The Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) 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:
| Adenovirus |
Date |
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
|
Oct. 15, 2019 |
| Anthrax |
Date |
BioThrax (Anthrax Vaccine Adsorbed)
|
Nov. 23, 2015 |
| Chickenpox |
Date |
ProQuad (MMRV) (frozen)
|
Feb. 27, 2023 |
Varivax (frozen)
|
Feb. 27, 2023
|
| Cholera |
Date |
Vaxchora
|
Dec. 12, 2022 |
| Haemophilus Influenzae type b (Hib) |
Date |
ActHIB
|
Oct. 13. 2022 |
Hiberix
|
April 30, 2018 |
PedvaxHIB
|
April 27, 2011 |
Pentacel
|
Oct. 21, 2022 |
Vaxelis
|
April 12, 2023 |
| Hepatitis A |
Date |
Havrix
|
Dec. 3, 2021 |
Twinrix
|
Dec. 18, 2018
|
Vaqta
|
Oct. 23, 2020
|
| Hepatitis B |
Date |
Engerix-B
|
Dec. 19, 2018 |
Heplisav-B
|
May 6, 2020 |
Pediarix
|
April 26, 2023 |
| PREHIVBRIO |
Nov. 30, 2021 |
Recombivax HB
|
Dec. 21, 2018
|
Twinrix
|
Dec. 18, 2018
|
Vaxelis
|
April 12, 2023 |
| Human Papillomavirus (HPV) |
Date |
Gardasil 9
|
Aug. 20, 2020 |
| Influenza, Northern Hemisphere |
Date |
| DoD-contracted |
Afluria (Quadrivalent)
|
July 1, 2022 |
FLUAD (Quadrivalent)
|
July 1, 2022
|
FluLaval (Quadrivalent)
|
July 1, 2022
|
Fluzone (Quadrivalent)
|
Nov. 2, 2022 |
| Not DoD-contracted |
Fluarix (Quadrivalent)
|
July 1, 2022
|
Flublok (Quadrivalent)
|
July 1, 2022
|
Flucelvax (Quadrivalent)
|
July 1, 2022
|
FluMist (Quadrivalent)
|
July 27, 2022 |
Fluzone High-Dose (Quadrivalent)
|
July 1, 2022
|
| Influenza, Southern Hemisphere |
Date |
Afluria (Quadrivalent) Southern Hemisphere
|
Feb. 17, 2022 |
Fluzone (Quadrivalent) Southern Hemisphere
|
Nov. 2, 2022 |
| Japanese Encephalitis |
Date |
Ixiaro
|
Oct. 4, 2018 |
| Meningococcal |
Date |
Bexsero (B)
|
Jan. 6, 2022 |
Trumenba (B)
|
Nov. 19, 2021 |
Menactra
|
April 27, 2018 |
| MenQuadfi |
June 16, 2022 |
Menveo
|
Oct. 14, 2022 |
| Measles-Mumps-Rubella |
Date |
M-M-R II
|
Feb. 27, 2023 |
| PRIORIX |
June 3, 2022 |
ProQuad (MMRV) (frozen)
|
Feb. 27, 2023 |
| Pneumococcal |
Date |
Pneumovax 23
|
Oct. 27, 2021 |
| Prevnar 13 |
Aug. 22, 2017 |
| Vaxneuvance |
June 17, 2022 |
| Prevnar 20 |
Sept. 30, 2022 |
| Polio |
Date |
IPOL
|
June 2, 2022 |
Kinrix
|
Nov. 23, 2022 |
Pediarix
|
April 26, 2023
|
Pentacel
|
Oct. 21, 2022
|
Quadracel
|
July 21, 2022 |
Vaxelis
|
April 12, 2023 |
| Rabies |
Date |
Imovax
|
Oct. 25, 2019 |
RabAvert
|
Aug. 3, 2018 |
| Rotavirus |
Date |
Rotarix
|
Nov. 4, 2022 |
RotaTeq
|
Aug. 14, 2020 |
| Shingles |
Date |
Shingrix
|
July 23, 2021 |
Zostavax (refrigerated)
|
Feb. 21, 2019 |
Zostavax (frozen)
|
Feb. 21, 2019
|
| Smallpox |
Date |
ACAM2000
|
March 1, 2018 |
JYNNEOS
|
March 16, 2023 |
Vaccinia Immune Globulin
|
Jan. 1, 2010 |
| Tetanus-Diphtheria-Pertussis |
Date |
Adacel
|
May 11, 2023 |
Boostrix
|
Nov. 23, 2022 |
Daptacel
|
July 21, 2022 |
Diphtheria and Tetanus Toxoid Adsorbed
|
Dec. 20, 2018 |
Infanrix
|
Nov. 23, 2022 |
Kinrix
|
Nov. 23, 2022
|
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
|
Aug. 13, 2021 |
| Tuberculosis |
Date |
Aplisol
|
Feb. 19, 2014 |
Tubersol
|
April 22, 2016 |
| Typhoid |
Date |
Typhim Vi (prescribing information starts on page 2)
|
March 20, 2020 |
Vivotif
|
Sept. 1, 2013 |
| Yellow Fever |
Date |
YF-VAX
|
Aug. 6, 2019 |
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Last Updated: June 02, 2023