FDA Told Pneumococcal Vaccine Likely to Cause Epidemic of Diabetes

Monday November 8, 1999, 9:58 am Eastern Time
Company Press Release
SOURCE: Classen Immunotherapies, Inc.


BALTIMORE, Nov. 8 /PRNewswire/ -- At last Friday's meeting of the FDA's Vaccines and Related Biological Products Advisory Committee meeting the committee heard testimony that the conjugated 7-valent pneumococcal vaccine was
likely to cause a large epidemic of diabetes. The committee was meeting to discuss whether to recommend approval of a new conjugated pneumococcal vaccine intended for preventing meningitis and other infections in children. The vaccine is similar in structure to conjugated vaccines to prevent hemophilus meningitis which have been widely used for 10 years and have been linked to large rises in insulin dependent diabetes. The difference is the 7-valent vaccine is composed of 7 different vaccines, each to a separate strain of pneumococcus, so its toxicity may be 7 times as great as the currently marketed hemophilus vaccines.

Dr. J. Bart Classen, an immunologist at Classen Immunotherapies, presented to the committee his recently published data in the British Medical Journal (BMJ 1999;319:1133) supporting a causal relationship between the hemophilus vaccine and the development of insulin dependent diabetes. The BMJ study looked at the rate of diabetes in children receiving 4 or 1 dose of a weak, early generation, hemophilus vaccine and compared this to the rate in children who received no vaccine. The children were followed for 10 years. In the group receiving 4 doses of vaccine the rate of diabetes was elevated by 26% after 7 years compared to children receiving 0 doses. There were an extra 58 cases of insulin dependent diabetes per 100,000 children immunized in the group receiving 4 doses of vaccine compared to children receiving 0 doses. The data is
particularly disturbing because it indicates the potential risks of the vaccine exceeds the potential benefit. Immunization against hemophilus is expected to prevent 7 deaths and 7 to 26 cases of severe disability per 100,000 children immunized in Finland.

Committee members were told that based on the rates of diabetes seen in Finland following the hemophilus vaccine that the pneumococcal vaccine could cause a major epidemic of diabetes. Taking into account both the rate of rise of diabetes in Finland and the larger population in the US, the early hemophilus vaccine would be expected to cause 2,300 cases of
diabetes a year in the US. However, the newer more potent hemophilus vaccines are expected to cause up to 4,000 cases of diabetes in the US.

Since the 7-valent pneumococcal vaccine contains 7 separate vaccines each similar to the hemophilus vaccine the pneumococcal vaccine may cause 28,000 cases of insulin dependent diabetes in the US each year. As with the hemophilus vaccine the risks with the conjugated pneumococcal vaccine are expected to exceed the benefit.

The FDA was also told that they should delay approval of the vaccine until methods were developed to give the vaccine without inducing diabetes. One such method being considered is early immunization.  Several studies have indicated that starting immunization in the first month of life may have the opposite effect and may actually prevent diabetes. Classen's work published in this month's Diabetes Care (Diabetes Care 22 (10): 1760, 1999) explains how early immunization may
prevent diabetes.

Dr. Classen's research has been published in numerous journals and featured in national news reports. For the latest information on the effects of vaccines on insulin dependent diabetes and other autoimmune diseases visit the Vaccine Safety Website (http://vaccines.net).

Classen Immunotherapies, Inc.
6517 Montrose Avenue
Baltimore, MD  21212  U.S.A.
Tel: (410) 377-4549
Fax: (410) 377-8526
Classen@vaccines.net
http://vaccines.net
SOURCE: Classen Immunotherapies, Inc.