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)
|
October 15, 2019 |
| Anthrax |
Date |
BioThrax (Anthrax Vaccine Adsorbed)
|
November 23, 2015 |
| Chickenpox |
Date |
ProQuad (MMRV) (prescribing information starts on page 2)
|
September 15, 2020 |
Varivax (refrigerated) (prescribing information starts on page 2)
|
September 15, 2020
|
Varivax (frozen) (prescribing information starts on page 2)
|
September 15, 2020
|
| Cholera |
Date |
Vaxchora (prescribing information starts on page 2)
|
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 (prescribing information starts on page 2)
|
June 11, 2019 |
Vaxelis (prescribing information starts on page 2)
|
October 27, 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)
|
October 23, 2020
|
| Hepatitis B |
Date |
Engerix-B
|
December 19, 2018 |
Heplisav-B (prescribing information starts on page 2)
|
May 6, 2020 |
Pediarix (prescribing information starts on page 2)
|
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)
|
October 27, 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)
|
August 27, 2020 |
Flucelvax (Quadrivalent) (prescribing information starts on page 2)
|
July 2, 2020 |
Fluad (Quadrivalent)
|
December 4, 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) (prescribing information starts on page 2)
|
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
|
December 11, 2020 |
ProQuad (MMRV) (prescribing information starts on page 2)
|
September 15, 2020 |
| Pneumococcal |
Date |
Pneumovax 23 (prescribing information starts on page 2)
|
September 25, 2020 |
Prevnar 13
|
August 22, 2017 |
| Polio |
Date |
IPOL
|
August 6, 2015 |
Kinrix (prescribing information starts on page 2)
|
November 6, 2019 |
Pediarix (prescribing information starts on page 2)
|
November 6, 2019
|
Pentacel (prescribing information starts on page 2)
|
June 11, 2019
|
Quadracel (prescribing information starts on page 2)
|
June 11, 2019 |
Vaxelis (prescribing information starts on page 2)
|
October 27, 2020 |
| Rabies |
Date |
Imovax
|
October 25, 2019 |
RabAvert
|
August 3, 2018 |
| Rotavirus |
Date |
Rotarix
|
November 12, 2019 |
RotaTeq (prescribing information starts on page 2)
|
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)
|
December 28, 2020 |
Boostrix (prescribing information starts on page 2)
|
September 10, 2020 |
Daptacel (prescribing information starts on page 2)
|
September 16, 2016 |
Diphtheria and Tetanus Toxoid Adsorbed (prescribing information starts on page 2)
|
December 20, 2018 |
Infanrix (prescribing information starts on page 2)
|
November 6, 2019 |
Kinrix (prescribing information starts on page 2)
|
November 6, 2019
|
Pediarix (prescribing information starts on page 2)
|
November 6, 2019
|
Pentacel (prescribing information starts on page 2)
|
June 11, 2019 |
Quadracel (prescribing information starts on page 2)
|
June 11, 2019
|
Tenivac (prescribing information starts on page 2)
|
December 6, 2019 |
Vaxelis (prescribing information starts on page 2)
|
October 27, 2020 |
| Tuberculosis |
Date |
Aplisol
|
February 19, 2014 |
Tubersol
|
April 22, 2016 |
| Typhoid |
Date |
Typhim Vi (prescribing information starts on page 2)
|
March 20, 2020 |
Vivotif
|
September 1, 2013 |
| Yellow Fever |
Date |
YF-VAX
|
August 6, 2019 |