Public should be told that vaccines may have long term adverse effectsBMJ 1999; 318 doi: https://doi.org/10.1136/bmj.318.7177.193 (Published 16 January 1999) Cite this as: BMJ 1999;318:193
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that present immunisation schedules may exacerbate the development of Type I diabetes and that very early immunisation with a 'cocktail' of vaccines may prevent the development of diabetes (1,2). The following provides clarification that should be helpful in understanding the issues involved. Classen and Classen cite their own unpublished reanalysis of the Finnish Haemophilus Influenzae Type b vaccine randomised controlled trial (3).
Their conclusions are at odds with the analyses and conclusions from the investigator, Dr. Jaako Tuomilehto, presented at the NIH workshop in Bethesda and independently being submitted for publication (personal communication). The review of the data by the Finnish investigators could not attribute the risk of Type 1 diabetes in Finnish children to differences in the timing of childhood vaccination in the vaccine trial. Actually, the incidence of Type 1 diabetes in Finland has risen during several decades and the risk seem to be almost linear since the early 1950s (4). Given the disparity of conclusions, it was suggested that the Classen and Classen analysis be sent to an independent statistician. Unfortunately, we are not aware that this has been done. Classen and Classen quote the aim of the NIH workshop as "to discuss our data" when in fact the title was "an evaluation of the possible role of vaccines and infectious diseases in Insulin dependent (Type 1) diabetes mellitus". Two independent reviews of available data specific to vaccines were presented by the Cochrane reviewers (5) and the Johns Hopkins Vaccine Safety Institute (6); neither found such an association and both indicated concerns over methodological issues in statistical analysis and the design and conduct of these studies. The conclusions of the workshop, presented at the U.S. Advisory Commission on Immunization Practices in June, 1998, was that existing studies in humans do not indicate an increase in Type 1 diabetes mellitus attributable to any vaccine or the timing of vaccine administration.
Readers may be interested to know that Dr. JB Classen has filed a European and US patent on his schedule that may have widespread implications should ever his views be implemented. He applies for a patent on immunisation schedules to be administered from birth (or "typically prior to 42 days of age") to reduce the likelihood of developing Type 1 diabetes mellitus, as well as protecting individuals from communicable diseases (7). One potential schedule (Annex 5 of the application (7)) refers to the administration of a 'cocktail' of DTP, Hib, Hepatitis B, MMR, Inactivated Polio vaccine and "NPI" (or non-paediatric immunogen). NPI is defined on page 114 of the application as an immunogen selected from a forty-odd group of antigens including anthrax, plague, HIV and yellow fever. The safety or efficacy of such a pediatric schedule have not been demonstrated.
If readers wish to peruse the applications, they can be obtained for a small fee
from: Search and Advisory Service The Patent office, Cardiff Road, Newport, Gwent,NP9 1RH, United Kingdom.
We agree that the public should be made aware of what is going on.
Cochrane Vaccines Field,
Division of Microbiology and Infectious Diseases,
National Institute of Health,
Bethesda MD 20892,
Diabetes and Genetic Epidemiology Unit,
National Public Health Institute,
1. Jefferson TO. Vaccines and their adverse effects - real or perceived
(editorial). BMJ 1998; 317:159-60.
2. Classen JB, Classen DC. Public should be told that vaccines may have long term adverse effects. BMJ 1999; 318: 193 (letter to the editor).
3. Eskola, J, Kayhty H, Takala AK, Peltola H, Ronnberg PR, Kela E, Pekkanen E, McVerry PH, Makela PH. A randomised prospective field trial of a conjugate vaccine in the protection of infants and young children against
invasive Haemophilus influenzae type b disease. NEJM 1990 323(20) 1381-7.
4. Tuomilehto J, Virtala E, Karvonen M, Lounamaa R, Pitkaniemi J, Reunanen A, Tuomilehto-Wolf E, Toivanen L. Increase in incidence of insulin-dependent diabetes mellitus among children in Finland. Int J Epidemiol. 1995 Oct;24(5):984-92.
5. Jefferson TO, Demicheli V. No evidence that vaccines cause insulin
dependent diabetes mellitus. Journal of Epidemiology and Community Health 1998; 52: 674-675.
6. Halsey, N and the Institute for Vaccine Safety Diabetes Workshop Panel.
Childhood Immunizations and Type 1 Diabetes: Summary of an Institute for
Vaccine Safety Workshop. Pediatric Infectious Disease Journal 1999 (in press).
7. Classen JB. Method and composition for an early vaccine to protect against
both common infectious disease and chronic immune mediated disorders or their sequelae. International Publication number WO 95/05193. World
Intellectual Property Organization; 23 February 1995.
Competing interests: No competing interests
The letter from John and David Classen has the potential to raise
concerns about the long term effects of vaccination but is grossly
misleading. There is now a considerable body of literature on the
relationship between diabetes and vaccination. While both have increased,
there is no convincing evidence to suggest that there is a causal, as
opposed to temporal,relationship.
describe a collaborative study with Professor Jaako Tuomilehto looking at
the effect of hib vaccine on the incidence of diabetes. The implication is
that this was a joint study . I do not know the details, but this was
certainly not the case. Dr John Classen presented his, as yet unpublished,
work at a seminar on March 20th 1998 in Baltimore, Maryland. He suggested
that the incidence of diabetes was lower in children who received a single
dose of Hib vaccine at 14 months than in those who received doses at 3, 4,
6 and 14 months. The workshop pannel concluded that the nalytical methods
'were incorrect'. Furthermore, data was available from Professor
Tuomilehto showing that careful follow-up over a ten year period showed
there was no difference in the incidence of diabetes between children who
had received one or four dosease of vaccine. The worksop panel examined
evidence from a number of sources and concluded that 'there is no evidence
that any vaccines have increased the risk of type 1 diabetes in animals or
Those reporting studies of the
adverse effects of vaccination, whatever their conclusions, have a duty
to present the full picture. Anything less is grossly irresponsible. We
applaud the sentiments underlying the Classens' letter, but regret that
they didn't live up to them.
David Elliman (St George's Hospital, London)
Bedford (Institute of Child Health, London)
Competing interests: No competing interests