FDA approval for a combined hepatitis A and B vaccine

MMWR Morb Mortal Wkly Rep. 2001 Sep 21;50(37):806-7.

Abstract

On May 11, 2001, the Food and Drug Administration (FDA) licensed a combined hepatitis A and B vaccine (Twinrix) for use in persons aged > or = 18 years. Twinrix is manufactured and distributed by GlaxoSmithKline Biologicals (Rixensart, Belgium), and is made of the antigenic components used in Havrix and Engerix-B (GlaxoSmithKline). The antigenic components in Twinrix have been used routinely in separate single antigen vaccines in the United States since 1995 and 1989 as hepatitis A and B vaccines, respectively.

MeSH terms

  • Drug Approval
  • Hepatitis A Vaccines* / administration & dosage
  • Hepatitis A Vaccines* / immunology
  • Hepatitis B Vaccines* / administration & dosage
  • Hepatitis B Vaccines* / immunology
  • United States
  • United States Food and Drug Administration
  • Vaccines, Combined*

Substances

  • Hepatitis A Vaccines
  • Hepatitis B Vaccines
  • Vaccines, Combined
  • twinrix