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Package inserts

The Food & Drug Administration's Center for Biologics Evaluation and Research 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
Cyfendus July 20, 2023
Chickenpox Date
ProQuad (MMRV) (frozen) 
Aug. 21, 2023
Varivax (frozen) 
Aug. 21, 2023
Cholera Date
Vaxchora
Dec. 12, 2022
COVID-19 Date
COMIRNATY (Pfizer-BioNTech) Oct. 17, 2023
SPIKEVAX (Moderna)
Sept. 11, 2023
Haemophilus Influenzae type b Date
ActHIB
Oct. 13. 2022
Hiberix
Dec. 20, 2023
PedvaxHIB
April 27, 2011
Pentacel 
Oct. 21, 2022
Vaxelis 
April 12, 2023
Hepatitis A Date
Havrix 
Oct. 27, 2023
Twinrix 
April 28, 2023
Vaqta 
Oct. 23, 2020
Hepatitis B Date
Engerix-B
Oct. 27, 2023
Heplisav-B 
May 8, 2023
Pediarix 
April 26, 2023
PREHIVBRIO  Nov. 30, 2021
Recombivax HB
Dec. 21, 2018
Twinrix 
April 28, 2023
Vaxelis 
April 12, 2023
Human Papillomavirus Date
Gardasil 9 
April 28, 2023
Influenza, Northern Hemisphere Date
DOD-contracted
Afluria (Quadrivalent) 
June 30, 2023
Fluzone (Quadrivalent) 
July 12, 2023
Fluzone High-Dose (Quadrivalent)
Nov. 29, 2023
Not DOD-contracted
FLUAD (Quadrivalent)
June 30, 2023
Fluarix (Quadrivalent) 
July 12, 2023
Flublok (Quadrivalent) 
June 30, 2023
Flucelvax (Quadrivalent) 
June 30, 2023
FluLaval (Quadrivalent) 
July 13, 2023
FluMist (Quadrivalent) 
June 30, 2023
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) 
April 26, 2023
Trumenba (B)
Nov. 19, 2021
MenQuadfi   June 9, 2023
Menveo
Oct. 14, 2022
Penbraya (ABCWY) Oct. 20, 2023
Measles-Mumps-Rubella Date
M-M-R II
Aug. 21, 2023
PRIORIX  June 3, 2022
ProQuad (MMRV) (frozen) 
Aug. 21, 2023
Pneumococcal Date
Pneumovax 23 
Oct. 27, 2021
Prevnar 13 Aug. 22, 2017
Vaxneuvance May 25, 2023
Prevnar 20  April 27, 2023
Polio Date
IPOL
June 2, 2022
Kinrix 
Oct. 27, 2023
Pediarix 
April 26, 2023
Pentacel 
Oct. 21, 2022
Quadracel 
July 21, 2022
Vaxelis 
April 12, 2023
Rabies Date
Imovax
Oct. 25, 2019
RabAvert
Oct. 3, 2023
Respiratory Syncytial Virus Date
ABRYSVO
Aug. 21, 2023
AREXVY
May 23, 2023
Rotavirus Date
Rotarix
Nov. 4, 2022
RotaTeq 
Aug. 14, 2020
Shingles Date
Shingrix 
May 22, 2023
Zostavax (refrigerated) 
Feb. 21, 2019
Zostavax (frozen) 
Feb. 21, 2019
Smallpox Date
JYNNEOS
Sept. 29, 2023
Tetanus-Diphtheria-Pertussis Date
Adacel 
May 11, 2023
Boostrix
Oct. 27, 2023
Daptacel 
July 21, 2022
Diphtheria and Tetanus Toxoid Adsorbed 
Dec. 20, 2018
Infanrix
Oct. 27, 2023
Kinrix 
Oct. 27, 2023
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
July 2023
Tuberculosis Date
Aplisol
Feb. 19, 2014
Tubersol
April 22, 2016
Typhoid Date
Typhim Vi
March 20, 2020
Vivotif
Sept. 1, 2013
Yellow Fever Date
YF-VAX
Aug. 6, 2019
Last Updated: February 08, 2024
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