The Controversy of the Latent Period Following Immunizations

Harold E Buttram, MD

September 21, 2001

Introduction

In 1986 the U.S. Congress passed the National Childhood Vaccine Injury Act, which set up a system whereby the families of vaccine-injured children could be compensated for such injuries. Based on personal experience and observation, there has been much criticism of this system and question whether not it is serving its intended purpose. (1)

One of the major areas of controversy surrounding the act involves its limitations in the latent periods, whereby certain defined reactions following vaccines must be identified within a certain time period to qualify for compensation by the childhood vaccine injury act. For the complication of encephalitis, the time limitation for the DTP or DTaP vaccine is 3 days; for the measles- mumps- rubella (MMR) vaccine it is 5 to 15 days.

The limitations in latent periods following vaccines have been generally accepted by our medical-legal system as guidelines in other areas as well. Prominent among these is the “shaken baby syndrome” (SBS) in which a parent or caretaker is accused of injuring or murdering an infant by violent shaking and causing a triad of findings now commonly accepted as diagnostic of SBS: retinal hemorrhages, subdural hematomas, and diffuse axonal injury. (2-5)

However, it has been observed that many cases attributed to the SBS have occurred in a time-related fashion following routine childhood vaccines, especially in compromised children that had been born from medically complicated pregnancies. (6) Consequently there are valid reasons for questioning whether or not some or many cases that have been accused of SBS were not the result of mistaken diagnoses, the true causes of death or injury of the child having been vaccines.

Since questions surrounding the latent period play a prominent role in many of these cases, it is timely and appropriate to review the background of this issue.

Are Current Guidelines in the Latent Period Artifactual?

(A) The DTP (diphtheria-tetanus-pertussis) Vaccine:

If we think in terms of a vaccine-induced encephalitis, most of the earlier literature deals with the pertussis vaccine. Flexner (1930) noted a strong tendency for the nervous system manifestations to declare themselves between the 10th and 13th days. (7) In a review of 108 cases recorded before 1929 by Gorter (1933) , the onset of encephalitis was “strikingly constant,” usually observed between the 10th and 12th days following vaccination, commonly with a febrile period on the 7th and 8th days, followed by recovery until onset of the encephalitis. (8) In 1929 an editorial in the Vaccinations and Behavioral Disorders, by Greg Wilson, the author made the following comment in regards to the latent period:

“Today the latent period is rarely mentioned in connection with neurological complications of immunization…Contemporary studies on the pertussis vaccine select an arbitrary time limit in which reactions have to occur to be considered as vaccine related. This time limit is usually 3 to 7 days.

“Perhaps the only study which explores the dynamics of post DPT reactions is an independent Australian study by Karlsson and Scheibner which, with a monitor which followed breathing volumes, found particular times of stress-induced breathing following DPT injections.” (16)

“Of special importance (for stress) are days 2,5,6, and 8,11,13-16 and 18-21. (17)

By way of explanation, the above study involved the use of a Cotwatch breathing monitor controlled by a micro-processor and designed to provoke alarms with breathing delays (apnea of hypopnea with 5% or less of normal breathing patterns) following DTP immunizations. It was found in the study that these periods of stressed breathing occurred in clusters of 15 minutes at a time on the post-vaccine days listed above, varying greatly from child to child. From our point of view, the important feature of the study is not so much the specific post-vaccine days on which the stressed breathing occurred but the fact that the clusters continued for 21 days following the vaccines, (18) which would tend to discredit the current medical-legal limitation for DPT reactions to 3 days.

Dr. Scheibner’s findings do have some support in a study which showed a fairly high incidence of cardio-respiratory complications in premature infants following vaccinations. (19) Unfortunately, this study was of limited duration. Another study throwing light on the latent period is one coming from Japan, from which it was found that increased histamine sensitivity in mice, brought about by the pertussis vaccine, showed two peaks, one on the 4th day following vaccination, and a second on the 12th day. (20) In the same vein, in a letter to the What Your Doctor May Not Tell You About Children’s Vaccinations, (22) Dr. Stephanie Cave makes the following observations about VAERS: “It is common knowledge that less than 10% of all adverse events following vaccinations are reported to VAERS, which means that instead of the 12,000 to 14,000 reports of hospitalizations, injuries, and deaths made every year, there may be as many as 120,000 to 140,000.”

Even a cursory examination of the VAERS database for DTP/DTaP vaccines will reveal that the latent periods for many vaccine reactions extend into the 7 to 13 day periods, some extending beyond 14 days. (23)

No review of the latent period would be complete without pointing out an almost insuperable difficulty in getting dependable data on these reactions due to the extreme reluctance of doctors to report on vaccine reactions, a pattern which has existed since the earliest days of childhood vaccines. There are a number of reasons for this. From their earliest years of training, medical doctors have been taught to look upon vaccines as one of the greatest achievements in medical science, and any question about the vaccines is often looked upon as disloyalty to the profession. In addressing this issue in the classic text, , (34) in which researchers Andrew Wakefield and Scott Montgomery, who have been investigating a possible causal relationship between the MMR vaccine and the autism-enterocolitis syndrome, carefully reviewed deficiencies in the early pre-licensing trials of the MMR vaccine. In the article they pointed out that follow up periods following the vaccine were a maximum of 28 days and in some studies even shorter periods. They stressed that such short periods of observations following the vaccine were totally inadequate to detect delayed reactions, including pervasive developmental delay (autism), immune deficiencies, and inflammatory bowel disease, which are known from earlier published reports to occur following both the natural measles infection and the measles vaccine.

The most interesting feature of the Wakefield/Montgomery article was that it was reviewed by four leading British authorities, all of whom had previously held positions in the regulation and licensing of medicines in the United Kingdom. (35) Taken as a whole, the reviewers were supportive of the article, three highly so. Peter Fletcher, formerly a senior professional medical officer for the Department of Health wrote, “being extremely generous, evidence of safety (of the MMR vaccine) was very thin.” Noting that single vaccines for measles, mumps, and rubella already existed, he argued, “caution should have ruled the day…granting of a product license was definitely premature.” Professor Duncan Vere, former member of the Committee on the Safety of Medicines, agreed that the periods for tests were too short. “In almost every case,” he wrote, “observation periods were too short to include the onset of delayed neurological or other adverse events.”

(D) The Hepatitis B vaccine:

Other than the references provided by John Classen, M.D. on the findings of increased diabetes from the hepatitis B vaccine with a latent period of 3 years, I am not aware of additional information bearing on the latent periods between hepatitis B vaccine and other forms of reactions, which reflects the sheer lack of data on the subject.

However, many reactions to hepatitis B vaccine may be taking place unrecognized, for two reasons: Reason one, I have in my possession a list of 109 references of published articles reporting on complications from the hepatitis B vaccine including autoimmune disorders, neurological disorders, vasculitis and cutaneous reactions. This list will be provided on request.

For reason two, in 1994 a special committee of the national Academy of Sciences (Institute of Medicine) published a comprehensive review of the safety of the hepatitis B vaccine. When the committee, which carries the responsibility for determining the safety of vaccines by Congressional mandate, investigated five possible and plausible adverse effects, they were unable to come to conclusion for four of them because they found that relevant safety research had not been done.

Furthermore, they found that serious “gaps and limitations” exist in both the knowledge and infrastructure needed to study vaccine adverse events. Among the 76 types of vaccine adverse events reviewed by the IOM, the basic scientific evidence was inadequate to assess definitive vaccine causality for 50 (66%). The IOM also noted that “if research… (is) not improved, future reviews of vaccine safety will be similarly handicapped. (36) For this reason, the published reports of hepatitis B vaccine reactions may only be a small portion of those actually taking place, with large numbers of delayed reactions taking place unrecognized.

Conclusion

Based on published evidence that many vaccine reactions take place beyond current medical-legal time limits that have been established for vaccines, and on overwhelming evidence that large numbers of delayed vaccine reactions may be taking place unrecognized, there are grounds for believing that these time limitations may be unrealistic and artifactual.

References

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