FDA Approves New Vaccine.(Brief Article)

2001 JUN 6 - (NewsRx.com & NewsRx.net) --

Twinrix(R) [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine], manufactured by GlaxoSmithKline Biologicals, received approval on May 14, 2001, from the U.S. Food and Drug Administration (FDA) for the prevention of infectious liver diseases, hepatitis A and hepatitis B, in adults.

Twinrix, the world's only combination hepatitis vaccine indicated for use in adults 18 years and older, has been proven safe and effective in the prevention of hepatitis A and B - two common forms of hepatitis.

"Hepatitis A and B are the only two forms of hepatitis currently preventable by vaccination and there are several patient populations at risk for both diseases, which is why a combination vaccine makes sense. GlaxoSmithKline is the first to offer a single vaccine to protect against both diseases simultaneously," said Dr. Mark Blatter, clinical trial investigator and medical director, Primary Physicians Research. "Vaccinating Americans with Twinrix is an important step to help eradicate hepatitis A as well as hepatitis B, which is up to 100 times more contagious than HIV in some settings."

Each year, 125,000 to 200,000 Americans are infected with hepatitis A, and 140,000 to 320,000 are infected with hepatitis B. Approximately 50% of persons with hepatitis A and 25% of persons with hepatitis B have no known risk factor for their infection. Since hepatitis A and B are the most common vaccine-preventable diseases in travelers, individuals who would benefit include those who travel to areas such as Africa, Asia (except Japan), the Caribbean, South America, Central America, the Middle East, and eastern and southern Europe. Other individuals who would benefit include men who have sex with men, chronic liver disease patients, health care personnel, personnel and residents of institutions, and military recruits and personnel.

"This combination hepatitis A & B vaccine is an important advance in ...