FDA Approves Accelerated Dosing Schedule For Glaxosmithkline's Twinrix - New Vaccine Schedule Offers Protection Against Hepatitis A And Hepatitis B
07 Apr 2007
GlaxoSmithKline announced recently 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 America and 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 or
older) 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.