pre-Filled Syringe | Rx | October 17, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |