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news.The FDA has approved the expanded use of GlaxoSmithKline's Havrix, for the prevention of hepatitis A in children aged 12 months and older. The drug was previously only approved for use in children ages two to18 years.
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This expanded indication will allow healthcare practitioners to vaccinate younger children against hepatitis A with Havrix and may help to further reduce the incidence of hepatitis A in the US, particularly among young children who often transmit the disease.
“The expanded indication of Havrix marks an important milestone in the fight against hepatitis A in the US,” said Dr William Hitchcock, of the American Board of Pediatrics, La Jolla, California. “Immunizing children under age two helps protect a very vulnerable population that often does not show symptoms of the disease but frequently spreads it to other children and family members.”
This extended approval is based on a pivotal trial which studied the administration of Havrix in over 1,000 healthy children in the US and Australia. The trial showed Havrix given to children down to the age of 11 months to be comparable to Havrix given to children approximately two years of age with regard to safety and immunogenicity.