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FDA approves accelerated dosing schedule for GlaxoSmithKline’s Twinrix®


GlaxoSmithKline [NYSE:GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved Twinrix® [Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine], for an accelerated dosing schedule that consists of three doses given within three weeks followed by a booster dose at 12 months. The approval means Twinrix, the only hepatitis A and hepatitis B combination vaccine available in the United States, is now available on a dosing schedule at 0, 7, 21-30 days, followed by a booster dose at 12 months. The vaccine was first approved for adults over age 18 years by the FDA in May 2001 on a 0, 1, 6-month dosing schedule.

“Hepatitis A and hepatitis B are serious liver diseases which can be prevented through vaccination,” stated travel medicine specialist Bradley A. Connor, M.D., Past President, International Society of Travel Medicine and a principal study investigator. “Twinrix’s new accelerated dosing schedule offers an option that could benefit individuals such as those preparing to travel internationally to high-risk areas. It may also benefit emergency first care responders, especially those deploying to disaster areas overseas, as well as others at risk for hepatitis, such as people with sexually transmitted diseases and those who are HIV positive.”

Many regions throughout the world are endemic for hepatitis A and hepatitis B, such as Africa, Asia, South Americaand parts of the Caribbean. Worldwide, approximately 1.5 million cases of hepatitis A are reported annually. In addition, hepatitis B has infected 2 billion people — one-third of the world’s population. Millions of Americans travel each year to countries where hepatitis A and hepatitis B are endemic. An overwhelming majority of these international travelers are not vaccinated before the trip. Therefore, international travelers may be at risk for contracting both hepatitis A and hepatitis B. They should consult their health care provider prior to traveling abroad.

The FDA approved the new dosing schedule after reviewing the safety and immune response of Twinrix given to 250 healthy adults (aged ≥18 years) at 0-, 7-, and 21- to 30-day schedule, followed by a booster dose at 12 months, compared to separate vaccinations with monovalent hepatitis A vaccine (HAVRIX at 0 and 12 months) and hepatitis B vaccine (ENGERIX-B at 0, 1, 2, and 12 months) given to 246 healthy adults as a control group. The study demonstrated that the individuals who completed the series of Twinrix on the accelerated dosing schedule had an immune response comparable to those individuals who received complete vaccination with separately administered hepatitis A and hepatitis B vaccines.


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