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Feds Deem Hepatitis B Vaccine Safe

May 19, 1999

WASHINGTON (AP) _ Federal scientists say Hepatitis B vaccine is safe and effective, despite reports that it can cause serious and even life-threatening side effects.

Testifying Tuesday before a House subcommittee investigating vaccine safety, officials said use of the vaccine has been monitored for 15 years and it has not been proven to be the cause of any deaths and is only rarely linked to serious side effects.

``Vaccines are extremely safe, but they are not risk-free,″ said Susan S. Ellenberg, an epidemiologist at the Food and Drug Administration. ``While serious complications are extremely rare, they do occur.″

Ellenberg, testifying before the Government Reform subcommittee on criminal justice, drug policy and human resources, said a federal organization, the Vaccine Adverse Event Reporting System, receives about 12,000 reports a year of incidents related to vaccines. Most incidents are minor, such as irritability or fever, but about 15 percent are serious, involving death, hospitalization or disability. All of the serious incidents are investigated, said Ellenberg, but no cause-and-effect connection with the hepatitis B vaccine has been found.

The 1,800 or so serious adverse event reports represent only a small fraction of the 1.2 million people who annually receive hepatitis B shots, the experts said.

Dr. Harold S. Margolis, a hepatitis authority at the Centers for Disease Control and Prevention, said his organization has seven investigations under way to determine whether any of the reported side effects can be linked to hepatitis vaccines. So far, no link has been found, he said.

The CDC, the World Health Organization, the American Medical Association and most other major health organizations have supported adding hepatitis B to the regimen of childhood vaccinations. Forty-two states now require it for school admission.

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