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The Food & Drug Administration's Center for Biologics Evaluation and Research regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products. It also approves the product labeling (package insert).
Please click below for the latest package inserts for licensed vaccines:
| Human Papillomavirus |
Date |
Gardasil 9
| April 28, 2023 |
| Influenza, Northern Hemisphere |
Date |
| DOD-contracted
|
Afluria (Quadrivalent)
| June 30, 2023 |
Fluzone (Quadrivalent)
| July 12, 2023 |
Fluzone High-Dose (Quadrivalent)
| Nov. 29, 2023 |
| Not DOD-contracted
|
FLUAD (Quadrivalent)
| June 30, 2023
|
Fluarix (Quadrivalent)
| July 12, 2023
|
Flublok (Quadrivalent)
| June 30, 2023
|
Flucelvax (Quadrivalent)
| June 30, 2023
|
FluLaval (Quadrivalent)
| July 13, 2023
|
FluMist (Quadrivalent)
| June 30, 2023 |
| Japanese Encephalitis |
Date |
Ixiaro
| Oct. 4, 2018 |
| Respiratory Syncytial Virus |
Date |
ABRYSVO
| Aug. 21, 2023 |
AREXVY
| May 23, 2023 |
| Smallpox |
Date |
JYNNEOS
| Sept. 29, 2023 |
| Tetanus-Diphtheria-Pertussis |
Date |
Adacel
| May 11, 2023 |
Boostrix
| Oct. 27, 2023 |
Daptacel
| July 21, 2022 |
Diphtheria and Tetanus Toxoid Adsorbed
| Dec. 20, 2018 |
Infanrix
| Oct. 27, 2023 |
Kinrix
| Oct. 27, 2023
|
Pediarix
| April 26, 2023
|
Pentacel
| Oct. 21, 2022 |
Quadracel
| July 21, 2022
|
Tenivac
| Dec. 16, 2022 |
Vaxelis
| April 12, 2023 |
| Tick-Borne Encephalitis |
Date |
TICOVAC
| July 2023 |
| Yellow Fever |
Date |
YF-VAX
| Aug. 6, 2019 |
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Last Updated: March 13, 2024