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FDA approves wider use of Merck’s hepatitis A vaccine

Merck & Co's hepatitis A vaccine, Vaqta, has been approved by the FDA for use in children as young as 12 months of age. Vaqta is now the first and only hepatitis A vaccine that can be used in children as young as 12 months old.

Prior to this approval the drug was only approved for use in people two years of age and older. The younger age indication for Vaqta was supported by positive results from a study of children designed to investigate the immunogenicity and safety of Vaqta in this age group.

“Surveillance data have shown that young children often transmit hepatitis A in the US, 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 Dr 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.”

Hepatitis A is a contagious disease caused by a virus that can result in an infection of the liver. Symptoms include jaundice, fever, abdominal pain, dark urine and nausea.