AEGiS-PRn: FDA Confirms Role of Hepatitis B Vaccine in Helping to Prevent Chronic Hepatitis B Infection Which Can Lead to Primary Liver Cancer PRNewswireImportant note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
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FDA Confirms Role of Hepatitis B Vaccine in Helping to Prevent Chronic Hepatitis B Infection Which Can Lead to Primary Liver Cancer

PRNewswire - December 14, 1999


PHILADELPHIA, Dec. 14 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has recognized the Centers for Disease Control and Prevention's (CDC) description of hepatitis B vaccines as preventing hepatitis B infections which can lead to primary liver cancer. SmithKline Beecham announced today that its Engerix-B(R) (Hepatitis B Vaccine (Recombinant)) labeling includes this statement in the Clinical Pharmacology section. Studies of hepatitis B vaccine use demonstrate that vaccination can significantly reduce the development of chronic hepatitis B infections and decrease the risk and incidence of primary liver cancer.

In the United States about 15 percent of the reported cases of primary liver cancer develop from chronic hepatitis B infections. The majority of the remaining cases are due to hepatitis C infections and alcoholic cirrhosis. Universal vaccination against hepatitis B infections will not completely eliminate primary liver cancer in the United States. On a worldwide basis, up to 80 percent of liver cancer cases are associated with chronic hepatitis B infections.

"Widespread use of hepatitis B vaccine has the potential to reduce dramatically hepatitis B virus infection and the development of liver cancer from chronic hepatitis B infection worldwide," said Dr. Michael Thun, vice president of epidemiology, American Cancer Society. "The American Cancer Society supports the FDA's recognition of the hepatitis B vaccine as a means of reducing the development of chronic infection, a primary factor which may contribute to liver cancer."

Liver cancer is a serious disease that is almost always fatal, with less than 5 percent of patients surviving five years after diagnosis. Persons with chronic hepatitis B virus infection are at 12 to 300 times higher risk of primary liver cancer than those without chronic infection. An estimated 1,000 to 1,500 people die each year in the United States of hepatitis B-related liver cancer.

Studies Show Hepatitis B Vaccination Decreases Incidence of Liver Cancer

Two recent studies have demonstrated the link between hepatitis B infection and the occurrence of primary liver cancer. The study published in The New England Journal of Medicine in 1997 (Chang et. al.) showed that universal childhood immunization against the hepatitis B virus in Taiwan decreased the incidence of liver cancer among children by 49 percent from 1981 to 1994. In addition, a Korean study published in the International Journal of Epidemiology in 1998 (Lee et. al.) showed that vaccination against hepatitis B decreased the risk of developing liver cancer in vaccinated adults by 42 percent.

"Studies show a rise in the incidence of liver cancer, particularly in young adults, and we need to continue encouraging adolescents and at-risk adults who have not yet been immunized to get the hepatitis B vaccine," said William Schaffner, M.D., professor and chairman, department of preventive medicine, Vanderbilt University. "Widespread immunization against hepatitis B is the most effective means to prevent the hepatitis B infection and, subsequently, liver cancer."

Hepatitis B: A Preventable Disease

Hepatitis B is a serious liver disease that can cause mild flu-like symptoms, fatigue, nausea, vomiting, abdominal pain or jaundice. As many as 150,000 Americans are infected annually, with up to 40 percent of new cases occurring in young adults. Hepatitis B can be spread through infected blood or body fluids. It can be transmitted through sexual contact, intravenous drug use, contact sports (via cuts and scrapes) and body piercing and tattooing. In some settings, hepatitis B virus is up to 100 times more contagious than HIV.

In addition to the FDA, leading medical organizations including the CDC and the World Health Organization (WHO) have recognized the hepatitis B vaccine as a significant tool to reduce chronic hepatitis B infections which may develop into primary liver cancer. In 1991, the CDC recommended hepatitis B immunization for all infants and in 1994 further recommended vaccination for those adolescents not previously immunized. Routine immunization against hepatitis B for infants and adolescents is also endorsed by the WHO, the American Academy of Pediatrics and the American Medical Association.

SmithKline Beecham's Engerix-B has been licensed in the United States for ten years. Engerix-B is generally well tolerated. Commonly seen adverse reactions include injection site soreness, fatigue and fever. However, as with all vaccines, rare adverse reactions may occur.

SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over- the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com.

Copies of complete prescribing information for Engerix-B are available by fax free of charge by calling 1-800-753-0352, ext. 736.

SOURCE SmithKline Beecham

CONTACT: Diana Littman of Cohn & Wolfe/Healthcare, 212-598-2857, for SmithKline Beecham; Brian Jones, 215-751-3415 or Richard Williams, 215-751-7002, both of SmithKline Beecham/
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