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Food and Drug Administration

FDA expands licensure for Prevar 13 to include people ages 18 through 49 years
FDA Approval - 7/11/16
FDA approves Vaxchora, a live oral vaccine to prevent cholera for adult travelers
FDA Approval - 6/10/16
FDA expands licensure of Trumenba MenB vaccine (Pfizer) administration to include 2-dose schedule and modification of the 3-dose schedule
FDA approval - 4/14/16
FDA expands licensure of Hiberix to include children ages 6 weeks through 4 years
FDA approval - 1/14/16
FDA expands Gardasil 9 licensure to include males age 16–26 years
FDA approval - 12/14/15
FDA licenses Fluad, injectable influenza vaccine (adjuvanted), for people age 65 years and older
FDA approval - 11/24/15
Two FDA CBER Mini-Sentinel Studies Completed on the Safety of Gardasil and Rotavirus Vaccines
FDA CBER - 4/23/15
Recall of Flulaval Quadrivalent
FDA recall notice - 4/15/15
FDA approves Quadracel (DTaP-IPV vaccine; Sanofi Pasteur) for use in children age 4 through 6 years
FDA approval - 3/25/15
FDA approves change in diluent storage temperature for Rotarix vaccine
FDA approval - 2/27/15
FDA Approves a Second Vaccine to Prevent Serogroup B Meningococcal Disease
FDA News Release - 1/23/15
Official Releases
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- AAP: American Academy of Pediatrics
- ACIP: Advisory Committee on Immunization Practices
- CDC: Centers for Disease Control and Prevention
- FDA: Food and Drug Administration
Additional FDA Information
FDA - Vaccine Index
Package Inserts
Vaccine Policy & Licensure
Complete List of Vaccines Licensed for Immunization and Distribution in the US
List maintained by the FDA of currently licensed vaccines
Biological Product Shortages
Tables listing current biological product shortages, resolved biological product shortages, and discontinued biological products
Influenza Virus Vaccine Safety & Availability
Information about the composition of seasonal influenza vaccines, and additional influenza-related resources from the FDA
Vaccine Adverse Event Reporting System (VAERS)
VAERS is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC)
This page was updated on July 14, 2016.
This page was reviewed on March 31, 2016.
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This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000589) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.