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Issue Number 50              January 26, 1999

CONTENTS OF THIS ISSUE

  1. Vaccine Initiative says National Vaccine Information Center incorrectly portrayed risks of side effects associated with hepatitis B vaccine
  2. Looking for the latest vaccine news and links to vaccine organizations? Visit "The Vaccine Page"

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(1)
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 Medicine.

"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. Gellin.

"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

References:
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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(2)
January 26, 1999
LOOKING FOR THE LATEST VACCINE NEWS AND LINKS TO VACCINE ORGANIZATIONS? VISIT "THE VACCINE PAGE"

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! News.

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.

 

Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
E-mail: admin@immunize.org Web: http://www.immunize.org/
Tel: 651-647-9009Fax: 651-647-9131

This page was updated on January 27, 1999