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| T01-23 | Print Media: 301-827-6242 |
| May 14, 2001 | Consumer Inquiries: 888-INFO-FDA |
On May 11 FDA approved a new combination vaccine that protects individuals 18 years of age or older against diseases caused by the hepatitis A virus (HAV) and the hepatitis B virus (HBV). The vaccine, called Twinrix, combines two already approved vaccines, Havrix (Hepatitis A Vaccine, Inactivated) and Engerix-B [Hepatitis B Vaccine (Recombinant)] so that people at high risk for exposure to both viruses can be immunized against both at the same time.
For example, Twinrix is recommended for travelers who, because of certain behaviors or occupations, are at high risk for HBV, and who are visiting countries where there is a high or intermediate rate of both HAV and HBV disease, as defined by the Centers for Disease Control.
HAV infection can be contracted by ingestion of contaminated water or food. Travel to certain areas of the world with poor hygienic conditions or being in places where usual sanitary conditions have broken down, such as a flood region, can increase the risk of HAV infection.
HBV infection is spread through contact with infected blood or other body fluids, through using contaminated needles or having unprotected sex with an infected person. Health care workers are also among those considered at risk.
Areas with a high rate of both HAV and HBV include Africa, parts of South America, and most of the Middle East, South and Southeast Asia.
HAV infection may be asymptomatic. However, symptoms occur more frequently in older age groups and typically include fever, malaise, and jaundice. Rarely, patients with HAV infection progress to liver failure and death.
HBV infection may also be asymptomatic or result in similar symptoms to HAV infection. However a small number of HBV infections in adults result in chronic hepatitis leading to cirrhosis and liver cancer.
Clinical trials of Twinrix, given in a three dose series at 0-, 1- and 6-months, demonstrated that the combination vaccine was as safe and effective as the already licensed separate HAV and HBV vaccines.
SmithKline Beecham Pharmaceuticals, in Philadelphia, Pa., will market and distribute Twinrix.
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