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Official Release Repository

A reverse chronological list of vaccine licensure announcements from FDA, vaccine recommendations from the Advisory Committee on Immunization Practices (ACIP) and CDC, and other resources from government sources. Use filters to narrow your search.

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Results (94)

FDA approves the use of Flucelvax Quadrivalent to persons 2 years of age and older

FDA Approval – March 3, 2021

FDA issues emergency use authorization (EUA) for single dose COVID-19 Janssen (Johnson and Johnson) vaccine.

FDA Approval – February 27, 2021

FDA approves MenQuadfi (MenACWY) conjugate vaccine for persons 2 years of age and older (available in 2021)

FDA Approval – April 23, 2020

FDA approves Fluad Quadrivalent for use in 2020-21 season for adults 65 years and older

FDA Approval – February 21, 2020

FDA licenses first U.S. vaccine for the prevention of Ebola virus disease (Merck)

FDA Approval – December 19, 2019

FDA approves Fluzone High Dose Quadrivalent for adults 65 years and older (available for 2020-21 season)

FDA Approval – November 4, 2019

FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox in adults 18 years of age and older at high risk for smallpox or monkeypox infection.

FDA Approval – September 24, 2019

FDA approves Dengvaxia, the first vaccine approved for the prevention of dengue disease in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

FDA Approval – May 1, 2019

FDA approves use of the 0.5 mL dose of Sanofi's Fluzone Quadrivalent influenza vaccine to include children age 6 through 35 months.

FDA Approval – January 23, 2019

FDA expands licensure of Gardasil 9 to include women and men from 27 to 45 years of age

FDA Approval – October 5, 2018

FDA expands licensure of Afluria and Afluria Quadrivalent to include children 6 through 59 months of age

FDA Approval – October 4, 2018

FDA expands licensure of Fluarix Quadrivalent (GSK) to include children 6 through 35 months of age

FDA Approval – January 11, 2018

FDA licenses Heplisav-B (Dynavax), a new vaccine to prevent hepatitis B in adults

FDA Approval – November 9, 2017

FDA licenses Shingrix (GSK), a new vaccine to prevent shingles in adults

FDA Approval – October 20, 2017

FDA expands licensure of Afluria Quadrivalent (Seqirus) to include people age 5 years and older

FDA Approval – August 31, 2017

FDA expands licensure of FluLaval Quadrivalent (GSK) to include people ages 6 through 35 months

FDA Approval – November 18, 2016

FDA approves Flublok Quadrivalent (Protein Sciences) for use in persons 18 years and older

FDA Approval – October 7, 2016

FDA expands licensure of Gardasil 9 to include a 2-dose regimen for individuals 9 through 14 years of age

FDA Approval – October 7, 2016

FDA expands licensure for Prevar 13 to include people ages 18 through 49 years

FDA Approval – July 11, 2016

FDA approves Vaxchora, a live oral vaccine to prevent cholera for adult travelers

FDA Approval – June 10, 2016

FDA expands licensure of Trumenba MenB vaccine (Pfizer) administration to include 2-dose schedule and modification of the 3-dose schedule

FDA Approval – April 14, 2016

FDA expands licensure of Hiberix to include children ages 6 weeks through 4 years

FDA Approval – January 14, 2016

FDA expands Gardasil 9 licensure to include males age 16-26 years

FDA Approval – December 14, 2015

FDA licenses Fluad, injectable influenza vaccine (adjuvanted), for people age 65 years and older

FDA Approval – November 24, 2015

Two FDA CBER Mini-Sentinel Studies Completed on the Safety of Gardasil and Rotavirus Vaccines

FDA CBER – April 23, 2015

Recall of Flulaval Quadrivalent

FDA recall notice – April 15, 2015

FDA approves Quadracel (DTaP-IPV vaccine; Sanofi Pasteur) for use in children age 4 through 6 years

FDA Approval – March 25, 2015

FDA approves change in diluent storage temperature for Rotarix vaccine

FDA Approval – February 27, 2015

FDA Approves a Second Vaccine to Prevent Serogroup B Meningococcal Disease

FDA News Release – January 23, 2015

This page was updated on October 30, 2023.

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