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[IP] Hep B Vaccine Linked to Onset of DM

Hepatitis B Vaccine Linked to Onset of Diabetes

But Larger Studies Are Needed to Know if Risk Is Real

By Paula Moyer
WebMD Medical News

June 13, 2000 (San Antonio) -- Faced with an ever-growing list of required
and recommended vaccinations for children -- as well as occasional reports
of safety problems linked to vaccines -- many parents understandably feel
confused.  No doubt adding to that confusion are reports that the vaccine
against hepatitis B, a blood-borne illness that can cause liver cancer, may
actually lead to the development of type 1 diabetes in children.

Type 1 diabetes is the form where the body doesn't make the insulin it

An Italian study presented here at the annual meeting of the American
Diabetes Association suggests that children who get the hepatitis B vaccine
are at greater risk for developing type 1 disease than those who have never
been vaccinated. On the basis of their research, Paolo Pozzilli, MD, and
colleagues say doctors should exercise caution in giving the vaccine to
children who have close relatives with type 1 diabetes.

But because type 1 diabetes is relatively rare in the overall population,
thorough studies involving several hundred thousand participants are needed
to prove a solid link, says Marion Rewers, MD, who was not involved in the
study. So the jury is still out, he says.

"The possibility of a link between hepatitis B vaccine [and type 1 diabetes]
is an interesting research area and has been recognized as such by a number
of investigators across the world," he tells WebMD. He says that at two
recent meetings, researchers "were in unanimous agreement that there was no
association. We need a monitoring system, so that if an association is found
in the future, it can be promptly identified." Rewers, a pediatric
endocrinologist, is a professor of pediatrics and preventive medicine at the
University of Colorado in Denver and chair of the ADA council on
epidemiology and statistics.

The CDC recommends that the hepatitis B vaccine be a part of routine
vaccination schedules for U.S. infants.

The hepatitis B vaccine is now required in Italy, says Pozzilli, a professor
of pediatrics at the University of Rome. Further, there is a low, relatively
stable rate of type 1 diabetes there. These conditions allowed the
researchers to compare the rate of diabetes in vaccinated children with that
in unvaccinated groups.

Investigators compared 150,000 children who had been vaccinated at age 3
months to an equal number of unvaccinated children. To assess the risk of
developing type 1 diabetes in children who got the vaccine later, after
vaccination became mandatory in Italy, 400,000 children who were vaccinated
at age 12 were compared with children who had not been vaccinated.

In the group as a whole, the rates of type 1 diabetes were 46 per 100,000
for children who had been vaccinated and 34 per 100,000 for children who had
not. For those vaccinated at age 12, the rates were 17.8 per 100,000 for
vaccinated children and 6.9 per 100,000 for unvaccinated children.

Although these may seem like large groups to study, they are not big enough
for scientists to see clear patterns for type 1 diabetes, Rewers says. For a
study like this to have value, the database should involve as many as
250,000 people in both the vaccinated and unvaccinated groups, he says.

"Caution is necessary when the potential of vaccine-related risks is
studied," Rewers tells WebMD. "Without sound supportive data, [parents] can
become unduly alarmed and stop immunizing their children." When immunization
rates drop, diseases that can cause serious illness -- and death -- return,
he tells WebMD.

The National Institutes of Health and the CDC are jointly establishing a
system known as "sentinel monitoring areas," Rewers tells WebMD. The
agencies will track the rate of type 1 diabetes in these areas -- consisting
of selected counties in the U.S. -- and will determine whether the rate is
related to things like immunizations, recommended infant feeding schedules,
and outbreaks of infection.

Rewers has not been involved with the development of any vaccine and has no
ties to any company that manufactures vaccines.

 2000 Healtheon/WebMD. All rights reserved.

Jan (61 y/o, T-1 11/5/50, pmpg 8/23/83) & Bluda Sue (MM507C, 3/99)
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