The following is a summary of Classen Immunotherapies' efforts to prove the correlation between infant vaccination and the development of type 1 diabetes, as reported in professional scientific journals.

April 1996

A study conducted by Classen Immunotherapies found that type 1 diabetes may be linked to the timing of child immunization.

In a study published in the April 1996 issue of Diabetologia, J. Barthelow Classen, MD, an immunologist and president of Classen Immunotherapies, found that giving children a single dose of tuberculosis vaccine at birth reduced the incidence of type 1 diabetes by 25 percent. Conversely, earlier Classen studies indicate that immunization eight weeks after birth can significantly increase the risk of type 1 diabetes.

According to Classen, the reason vaccination timing has such a strong correlatation to diabetes may be because of interferon, which vaccines use to kill viruses. Classen says that a virus may be at the root of some incidence of diabetes. If that is true, the interferon in vaccines may kill those viruses when administered at birth because the body does not naturally produce any at that time. However, Classen speculates, if the interferon is introduced later, after the body has started manufacturing interferon for itself, it may cause autoimmune diseases such as diabetes.

The study re-used data from a Swedish study which followed 400,000 immunized and non-immunized children for 12 years.

June 1996

Research conducted by J. Barthelow Classen,MD, indicates the timing of vaccination schedules for children may have an effect on the rate of type 1 diabetes-sometimes causing the vaccine to do more harm than good.

"Up to 50 percent of all type 1 diabetes could be avoided," Classen said.

Most public health officials say Classen's research is not developed enough.

"Vaccination and childhood diabetes are so important, any correlation needs to be investigated," said Philip Russell, professor of international health at Johns Hopkins University and former commander of the Army Research and Development Command.

Russell was instrumental in organizing a conference in January 1996 where Classen presented his findings to representatives from the NIH, the FDA and the CDC. Public health officials at the conference called Classen's research "intriguing" and told him to continue developing his theory.

In a Classen study, published in the May 1996 issue of the New Zealand Medical Journal, the incidence of type 1 diabetes rose by 60 percent in New Zealand when a massive Hepatitis B immunization program was started. The vaccine was delivered to children six weeks and older.

There is no federal law requiring when or even if vaccines are given. However, the Centers for Disease Control recommend timing schedules for each. Most states, in turn, require these schedules to be met before a child can enter school.

December 1997

Using epidemiological and statistical models developed at LDS Hospital in Salt Lake City, Utah, David and Bart Classen of Classen Immunotherapies compiled and compared data on type 1 diabetes from European countries. They found supporting evidence that children immunized for tuberculosis at birth (BCG vaccine) had their chance of developing type 1 diabetes by age 15 reduced by 33 percent. Analysis also showed an increased risk of developing type 1 diabetes associated with administering the BCG vaccine at school age.

The researchers also found evidence that the risk of developing type 1 diabetes was higher when the hepatitis B and hemophilus B vaccines were administered after children were two months old.

These results, published in the October 1997 issue of Infectious Diseases in Clinical Practices, support previous findings from animal studies (Autoimmunity, 1996, 24:137-145) that found an association between immunizing rodents at birth with common pediatric vaccines and a decreased risk of type 1 diabetes.

"Based on our epidemiological data and previous animal studies, there appears to be a very tight window in which conditions are ideal to administer the first dose of common vaccinations," says David Classen. "The next step is to verify this hypothesis with a large clinical trial involving humans, either in the United States or abroad."

December 1999

"We found that neither Hemophilus influenza type B [HiB] nor hepatitis B virus (HBV) vaccination increased the risk of diabetes."

With this statement, the Centers for Disease Control and Prevention (CDC) hopes to put to rest any controversy suggesting that these childhood vaccines can lead to autoimmune diseases such as type 1 diabetes.

CDC researchers, using diabetes case registries, matched three controls to each of the 140 identified cases of type 1 diabetes. They discovered that HBV vaccination was associated with a decreased, rather than increased, risk of diabetes.

"Moreover, risk did not vary by timing of HBV vaccination," says Frank Destefano of the CDC.