Statement on Vaccine Adverse Event Detection Methodologies

National Vaccine Information Center
Institute of Medicine Vaccine Safety Forum
November 6, 1995

I think I can sum up the position of the National Vaccine Information Center on the subject of improving methodologies for detecting vaccine adverse events in two sentences: If you don't believe they occur, you won't look for them. If you don't look for them, you won't find them.

One handout developed by the National Vaccine Program at the CDC last year suggested to inquiring parents that the biological effects of injecting viral and bacterial antigens into the human body are identical to the biological effects of ingesting milk in the human body for the purposes of calculating the risk of injury or death on any given day. It is difficult to reconcile that kind of unscientific rationalization, used to dismiss the known and unknown biological effects of vaccines on the body and support the nonexistence of vaccine injuries and deaths, with any hope of improving adverse event detection methodologies.

It is this kind of cavalier attitude which fails to treat the inherent capability of multiple viral and bacterial antigens to have a profound impact on the immune system that I suspect caused the Pentagon to inject U.S. troops heading for the Gulf War with multiple vaccines, including experimental ones, without a second thought. Yet there are signs that vaccine adverse event detection may be heading into a new era as a microbiologist specializing in the immune system prepares to testify at the Presidential Advisory Committee on Gulf War Veterans Illnesses tomorrow that multiple vaccinations did, indeed, contribute to the veterans subsequent health problems by weakening their immune systems and making them more susceptible to chemical and biological agents they were exposed to during the War.

Likewise, I believe there is hope that vaccine adverse event detection may be heading into a new era because of researchers who are investigating how vaccines may be contributing to the development of autoimmune, neurological and psychiatric disorders in some individuals. The new field of neuroimmunology will no doubt one day give us many answers to questions about how vaccines work in the body but, in the meantime, the success of detection methodologies are entirely dependent upon the willingness of those doing the detecting to believe in the plausibility of cause and effect and explore all possibilities.

So, because efficient detection is inextricably linked with acceptance of the possibility of cause and effect by both reporters and data collectors, it would seem that any efficient detection system would have to first count on a high reporting rate by private physicians, public health clinics and emergency rooms of adverse events occurring within 30 days of vaccination. Parents have to be educated by physicians about how to recognize negative changes in their children's physical, mental and emotional health following vaccination and to seek immediate medical attention as well as report these changes to doctors so doctors can, in turn, report them to VAERS. If causality continues to be erroneously determined by providers at the reporting level, there will be no way to improve detection of vaccine adverse events.

Once a death, hospitalization or injury is reported following vaccination, data collectors must also be ready to accept the possibility of cause and effect. Ideally there should be a 48-hour on-site follow-up and investigation of the report as occurs in India. If the patient is an adult, he or she should be interviewed. If the patient is a child, the parents should be interviewed. Deaths labeled SIDS, especially when they occur under a month of age, should be suspect and thoroughly investigated. A mechanism should be developed to monitor the outcome of serious events such as seizures with long term follow-up at six months, a year and two years to gather data on permanent damage.

But mechanisms for detecting adverse events which occur within 30 days of vaccination are different from those which must be set up to detect health problems which have a more subtle or delayed onset or which do not become measurable until children attend school, such as is the case with learning disabilities. This kind of detection would require the kind of retrospective evaluation of historical data that Dr. Barthelow Classen has described as well as the creation of prospective studies which include as controls unvaccinated individuals compared to vaccinated individuals over a period of 10 or 20 years. Expensive? Yes. Logistically difficult? Yes. But not impossible if we really want to find out if vaccines are contributing to the development of immune and neurological damage which does not become apparent until later in life.

An additional source of information for detection of adverse events is analysis of VAERS data. For example, between May 1993 and September 1994, 482 adverse events were reported following the administration of the newly licensed DPTH vaccine. Most were in children under a year of age and 50 percent of the reported events occurred within 24 hours and more than 80 percent within 48 hours of vaccination. 175 children ended up in the emergency room, 56 had convulsions, 78 were hospitalized, 17 did not recover and 35 died.

And when you take a closer look at individual reports, you see identifiable patterns of classic vaccine reactions similar to those described in the medical literature for decades, including babies screaming and shrieking uncontrollably for hours and hours. One infant, who had been injected with DPT, HIB, hepatitis B and OPV at six weeks old, screamed every day from the day after vaccination until he died two weeks later and his death was written off as SIDS. Another four month old baby had his first afebrile grand mal seizure within 24 hours of his DPT/HIB/OPV vaccinations just like his sibling did at five months when he was vaccinated. The same patterns are seen throughout the more than 40,000 reports made so far to VAERS — reports that represent only 10 percent of what is occurring.

This is valuable data. It could be used to not only identify patterns which need further investigation but also to help identify categories of high risk children who should be screened out of the mass vaccination program. The rush to develop and recommend for universal use multiple viral and bacterial vaccines to be given simultaneously should make the development of failsafe detection methodologies a priority in any credible mass vaccination program.