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Title: UK Approves Neis-Vac-C Meningococcal Vaccine For Individuals One Year And Older
URL: http://www.pslgroup.com/dg/1DA042.htm
Doctor's Guide
July 19, 2000


DEERFIELD, IL and LONDON, UK -- July 19, 2000 -- Baxter's Hyland Immuno business announced that the United Kingdom (U.K.) Medicines Control Agency has granted market authorization for NeisVac-C, a group C meningococcal conjugate vaccine. The vaccine is indicated, in individuals one year of age and older, for the prevention of group C meningococcal infection, which is a leading cause of meningitis.

NeisVac-C is one of a new generation of "conjugate" vaccines in which the body's immune system elicits a stronger, longer lasting antibody response across a wider age range than non-conjugate vaccines. The end result is a higher level of protection against infectious diseases. This long-term protection in children enables conjugate vaccines, such as NeisVac-C, to be used in routine child immunization programs.

The populations at risk from meningitis span all age categories from infants to adults. In Europe and North America, group C meningococcus is a leading cause of meningococcal infection, frequently resulting in permanent brain damage and death. In the United States, meningococcal C infections occur at an estimated rate of one to three cases out of 100,000 people each year -- primarily children and young adults -- with a fatality rate of approximately 15 percent.

"NeisVac-C vaccine performed very well in our clinical studies, eliciting higher antibody levels for all age ranges. In addition, clinical trial results of NeisVac-C suggest that this vaccine may be able to provide protection in infants under 12 months after one or two doses," said Dr. Peter Richmond, MRCP, FRACP, who served as principal investigator for the clinical studies of NeisVac-C, and currently serves as senior lecturer at the University of Western Australia Department of Pediatrics, Princess MargaretHospital for Children in Australia.

The Public Health Laboratory Service of the U.K. has received reports of more than 1,000 cases of meningococcal meningitis annually since 1991, with 2,882 in England and Wales for the 1998/1999 reporting period. Group C meningococci account for 35 to 40 percent of all cases and have caused an estimated 150 deaths in the 1998/1999 reporting period, more than half of all meningococcal related deaths. The number of reported cases of meningococcal disease in U.K. teenagers has doubled since 1994. In the fall of 1999, the U.K. Department of Health initiated a vaccination campaign whereby all individuals under 18 years of age will be vaccinated with group C meningococcal conjugate vaccines before the end of 2000. The National Health Service in the U.K. will soon begin distributing three million doses of NeisVac-C vaccine as part of its ongoing vaccination campaign to prevent group C meningococcal infections.

"We are delighted to support the efforts of the National Health Service and the Department of Health in the U.K. NeisVac-C vaccine should provide excellent long-term protection for millions of people, greatly reducing their risk of contracting this potentially lethal infection," said Thomas Glanzmann, president of Baxter's Hyland Immuno business.

Similar vaccination campaigns may be initiated within the next few years throughout most of Europe and the United States following regulatory approval of group C meningococcal conjugate vaccines. Baxter is pursuing regulatory approval for NeisVac-C vaccine throughout the rest of Europe and in the United States.

The U.K. National Health Service will soon request bids from manufacturers of group C meningococcal conjugate vaccines for 2001 immunization schedules. It is estimated that the worldwide market for group C meningococcal vaccines will reach US$600 million per year.

North American Vaccine, U.K. Ltd. submitted its application for market authorization of NeisVac-C in the U.K. last year. NeisVac-C will initially appear in the U.K. labeled from North American Vaccine. Baxter completed its acquisition of North American Vaccine, Inc. in late June 2000.

Related links: Baxter.

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