CLAIM: A packaging insert provided with the diphtheria, tetanus and pertussis vaccine shows it causes sudden infant death syndrome, or SIDS.
AP’S ASSESSMENT: Missing context. The Centers for Disease Control and Prevention says multiple studies over decades have found no causal link between childhood immunizations and SIDS. At least one federally approved vaccine for diphtheria, tetanus and pertussis, or DTaP, does list SIDS among a host of other potential adverse reactions on its packaging insert. But the drug maker and experts say the list includes voluntary reports of adverse medical events experienced by people after receiving the vaccine, which have not all been proven to be correlated to the immunization.
THE FACTS: Social media users this week are reviving long standing concerns that certain vaccines can lead to sudden infant death syndrome.
A number of posts highlighted the fact that the syndrome is among those listed on the packaging insert as a potential adverse reaction to the DTaP vaccine, an immunization given to children 7 years old or younger.
SIDS is an unexplained death of a seemingly healthy baby who is less than a year old, and is the leading cause of death among those under one. It’s sometimes referred to as “crib death” because infants often die in their sleep.
“If SIDS isn’t related, then why is it written as a side effect on the DTAP insert?” one Instagram user asked in a post that received nearly 3,000 likes as of Thursday.
Infanrix, a DTaP vaccine made by GlaxoSmithKline, lists SIDS among a range of adverse effects, including respiratory illnesses and immune system and nervous system disorders.
A spokesperson for the drug maker on Wednesday didn’t specifically address the SIDS concern, but pointed to language included in the vaccine packaging explaining how the list of potential side effects was compiled.
“As described in the Infanrix prescribing information, in addition to reports in clinical trials, also included are worldwide voluntary reports of adverse events received for Infanrix since it was introduced to the market,” Alison Hunt said in a statement. “These adverse events were reported voluntarily from a population of uncertain size; therefore, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination.”
Information provided in the vaccine packaging also represents a legal document with different standards than a true scientific study, said Charlotte Moser, co-director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Pharmaceutical companies have to report any noted medical issues, even if those who took the immunization experienced them at similar rates as those that did not, she explained via email.
Organizations such as the CDC, the American Academy of Pediatrics or the American Academy of Family Physicians, in contrast, take the extra steps to determine whether the side effects are likely related to the shot.
“For this reason, the number of side effects listed in the package insert is much greater than that listed by the CDC, AAP or AAFP,” Moser wrote. “But the side effects indicated in the educational materials provided by these groups more accurately reflect the findings of the scientific studies.”
The National Academy of Medicine, in a 1994 study, found insufficient evidence of a causal relationship between the syndrome and an earlier version of the vaccine, she added.
“The original vaccine did not cause SIDS,” Moser said. “It would follow that the newer version would not either.”
A spokesperson for the Centers for Disease Control and Prevention pointed to information the agency has on its website dedicated to concerns around childhood immunizations and SIDS, which states that “studies have found that vaccines do not cause and are not linked to SIDS.”
Among the many studies it cites is a 2018 paper on the safety of DTaP vaccines published in the journal Pediatrics that argues any connection between the immunization and SIDS is coincidental.
“It would not be uncommon to observe a coincidental close temporal relationship between vaccination and SIDS because this condition peaks at a time when children receive a relatively large number of recommended vaccinations,” the study concludes.
Cases of SIDS have declined considerably over the decades: there were about 38 SIDS deaths per 100,000 live births in 2020, down from 130 deaths per 100,000 live births in 1990, according to the CDC.
Part of that decline has been credited to public awareness campaigns encouraging parents to take preventative steps, such as having infants sleep on their back, as opposed to their stomach or side.
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This is part of AP’s effort to address widely shared misinformation, including work with outside companies and organizations to add factual context to misleading content that is circulating online. Learn more about fact-checking at AP.
