The U.S. Food and Drug Administration has approved the expanded use of GlaxoSmithKline's Havrix (Hepatitis A vaccine, inactivated) for the prevention of Hepatitis A in children aged 12 months and older. Havrix was previously approved by the FDA for use in children ages two through 18 years. 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 United States, 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 United States. Immunising 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," said William P. Hitchcock, managing director, American Board of Paediatrics.

According to a company release, the FDA approved the expanded use of Havrix in children to 12 months and older on the basis of a pivotal trial which studied the administration of Havrix in children in the United States and Australia. The prospective, open, comparative, multi-center clinical trial involved over 1,000 healthy children and 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. The study also showed that Havrix could be given concomitantly with Omnihib [Haemophilus b conjugate vaccine (tetanus toxoid conjugate)], also called Hib conjugate vaccine (PRP-T).

Later this month, the Advisory Committee on Immunisation Practices (ACIP) will convene to determine if Hepatitis A vaccination requirements should be expanded to all children 12 months of age or older, thus helping reduce the burden of one of the most commonly reported vaccine-preventable diseases in the country.

Hepatitis A is a serious liver disease caused by the hepatitis A virus. This virus is found in the stool of persons with hepatitis A and is spread by close personal contact and by eating food or drinking water contaminated with the hepatitis A virus. Hepatitis A can be easily passed by those infected with the disease to others within the same household.