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Lesson 4A, Part 8E - 10/10/03 - Yazbak SIDS, Vaccines & VAERS: A Follow Up

SIDS, VACCINES AND VAERS: A FOLLOW-UP

By Red Flags Columnist, F. Edward Yazbak, MD, FAAP

TL Autism Research

Falmouth, Massachusetts

E-mail: TLAutStudy@

Sudden Infant Death Syndrome in VAERS: A Review, , published on September 22, 2003 at the 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 Gottstein Mintz "The CDC should appropriately prove its claim that SIDS is not linked to vaccines," which was published shortly thereafter at the online conference 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."

Under "Editor’s Note", Catherine D. DeAngelis, MD stated:

"This report should help allay the fears of the antivaccine groups; it should, but will it?"

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.

 

|  |SIDS Deaths |% Under |

|Year | |4 weeks of age |

|1988 |94 |5 |

|1989 |103 |5 |

|1990 |90 |4 |

|1991 |72 |13 |

|1992 |67 |9 |

|1993 |62 |6 |

|1994 |72 |9 |

|1995 |34 |3 |

|1996 |42 |10 |

|1997 |39 |7 |

|1998 |29 |3 |

|1999 |23 |4 |

|2000 |26 |4 |

|2001 |23 |4 |

|2002 |22 |5 |

Table I: Number of cases of SIDS in Massachusetts in the last 15 years and percentage of infants under 4 weeks of age

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.

 

|Year |SIDS deaths |All SIDS |Live Births | ................
................

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