New IOM Report on Vaccine Adverse Effects Shows Alarming Lack of Good Science
SafeMinds notes: Parents should still be concerned.

August 25, 2011 Washington DC. The Institute of Medicine's Panel on Adverse Effects of Vaccines issued a report today on the evidence and causality of vaccine harms. Despite a glowing press release, the report does little to allay public concerns over adverse effects of vaccines and suggests that we urgently need more science on vaccine adverse effects.

The IOM report took two years to produce, mostly behind closed doors, and was paid for by the Department of Health and Human Services, the government agency which is also a defendant against the vaccine-injured in the government's vaccine court.


The report investigated 158 potential adverse outcomes from vaccines. Of these, 135 or 85% were found to have inadequate research to accept or reject a causal association. Of the 23 outcomes where the research was deemed adequate, 18 or 78% were found supportive of harm. Vaccines were cleared of safety concerns for just five of the outcomes considered. "These statistics are hardly reassuring to parents who are now asked to give their young children over 32 vaccinations," noted Sallie Bernard, President of SafeMinds.


The report found likely causality of immune dysfunction, seizures and encephalopathy from some vaccines. These conditions are often found in individuals with autism. "It is plausible that a subset of children became autistic because of these adverse events from their vaccines. There are many cases of autism compensated by the vaccine court after having one of these conditions," noted Lyn Redwood, RN, Director of SafeMinds. Details of a recent review of compensated cases are available here.

Due to a narrow set of objectives defined for the IOM by the government, the report only looked at a small set of published research studies linking just two vaccines to developmental disorders such as autism. Only four epidemiological studies were considered of sufficient quality to evaluate the MMR vaccine in relation to autism and no studies were deemed of sufficient quality for the DtaP vaccine and autism analysis. The committee did not attempt to evaluate six other vaccines for autism causation, the safety of the cumulative vaccine schedule and health outcomes like autism, or the safety of vaccine ingredients like mercury and aluminum in the context of chemical exposures from other sources like air pollution or consumer products. A SafeMinds review of the epidemiological studies on MMR and thimerosal and autism is available here

That 85% of even a small subset of health outcomes has inadequate science speaks of the critical need for more research on vaccine safety. SafeMinds calls on Congress and the Administration to institute a rigorous science program on vaccine safety. This program would include the establishment of an independent Vaccine Safety Agency (similar to the National Transportation Safety Board), the launch of a study comparing health outcomes between vaccinated and unvaccinated children, the inclusion of vaccines as an exposure variable in the National Children's Study and mandatory reporting by physicians to the Vaccine Adverse Event Reporting System.


The Coalition for SafeMinds is a 501C-3 organization dedicated to restoring health and protecting future generations by eradicating the devastation of neurological disorders induced by mercury and other toxicants.

Background Information

Bibliography of science on vaccine adverse events - the additions SafeMinds sent in on December 31, 2010 to add to the existing IOM bibliography for the Vaccine Safety Review Committee to consider in its private deliberations.

HRSA announcement setting up the IOM committee.

HRSA's charge to the committee.

SafeMinds comments to committee in April 2009.

SafeMinds Comments Sent Via E-mail 4/2009 from Theresa Wrangham and Sallie Bernard