VAQTA
VAQTA is an inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts.
Advisory Board:
There were no product-specific concerns that would have benefited from an advisory committee discussion.
Indications: For the prevention of disease cause by hepatitis A virus (HAV) in persons 12 months of age and older.
Key Regulatory Milestones:
1996 – VAQTA licensed in the U.S.
07/19/2012 – PDUFA goal date
10/23/2020 – FDA approval date