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Issue Number 18                                            September 2, 1998

CONTENTS OF THIS ISSUE

1. SIMPLIFIED PEDIATRIC DOSING REGIMEN NOW AVAILABLE FOR RECOMBIVAX HB


2. NATIONAL MULTIPLE SCLEROSIS SOCIETY'S MEDICAL ADVISORY BOARD SAYS THERE IS NO CURRENT EVIDENCE OF A LINK BETWEEN HEPATITIS B VACCINE AND MULTIPLE SCLEROSIS
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(1)
August 27, 1998
SIMPLIFIED PEDIATRIC DOSING REGIMEN NOW AVAILABLE FOR RECOMBIVAX HB

On August 27, 1998, Merck Vaccine Division announced that it has simplified the dosing regimen for RECOMBIVAX HB and discontinued the production and distribution of its 2.5 mcg pediatric dose.

On August 9, 1998, the FDA approved Merck Vaccine Division's (MVD) supplemental license application which made the 5 mcg dose of RECOMBIVAX HB Merck's standard dosing regimen for children ages 0-19 regardless of risk for exposure.

According to Thomas M. Vernon, MD, Vice President, MVD Policy, Public Health and Medical Affairs, "We have been strongly encouraged by public health officials and many practitioners, including members of the AAP, to provide oneconvenient formulation for allchildren and adolescents age 0-19. The change was made to simplify and eliminate confusion about the dosing schedule of RECOMBIVAX HB."

Children who were initiated with the 2.5 mcg dose of RECOMBIVAX HB do not need to be revaccinated and may complete the vaccine series with either the 2.5 mcg or the 5 mcg dose.  When using RECOMBIVAX HB, all new vaccinees 0-19 years of age should initiate and complete the series with the 5 mcg dose. Dosing intervals remain the same.

Currently, there are two hepatitis B vaccines licensed by the FDA for use in the United States. The products are RECOMBIVAX HB, manufactured by Merck & Co., and Engerix-B, manufactured by SmithKline Beecham. According to the Centers for Disease Control and Prevention, these two vaccines may be used interchangeably. Consult the package inserts for
complete information.

If you have any questions regarding the change in RECOMBIVAX HB, please contact your Merck Vaccine Specialist or the RECOMBIVAX Information Line at 1-800-622-4477.
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(2)
August 21, 1998
NATIONAL MULTIPLE SCLEROSIS SOCIETY'S MEDICAL ADVISORY BOARD SAYS THERE IS NO CURRENT EVIDENCE OF A LINK BETWEEN HEPATITIS B VACCINE AND MULTIPLE SCLEROSIS

"There is no evidence of a link between hepatitis B vaccination and MS." This is the official position of the National Multiple Sclerosis Society, published in the National MS Society position paper entitled, "Hepatitis B Vaccine and Multiple Sclerosis."   The paper, which was released to the public on August 21, 1998, was written in response to the media attention that has been drawn to anecdotal reports suggesting that vaccination against hepatitis B virus may increase the risk for developing multiple sclerosis.

The summary of the report reads:

  1. Such reports have NOT been confirmed by any statistically significant scientific studies to date;
  2. Because of the potential for public concern about this issue, further studies of the possibility of association of hepatitis B vaccine and demyelinating disease including MS, are underway in the U.S. and Europe;
  3. Hepatitis B infection can result in a serious, sometimes fatal disease and vaccination is effective in its prevention;
  4. In the view of the Medical Advisory Board of the National Multiple Sclerosis Society, there is no evidence of a link between hepatitis B vaccination and MS;
  5. People with MS are encouraged to discuss the small general risks of any viral immunization with their physicians.

For a complete copy of the report, visit the National Multiple Sclerosis Society (NMSS) website at http://www.nmss.org/. You may also get a copy of the report by calling NMSS at 1-800-344-4867  (FIGHT MS). Press #1 and you will be connected to the MS Society
in your area.

CDC has also developed a fact sheet in response to the media attention to hepatitis B vaccine and autoimmune disorders such as multiple sclerosis. The fact sheet is called "Hepatitis B vaccine: what you may had heard...and what you should know." You may obtain  a copy from CDC's National Immunization Program.

 

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 June 15, 1999