Vaccine inserts list reported SIDS cases, it doesn't prove connection to DTaP | Fact check

The claim: Insert in a DTaP vaccine package proves it causes SIDS

A Sept. 6 Instagram post (direct link, archive link) includes an image of the insert from the packaging of a diphtheria, tetanus and pertussis (DTaP) shot. It includes a list of adverse events reported after vaccination, including sudden infant death syndrome, or SIDS.

"If SIDS – sudden infant death – isn't linked to vaccines, why is it listed as a side-effect on the DTaP vaccine insert?" reads a slide in the post.

The post was liked more than 6,000 times in two weeks.

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Our rating: False

The document is not proof that any routine childhood vaccine causes SIDS. The insert lists adverse events reported after vaccination, including SIDS, but it does not say there is a causal link or list it as a side effect. Multiple studies have shown routine childhood immunizations don't cause SIDS.

Studies have debunked vaccine as cause of SIDS

The image in the post is an authentic picture of an insert from the Infanrix DTaP vaccine, listing sudden infant death among adverse events reported after receiving the shot. That insert makes clear the FDA does not say there is a link between sudden infant death and the vaccine.

“Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination,” the insert reads.

Cherie Duvall-Jones, an FDA spokesperson, told USA TODAY in an email that the agency is aware of a "very low" number of reports of SIDS after DTaP vaccination in the Vaccine Adverse Event Reporting System (VAERS). She said the agency has not seen any safety concerns or a causal link.

USA TODAY has previously debunked a claim that misrepresents VAERS data as evidence vaccines cause SIDS, as reports in the system are unconfirmed and can prove to be coincidental to the timing of a shot.

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The post's caption claims that the safety of vaccines is not well studied, but "multiple research studies and safety reviews" have not shown any link between vaccines and SIDS, according to the Centers for Disease Control and Prevention. At least two studies explicitly looked at VAERS data and DTaP vaccines.

One paper reviewed 26 years of VAERS reports and found 350 deaths attributed to SIDS reported after vaccination. While the paper did not attempt to determine a causal relationship, it noted that it did not find any new or unexpected safety issues.

A second paper looked directly at SIDS rates after DTaP vaccination in a population of more than 120,000 children over 11 years and found no increased risk of SIDS.

A meta-analysis looking broadly at SIDS risk across several years and multiple studies for all routine infant immunizations actually found the opposite was true – vaccinated infants had half the rate of SIDS as the unvaccinated.

The post's caption also questions the lack of studies using placebos to compare children with the vaccine to those without, but an expert said there's a reason why that can't happen.

Designing a study where some infants receive a placebo would be impossible to do ethically, Dr. Sean O’Leary, director of the Colorado Pediatric Practice-Based Research Network for Children's Hospital Colorado, told USA TODAY.

“We can’t randomize a large population of infants to be vaccinated or not since we know vaccines save lives,” he said.

USA TODAY reached out to the user who shared the post for comment but did not immediately receive a response.

Lead Stories also debunked the claim.

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This article originally appeared on USA TODAY: SIDS after vaccination does not prove shots are cause | Fact check