Vaccine to Prevent Hepatitis A Receives Approval From FDA

The Food and Drug Administration on Wednesday announced approval of the first vaccine to prevent hepatitis A, a highly contagious illness of particular danger to international travelers that causes liver disease with debilitating symptoms that can persist for a year.

Travelers to endemic areas, such as Mexico and parts of the Caribbean, are especially vulnerable to infection, which is spread by contaminated drinking water, ice, fruits, salad and and raw or undercooked shellfish harvested from tainted waters.

“This vaccine is a major advance in the prevention of hepatitis A, which is a worldwide problem,” FDA Commissioner David A. Kessler said in a statement.

In the United States, about 23,000 cases of the disease are reported annually, although an estimated 100,000 to 150,000 Americans are believed to be infected each year and about 10 million are infected worldwide.

While hepatitis A is not regarded as a major public health problem within the United States, potential hazards from the disease always have existed for travelers--an estimated 24 million Americans are expected to visit endemic areas this year--so the vaccine, manufactured by SmithKline Beecham Pharmaceuticals, is likely to jump to the top of the recommended list of vaccinations travelers receive.

The virus is especially prevalent in developing countries with poor sanitary conditions and hygiene standards.

Outbreaks of hepatitis A also occur in institutional settings, such as day-care centers and institutions for mentally impaired children and adults, according to the FDA.

Transmission of the disease also has been associated with food handlers, homosexual men and intravenous drug users.

Symptoms include jaundice (yellowing of the skin and eyes), fever, nausea, vomiting, diarrhea and appetite loss. Respiratory symptoms, rash and joint pain also may develop. Those who become ill often can be laid up and out of work or school for as long as a month.

The development of the vaccine, which will be marketed under the trade name Havrix, “offers a major advancement in the prevention of a very severe illness that is common among travelers,” said Dr. Raymond S. Koff, professor of medicine at the University of Massachusetts Medical School.