FDAnews
www.fdanews.com/articles/75401-fda-cuts-merck-approved-age-for-hepatitis-a-vaccine

FDA CUTS MERCK APPROVED AGE FOR HEPATITIS A VACCINE

August 15, 2005

Merck has announced that U.S. regulators have approved use of its already marketed hepatitis A vaccine for children as young as 12 months old, rather than the previous approved use for patients at least two years of age.

The VAQTA vaccine is used to prevent infection with hepatitis A, a virus that children sometimes pick up without developing symptoms and pass on to their siblings and other children.

Although the source of hepatitis A is not known in nearly half of all cases, it tends to be spread by oral contact with fecal matter and ingestion of contaminated food or water. There were an estimated 8,800 reported cases of hepatitis A in the United States during 2002, the drugmaker said.