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246 May 16, 2001
CONTENTS OF THIS ISSUE
- FDA approves combination
vaccine for protection against hepatitis A and B
- Punjabi VISs now
available on IAC's website
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May 16, 2001
FDA APPROVES COMBINATION VACCINE FOR PROTECTION AGAINST HEPATITIS A AND B
The Food and Drug Administration (FDA) announced that it has approved
Twinrix, a new combination vaccine from GlaxoSmithKline that protects adults
against hepatitis A and B.
The complete text of the FDA announcement is reprinted below:
NEW COMBINATION VACCINE APPROVED FOR PROTECTION AGAINST TWO HEPATITIS VIRUSES
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 forexposure 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 floodregion, 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
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 [GlaxoSmithKline], in Philadelphia, Pa., will market and distribute Twinrix.
To read FDA's announcement of the approval online, go to: http://www.fda.gov/bbs/topics/ANSWERS/2001/ANS01084.html
For consumer inquiries by telephone, call: (888) 463-6332 (888-INFO-FDA).
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May 16, 2001
PUNJABI VISs NOW AVAILABLE ON IAC'S WEBSITE
Punjabi-language translations of seven Vaccine Information Statements (VISs)
are now available on the website of the Immunization Action Coalition (IAC).
Thank you to the California Department of Health Services, Immunization Branch, for providing the Punjabi translations of the
English-language VISs created by the Centers for Disease Control and Prevention.
To obtain camera-ready copies of the following VISs in Punjabi, use the following links:
To obtain camera-ready copies (PDF format) of English-language or
foreign-language translations of VISs for other vaccine-preventable diseases,
as well as instructions for using VISs, visit IAC's website at: http://www.immunize.org/vis