Comment on IOM Study Designs for the Safety Evaluation of Different Childhoood Immunization Schedules
The Committee on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule has commissioned a discussion paper from a consultant, Martin Kulldorff, Ph.D., titled, Study Designs for the Safety Evaluation of Different Childhood Immunization Schedules. This paper will be available on the project’s website on May 14th. We will be inviting comments and reactions to the paper to inform the committee discussion. The comment period will be open from May 14th until May 31st, 2012, and can be accessed on
from the document:
"To date, much of the debate on vaccine safety in the context of autism has focused on the safety of individual vaccines, the adjuvants used (e.g. mercury, aluminum) etc. The childhood vaccine schedule currently followed by the CDC requires that vaccinations start at birth and calls for ~48 doses of 14 vaccines prior to the age of six. Some people believe that the rate of increase in autism is directly correlated to the vaccine schedule, and changes made in this schedule over the last few decades. In other words, some people believe that the autism epidemic is caused by the vaccine SCHEDULE and the neuro-immunological consequences of giving many vaccines at once, with the first one given at birth. Their contention is that the current vaccine schedule has not been adequately evaluated for risks due to the age at which vaccines are given, the effect of giving several vaccines at once etc.
To understand whether this is true or not, the vaccine schedules as well as vaccine-vaccine interactions will have to be studied. The IOM is inviting public comment on a study on the safety of various vaccine schedules through May 31st."
"Most post-marketing studies evaluate the general question as to whether or not a vaccine causes an adverse event among the majority of children receiving the vaccine. Very few post-marketing studies have evaluated whether the risk of adverse events depends on the scheduling of the vaccines. For example, very few post-marketing studies have evaluated whether the risk of adverse events depends on the age at which a vaccine is given; on the relative timing of two different vaccines; or on a combined cumulative effect generated by the timing of dozens of different vaccines."