Merck & Co., Inc. has announced that the US FDA has approved Vaqta (hepatitis A vaccine, inactivated) for use in children 12 months of age and older. Vaqta is now the first and only hepatitis A vaccine that can be used in children as young as 12 months of age. Previously, Vaqta was approved for use in people two years of age and older.

"Surveillance data have shown that young children often transmit hepatitis A in the United States, but since 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," said Fernando Guerra, director of Health, San Antonio Metropolitan Health District. "The expanded age indication for Vaqta is good news for parents, doctors and the public health community because it means we can help protect children against hepatitis A earlier in life," Guerra added.

The younger age indication for Vaqta is supported by the results of an open-label study of children with no evidence of hepatitis A infection. The study was designed to investigate the immunogenicity and safety of Vaqta in this age group when it was administered with and without other routinely used vaccines given at the same age.

In this study of 617 children 12-23 months of age, 343 children were evaluated for indicators of an immune response to VAQTA after the second dose of a two dose series. Of these children (n=343), 100 percent developed protective immune responses. The study also showed that Vaqta may be given concomitantly with M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live), another Merck vaccine.