Issue Number 23                                        October 13, 1998

CONTENTS OF THIS ISSUE

1. World Health Organization says there is no scientific justification to suspend hepatitis B immunization in France
2. Engerix-B approved by FDA for use in patients with hepatitis C
3. Hepatitis Foundation International schedules programs on hepatitis C virus infection in five major cities
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(1)
October 2, 1998
WORLD HEALTH ORGANIZATION SAYS THERE IS NO SCIENTIFIC
JUSTIFICATION TO SUSPEND HEPATITIS B IMMUNIZATION IN FRANCE

On October 2, 1998, the World Health Organization (WHO) issued the following press release in response to the French Ministry of Health's decision to suspend routine hepatitis B immunization of adolescents in French schools while continuing the immunization of infants and high-risk adults with hepatitis B vaccine:

PRESS RELEASE WHO/67
2 October 1998

On 1 October 1998, the French Ministry of Health announced a decision to suspend routine HB immunization of adolescents in French schools, while continuing the immunization of   infants and high risk adults. This decision followed concerns, despite lack of scientific evidence establishing a causal relationship, that Hepatitis B immunization might be linked to the development or flare-up of demyelinating diseases such as multiple sclerosis (MS), and comes in the wake of enormous pressure from anti-vaccine groups.

WHO, with the assistance of external experts in neurology, epidemiology, immunology and public health, has carefully reviewed the scientific evidence on whether Hepatitis B vaccine can cause demyelinating diseases such as MS. WHO believes that available scientific data does not demonstrate a causal association between HB immunization and central nervous system diseases, including MS.

Over 1 billion doses of Hepatitis B (HB) vaccine have been used since 1981 with an outstanding record of safety and efficacy, and the vaccine is 95% effective in preventing the development of the chronic carrier state of Hepatitis B. HB vaccine is the first vaccine against a major human cancer, as it is the chronic carriers of Hepatitis B who are at a high risk of death from cirrhosis of the liver and liver cancer.

Recognizing the enormous value of Hepatitis B vaccine, the World Health Assembly recommended in 1992 that all countries incorporate Hepatitis B vaccine into their routine immunization programmes. To date, 100 countries have added Hepatitis B vaccine into their national immunization programmes, and many industrial countries have begun programmes of immunizing adolescents as well.

Although France will continue infant and high risk adult immunization, WHO is concerned that the decision taken yesterday may lead to loss of public confidence in this vaccine, and decisions by other countries to suspend or delay introduction of HB vaccine. There are over 350 million chronic carriers of Hepatitis B at high risk from cirrhosis of the liver and liver cancer. Stopping immunization could see these numbers increase.

There have been previous experiences with other vaccines, such as Diphtheria, Tetanus, Pertussis (DTP) vaccine, where unsubstantiated hypotheses and anti-vaccine information lead to loss of public confidence and reduced coverage. Millions of cases of pertussis and hundreds of deaths followed reduced use of DTP in several countries.

WHO strongly recommends that all countries already using Hepatitis B vaccine as a routine vaccine in their national immunization programmes continue to do so, and that countries not yet using the vaccine begin as soon as possible.

For further information please contact Gregory Hartl, Health Communications and Public Relations, WHO, Geneva, telephone: (41 22) 791 4458, fax: (41 22) 791 4858. E-mail: hartlg@who.ch

All WHO Press Releases, Fact Sheets and Features can be obtained on Internet on the WHO home page http://www.who.int/
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(2)
August 12, 1998
ENGERIX-B APPROVED BY FDA FOR USE IN PATIENTS WITH HEPATITIS C

On August 12, 1998, the FDA approved a supplemental product license application of SmithKline Beecham's Engerix-B vaccine for use in patients with hepatitis C virus infection.

Engerix-B is one of two hepatitis B vaccines licensed for use in the United States. The other is Recombivax HB, which is manufactured by Merck & Co. Either vaccine is appropriate for preventing hepatitis B virus infection in groups at risk, including patients with HCV infection who have risk factors for hepatitis B virus infection. Clinicians should evaluate their patients who have hepatitis C virus infection to determine their need for hepatitis B vaccine.

For a list of who's at risk for hepatitis B virus infection, see, "Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination: recommendations of the Immunization Practices Advisory Committee (ACIP)," MMWR 1991:40;(No.RR-13).

[Editors' note: In March 1997, the National Institutes of Health (NIH) Consensus Development Conference recommended that hepatitis A and B vaccine be provided to all patients who are
infected with hepatitis C virus. To obtain a copy of the NIH Consensus Statement, "Management of Hepatitis C," call 888/644-2667.]
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(3)
October 13, 1998
HEPATITIS FOUNDATION INTERNATIONAL SCHEDULES PROGRAMS ON
HEPATITIS C VIRUS INFECTION IN FIVE MAJOR CITIES

The Hepatitis Foundation International (HFI) has scheduled 5 half-day programs in major cities to address the concerns of people who are infected with hepatitis C virus. Following is
HFI's press release announcing the programs:

HFI PRESS RELEASE: "Hepatitis C Action Alert Programs Highlight Need for Hepatitis A and B Immunization in Hepatitis C Positive Individuals"

An estimated 4 million Americans are infected with hepatitis C, a slowly progressing liver disease that can, over a period of  20 to 30 years, lead to cirrhosis or cancer of the liver.
Unfortunately, there is no vaccine to prevent it.

However, patients who have hepatitis C should be warned about the risk of exposure to both hepatitis A and B, two viral diseases that also cause an inflammation of the liver.   Co-infection with one or more of these can lead to serious, life-threatening complications.

Hepatitis A is spread through food and water contaminated with infected feces. It is frequently spread through person-to-person contact, anal or oral contact, or by eating raw shellfish harvested from contaminated waters.

Hepatitis B is transmitted primarily through unprotected sexual contact with an infected person, or sharing contaminated IV needles, or from unsterile body piercing and tattooing instruments.

Fortunately, safe and effective vaccines are available for both hepatitis A and B to prevent infection. Hepatitis C patients should ask their doctor about being immunized against both
hepatitis A and B.

For anyone interested, HFI has scheduled 5 half-day programs in major cities to address this and many other concerns of vital importance to hepatitis C positive individuals. Locations are as follows: Houston, TX on October 17th; Philadelphia, PA on October 24th; Boston, MA on October 31st; Detroit, MI on November 14th; and Tampa, FL on December 5th. Registration by mail or phone before the event is $15, and at the door it is $25. Price includes refreshments and a packet of hepatitis information. To register contact HFI at 800/891-0707 or visit their website at: http://www.HepFI.org

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