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 (prescribing information starts on page 2)
|
Oct. 15, 2019 |
| Anthrax |
Date |
BioThrax (Anthrax Vaccine Adsorbed)
|
Nov. 23, 2015 |
| Chickenpox |
Date |
ProQuad (MMRV) (prescribing information starts on page 2)
|
April 13, 2021 |
Varivax (refrigerated) (prescribing information starts on page 2)
|
Sept. 15, 2020
|
Varivax (frozen) (prescribing information starts on page 2)
|
Sept. 15, 2020
|
| Cholera |
Date |
Vaxchora (prescribing information starts on page 2)
|
Dec. 23, 2020 |
| Haemophilus Influenzae type b (Hib) |
Date |
ActHIB (prescribing information starts on page 2)
|
May 24. 2019 |
Hiberix
|
April 30, 2018 |
PedvaxHIB
|
April 27, 2011 |
Pentacel (prescribing information starts on page 2)
|
Feb. 17, 2021 |
Vaxelis (prescribing information starts on page 2)
|
Oct. 27, 2020 |
| Hepatitis A |
Date |
Havrix (prescribing information starts on page 2)
|
Dec. 3, 2021 |
Twinrix (prescribing information starts on page 2)
|
Dec. 18, 2018
|
Vaqta (prescribing information starts on page 2)
|
Oct. 23, 2020
|
| Hepatitis B |
Date |
Engerix-B
|
Dec. 19, 2018 |
Heplisav-B (prescribing information starts on page 2)
|
May 6, 2020 |
Pediarix (prescribing information starts on page 2)
|
Nov. 6, 2019 |
| PREHIVBRIO (prescribing information starts on page 2) |
Nov. 30, 2021 |
Recombivax HB
|
Dec. 21, 2018
|
Twinrix (prescribing information starts on page 2)
|
Dec. 18, 2018
|
Vaxelis (prescribing information starts on page 2)
|
Oct. 27, 2020 |
| Human Papillomavirus (HPV) |
Date |
Gardasil 9 (prescribing information starts on page 2)
|
Aug. 20, 2020 |
| Influenza, Northern Hemisphere |
Date |
| DoD-contracted |
Afluria (Quadrivalent) (prescribing information starts on page 2)
|
July 1, 2022 |
FLUAD (Quadrivalent)
|
July 1, 2022
|
FluLaval (Quadrivalent) (prescribing information starts on page 2)
|
July 1, 2022
|
Fluzone (Quadrivalent) (prescribing information starts on page 2)
|
July 1, 2022 |
| Not DoD-contracted |
Fluarix (Quadrivalent) (prescribing information starts on page 2)
|
July 1, 2022
|
Flublok (Quadrivalent) (prescribing information starts on page 2)
|
July 1, 2022
|
Flucelvax (Quadrivalent) (prescribing information starts on page 2)
|
July 1, 2022
|
FluMist (Quadrivalent) (prescribing information starts on page 2)
|
July 27, 2022 |
Fluzone High-Dose (Quadrivalent) (prescribing information starts on page 2)
|
July 1, 2022
|
| Influenza, Southern Hemisphere |
Date |
Afluria (Quadrivalent) Southern Hemisphere (Prescribing information starts on page 2)
|
Feb. 17, 2022 |
Fluzone (Quadrivalent) Southern Hemisphere (prescribing information starts on page 2)
|
Feb. 14, 2022 |
| Japanese Encephalitis |
Date |
Ixiaro (prescribing information starts on page 2)
|
Oct. 4, 2018 |
| Meningococcal |
Date |
Bexsero (B) (prescribing information starts on page 2)
|
Oct. 24, 2019 |
Trumenba (B)
|
Nov. 19, 2021 |
Menactra
|
April 27, 2018 |
| MenQuadfi (prescribing information starts on page 2) |
June 16, 2022 |
Menveo (prescribing information starts on page 2)
|
Oct. 14, 2022 |
| Measles-Mumps-Rubella |
Date |
M-M-R II
|
Dec. 11, 2020 |
| PRIORIX (prescribing information starts on page 2) |
June 3, 2022 |
ProQuad (MMRV) (prescribing information starts on page 2)
|
April 13, 2021 |
| Pneumococcal |
Date |
Pneumovax 23 (prescribing information starts on page 2)
|
Oct. 27, 2021 |
| Prevnar 13 |
Aug. 22, 2017 |
| Vaxneuvance |
July 16, 2021 |
| Prevnar 20 (prescribing information starts on page 2) |
June 10, 2021 |
| Polio |
Date |
IPOL
|
Aug. 6, 2015 |
Kinrix (prescribing information starts on page 2)
|
Nov. 6, 2019 |
Pediarix (prescribing information starts on page 2)
|
Nov. 6, 2019
|
Pentacel (prescribing information starts on page 2)
|
Feb. 17, 2021
|
Quadracel (prescribing information starts on page 2)
|
Feb. 17, 2021 |
Vaxelis (prescribing information starts on page 2)
|
Oct. 27, 2020 |
| Rabies |
Date |
Imovax
|
Oct. 25, 2019 |
RabAvert
|
Aug. 3, 2018 |
| Rotavirus |
Date |
Rotarix
|
Nov. 12, 2019 |
RotaTeq (prescribing information starts on page 2)
|
Aug. 14, 2020 |
| Shingles |
Date |
Shingrix (prescribing information starts on page 2)
|
July 23, 2021 |
Zostavax (refrigerated) (prescribing information starts on page 2)
|
Feb. 21, 2019 |
Zostavax (frozen) (prescribing information starts on page 2)
|
Feb. 21, 2019
|
| Smallpox |
Date |
ACAM2000
|
March 1, 2018 |
JYNNEOS
|
June 16, 2021 |
Vaccinia Immune Globulin
|
Jan. 1, 2010 |
| Tetanus-Diphtheria-Pertussis |
Date |
Adacel (prescribing information starts on page 2)
|
Dec. 28, 2020 |
Boostrix (prescribing information starts on page 2)
|
Sept. 10, 2020 |
Daptacel (prescribing information starts on page 2)
|
Sept. 16, 2016 |
Diphtheria and Tetanus Toxoid Adsorbed (prescribing information starts on page 2)
|
Dec. 20, 2018 |
Infanrix (prescribing information starts on page 2)
|
Nov. 6, 2019 |
Kinrix (prescribing information starts on page 2)
|
Nov. 6, 2019
|
Pediarix (prescribing information starts on page 2)
|
Nov. 6, 2019
|
Pentacel (prescribing information starts on page 2)
|
Feb. 17, 2021 |
Quadracel (prescribing information starts on page 2)
|
Feb. 17, 2021
|
Tenivac (prescribing information starts on page 2)
|
Dec. 6, 2019 |
Vaxelis (prescribing information starts on page 2)
|
Oct. 27, 2020 |
| 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: October 21, 2022