Conclusion
DTP and hepatitis B vaccines do not cause sudden infant death syndrome (SIDS). Other vaccines currently routinely recommended to the general population in the U.S.* have not been shown to cause SIDS.
Epidemiological evidence
In a 2003 report entitled Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy, the Institute of Medicine (IOM), now called the National Academy of Medicine (NAM), concluded that the evidence favored rejection of a causal relationship between DTP vaccine or exposure to multiple vaccines and SIDS [1]. The 2012 IOM report found no new relevant studies of quality in the literature assessing SIDS and DTaP vaccination [2]. Two large randomized controlled trials found no association between SIDS and pentavalent rotavirus vaccine [3,4]. No increase in the risk of SIDS after immunization with the DTP vaccine was found among a cohort of 129,834 U.S. children born between 1974 and 1984 [5]. A Vaccine Safety Datalink study of more than 350,000 live births between 1993 and 1998 found no association between hepatitis B birth immunization and neonatal death [6]. A meta-analysis found that immunizations are actually associated with a reduced risk of SIDS; however, this may be attributable to the healthy vaccinee effect [7]. A reanalysis of three case-control studies included in this meta-analysis using the self-controlled case series method found neither an increased nor reduced risk of SIDS during the period after vaccination [8]. A 2016 retrospective observational study of California infants found no cases of SIDS that were considered to be related to the administration of 46,486 doses of DTaP-IPV/Hib vaccine [9]. Case-control and self-controlled case series analyses of the Taiwanese death registration databases found no association between SIDS and DTaP vaccine [10].
Proposed biological mechanism
The IOM concluded that there was no mechanistic evidence for an association between SIDS and diphtheria, tetanus or pertussis vaccination, as the publications reviewed provided no evidence beyond a temporal association 2.
* These conclusions do not necessarily consider vaccines recommended only for special populations in the United States such as Yellow Fever vaccine (international travelers) or Smallpox vaccine (military personnel), or vaccines no longer recommended to the public such as the Janssen (J&J) COVID-19 vaccine.
References
1. Institute of Medicine Immunization Safety Review C. In: Stratton K, Almario DA, Wizemann TM, McCormick MC, eds. Immunization Safety Review: Vaccinations and Sudden Unexpected Death in Infancy. Washington (DC): National Academies Press (US). Copyright 2003 by the National Academy of Sciences. All rights reserved.; 2003.
2. Institute of Medicine. In: Stratton K, Ford A, Rusch E, Clayton EW, eds. Adverse Effects of Vaccines: Evidence and Causality. Washington (DC): National Academies Press (US); 2012.
3. Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, Binka FN, Steele AD, Laserson KF, Ansah NA, Levine MM, Lewis K, Coia ML, Attah-Poku M, Ojwando J, Rivers SB, Victor JC, Nyambane G, Hodgson A, Schodel F, Ciarlet M, Neuzil KM. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet 2010; 376(9741): 606-14.
4. Goveia MG, Rodriguez ZM, Dallas MJ, Itzler RF, Boslego JW, Heaton PM, DiNubile MJ. Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy premature infants. The Pediatric infectious disease journal 2007; 26(12): 1099-104.
5. Griffin MR, Ray WA, Livengood JR, Schaffner W. Risk of sudden infant death syndrome after immunization with the diphtheria-tetanus-pertussis vaccine. The New England journal of medicine 1988; 319(10): 618-23.
6. Eriksen EM, Perlman JA, Miller A, Marcy SM, Lee H, Vadheim C, Zangwill KM, Chen RT, DeStefano F, Lewis E, Black S, Shinefield H, Ward JI. Lack of association between hepatitis B birth immunization and neonatal death: a population-based study from the vaccine safety datalink project. The Pediatric infectious disease journal 2004; 23(7): 656-62.
7. Vennemann MM, Hoffgen M, Bajanowski T, Hense HW, Mitchell EA. Do immunisations reduce the risk for SIDS? A meta-analysis. Vaccine 2007; 25(26): 4875-9.
8. Kuhnert R, Schlaud M, Poethko-Muller C, Vennemann M, Fleming P, Blair PS, Mitchell E, Thompson J, Hecker H. Reanalyses of case-control studies examining the temporal association between sudden infant death syndrome and vaccination. Vaccine 2012; 30(13): 2349-56.
9. Hansen J, Timbol J, Lewis N, Pool V, Decker MD, Greenberg DP, Klein NP. Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers. Vaccine 2016; 34(35): 4172-9.
10. Huang WT, Chen RT, Hsu YC, Glasser JW, Rhodes PH. Vaccination and unexplained sudden death risk in Taiwanese infants. Pharmacoepidemiology and drug safety 2017; 26(1): 17-25.
