Genetically Engineered Hepatitis B Vaccine

FDA Consumer, October 1986 | Go to article overview

Genetically Engineered Hepatitis B Vaccine


Genetically Engineered Hepatitis B Vaccine

The first genetically engineered human vaccine was approved by FDA July 23. The new vaccine, called Recombivax HB, provides a second vaccine for the prevention of hepatitis B, one of the most serious forms of viral hepatitis.

The new vaccine is produced by yeast cells into which the gene for production of the outer coat of the hepatitis B virus has been inserted. The outer coat is not infectious, but can provide immunity against the entire virus. The original vaccine, approved in 1981, is manufactured from the blood plasma of individuals chronically infected with hepatitis B.

Hepatitis, or inflammation of the liver, results in fever, nausea, vomiting and jaundice. Hepatitis B can become a chronic infection that destroys the liver. Some research also suggests hepatitis may lead to liver cancer. Hepatitis B can be passed from mother to child, as well as by intravenous drug use, and by blood, semen and possibly saliva.

Only 3 percent to 30 percent of people in various groups at high risk of contrcting hepatitis B have been vaccinated using the older, plasma-derived product. The low use m ay result from fear of getting acquired immunodeficiency syndrome (AIDS) since most of the donors of the plasma used to make the odler vaccine are at high risk for AIDS. (Many of the risk factors for hepatitis B are the same as those for AIDS.)

About 200,000 new hepatitis B infections occur each year in the United States, primarily in young adults. Up to 10 percent of those infected become chronic carriers who may develop chronic liver disease that can lead to cirrhosis and liver cancer. …

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Genetically Engineered Hepatitis B Vaccine
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