Adenovirus Type 4 and Type 7 Vaccine, Live Oral

Proper Name: Adenovirus Type 4 & 7 Vaccine, Live Oral

Adenovirus Type 4 and Type 7 Vaccine, Live, Oral contains viable, selected strains of human adenovirus Type 4 and human adenovirus Type 7 prepared in human-diploid fibroblast cell cultures (strain WI-38).

Advisory Board:

The application was not referred to the Vaccines and Related Biological Products Advisory Committee because the review of information submitted in the Biologics License Application (BLA), including the clinical study design and trial results, did not raise concerns or controversial issues which would have benefited from an advisory committee discussion.

Indications: Active immunization for the prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7.

Key Regulatory Milestones:

09/30/2008 – submitted biologics license application (BLA) 125296

07/2004 – Efficacy and safety data in the BLA first submitted

07/16/2009 – Complete Response letter was sent to the applicant

09/13/2010 – submitted a complete response to the Complete Response letter

03/16/2011 – response reset the review clock to a due date

03/16/2011 – PDUFA Goal Date

10/15/2019 – FDA approval date

Package Insert