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Official Releases

Food and Drug Administration

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
FDA Approves FluZone (Sanofi Pasteur) Intradermal Quadrivalent Influenza Vaccine
FDA supplemental approval - 12/12/14
FDA Approves Gardasil 9 for Prevention of Certain Cancers Caused by Five Additional Types of HPV
FDA news release - 12/10/14
First Vaccine Approved by FDA to Prevent Serogroup B Meningococcal Disease
FDA news release - 10/29/14
FDA expands age indication for Meningococcal conjugate vaccine (Menveo, Novartis) to include infants and toddlers ages two months and older
FDA approved products - 8/1/13
Influenza Virus Vaccine 2013-2014
FDA - 2/27/13
FDA Approves Use of Prevnar 13 Vaccine in Older Children and Teens (6-17 years)
FDA product approval - 1/25/13
Quadrivalent formulation of Fluarix (inactivated influenza vaccine) approved
FDA licensure - 12/14/12
FDA approves first seasonal influenza vaccine manufactured using cell culture technology
FDA press release - 11/20/12
FDA Approves Vaccine Formulation for the 2012-2013 Influenza Season
FDA press release - 8/13/12
FDA approves Menhibrix, a new combination (meningococcal and Hib) vaccine for infants
FDA press release - 6/14/12
FDA approves first quadrivalent vaccine to prevent seasonal flu
FDA press release - 3/1/12
FDA expands use of Prevnar 13 vaccine for people ages 50 and older
FDA press release - 12/30/11
FDA recommends against the use of autoinjectors to administer influenza vaccine, reminding HCPs to administer approved vaccines in accordance with their labeling
FDA communication - 10/26/11
FDA Approves Vaccines for the 2011-2012 Influenza Season
FDA press release - 7/18/11
FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People
FDA press release - 7/8/11
FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers
FDA press release - 4/22/11
FDA approves Zostavax vaccine to prevent shingles in individuals 50 to 59 years of age
FDA press release - 3/24/11
Fluzone influenza vaccine and VAERS reports of febrile seizures in children
FDA and CDC update - 1/20/11
Adenovirus Type 4 and Type 7 Vaccine, Live, Oral
FDA licensure - 3/16/11
Official Releases
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- AAP: American Academy of Pediatrics
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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
Package Inserts
Manufacturers' labeling of vaccines licensed for use in the United States
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 January 26, 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.