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http://dailynews.yahoo.com/h/nm/20010514/bs/health_glaxosmithkline_twinrix_dc1.html
Monday May 14 3:26 PM ET
FDA OKs Combination Hepatitis A,B Vaccine
WASHINGTON (Reuters) - U.S. regulators said Monday they
approved a combination hepatitis vaccine made by GlaxoSmithKline Plc (GSK.L) (NYSE:GSK
- news) to protect people from both the A and B strains of the infectious liver
disease.
The Food and Drug Administration (news - web sites)
approved the Twinrix vaccine for individuals 18 years and older to allow people
at high risk to be immunized against both viruses simultaneously.
“Clinical trials of Twinrix...demonstrated that the
combination vaccine was as safe and effective as the already licensed separate
vaccines,” the FDA said in a statement.
GlaxoSmithKline said hepatitis A and B are the most common
vaccine-preventable diseases in travelers.
Twinrix would benefit people traveling to high-risk
hepatitis areas in the developing world, the British drug company said, as well
as men who have sex with other men, chronic liver disease patients, health-care
personnel, personnel and residents of institutions, and military personnel.
Hepatitis A can be contracted from contaminated food or
drinking water. Hepatitis B is spread
through contact with infected blood or other body fluids, often as a result of
contaminated needles or unprotected sex with an infected person.
Both diseases can produce symptoms that include fever,
weakness and jaundice. While hepatitis A is rarely fatal, hepatitis B can
result in chronic hepatitis, cirrhosis and liver cancer.
Each year, 125,000 to 200,000 Americans are infected with
hepatitis A, and 140,000 to 320,000 are infected with hepatitis B, the company
said.
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