CLAIM: A package insert included with the diphtheria, tetanus and pertussis vaccine shows that it causes sudden infant death syndrome, or SIDS.
PA ASSESSMENT: Context missing. The Centers for Disease Control and Prevention say that several studies over decades have found no causal link between childhood vaccinations and SIDS. At least one federally approved vaccine for diphtheria, tetanus, and pertussis, or DTaP, lists SIDS among a host of other potential adverse effects on its package insert. But the drugmaker and experts say the list includes voluntary reports of adverse medical events experienced by people after receiving the vaccine, not all of which have been linked to vaccination.
THE FACTS: This week, social media users are reigniting long-standing concerns that certain vaccines can cause sudden infant death syndrome.
A number of posts highlighted that the syndrome is among those listed on the package insert as a potential adverse reaction to the DTaP vaccine.a vaccination given to children 7 years of age or younger.
SIDS is the unexplained death of an apparently healthy baby under the age of one and is the leading cause of death in those under the age of one. This is sometimes called “cradle death” because infants often die in their sleep.
“If SIDS is not related, then why is it written as a side effect on the DTAP insert?” asked an Instagram user in a post that received nearly 3,000 likes on Thursday.
Package leaflet for Infanrix, a DTaP vaccine manufactured by GlaxoSmithKline, lists SIDS among a range of adverse effectsincluding respiratory diseases and disorders of the immune system and nervous system.
A spokesperson for the drugmaker on Wednesday did not 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 Infanrix’s prescribing information, in addition to clinical trial reports, also included are global voluntary adverse event reports received for Infanrix since its introduction 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.
The information provided in the vaccine package also represents a legal document with different standards from a real scientific study, said Charlotte Moser, co-director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Pharmaceutical companies must report any medical problems found, even if those who took the vaccine encountered them at similar rates to those who did not, she explained by email.
Organizations such as the CDC, American Academy of Pediatrics, or American Academy of Family Physicians, on the other hand, take additional steps to determine if side effects are likely vaccine-related.
“For this reason, the number of side effects listed in the package insert is far greater than those listed by the CDC, AAP, or AAFP,” Moser wrote. “But the side effects listed in the educational materials provided by these groups more accurately reflect the results of scientific studies.”
The National Academy of Medicine, in a 1994 studyfound insufficient evidence of causation between the syndrome and an earlier version of vaccine, she added.
“The original vaccine did not cause SIDS,” Moser said. “It would follow that the new version would not be either.”
A spokesperson for the Centers for Disease Control and Prevention pointed out information on the agency’s website devoted to concerns about childhood vaccinations and SIDS, which states that “studies have shown that vaccines do not cause and are not linked to SIDS”.
Among the many studies he cites is a 2018 article on the safety of DTaP vaccines published in the journal Pediatrics which argues that any link between vaccination and SIDS is coincidental.
“It would not be uncommon to observe a fortuitous close temporal relationship between vaccination and SIDS, as this condition peaks at a time when children are receiving a relatively large number of recommended vaccinations,” the study concludes.
SIDS cases have has decreased considerably over the decades: There were about 38 SIDS deaths per 100,000 live births in 2020, up from 130 deaths per 100,000 live births in 1990, according to the CDC.
Part of this decline was attributed to public awareness campaigns encourage parents to take preventative measures, such as putting infants to sleep on their backs, rather than on their stomachs or sides.
This is part of AP’s efforts to combat widely shared misinformation, including working with outside companies and organizations to add factual context to misleading content circulating online. Learn more about fact-checking at AP.