FDA OKs dosing schedule for GSK vaccine

GlaxoSmithKline has reported the FDA’s approval of its hepatitis vaccine Twinrix, for an accelerated dosing schedule.

The approval means Twinrix, the only hepatitis A and hepatitis B combination vaccine available in the US, is now available on a dosing schedule that consists of three doses given within three weeks followed by a booster dose at 12 months.

“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,” stated travel medicine specialist Bradley Connor, Past President, International Society of Travel Medicine.

Many regions throughout the world are endemic for hepatitis A and hepatitis B, such as Africa, Asia, South America and parts of the Caribbean.

The FDA approved the new dosing schedule after reviewing the safety and immune response of Twinrix in a trial. 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.