November 1999
There is little point in arguing with parents who bring in an apparently healthy baby to be immunized and find the baby dead or convulsing in the crib the next day, even though the vaccine was not the culprit.
I cannot put myself in their place, but I can only imagine their rage at themselves, their doctor, the manufacturers, the Centers for Disease Control and Prevention (CDC) and anyone else they can think of. Most of these families go through counseling to help cope with their loss. Some are drawn to antivaccine groups and others willingly tell their stories to the media, to friends and anyone else who will listen. To the parents, telling is retribution, it is unburdening. To the press it is a "story" in a competitive industry that needs "news."
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It is difficult for most people, and particularly parents such as these, to understand that the adverse event, although it followed the immunization, may not be causally related. We start infant immunization during the most hazardous time of childhood. The mortality rate is highest during the first month of life and then falls with each successive month. The high death rate during the first two months of life was observed long before hepatitis vaccine was given to newborns.
The chance of an infant dying is greater the month prior to the two-month immunization than it is during the month following this immunization. It also is about three times greater than when the six-month shot is given. There are about 3,000 cases of sudden infant death syndrome (SIDS) annually in the United States, the risk of which is greatest about the time of the two-month immunization. Some of these by chance alone are going to occur the day before a child is scheduled for immunization and some the day after a child is immunized.
There are excellent studies, however, which show that SIDS is not caused by immunization. Similarly, risk of onset of infantile spasms is greatest during the period that the initial diphtheria-tetanus-acellular pertussis (DTaP) series is given and again, there are studies which show no causal relationship.
In Denmark, the rate and age of infantile spasms are the same now as they were before routine infant immunization against pertussis was started. In my file is a photo of a baby whom I saw with the classic a salaam seizure with an EEG showing hypsarrhythmia. This child was scheduled to start immunization two days after the onset of these seizures. How would this have been interpreted if the appointment were three days earlier?
In the famous English encephalopathy study, there was an increase in cases
during the first three days after immunization. But there was a corresponding
decrease between three and 28 days later. It is likely, therefore, that the
immunization prematurely precipitated a process, which was destined to start a
short time later. This is the context in which we must interpret
a temporally associated adverse event.
Unfortunately, it is virtually impossible to prove that something will never, ever happen. The best that one can do is provide a reasonable assurance of safety based on the information available and to weigh this against the risk of doing nothing. If we have had a death from intussusception following immunization, how many deaths had we prevented from rotavirus diarrhea? This does not provide much comfort to the parents whose child died following immunization and one will never be able to identify the parents whose children did not die as a result of rotavirus diarrhea.
Considering the track records we have had with vaccines, we have done remarkably well. We have not been complacent, however. After a vaccine is licensed, one continues to carefully monitor what happens as the number of individuals immunized accrues from thousands, to millions and to hundreds of millions. An event that occurs once in one million or once in several hundred thousand doses, e.g., paralytic disease from live polio vaccine, may not be seen during the first months or even years after a vaccine is released. We have had a recent example of this system identifying the relationship between intussusception and rotavirus vaccine administration. Conversely, this surveillance of vaccine reactions has been invaluable when vaccine safety is questioned. This system has been useful in providing data to counter claims that measles-mumps-rubella vaccine causes autism or colitis or that hepatitis vaccine causes multiple sclerosis. In both cases, there does not appear to be a causal relationship.
Unfortunately, life is not totally risk free. One cannot guarantee that a vaccine will not injure some child at some time. On the other hand, what parent would have imagined that the child they send to Columbine High or the child who was sent to school on a bus in Texas would not return. We do not stop sending children to school because of these events; we cannot stop immunizing children against diseases which could kill them.
I recall a child who developed encephalitis from pertussis because the parents were afraid to give their child the vaccine. Comforting these parents is even more difficult than talking to parents whose child experienced a horrible event after receiving a vaccine. It may be possible to stop using a vaccine because the risk of the vaccine is judged greater than the risk of disease. This was the case of smallpox vaccination; it was recommended that the vaccine no longer be given. Similarly, when a safer vaccine becomes available, as with the recommendation that oral polio vaccine no longer be given, the recommendation changes. These decisions are made with great sophistication in vaccinology after long, often heated, deliberation. They are complex issues and the responsibility for outcome of these decisions is awesome.
I am a grandfather whose daughter and daughter-in-law come to me with these issues after having discussed them many times with their very intelligent, well-meaning friends. I advise that my grandchildren be immunized according to the recommendations of those who have spent much of their careers pondering the information. I do not mean to denigrate the opinions of others. Unfortunately, many do not trust "authority" for a variety of reasons. One is obligated, however, to respectfully enter into a discussion of the issues. Unfortunately for pediatric practitioners, the time spent in doing this is not billable. Nor do I believe it is fair to ask that my grandchildren attend school or preschool with children who are unprotected against a vaccine-preventable illness they might contract. Whether society believes a parent has the right to deny their child an education or protection against vaccine-preventable diseases are very complex issues.
We are fortunate that most of us do not remember children with measles, congenital rubella syndrome, diphtheria, whooping cough and other vaccine-prevented diseases. We focus now on the potential problems that might be associated with the vaccines that have made most of these diseases a memory. Unfortunately, they are not all a memory. Within our memory we have had a measles epidemic which caused over 100 deaths. It is my guess that England will again learn the consequences of not vaccinating their children this time against measles. The colitis-autism scare has reduced immunization with MMR to a low point which I believe will result in an epidemic. Previously, British mistrust of pertussis vaccine resulted in a whooping cough epidemic. The cost of this mistrust is borne by innocent children. I hope I never again have to comfort parents of a child injured by a preventable disease because their parents did not trust that the vaccine was safe. Nor, I will never have their deaths or disability on my conscience.
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