Hepatitis A vaccine approved for use in young children

September 1, 2005

The FDA announced in August that it has expanded the indication for Merck's approved hepatitis A vaccine (Vaqta) to include patients 12 months and older. Previously, Vaqta was approved for children 2 years and older. The change is the result of an open-label study of children with no evidence of hepatitis A infection.

The FDA announced in August that it has expanded the indication for Merck's approved hepatitis A vaccine (Vaqta) to include patients 12 months and older. Previously, Vaqta was approved for children 2 years and older. The change is the result of an open-label study of children with no evidence of hepatitis A infection.

"Surveillance data have shown that young children often transmit hepatitis A in the United States ...[Because] they do not typically show symptoms, they unknowingly pass the infection on to older siblings and parents who can become very ill from hepatitis A," stated Fernando Guerra, MD, MPH, director of health, San Antonio (Texas) Metropolitan Health District.

Of the 617 children 12 to 23 months of age who were tested in the study, 343 were evaluated for indicators of an immune response to Vaqta after the second dose of a two-dose series. All 343 children developed a protective immune response. The study also showed that Vaqta can be given concomitantly with MMR II (Merck's measles, mumps, and rubella live virus vaccine).