SIDS, VACCINES AND VAERS: A FOLLOW-UP

By RFD Columnist, F. Edward Yazbak, MD, FAAP

TL Autism Research
Falmouth, Massachusetts
E-mail: TLAutStudy@aol.com

Sudden Infant Death Syndrome in VAERS: A Review, published on September 22, 2003 at the redflagsdaily.com Online Conference on Vaccines, raised many questions. One of them was whether the cases of Sudden Infant Death Syndrome (SIDS) under the age of 1 month, which were reported to the Vaccine Adverse Event Reporting System (VAERS), could have been related to the Hepatitis B vaccination, which was administered alone to the infants shortly after birth.

Private physicians, parents or the officials of the immunization programs in the local state health departments must have felt strongly enough about the cases to report them to VAERS, in spite of a Medical Examiner’s diagnosis of SIDS, which by definition means that the death was both sudden and unexplained.

Some of the reported deaths were clearly neither unexplained nor sudden, and the majority of SIDS deaths were never reported to VAERS. The Centers for Disease Control and Prevention (CDC) estimated that there were some 5400 SIDS deaths in 1990 and 2,523 in 2000. Only 916 reports of SIDS were filed with VAERS between 1990 and 2002, a mean of 80 cases per year.

A commentary by Sandy Mintz "The CDC should appropriately prove its claim that SIDS is not linked to vaccines," which was published shortly thereafter at the online conference [P4F2] raised very valid points and called for further focused studies by the CDC. A week later, David Foster wrote: "Is This What The Institute Of Medicine Calls A Vaccine Safety Review?" [P6], in which he vividly reported what he believed really happened at the Institute of Medicine’s Vaccine Safety Review Session "Potential Role of Vaccination in Sudden Unexplained Death in Infancy," held in October 2002. The CDC often uses the report of that particular session to support its contention that a Vaccine-SIDS connection does not exist. For the benefit of the readers who did not see the full report, the press release / summary is reproduced in its entirety at the end of this presentation. Its irrelevance should be evident after one becomes aware of the findings of this investigation and David Foster’s observations.

Concerning neonatal deaths following Hepatitis B vaccination, it is only fair to mention a 1999 report by Drs. Niu, Salive and Ellenburg titled "Neonatal Deaths After Hepatitis B Vaccine, The Vaccine Adverse Event Reporting System, 1991-1998.

(Arch Pediatr Adolesc Med. 1999;153:1279-1282).

Manette T. Niu, MD is associated with the Division of Biostatistics and Epidemiology, Center for Biologic Evaluation and Research, Food and Drug Administration (FDA).

The purpose of the study was to evaluate reports to VAERS of neonatal deaths (aged 0-28 days) after hepatitis B vaccination from January 1, 1991, through October 5, 1998. There were 1771 neonatal reports in all and 18 deaths, divided about equally by gender (8 boys, 9 girls and one case where the sex of the infant was not reported). The median time from vaccination to onset of symptoms was 2 days. Obviously, the median time from symptoms to death was 0 days. The mean birth weight was just above 3 kg (6lb 6oz). In 17 cases, autopsies were performed. The cause of death was SIDS in 12 (66.7%) of those cases and infection in 3 (16.7%). Of the remaining 3 (16.7%), 1 infant was thought to have died because of an intracerebral hemorrhage; another had a congenital heart disease; and in one infant the cause of death was listed as suffocation.

The authors concluded: "Few neonatal deaths following HepB vaccination have been reported despite the use of at least 86 million doses of pediatric vaccine given in the United States, since 1991. While the limitations of passive surveillance systems do not permit definitive inference, these data suggest that HepB immunization is not causing a clear increase in neonatal deaths."

There is little else on the subject in the medical literature.

In Sudden Infant Death Syndrome in VAERS: A Review, it was pointed out that 12 of 21 (57%) reports of Neonatal SIDS to VAERS over 10 years came from New Hampshire alone. Further investigation revealed that in New Hampshire, the office of the Chief Medical Examiner refers any sudden infant death, while the final diagnosis is pending, to both the NH SIDS Program as a possible SIDS and the NH Immunization Program for their follow-up, as a possible vaccine adverse event. Once the final diagnosis of the infant's death has been made, a copy of the death certificate is sent to the NH Immunization Program, which then reports to VAERS, if appropriate.  Apparently there are approximately 10-15 referrals per year in all, of which approximately 6 to 10 end up with a final diagnosis of SIDS. Two requests for further information to the NH immunization Program were not acknowledged. 

The incidence of SIDS in neighboring Massachusetts and the percentage of those infants under the age of 4 weeks is shown in Table I.

The population of Massachusetts is approximately 6 times that of New Hampshire.

It is not possible to make any inference or draw any statistically significant conclusion from the fact that in 1991, the year neonatal hepatitis B vaccination was recommended, the percentage of infants under the age of 4 weeks with the diagnosis of SIDS, reached an all-time high of 13% in Massachusetts. Similarly, whether the fact that the average percentage of SIDS under age 4 weeks in the 3 and 6 years starting 1991 was about double that in the 3 years before 1991 (9.39 and 8.33% vs. 4.67) may or may not be relevant.

The State of Washington has kept careful SIDS statistics for years as shown in Table II.

Source: Washington State Department of Health, MCH Assessment

Data Source: Birth and Death Certificates, Center for Health Statistics, Washington State DOH.

*Rates prior to 1999 adjusted by the ICD10-ICD9 comparability ratio for SIDS of 1.0362

There were 1,826 cases of SIDS in Washington State between 1981 and 1990, of which 126 (6.9%) were under the age of 30 days. In the 10 years after 1991, there were 88 (9.3%) cases under the age of 30 days out of 946. This represents a statistically significant increase in the number of SIDS deaths in infants less than 30 days of age.  (X2=5.05, P<0.025)

Thus, while the total number of SIDS in the State of Washington has decreased by 48%, the proportion of those infants under 1 month of age has undergone a statistically significant increase of 35% since the introduction of Neonatal Hepatitis B vaccination [(9.3%-6.9)/6.9].

International SIDS statistics are not easily available by age group. The incidence of SIDS in 22 countries with complete data is reported in Table III.

Table III. SIDS in the USA and in other reporting nations (Updated 24^th August 2000)

Although the incidence of SIDS in the United States is half of what it used to be, it is disturbing to find out that it is the third highest of the 22 nations with complete data and more than double that of Japan and several European countries.

It is difficult to understand why the incidence of SIDS in 2000 was higher in New Zealand and Germany than it was in the United States. Infants (<1 year old) in New Zealand receive DTAP (Diphtheria, Tetanus and Acellular Pertussis vaccine), HIB (Haemophilus Influenzae B vaccine), OPV (Oral Polio vaccine) and Hepatitis B vaccine when they are 6 weeks old and again at 3 and 5 months of age. Infants in Germany receive Hepatitis B vaccine, HIB, IPV (Inactivated Polio vaccine), Pertussis and Tetanus Toxoid vaccines at 2, 3, 4, and 11-14 months of age and Measles and Rubella vaccines at 11-14 months. WHO records do not mention whether any of the above vaccines contained or still contain Thimerosal.

Vaccination schedules of most nations are available by accessing the WHO Vaccine Preventable Diseases Monitoring System.

The CDC has always argued that a Vaccine-SIDS connection does not exist because in the decade of the nineties, the incidence of SIDS in the United States decreased while infants were receiving more vaccines in the first year of life.

The Institute of Medicine (IOM) special report "Potential Role of Vaccination in Sudden Unexplained Death in Infancy" [See Press Release below] stressed that SIDS was the leading cause of post-neonatal mortality in the United States in 2000, that between 1990 and 2000, the incidence of SIDS decreased dramatically and that in the same period the infant mortality decreased from 9.2 per 1000 live births to 6.9 per thousand, the "lowest infant mortality rate ever recorded in the United States".

The report seems to intimate that the decrease in post neonatal and infant mortality is somehow related to the decrease in the number of SIDS cases and the success of the "Back to Sleep" campaign.

The Infant Mortality Rate (IMR) and the Post-Neonatal Mortality Rate (PNMR) had actually been dropping consistently since the 1950’s as shown in table IV.

Infant Mortality refers to death during the first year of life; Neonatal Mortality refers to death during the first 28 days of life and Post-Neonatal Mortality refers to death between 28 and 364 days of age. Rates are per 1,000 live births.

Source CDC, National Center for Health Statistics, National Vital Statistics System.

Internationally, the United States was ranked 8^th in infant mortality in 1970 and 16^th in 1980 among 20 industrialized nations.

According to a 1997 study by Gerard Anderson, Ph.D., Professor of Health Policy and Management at Johns Hopkins School of Public Health, the United States’ infant mortality ranking had slipped to 23^rd (out of 29 industrialized countries), because the Infant Mortality Rate in the other countries had dropped even faster.

The United States consistently spends more resources on health care than any other industrialized nation. In 1996 the U.S. spent 14.2 percent of its gross domestic product (GDP) on health. Germany was next with 10.5 percent. The U.S. also spent the most per capita on health care in 1996 ($3,708). Switzerland was second with the equivalent of $2,412. Of the G7 countries (U.S., France, Germany, Japan, Great Britain, Canada and Italy), only the U.S. remains without universal publicly mandated health insurance coverage.

The Infant Mortality Rate and the spent health care dollars per capita among the G7 countries in 2001 are shown in Table V.

Source: The CIA Factbook 2001.

Table V Infant Mortality Rate and Healthcare Cost-G7 Countries

The March of Dimes regularly reports health statistics on infants and children in developing countries.

The following table (Table VI) is part of a larger table listing the changes in the mortality rates of infants and children less than 5 years, in developing countries, over the last four decades. The countries listed had an Infant Mortality Rate of less than 10 per1000 live births in 1999. The United Kingdom and the United States were listed for comparison.

Table VI Mortality Rates in 7 Developing Countries, the UK & the USA

Source: UNICEF State of the World's Children, 2001 and 1999 editions.

If the above figures are correct and if comparisons are indeed valid, then it is seems that the infant mortality and the mortality of children under age 5 years of age have been decreasing at a faster rate in some developing countries than they have in the United States.

The three leading causes of infant death in 2000 in the United States were congenital malformations, low birth weight and sudden infant death syndrome (SIDS), which together accounted for almost one-half of all infant deaths.

Post-neonatal mortality contributes substantially to infant mortality. Post-neonatal mortality has decreased substantially in the last few years. Most of the decline resulted from reduced mortality from infections and SIDS.

Discussion

The above findings suggest that the conclusions of the IOM Committee study of the "Potential Role of Vaccination in Sudden Unexplained Death in Infancy" were not justified.

The following quotes from the attached Press Release are particularly questionable:

" These and other findings about childhood vaccines, SIDS, and other types of sudden unexpected death in infancy (SUDI) do not warrant a review of the childhood vaccination schedule"

"Although the timing of infant vaccinations coincides with the period when SIDS is most likely to occur, parents should rest assured that the number and variety of childhood vaccines do not cause SIDS"

"We do not have the data that would definitively answer all questions about links between vaccines and SIDS and other forms of sudden, unexpected death in infancy. However, we believe that the data we do have, along with the increasing rarity of these kinds of infant deaths, make a review of the vaccine schedule unnecessary"

"While the number and variety of vaccines infants receive is not linked to SIDS, there is not enough evidence to determine whether exposure to multiple different vaccines is causally linked to SUDI in general. Evidence also is not sufficient or adequate to determine if HepB, the only vaccine given to newborns, is linked to neonatal deaths"

"The number of infant deaths declined between 1990 and 2000, dropping from 9.2 deaths per 1,000 live births to 6.9 per 1,000, the lowest infant mortality rate ever recorded in the United States. Because SUDI are difficult to define, there are no data on the national rate of SUDI in the United States. SIDS is the leading diagnosis for postneonatal death–death occurring after the first 27 days–and there were 2,523 deaths attributed to SIDS in the United States in 2000. The rate of SIDS has been declining over the past several years"

It is no consolation for parents who lose a healthy infant very shortly after a vaccination to know that SIDS is now less common and that an Institute of Medicine Committee did not find evidence of a link between their infant’s sudden and unexplained demise and vaccination. Just as upsetting for them will certainly be the fact that even a review of the present vaccination schedule is considered "unnecessary".

It appears that proportionately more neonatal sudden deaths have been occurring since 1991, the year the Hepatitis B vaccination of the newborn was introduced.

It is unclear why the CDC and the IOM Special Committee still insist that vaccines do not play any role in SIDS causation when certain State Health Departments review all SIDS deaths routinely and report a few to VAERS when indicated.

Conclusions

Conflicts of interest must be removed and independent evaluation of data must occur if true science is to be found.

A comprehensive and unbiased review of the possible role of vaccines in the causation of SIDS should be launched.

The CDC should require that each and every State Health Department review every case of SIDS and report to VAERS those suspected to be vaccine-related.

VAERS is a valuable resource and it should be utilized.

* * *

* * *

Date: March 12, 2003
Contacts: Christine Stencel, Media Relations Officer
Cory Arberg, Media Relations Assistant
Office of News and Public Information
(202) 334-2138; e-mail

For Immediate Release

SIDS Not Linked to Number and Variety of Childhood Vaccines

WASHINGTON–The evidence does not support a causal link between sudden infant death syndrome (SIDS) and either the diphtheria, tetanus, and whole-cell pertussis (DTwP) vaccine or exposure to multiple childhood vaccines, says a new report from the Institute of Medicine of the National Academies. Only an older version of a vaccine against diphtheria and pertussis that is no longer administered to infants is causally related to fatal anaphylaxis, a rare and severe inflammatory reaction. These and other findings about childhood vaccines, SIDS, and other types of sudden unexpected death in infancy (SUDI) do not warrant a review of the childhood vaccination schedule, the report concluded.

"Although the timing of infant vaccinations coincides with the period when SIDS is most likely to occur, parents should rest assured that the number and variety of childhood vaccines do not cause SIDS," said Marie McCormick, chair of the committee that wrote the report and professor and chair, department of maternal and child health, Harvard School of Public Health, Boston. "We do not have the data that would definitively answer all questions about links between vaccines and SIDS and other forms of sudden, unexpected death in infancy. However, we believe that the data we do have, along with the increasing rarity of these kinds of infant deaths, make a review of the vaccine schedule unnecessary."

American children routinely receive five vaccines against seven infectious agents before age 1: the DTaP vaccine–which contains a different form of the pertussis component than DTwP, which it replaced in the United States in 1997 -- and vaccines against Haemophilus influenzae type b, hepatitis B (HepB), polio, and pneumococcal bacteria. Although HepB is given to newborns, the others typically are administered at 2 months of age, with additional doses of certain vaccines given at 4 and 6 months.

SUDI encompasses sudden, unexpected deaths in which there may or may not be a clear cause of death. SIDS is the diagnosis most often given for infant deaths that occur without warning and for which no cause is identified. Medical researchers have not reached consensus on the risk factors for SIDS or how it occurs, although current guidelines to place babies on their backs or sides to sleep are based on theories that the prone position may contribute to SIDS. Another possible explanation, the "triple-risk" hypothesis, postulates that SIDS may occur through the interaction of an underlying biological vulnerability, a critical development period, and exposure to an outside trigger. It has been speculated that vaccination may act as such a trigger. Further research could show that there are many causes of SIDS.

Evidence from studies based on human exposure is strong enough to favor rejection of any causal connection between SIDS and multiple doses of different vaccines. In addition, the report reaffirmed previous findings that SIDS is not linked to the older DTwP. Because the currently used DTaP vaccine has fewer side effects than DTwP, the committee found no reason to suspect any link between DTaP and SIDS. However, without sufficient or adequate evidence available, the committee could not definitively reject a link between DTaP and SIDS. Evidence was also insufficient or inadequate to determine whether relationships exist between other individual vaccines and SIDS.

Although some research suggests that an abnormal immune response to common respiratory bacteria or viruses may be a factor in SIDS, there are no studies demonstrating the ability of vaccines to provoke abnormal inflammatory responses of the kinds seen in some SIDS cases. The committee concluded that the ability of vaccines to act as triggers of SIDS is only theoretical. A similar conjecture that fever or other common side effects of vaccination could spur an acute metabolic reaction in babies with an innate metabolic condition is also theoretical.

Although very rare, anaphylaxis from any cause–such as a food, drug, or environmental allergen–can lead to sudden, unexpected death. On the basis of a well-documented case of fatal anaphylactic shock in twin babies that occurred after each received a second dose of diphtheria toxoid and whole-cell pertussis vaccine (DwP), the committee concluded that the evidence favors acceptance of a link between this vaccine and infant death due to anaphylaxis. The case occurred in 1946, however, and the committee did not find any other well-documented reports of infant deaths related to anaphylaxis following vaccination, despite the widespread use of childhood vaccines during the 57 years since that case. Moreover, DwP is no longer used in the United States.

While the number and variety of vaccines infants receive is not linked to SIDS, there is not enough evidence to determine whether exposure to multiple different vaccines is causally linked to SUDI in general. Evidence also is not sufficient or adequate to determine if HepB, the only vaccine given to newborns, is linked to neonatal deaths, the report says.

A standard definition of SUDI should be developed, and criteria related to SIDS and SUDI should be consistently applied for research and reporting purposes. Comprehensive postmortem work-ups should be performed on all infants who die suddenly and unexpectedly, the report says.

The number of infant deaths declined between 1990 and 2000, dropping from 9.2 deaths per 1,000 live births to 6.9 per 1,000, the lowest infant mortality rate ever recorded in the United States. Because SUDI are difficult to define, there are no data on the national rate of SUDI in the United States. SIDS is the leading diagnosis for postneonatal death–death occurring after the first 27 days–and there were 2,523 deaths attributed to SIDS in the United States in 2000. The rate of SIDS has been declining over the past several years.

This study is the sixth in a series of eight on vaccine safety sponsored by the Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.

Copies of Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy will be available later this year from the National Academies Press; tel. (202) 334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a pre-publication copy from the Office of News and Public Information (contacts listed above).

# # #

INSTITUTE OF MEDICINE
Board on Health Promotion and Disease Prevention

Immunization Safety Review Committee


Marie C. McCormick, M.D., Sc.D. (chair)
Professor and Chair
Department of Maternal and Child Health
Harvard School of Public Health
Boston

Ronald Bayer, Ph.D. ^*
Professor
Division of Sociomedical Sciences
Joseph L. Mailman School of Public Health
Columbia University
New York City

Alfred Berg, M.D., M.P.H.
Professor and Chair
Department of Family Medicine
School of Medicine
University of Washington
Seattle

Rosemary Casey, M.D.
Associate Professor of Pediatrics
Jefferson Medical College, and
Director
Lankenau Faculty Pediatrics
Wynnewood, Pa.

Joshua Cohen, Ph.D.
Senior Research Associate
Harvard Center for Risk Analysis
Harvard School of Public Health
Boston

Betsy Foxman, Ph.D.
Professor
Department of Epidemiology
School of Public Health
University of Michigan
Ann Arbor

Constantine Gatsonis, Ph.D.
Professor of Medical Science and Applied Mathematics, and
Director, Center for Statistical Sciences
Brown University
Providence, R.I.

Steven Goodman, M.D., M.H.S., Ph.D. ^*
Associate Professor
Department of Oncology
Division of Biostatistics
School of Medicine
Johns Hopkins University
Baltimore

Ellen Horak, M.S.N.
Education and Nurse Consultant
Public Health Certification Program
Public Management Center
University of Kansas
Topeka

Michael Kaback, M.D.
Professor of Pediatrics and Reproductive Medicine
University of California
San Diego

Gerald Medoff, M.D.
Professor
Department of Internal Medicine
School of Medicine
Washington University
St. Louis

Rebecca Parkin, Ph.D.
Associate Research Professor
Department of Occupational and Environmental Health
School of Public Health and Health Services
George Washington University
Washington, D.C.

Bennett A. Shaywitz, M.D.
Co-Director
Center for the Study of Learning and Attention, and
Professor of Pediatrics and Neurology
School of Medicine
Yale University
New Haven, Conn.

Christopher Wilson, M.D.
Professor and Chair
Department of Immunology
University of Washington
Seattle

INSTITUTE STAFF

Kathleen Stratton, Ph.D.
Study Director