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
|
October 15, 2019 |
| Anthrax |
Date |
BioThrax (Anthrax Vaccine Adsorbed)
|
November 23, 2015
|
| Chickenpox |
Date |
| ProQuad (MMRV) (prescribing information starts on page 2) |
January 22, 2019 |
Varivax (refrigerated) (prescribing information starts on page 2)
|
January 23, 2019
|
Varivax (frozen)
|
January 23, 2019
|
| Cholera |
Date |
| Vaxchora
|
February 13, 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
|
June 11, 2019
|
| Vaxelis (prescribing information starts on page 2) |
May 5, 2020 |
| Hepatitis A |
Date |
Havrix (prescribing information starts on page 2)
|
December 19, 2018
|
Twinrix (prescribing information starts on page 2)
|
December 18, 2018 |
| Vaqta (prescribing information starts on page 2) |
December 20, 2018 |
| Hepatitis B |
Date |
Engerix-B
|
December 19, 2018 |
| Heplisav-B (prescribing information starts on page 2) |
May 6, 2020 |
Pediarix
|
November 6, 2019 |
Recombivax HB
|
December 21, 2018
|
Twinrix (prescribing information starts on page 2)
|
December 18, 2018
|
Vaxelis (prescribing information starts on page 2)
|
May 5, 2020 |
| Human Papillomavirus (HPV) |
Date |
| Gardasil 9 (prescribing information starts on page 2) |
June 12, 2020
|
| Influenza, Northern Hemisphere |
Date |
| DoD-contracted |
Afluria (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2020 |
Flucelvax (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2020
|
| Fluad (Quadrivalent) |
July 2, 2020
|
| Not DoD-contracted |
Fluarix (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2020
|
Flublok (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2020
|
FluLaval (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2020
|
FluMist Intranasal (Quadrivalent) (prescribing information starts on page 2)
|
July 9, 2020
|
Fluzone (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2020
|
Fluzone High-Dose (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2020
|
| Influenza, Southern Hemisphere |
Date |
| Fluzone (Quadrivalent) Southern Hemisphere |
September 2019 |
| Japanese Encephalitis |
Date |
| Ixiaro (prescribing information starts on page 2) |
October 4, 2018 |
| Meningococcal |
Date |
Bexsero (B)
|
October 24, 2019
|
Trumenba (B)
|
March 14, 2018 |
Menactra
|
April 27, 2018 |
Menveo (prescribing information starts on page 2)
|
July 28, 2020
|
| Measles-Mumps-Rubella |
Date |
M-M-R II
|
May 16, 2017 |
ProQuad (MMRV) (prescribing information starts on page 2)
|
January 22, 2019
|
| Pneumococcal |
Date |
Pneumovax 23
|
November 26, 2019
|
| Prevnar 13
|
August 22, 2017 |
| Polio |
Date |
IPOL
|
August 6, 2015
|
Kinrix
|
November 6, 2019
|
Pediarix
|
November 6, 2019
|
Pentacel
|
June 11, 2019 |
Quadracel (prescribing information starts on page 2)
|
June 11, 2019
|
Vaxelis (prescribing information starts on page 2)
|
May 5, 2020
|
| Rabies |
Date |
| Imovax |
October 25, 2019
|
| RabAvert
|
August 3, 2018 |
| Rotavirus |
Date |
Rotarix
|
November 12, 2019
|
RotaTeq
|
February 23, 2017 |
| Shingles |
Date |
Shingrix (prescribing information starts on page 2)
|
May 17, 2019
|
| Zostavax (refrigerated) (prescribing information starts on page 2) |
February 21, 2019 |
Zostavax (frozen) (prescribing information starts on page 2)
|
February 21, 2019 |
| Smallpox |
Date |
| ACAM2000
|
March 1, 2018
|
| JYNNEOS |
September 24, 2019 |
| Vaccinia Immune Globulin
|
January 1, 2010
|
| Tetanus-Diphtheria-Pertussis |
Date |
Adacel (prescribing information starts on page 2)
|
January 11, 2019
|
Boostrix
|
April 25, 2019
|
Daptacel
|
September 16, 2016
|
Diphtheria and Tetanus Toxoid Adsorbed (prescribing information starts on page 2)
|
December 20, 2018
|
Infanrix
|
November 6, 2019 |
| Kinrix
|
November 6, 2019
|
| Pediarix
|
November 6, 2019
|
Pentacel
|
June 11, 2019
|
| Quadracel (prescribing information starts on page 2) |
June 11, 2019 |
Tenivac
|
December 6, 2019
|
Vaxelis (prescribing information starts on page 2)
|
May 5, 2020 |
| Tuberculosis |
Date |
Aplisol
|
February 19, 2014 |
| Tubersol
|
April 22, 2016 |
| Typhoid |
Date |
| Typhim Vi
|
March 20, 2020
|
| Vivotif
|
September 1, 2013
|
| Yellow Fever |
Date |
| YF-VAX
|
August 6, 2019 |