Subject: Lab-Made Vaccine For Hepatitis B Is Cleared by FDA
Date: Published: 7/24/86 70 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

   Lab-Made Vaccine
   For Hepatitis B
   Is Cleared by FDA
    ---
   By Joe Davidson
   Staff Reporter of The Wall Street Journal

   WASHINGTON -- The Food and Drug Administration approved
the first genetically engineered vaccine, a hepatitis B serum
that "opens a new era in vaccine production," said FDA
commissioner Frank Young.
   The vaccine was developed by Chiron Corp., of Emeryville,
Calif., and Merck Sharp & Dohme Research Laboratories, a unit
of Merck & Co., Rahway, N. J. 
   An existing vaccine is derived from the blood of those
with the hepatitis B virus.  Hepatitis can destroy the liver,
and cause fever, vomiting and jaundice.  It also can lead to
liver cancer and can be passed by intravenous drug use,
semen, saliva and from mother to unborn child.
   About 200,000 new infections occur annually in the U. S.,
and of the 10,000 people hospitalized, about 250 die from
severe infection.  Each year about 20,000 Americans become
chronic carriers of the disease and they can infect others.
The economic impact of hepatitis B in the U. S. is $1 million
a day, according to Merck, which also makes the existing
vaccine.
   Merck officials wouldn't estimate anticipated sales of the
vaccine and said a price hasn't been firmly established.  But
they said they expect the price to be close to that of the
current vaccine, which is $110 for three doses.
   Chiron said it expects the vaccine to "greatly expand the
Hepatitis B market."  A company spokesman said, "We'll be
disappointed if it doesn't turn out to be a $100
million-a-year product."
   The new vaccine, called Recombivax HB, is made with the
use of genetically altered yeast cells.  Dr. Young said the
development of a vaccine independent of human blood serum
"opens the door for the production of other vaccines that
have so far been impractical, potentially unsafe or
impossible to make."
   The existing vaccine has been available since 1981.  Since
then, one million people in the U. S. and about three million
world-wide have been inoculated, according to a Merck
spokesman.  The existing vaccine will continue to be available
when Recombivax HB becomes available next year.
   Federal officials hope the new vaccine will encourage more
of those in the high-risk group for hepatitis B to be
vaccinated.  They estimate that only 3% to 30% of those in
that group currently use the plasmaderived vaccine.  The FDA
said the low rate possibly reflects fear of AIDS, or acquired
immune deficiency syndrome, as most of the blood used to make
the hepatitis B vaccine comes from persons at high risk for
AIDS. 
   Dr. Young said the AIDS virus is killed when processing
the existing vaccine, "but the new lab-made vaccine should
further reassure high-risk groups that they can be safely
vaccinated.  I would urge high-risk individuals such as dental
and medical workers, susceptible homosexuals and drug users,
as well as certain other groups to take advantage of this
life-saving protection."

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