Zostavax

Proper Name: Zoster Vaccine, Live

ZOSTAVAX is a lyophilized preparation of the Oka/Merck strain of live, attenuated varicella-zoster virus (VZV). ZOSTAVAX, when reconstituted as directed, is a sterile suspension for subcutaneous administration.

Advisory Board:

A Vaccines and Related Biologics Products Advisory Committee meeting was not held as there were no issues or concerns that presented during the review of the supplement that required consult from the advisory committee.

Indications: For prevention of herpes zoster (shingles) in individuals 50 years of age and older.

Key Regulatory Milestones:

05/25/2006 – ZOSTAVAX was initially approved

07/12/2007 – supplemental BLA 125123/90 approved

03/24/2011 – Approval for use in persons 50-59 was granted

11/22/2013 – written feedback from CBER in a Type C meeting briefing package submitted on November 1, 2013

10/03/2016 – Merck submitted a BLA supplement

10/04/2016 – Type C meeting

04/22/2018 – PDUFA goal date

02/21/2019 – FDA approval date

Package Insert