Verified Clinical Benefit | Infectious Disease Accelerated Approvals Vaccines
This listing includes accelerated approvals (AAs) for infectious disease indications with postmarketing trials that have verified clinical benefit and for which traditional approval has been subsequently granted for the specific indication.
Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. See Postmarket Requirements and Commitments for the status of specific requirements.
Visit Accelerated Approvals for listings of ongoing, verified clinical benefit, and withdrawn infectious diseases and non-malignant hematological, neurological, and other disorder indications accelerated approvals.
Indications may remain on this page until FDA updates product labeling or publishes a Federal Register notice regarding a change in status.
Total approval time was adjusted based on management decision. This is a legacy practice and is no longer exercised.
|Drug Name||Accelerated Approval Indication||Accelerated Approval Date||Traditional Approval Date|
|Fluarix (influenza virus vaccine)||For the prevention of influenza in adults 18 years and older||8/31/2005||10/2/2009|
|Afluria (influenza virus vaccine)||For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine||9/28/2007||12/2/2011|
|Hiberix (haemophilus B conjugate vaccine (tetanus toxoid conjugate))||Active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b||8/19/2009||4/30/2018|
|Agriflu (influenza virus vaccine)||Active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine||11/27/2009||10/29/2010|
|FluLaval; FluLaval Quadrivalent (influenza vaccine)||Findicated for prevention of influenza in persons 3 to 8 years||6/9/2011||8/15/2013|
|Prevnar 13 (pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein))||To include the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in persons 50 years of age or older||12/30/2011||5/22/2015|
|Fluzone High Dose (influenza vaccine)||For prevention of influenze in adults 65 years of age and older||6/27/2012||10/31/2014|
|FluBlok (influenza vaccine)||For active immunization against disease caused by influenza virus subtypes A and type B contained in the vaccine. Influenza vaccine is approved for use in persons 50 years of age and older||10/29/2014||10/7/2016|
|Trumenba (meningococcal group B vaccine)||Active immunization to prevent invasive meningococcal disease caused by N. meningitidis serogroup B in individuals 10 through 25 years of age.||10/29/2014||3/13/2017|
|Trumenba (meningococcal group B vaccine)||Two-dose schedule (a dose administered at 0 and 6 months) of Trumenba for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B||4/14/2016||11/19/2021|
|Flucelvax Quadrivalent (influenza vaccine)||For prevention of influenza in persons 4 years to <18 years of age||5/23/2016||3/3/2021|
|Audenz (influenza a (H5N1) monovalent vaccine, adjuvanted)||For active immunization of influenza in persons 6 months through 17 years of age||1/31/2020||11/17/2021|