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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
Chikungunya Date
IXCHIQ
November 2023
Cholera Date
Vaxchora
June 11, 2024
COVID-19 Date
COMIRNATY (Pfizer-BioNTech) Oct. 10, 2024
SPIKEVAX (Moderna)
Sept. 6, 2024
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 
Sept. 11, 2024
Pediarix 
April 26, 2023
Recombivax HB
Dec. 21, 2018
Twinrix 
April 28, 2023
Vaxelis 
April 12, 2023
Human Papillomavirus Date
Gardasil 9 
March 14, 2024
Influenza, Northern Hemisphere Date
DOD-contracted
Afluria (Trivalent)
July 1, 2024
Flulaval (Trivalent)
July 1, 2024
Fluzone High-Dose (Trivalent)
July 1, 2024
Not DOD-contracted
Fluad (Trivalent)
July 1, 2024
Fluarix (Trivalent)
July 1, 2024
Flublok (Trivalent)
Oct. 15, 2024
Flucelvax (Trivalent)
July 1, 2024
Fluzone (Trivalent)
July 1, 2024
Influenza, Southern Hemisphere Date
Afluria Southern Hemisphere 
March 17, 2024
Fluzone Southern Hemisphere 
Feb. 14, 2024
Japanese Encephalitis Date
Ixiaro 
Oct. 4, 2018
Meningococcal Date
Bexsero (B) 
Aug. 19, 2024
Trumenba (B)
June 18, 2024
MenQuadfi  Sept. 20, 2024
Menveo
Aug. 30, 2024
Penbraya (ABCWY) Sept. 9, 2024
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
CAPVAXIVE June 17, 2024
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
April 26, 2024
RabAvert
May 9, 2024
Respiratory Syncytial Virus Date
ABRYSVO
Oct. 22, 2024
AREXVY
Aug. 21, 2024
MRESVIA Oct. 3, 2024
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
Oct. 18, 2024
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: November 29, 2024
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