http://www.vaccinealliance.org/frameset.html
Wednesday November 14 7:18 PM ET
By Ori Twersky
WASHINGTON (Reuters Health) - The US Food and Drug Administration (news
- web
sites) has approved a combination vaccine for hepatitis A and hepatitis B,
the manufacturer announced on Monday.
The Twinrix vaccine is the ``world's only combination vaccine for the
prevention of hepatitis A and B,'' GlaxoSmithKline said. Hepatitis A and
hepatitis B are viruses that infect the liver. Hepatitis A can be spread in
fecally contaminated food and water, and symptoms include nausea, vomiting and
sometimes jaundice, a yellowing of the skin due to reduced liver function.
Hepatitis B can be spread by infected blood or body fluids, such as during
sexual contact, sharing IV needles, or by using contaminated equipment in body
piercing or tattooing. Thelma Thiel, chair and CEO of the Hepatitis Foundation
International, said she was pleased by the approval. ''I think if we can reduce
the number of vaccinations, especially for children and particularly in border
states, that is wonderful,'' she told Reuters Health.
The approval is also especially important for Americans traveling overseas,
who often are vaccinated for hepatitis A but not hepatitis B, she said.
Glaxo noted that others who would benefit from being vaccinated include
``men who have sex with men, chronic liver disease patients, healthcare
personnel, personnel and residents of institutions, and military recruits and
personnel.''
Approval for Twinrix was based on 11 clinical trials involving 1,551
participants, in which over 99% demonstrated a response to the hepatitis A
component and 98.5% demonstrated a response to the hepatitis B component, the
company said.
The trials also demonstrated that the combined components are equivalent to
receiving the separate vaccinations, according to Glaxo.
Twinrix reduces the number of injections needed from five to three. Glaxo
believes the change will encourage people to get vaccinated while cutting the
cost associated with administering two separate vaccinations. ``We feel that we
are filling a very important need,'' Carmel Hogan, a company spokesperson, told
Reuters Health.
Each year, an estimated 125,000 to 200,000 Americans are infected with
hepatitis A and another 140,000 to 320,000 are infected with hepatitis B, the
company said.
Twinrix currently is approved in 70 markets worldwide, including the
European Union (news
- web
sites), where it was launched in 1996. Glaxo has distributed more than 11.9
million doses, Hogan said.
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