Issue Number 50
January 26, 1999
CONTENTS OF THIS ISSUE
- Vaccine Initiative says National
Vaccine Information Center incorrectly portrayed risks of side effects associated with
hepatitis B vaccine
- Looking for the latest vaccine news
and links to vaccine organizations? Visit "The Vaccine Page"
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January 22, 1999
VACCINE INITIATIVE SAYS NATIONAL VACCINE INFORMATION CENTER INCORRECTLY PORTRAYED RISKS OF
SIDE EFFECTS ASSOCIATED WITH HEPATITIS B VACCINE
The Vaccine Initiative, a special project of the Infectious Diseases Society of America
and the Pediatric Infectious Diseases Society, released information on Friday, January 22,
1999, stating that the figures released by the National Vaccine Information Center on
Friday, January 22, 1999, incorrectly portrayed risks of side effects associated with
hepatitis B vaccine.
The press release explains why it is not possible to determine the number of adverse
effects from a given vaccine simply by looking at the number of Vaccine Adverse Events
Reporting System (VAERS) reports. The press release also states that "studies done
around the world have consistently demonstrated the ability of this vaccine to protect
against hepatitis B and its complications."
The press release is reprinted below:
Company Press Release Source: Infectious Diseases Society of America
Hepatitis B Vaccine Effective in Reducing Incidence of Disease; Recent Analysis of
Hepatitis B Data Misrepresents Risk of Vaccination
WASHINGTON, Jan. 22 /PRNewswire/ -- Figures released today by a patient advocacy group
incorrectly portray the risks of serious side effects associated with giving the hepatitis
B vaccine to children, stated Bruce Gellin, M.D., staff director of the Vaccine
Initiative, a special project of the Infectious Diseases Society of America (IDSA) and the
Pediatric Infectious Diseases Society (PIDS). The Initiative is co-chaired by former
Secretary of Health and Human Services Dr. Louis Sullivan and Dr. Samuel Katz, Wilburt C.
Davison professor and chairman emeritus of Pediatrics at the Duke University School of
"Parents should know that ensuring their child receives the hepatitis B vaccine is in
accordance with the best scientific thinking. Studies done in the U.S. and around the
world have consistently demonstrated the ability of this vaccine to protect against
hepatitis B and its complications. In addition, every rigorous scientific study to date
has found an extremely low incidence of serious side effects among those who have been
vaccinated," stated Dr. Gellin.
He continued, "In response to concerns raised about the hepatitis B vaccine, the
World Health Organization convened an expert panel in September 1998 to review all
available data, which concluded: 'No evidence presented at this meeting indicates a
need to change public health policies with respect to HB immunization. Therefore, based on
demonstrated important benefits -- including the prevention of cirrhosis and cancer -- the
group supports the WHO recommendations that all countries should have universal infant
and/or adolescent immunization programs and continue to immunize adults at increased risk
of HB infection as appropriate.'"
The figures released today by the National Vaccine Information Center (formerly known as
Dissatisfied Parents Together, or DPT) analyzed data from the federal government's Vaccine
Adverse Events Reporting System (VAERS) database. They claim that their analysis shows
that there are more serious reactions from the vaccine than there are cases of the disease
in children under 14. However, it is not possible to determine the number of adverse
effects from a given vaccine simply by looking at the number of VAERS reports.
The VAERS database is used to examine overall trends and unusual occurrences for further
study, not to determine exact numbers of case reports. VAERS accepts all reports of health
effects that follow vaccination, regardless of the cause. In some cases, these adverse
effects have merely a coincidental rather than a causal relationship to the administration
of a vaccine. Other cases may be reported more than once. This can happen if a provider, a
parent, and a manufacturer file a report for the same child, or if a child has several
effects (fever, headache, persistent crying), and a report is filed under each side
effect. A published review of VAERS data from 1991-94 show no unexpected events in
infants, who received approximately 12 million doses of the hepatitis B vaccine during
that period. In addition, an analysis of data from the National Center for Health
Statistics show no increase in reports of infant deaths since 1991, the year routine
hepatitis B immunization began. A list of references is below.
"Parents and health care providers continue to support routine immunization against
hepatitis B and the other vaccine-preventable diseases. In a study conducted by IDSA in
1997, we found that 90% of those surveyed believed that it is very important for their
child's health that they be vaccinated. In addition, the major American medical groups
concerned with children's health, including the American Academy of Pediatrics, the
American Academy of Family Physicians, and the Advisory Committee on Immunization
Practices, continue to support universal infant hepatitis B immunization," said Dr.
"It is especially important to protect children against hepatitis B, because those
who become infected before the age of six have a much higher likelihood of developing
chronic liver disease, including cancer," Gellin noted.
He continued, "We need to preserve parents' trust in vaccination by ensuring that
they receive the most complete and accurate information about the vaccines that are
recommended for their children."
For more information on the hepatitis B vaccine, contact the CDC's National Immunization
Program Hotline at 1-800-232-2522, or the Hepatitis Branch hotline at 1-888-4HEP-CDC, or
visit the following Web sites: National Immunization Program: http://www.cdc.gov/nip
CDC Hepatitis Branch: http://www.cdc.gov/ncidod/diseases/hepatitis/hepatitis.htm
The Vaccine Initiative: http://www.idsociety.org
1. Niu MT, Davis DM, Ellenberg SS. Recombinant hepatitis B vaccination of neonates and
infants: emerging safety data from VAERS. Pediatr Infect Dis J,1996; 15: 771-6.
2. Niu MT, Rhodes P, Salive M, Lively T, Davis DM, Black S, et al. Comparative safety of
two recombinant hepatitis B vaccines in children: data from VAERS and Vaccine Safety
Datalink. J Clin Epidemiol 1998;51:503-10.
3. Kiely, J. National Center for Health Statistics, Presentation at the Vaccine Safety
Forum, October 16, 1998 Washington, D.C.
SOURCE: Infectious Diseases Society of America
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January 26, 1999
LOOKING FOR THE LATEST VACCINE NEWS AND LINKS TO VACCINE ORGANIZATIONS? VISIT "THE
If you want to read the latest vaccine news stories go to The Vaccine Page website at http://www.vaccines.com Here you will be able
to click to a listing of vaccine news stories made available to the Vaccine Page by Yahoo!
The Vaccine Page also has links to vaccine sites, both national and international, for
adults, parents, practitioners, and researchers. It also provides links to journals and
immunization advocacy organizations.