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Package inserts

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
Last Updated: June 02, 2023
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