Vaccine Safety Tests: What Are They? Why Do We Need Them? Why Are They Not Being Done?

As Related to Current Epidemics of Childhood Autism and Learning Disabilities

Introduction

At the present time Americans and their children are in the midst of an epidemic of chronic disease and disability. The Centers for Disease Control admits that 1 American child in 166 has been diagnosed with autism spectrum disorder. (1) In 1970, autism affected 4 in 10,000 children. (2) By 1991, 5,000 autistic children were in the public school system; by 2001, that number had grown to 94,000. (3)
Today, the CDC reports that 9 million American children under 18 have been diagnosed with asthma, (4) whereas in 1979 asthma affected approximately 2 million children under age 14. (5)
Today, nearly 3 million children in public schools are classified as learning-disabled,compared with 796,000 in 1976. (6) Comparable increases have been taking place in the attention deficit hyperactive disorder (ADHD) with 4 million children between ages 3 and 17 nowdiagnosed with this condition.
(7-8)
In spite of the work of medical pioneers such as AJ Wakefield (9) and VK Singh (10), the Institute of Medicine (IOM) and Centers for Disease Control (CDC) continue to deny a causal relationship between the current epidemics of childhood diseases and immunizations, stating that such a relationship has never been proven. It is the purpose of this paper to demonstrate that their positions on this issue are untenable.

What Constitutes Scientific Proof?

Since the issue before us is that of scientific proof, what would constitute proof of safety for vaccines? Generally speaking, as established by customary practices in licensing of pharmaceutical medications, there would need to be sufficient numbers of test subjects (in this case children receiving immunizations) compared with sufficient numbers of non-immunized children serving as controls, with surveillance periods continued for sufficient periods of time (months or years) to be meaningful. In addition there would need to be a separate category of before-and-after tests specifically designed to screen for adverse effects to the neurological, immunologic, and hematological systems of the body. Finally, both surveillance and before-and-after categories would need to be performed in several separate medical centers to assure reproducibility. Any pharmaceutical agent, having passed all of these safety requirements, could then be considered reasonably safe by current standards of scientific proof.
Based on many years of observation, there have never been any studies meeting these safety criteria for any vaccine in use today. As one example, pre-licensing surveillance periods have been limited to short periods only: several days to several weeks. There are no long-term (months or years) safety studies on any childhood vaccine in use today. Consequently there are legitimate grounds for suspecting that many vaccine reactions are taking place unrecognized as to their true nature. All we have are epidemiologic studies, which are indicators but not proof in and of themselves, and a few limited before-and-after studies, most of which have never been repeated.

Before-and-After Tests: The Missing Link in Vaccine Safety

The relatively few examples of before-and-after testing of vaccines that have been garnered through the years are too small and limited to approach proof one way or the other, but these few are far from reassuring about the safety of current vaccine programs. A few examples are provided below:

• From Germany: Eibl et al (1984) reported a study which involved the testing of T-lymphocyte subpopulations (white blood cells which help govern the immune system) in 11 healthy adults before-and-after routine tetanus booster immunizations. (11) The results showed a significant though temporary drop in T-helper lymphocytes. Special concern rests in the fact that in 4 of the subjects the T-helper lymphocytes dropped to levels found in active AIDS patients.
• From Japan: S Nouno et al (1990) did before-and-after testing of 61 children with epilepsy or a history of febrile seizures which showed significant increases in “epileptic spikes” on electroencephalograms following DTP, DT, or BCG vaccines. (12)
• As reported from Russia in Mediators Inflammation (2003), a study was undertaken to analyze the immune responses of live attenuated Rubella vaccine in eighteen school girls ages 11 to 13 years by collecting blood before immunization and again at 7 and 30 days after immunization to test whether or not there would be immune suppression. (13) Subclasses of lymphocytes were tested before and after vaccine. Also plasma samples were tested for cytokines (cellular messengers) including interleukins (IL) 4 and 10, tumor necrosis factor, and gamma- interferon (all pro-inflammatory messengers). It was found that certain lymphocyte subsets were decreased and that IL 10 and tumor necrosis factor were markedly increased following Rubella vaccine. The study concluded: “Our data indicate that the vaccination with live attenuated rubella vaccine results in moderate but sustained immune disturbance. The signs of immuno-suppression, including defective lymphocyte response to mitogens and cytokine production, may persist for at least a month following vaccination.”
• From Johns Hopkins University, F Imani and KE Kehoe (2001) demonstrated that infection of human B cells with rhinovirus or measles virus could lead to the initial steps of IgE class switching. Since many viral vaccines are live viruses, the authors speculated that live virus vaccines may also induce (genetic) IgE class switching in human B cells. To examine this possibility, the authors selected the commonly used live attenuated measles mumps rubella (MMR) vaccine, in which they demonstrated that infection of a human IgM B cell line with MMR resulted in an increase in the expression of (allergy inducing) IgE. (14)
• From the United Kingdom (15), Texas (16), and Australia, (17-18) preterm infants in hospital settings were administered DPT (Diptheria/Pertussis/Tetanus) and/or Hib (Hemophilus influenzae) vaccines and monitored for episodes of apnea and bardycardia. In each study the results were compared with unimmunized infants serving as controls. Each study showed significant increases in apnea and bradycardia following immunizations in preterm infants as compared with controls. In some instances oxygen desaturation required supplemental oxygen, leading to the conclusion that vaccine-related cardio-respiratory events are relatively common following immunizations in preterm babies. Similar studies from Switzerland using the acellular DPaT vaccine, Hib, inactivated polio virus (IPV), and Hepatitis B vaccine in preterm infants showed comparable incidences of apnea and bradycardia as with the whole-cell pertussis vaccine. (19). A report from the united Kingdom in 1999 cited four infants with apnea severe enough to warrant full resuscitation measures following DPT and Hib vaccines. (20)

Vaccine Safety Tests: Why Do We Need Them?

As reviewed in the introduction, we are witnessing a very rapid increase in patterns of childhood illnesses and disabilities, and the end is not yet in sight. The IOM and CDC acknowledge that we have a major epidemic of childhood autism and other forms of disabilities. They do not claim to know the causes, and yet for all intents and purposes they deny the possibility that childhood immunizations in their present forms and schedules could be contributing to this adverse health trend. Given a record of inadequate safety testing, their positions on this issue are indefensible.
In our opinion there is no issue of greater urgency to our society than finding and reversing the causes of this adverse childhood health trend. If, as many are coming to suspect, the cause will in large measure be traced to current child vaccine programs, then with thegreatest possible dispatch, safer methods of immunization should be sought.
In this regard, until more is known about vaccine safety issues, at a recent conference sponsored by the Autism Research Institute, (headquarters in San Diego, California), one of the speakers offered the following safety guidelines for childhood immunizations:

• “DO NOT GIVE VACCINES TO ILL CHILDREN,” (Even if just a common cold)
• “SEPARATE VACCINES IN TIME”
• “USE THIMEROSAL FREE VACCINES” (Thimerosal consists of approximately 50% ethyl mercury, an organic form of mercury)
• “SEPARATE M,M, AND R (Measles-Mumps-Rubella) WHEN AVAILABLE”
• “GIVE VITAMIN C AND VITAMIN A BEFORE VACCINES.” (21)

(COMMENT: Undoubtedly other safety measures can and should be added to this list, but these are the ones that have been publicly offered to date).

Examples of Deficiencies in Vaccine Safety Testing

As one example of deficiencies, A Peter Fletcher, MB, BS, PhD, former member of the United Kingdom health agency responsible for licensing new drugs, wrote the following concerning the short prelicensing testings of the MMR (Measles-Mumps-Rubella) vaccine:
“Being extremely generous, evidence on safety was very thin; being realistic there were too few patients being followed-up for insufficient time. Three weeks is not enough…neither is 4 weeks… Caution should have been demanded and strong encouragement should have been given to conduct a 12-month observational study on 10-15,000 patients and a prospective monitoring programme set up with a computerized primary care database. The granting of a Product License was premature.” (22)
With regard to the critically important before-and-after safety tests, we will make just one comment. Among the 10 references listed above for before-and-after tests, 8 were from foreign medical centers and laboratories, only 2 from the U.S.A. Should it no be the other way around?

Vaccine Safety Tests: Why Are They Not Being Done?

If more people would ask this question, then we could see a genuine beginning of accomplishments in this field.

Summary and Conclusions

In our opinion, the missing link in today’s childhood vaccine programs is that of credible, systematic safety testing designed to disclose as yet unrecognized adverse vaccine reactions, and in finding these adverse effects, to seek safer methods of immunizations. Failures to do this in all probability have contributed to today’s increasing pattern of childhood illnesses and disabilities.

References

1. American Academy of Pediatrics, Autism A.L.A.R.M., January, 2004.
2. U.S. Department of Education, National Center for Education Statistics, Digest of Education Statistics (2002).
3. B.Bloom et al, Summary Health Statistics for U.S. Children: National Health Interview survey, 2001,” National Center for Health Statistics, Vital and Health Statistics Series 10, No. 216 (November 2003).
4. DM Mannino et al, Surveillance for asthma: United States, 1960-1995, Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, April, 1998, 47 (no. SS-1).
5. See note 3
6. See note 4
7. The above references and related information came from an article by Barbara Loe Fisher, “In the Wake of Vaccines,” Mothering Magazine, September-October, 2004.
8. Bradstreet JJ, El Dahr J, Anthony A, Wakefield AJ, Detection of measles virus genomic RNA in cerebrospinal fluid of three children with regressive autism: a report of three cases, J Assoc Amer Physic Surg, Summer, 2004, 9(1):38-47.
9. Singh VK, Rivas WH, Prevalence of serum antibodies to caudate nucleus in autistic children, Neuroscience Letters, 2004; 355:53-56.
10. Eibl M et al, Abnormal T-lymphocyte subpopulations in healthy subjects after tetanus booster immunization (letter) NEJM, 1984; 310(3):198-199.
11. Nouno S et al, Adverse effect on EEG and clinical condition after immunizing children with convulsive disorder, Acta Paediatr Japan, Aug., 1990; 32(4):357-360.
12. Pukalsky AL et al, Cytokine profile after rubella vaccine inoculation: evidence of immunosuppressive effect of vaccination, Mediators of inflamm., August, 2003; 12(4):203-207.
13. Imani F, Kehoe KE, Infection of human B lymphocytes with MMR vaccine induces IgE class switching, Clinical Immunology, Sept., 2001; 100(3):355-361.
14. Sen S, Togawa K, Yamatogi Y et al, Adverse events following vaccination in premature infants, Acta Paediatr, 2001; 90:916-920.
15. Sanchez PJ, Laptook AR, Fisher L et al, Apnea after immunization of preterm infants, J Pediatr, 1997; 130(5):746-751.
16. Botham SJ, Isaacs D, Henderson-Smart DJ, Incidence of apnoea and bradycardia in preterm infants following DTP immunization: a prospective study, J Paediatr Child Health, 1997; 33(5):418-421.
17. Botham SJ, Isaacs, C, Incidence of apnoea and bradycardia in preterm infants following triple antigen immunization, J Paediatr Child Health, 1994; 33(5):418-421.
18. Schulzke S, Fahnenstich H, Apnea and bradycardia in preterm infants following routine immunization including acellular Pertussis-containing vaccines
19. Slack MH, Schapira D, severe apnoeas following immunization in premature infants, Arch Diseases child Fetal Neonatal Ed, 1999; 81(1): F67-F68.
20. “Vaccine Safety Issues,” Stephanie F Cave, MD, presented during the “Spring DAN Conference, Washington DC, sponsored by Autism Research Institute, 4182 Adams Avenue, San Diego, CA 92116.
21. Referee 1, Measles, mumps, rubella vaccine: through a glass darkly by AJ Wakefield and Scott M Montgomery, Adverse Drug React Toxicol Rev, 2000; 19(3) 1-2, Oxford University Press (Article contains reports from 4 referees commenting on article by Wakefield and Montgomery, one referee being A Peter Fletcher).