Comirnaty Purple Book BLA 125742
- BLA number
- 125742
- Proprietary names
- Comirnaty
- Proper names
- COVID-19 Vaccine, mRNA
- Applicant
- BioNTech Manufacturing GmbH
- Center
- CBER
- First observed release
- 2021-08-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | 2021-08-23 | |
| 002 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Multi-Dose Vial | Disc | Licensed | 2021-12-16 | |
| 003 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Single-Dose Vial | Disc | Licensed | 2022-08-25 | |
| 004 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Pre-Filled Syringe | Disc | Licensed | 2023-08-23 | |
| 005 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 30UG/0.3ML | For Injection | Intramuscular | Pre-Filled Syringe | Rx | Licensed | 2023-10-17 | |
| 006 | Comirnaty | COVID-19 Vaccine, mRNA | 351(a) | 10UG/0.3ML | For Injection | Intramuscular | Single-Dose Vial | Rx | Licensed | 2025-08-27 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2026-03-01 | U | 001 | Comirnaty | 351(a) | Disc | BioNTech Manufacturing GmbH |
| 2026-03-01 | U | 002 | Comirnaty | 351(a) | Disc | BioNTech Manufacturing GmbH |
| 2026-03-01 | U | 003 | Comirnaty | 351(a) | Disc | BioNTech Manufacturing GmbH |
| 2026-03-01 | U | 004 | Comirnaty | 351(a) | Disc | BioNTech Manufacturing GmbH |
| 2026-03-01 | U | 005 | Comirnaty | 351(a) | Rx | BioNTech Manufacturing GmbH |
| 2026-03-01 | U | 006 | Comirnaty | 351(a) | Rx | BioNTech Manufacturing GmbH |
| 2025-09-01 | N | 004 | Comirnaty | 351(a) | Rx | BioNTech Manufacturing GmbH |
| 2025-08-01 | U | 001 | Comirnaty | 351(a) | Disc | BioNTech Manufacturing GmbH |
| 2025-08-01 | U | 002 | Comirnaty | 351(a) | Disc | BioNTech Manufacturing GmbH |
| 2023-10-01 | U | 002 | Comirnaty | 351(a) | Rx | BioNTech Manufacturing GmbH |
| 2023-10-01 | U | 003 | Comirnaty | 351(a) | Rx | BioNTech Manufacturing GmbH |
| 2021-12-01 | U | 001 | Comirnaty | 351(a) | Rx | BioNTech Manufacturing GmbH |
| 2021-08-01 | N | 001 | Comirnaty | 351(a) | Rx | BioNTech Manufacturing GmbH |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2026-03-01 | 002 | Comirnaty | 351(a) | Disc | Licensed | 2021-12-16 |
| 2026-03-01 | 003 | Comirnaty | 351(a) | Disc | Licensed | 2022-08-25 |
| 2026-03-01 | 004 | Comirnaty | 351(a) | Disc | Licensed | 2023-08-23 |
| 2026-03-01 | 005 | Comirnaty | 351(a) | Rx | Licensed | 2023-10-17 |
| 2026-03-01 | 006 | Comirnaty | 351(a) | Rx | Licensed | 2025-08-27 |
| 2025-09-01 | 004 | Comirnaty | 351(a) | Rx | Licensed | 2025-08-27 |
| 2025-08-01 | 001 | Comirnaty | 351(a) | Disc | Licensed | 2021-08-23 |
| 2025-08-01 | 002 | Comirnaty | 351(a) | Disc | Licensed | 2023-09-11 |
| 2023-10-01 | 002 | Comirnaty | 351(a) | Rx | Licensed | 2023-09-11 |
| 2023-10-01 | 003 | Comirnaty | 351(a) | Rx | Licensed | 2023-09-11 |
| 2021-08-01 | 001 | Comirnaty | 351(a) | Rx | Licensed | 2021-08-23 |