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Polio Vaccine

Recently, polio immunization practices in Japan were temporarily stopped because of oral polio vaccine (OPV) safety concerns.1 Since 1981, no poliomyelitis cases due to wild poliovirus were reported in Japan. Currently, the national childhood immunization program recommends OPV to be given twice to children from age 3 to 90 months. During the last decade, an estimated 90% of children completed vaccination according to this recommendation. There is only one OPV manufacturer in Japan, and most of Japanese children receive its product.

In April 2000, the Fukuoka Prefectural Government received reports of a fatal case of encephalopathy and a case of acute flaccid paralysis after OPV immunization. Because both children had received OPV from the same batch before onset of their illness, the Fukuoka Government suspended mass immunization in the Prefecture, and reported these cases to the Ministry of Health and Welfare (MHW). MHW recommended suspending OPV vaccination for all 47 prefectures and requested active surveillance for adverse events after OPV. Concurrently, MHW also dispatched an investigation team to Fukuoka Prefecture.

Case 1:

On 15 Apr 2000, a 38-month-old girl presented to her pediatrician with fatigue. Subsequently, she developed acute respiratory distress followed by cardiac arrest and coma; the patient remained afebrile. On 24 April, the girl died. Polio-vaccine virus type 3 was isolated from a stool specimen, and nucleotide sequencing of VP was identical to the Sabin strain used in the vaccine.

After reviewing the patient's case, the investigation team concluded that her clinical course is not compatible with neither acute flaccid paralysis or bulbar or bulbospinal poliomyelitis. The etiology of this case remains unknown.

Case 2:

23 days after his second dose of OPV, a 13-month-old boy presented with a fever of 39C and right gait disturbance. Subsequently, he developed typical acute flaccid paralysis. Stool specimens tested negative for poliovirus so far; test results for other enteroviruses are pending. The team concluded that this boy had a possible case of vaccine associated polio paralysis (VAPP).

Case 3:

As a result of active case finding, MHW received an additional report of a case of adult AFP from the Miyazaki Prefectural Government: On 17 May, a 37-year-old male had presented with a fever of 38.9C and subsequently developed left lower limb paralysis on 20 May. On 23 May, the patient was quadriplegic but recovered gradually. Poliovirus identical to the Sabin 3 strain was isolated from stool specimens and a throat swab. On April 26, his 10-month-old daughter had received OPV. The patient was diagnosed having vaccine-related spinal poliomyelitis. His immunization history is currently under investigation.

During the active surveillance, MHW received 10 more reports of adverse events after OPV, but a relation with OPV in all these cases appeared to beunlikely.

MHW's records and subsequently the National Adverse Reaction Reporting System (NARRS) from 1977 until 1996 indicate that vaccine-associated polio paralysis (VAPP) occurs in one of 4.4 million vaccinees and secondary VAPP is observed one per 5.8 million doses distributed. During the same period, about 3.0 to 4.1 million doses of OPV were produced annually. Reporting rates of NARRS are considerably lower than those from other industrialized countries.

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Pneumococcal Pneumonia Vaccine

On February 17, 2000, The FDA cleared a new pneumococcal pneumonia vaccine with questionable safety, and a US government advisory panel is reported a plan to selectively target African-American and Native American children for immunization. This plan was criticized for making children of racial minorities "human guinea pigs". It is possible that 1% or more of the children who receive the vaccine may develop insulin dependent diabetes or another autoimmune disease from the vaccine.2

The CDC's Advisory Committee on Immunization Practices recommended that children under 2 receive the new pneumococcal vaccine, asking that black and Native American children age 2-5 be selectively targeted for immunization. This policy came under criticism because the vaccine had not been properly tested for safety and the FDA had been told by an expert that the vaccine might cause autoimmune disease.

The controversial vaccine was the conjugated 7-valent pneumococcal vaccine, which is a combination of 7 different vaccines, each to a separate strain of pneumococcal pneumonia bacteria. The vaccine is similar in structure to the already marketed hemophilus meningitis vaccine, which has been linked to insulin dependent diabetes.3

Dr. Classen told the FDA that the 7 valent pneumococcal vaccine could be 7 times as toxic as the hemophilus vaccine, possibly causing an estimated 400 to 700 children to develop insulin dependent diabetes per100,000 children immunized. These cases of diabetes may not occur until 3.5 to 10 years following immunization.

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Hemophilus Meningitis Vaccine

Dr. J. Bart Classen, an immunologist at Classen Immunotherapies 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 vaccine was incriminated in causing over 58 cases of insulin dependent diabetes per 100,000 children immunized in Finland.4,5

Classen also presented data at the International Public Conference on Vaccination which showed that vaccines are the largest cause of insulin dependent diabetes in children. His data indicated that vaccines cause approximately 80% of cases of insulin dependent diabetes in children who have received multiple vaccines starting after 2 month of life.

Dr. Classen presented data supporting a causal relationship between many different vaccines and the development of insulin diabetes. His data included the pertussis, mumps, rubella, hepatitis B, hemophilus influenza and others. The data indicated people with vaccine induced diabetes may not develop the disease until 4 or more years after receiving a vaccine.

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, see the Vaccine Safety Website.

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  1. A ProMED-mail post from Takahashi, Hiroshi, MD (, archived by Medscape at Oral polio vaccination, adverse events - Japan; ProMED 15 June 2000; Vol. 2000, No. 140.

  2. From: Agnes Cushing ; To: List; Date: Monday, March 13, 2000 6:22 AM; Subject: [secretin-discussion] Pneumonia Vaccine radio show; Bart Classen. New "Tuskegee-Like Experiment" Planned with Pneumococcal Pneumonia Vaccine, Reported by Classen Immunotherapies, Baltimore, Feb. 18, 2000. PRNewswire.

  3. Classen JB. Hemophilus meningitis vaccine and meningitis. BMJ 1999; 319: 1133.

  4. Classen JB. Hemophilus meningitis vaccine and meningitis. BMJ 1999; 319: 1133.

  5. Vaccine Safety Website.

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Program Director, Continuum Center for Health and Healing,
Beth Israel Hospital / Albert Einstein School of Medicine

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