Vaccines and Sudden Infant Death Syndrome (SIDS)

The ABC news program 20/20 aired a story in 1999 claiming that the hepatitis B vaccine caused sudden infant death syndrome (SIDS). The story included a picture of a 1-month-old girl who died of SIDS only 16 hours after receiving the second dose of hepatitis B vaccine.

At the time of introduction of the hepatitis B vaccine for routine use in all infants, about 5,000 children died every year from SIDS. Within 10 years of the introduction of the hepatitis B vaccine the use of the vaccine increased to about 90 percent of all infants and the incidence of SIDS in that group decreased dramatically to about 1,600 cases each year.

The cause of the decrease in SIDS cases was the introduction of the “Back to Sleep” program by the American Academy of Pediatrics (AAP).

However, since immunizations are given to about 90 percent of children less than 1 year of age, and about 1,600 cases of SIDS occur every year, it would be expected, statistically, that every year about 50 cases of SIDS will occur within 24 hours of receipt of a vaccine. However, because the incidence of SIDS is the same in children who do or do not receive vaccines, we know that SIDS is not caused by vaccines.


Yang YT and Shaw J. Sudden infant death syndrome, attention-deficit/hyperactivity disorder and vaccines: longitudinal population analyses. Vaccine 2018;36:595-598.
The authors analyzed six years of vaccine uptake data for 3-month-olds from the National Immunization Survey and state-level National Vital Statistics SIDS reports and found vaccination coverage for routinely used childhood vaccines was not associated with an increased risk of SIDS.

Moro PL, Arana J, Cano M, Lewis P, Shimabukuro TT. Deaths reported to the Vaccine Adverse Event Reporting System, United States, 1997-2013. CID 2015;61:980-987.
The authors examined deaths reported to VAERS in the United States during a 16-year period, with nearly half of the deaths attributed to SIDS. As with the previous 2001 study, SIDS reports progressively decreased over time, during which the addition of seven-valent pneumococcal vaccine and rotavirus vaccine were added to the recommended vaccine schedule, and the DTaP-HepB-IPV combination vaccine was licensed for use.

Traversa G, Spila-Alegiani S, Bianchi C, Ciofi degli Atti M, Frova L, et al. Sudden unexpected deaths and vaccinations during the first two years of life in Italy: a case series study. PLoS ONE 2011;6(1):e16363.
The authors found no increased risk for sudden unexplained death (SUD) and any vaccination in the time windows of 0-7 days or 0-14 days after vaccine receipt.

Vennemann, MMT, Butterfab-Bahloul T, Jorch G, et al. Sudden infant death syndrome: no increased risk after immunisation. Vaccine 2007;25: 336-340.
The authors investigated the risk of SIDS with immunization in the first year of life, particularly with a hexavalent vaccine containing 15 different antigens. They found no increased risk of SIDS in the 14 days after immunization. As with previous studies, patients with SIDS were vaccinated less frequently and later than those infants without SIDS.

Eriksen EM, Perlman JA, Miller A, Marcy SM, Lee H, et al. Lack of association between hepatitis B birth immunization and neonatal death: A population-based study from the Vaccine Safety Datalink Project. Pediatr Infect Dis J 2004;23:656-661.
The authors evaluated more than 360,000 births during a five-year period to determine if a correlation existed between hepatitis B vaccine receipt at birth and neonatal death. The authors found no relationship between hepatitis B vaccine receipt at birth and neonatal death, and the proportion of deaths from unexpected causes (e.g., SIDS) was not different between vaccinated and unvaccinated infants.

Fleming PJ, Blair PS, Platt MW, Tripp J, Smith IJ, et al. The UK accelerated immunisation programme and sudden unexpected death in infancy: case-control study. BMJ 2001;322:1-5.
In the early 1990s, the schedule for routine infant immunizations in the United Kingdom was accelerated to give the vaccines at an earlier age. The authors found that the accelerated immunization program did not increase the risk of SIDS in a study population of 17.7 million infants. Immunization uptake was lowest among the infants who died from SIDS.

Jonville-Bera AP, Autret-Leca E, Barbeillon, Paris-Llado J and the French Reference Centers for SIDS. Sudden unexpected death in infants under 3 months of age and vaccination status – a case-control study. Br J Clin Pharmacol 2001;51:271-276.
The authors conducted a two-year prospective study on the vaccination status of infants with SIDS who died between 1 and 3 months of age to assess whether vaccination increased the risk of SIDS in this population in France. The authors found DTPP ± Hib immunization did not increase the risk of SIDS.  

Silvers LE, Ellenberg SS, Wise RP, Varricchio FE, Mootrey GT, et al. The epidemiology of fatalities reported to the Vaccine Adverse Event Reporting System 1990-1997. Pharmacoepidemiol Drug Saf 2001; 279-285.
The authors examined fatalities reported to VAERS in the United States during a seven-year period and found that reports peaked in 1992-1993 and then declined, with nearly half of the deaths attributed to SIDS. The trend in decreasing SIDS rates correlated with the 1992 American Academy of Pediatrics recommendation for infants to sleep on their side or back and the National Institute of Child Health and Human Development “Back to Sleep” campaign in 1994. The authors concluded that these data support findings of past controlled studies showing that the temporal association between infant vaccination and SIDS is coincidental and not causal.

Griffin MR, Ray WA, Livengood JR, Schaffner W. Risk of sudden infant death syndrome after immunization with the diphtheria-tetanus-pertussis vaccine. New Engl J Med 1988;319(10):618-623.
The authors evaluated recent immunization with DTP as a possible risk factor for SIDS during a 10-year period in Tennessee. They found no increase in the risk of SIDS after immunization with DTP vaccine and no correlation between SIDS and age at first immunization. Additionally, the rate of SIDS decreased in the first week after immunization.

Hoffman HJ, Hunter JC, Damus K, Pakter J, Peterson DR, et al. Diphtheria-tetanus-pertussis immunization and sudden infant death: results of the National Institute of Child Health and Human Development Cooperative Epidemiological Study of Sudden Infant Death Syndrome Risk Factors. Pediatrics 1987;79:598-611.
The authors investigated the possible association between diphtheria-tetanus-pertussis (DTP) immunization and subsequent occurrence of sudden infant death in the United States using data from a national SIDS epidemiological database. They found no temporal association between SIDS and DTP vaccine receipt. Infants with SIDS were less likely to have been immunized than infants without SIDS.

Keens TG, Davidson Ward SL, Gates EP, Andree DI, Hart LD. Ventilatory pattern following diphtheria-tetanus-pertussis immunization in infants at risk for sudden infant death syndrome. AJDC 1985;139:991-994.
The authors evaluated the effects of DTP immunization on the ventilatory pattern during sleep in infants at increased risk for SIDS, including those with unexplained apnea and those who were siblings of SIDS victims. Overnight pneumograms were recorded the night before and the night following DTP immunization. The authors found that DTP immunization did not increase abnormalities of the ventilatory pattern in infants at increased risk for SIDS.

Reviewed by Paul A. Offit, MD, Lori Handy, MD, MSCE on January 07, 2019

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