FDA APPROVES FIRST VACCINE TO PREVENT HEPATITIS A INFECTION

Abstract

Federal health officials yesterday licensed the first vaccine in the United States to prevent hepatitis A, a serious and common viral liver infection.

The Food and Drug Administration said it gave SmithKline Beecham P.L.C. approval to sell the vaccine. The company said it would begin distributing the vaccine, Havrix, in the next several weeks.

The United States was the 41st country to license Havrix. An FDA spokeswoman said the agency wanted to be sure that the vaccine caused no significant adverse effects. An estimated 1.3 million people in Europe and Asia have received Havrix since 1991.