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
|
April 30, 2018 |
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)
|
July 12, 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 |
ACAM2000
|
March 1, 2018 |
JYNNEOS
|
Sept. 29, 2023 |
Vaccinia Immune Globulin
|
Jan. 1, 2010 |
| 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
|
Aug. 13, 2021 |
| 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 |
You are leaving Health.mil
The appearance of hyperlinks does not constitute endorsement by the Department of Defense of non-U.S. Government sites or the information, products, or services contained therein. Although the Defense Health Agency may or may not use these sites as additional distribution channels for Department of Defense information, it does not exercise editorial control over all of the information that you may find at these locations. Such links are provided consistent with the stated purpose of this website.
You are leaving Health.mil
View the external links disclaimer.
Last Updated: November 13, 2023