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No, the FDA didn't hide information linking vaccine to autism
The federal government tried to hide that a common vaccine given to children causes autism, according to a misleading viral story on Facebook.
"Now it’s official: FDA announced that vaccines are causing autism," stated a headline on truthcommand.com.
The story stated: "For years, fears over vaccines and the onset of autism have been dispelled by medical professionals, but this has all changed. Parents over the years have been criticized for abstaining from getting their child vaccinated over autism fears, but now it turns out they were right all along."
Facebook users flagged the post as being potentially fabricated, as part of the social network’s efforts to combat fake news. We found that the website misled readers about information related to the potential adverse side effects of the DTaP vaccine Tripedia manufactured in the past by Sanofi Pasteur.
DTaP, a vaccine given to children in multiple doses, stands for Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine. According to the Centers for Disease Control and Prevention, getting those diseases is much riskier than getting the vaccine. Mild problems such as a fever or swelling are common, while severe problems such as a serious allergic reaction are so "rare it is hard to tell if they are caused by the vaccine."
The internet has been fueled with misinformation for years about a vaccine-autism link. A 1998 article in a British medical journal, the Lancet, claimed to show a link between the MMR (measles, mumps, rubella) vaccine and autism but in 2010, the Lancet retracted the study. Scientists have repeatedly debunked the myth that vaccines cause autism through peer-reviewed studies. And yet, the spread of misinformation continues -- including by Donald Trump before and during his race for president.
Vaccine pamphlet on adverse side effects
Truthcommand.com stated that the U.S. Food and Drug Administration admitted that autism is a potential side effect in an online pamphlet about Tripedia:
"Adverse events reported during post-approval use of Tripedia vaccine include idiopathic thrombocytopenic purpura, SIDS, anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence and apnea. Events were included in this list because of the seriousness or frequency of reporting."
But that section also includes a disclaimer about adverse events:
"Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to components of Tripedia vaccine."
Through the federal government’s Vaccine Adverse Event Reporting System (VAERS), anyone can file a report: doctors, patients, family members -- and they don’t need proof that the event was caused by the vaccine. Government researchers examine the reports and turn over anything suspicious to outside groups, such as the Institute of Medicine for more research.
Marie McCormick, an expert on child health at the Harvard School of Public Health, told PolitiFact that the reporting system can be gamed.
When the measles-thimerosal-autism controversy first emerged, activists encouraged parents to report adverse events regardless of the duration of time since the vaccination and prior events such as previous indications of developmental problems.
What happened to the pamphlet on FDA’s website
Truthcommand.com suggested that the FDA had tried to hide the autism link by deleting this pamphlet from the FDA’s website.
But the FDA told PolitiFact that the pamphlet written by Sanofi Pasteur in 2005 wasn’t actually deleted -- the FDA archived it and sent PolitiFact a link to the pamphlet.
It’s no surprise that the pamphlet was archived on the FDA’s website because the vaccine hasn’t been available for many years.
Cristine K. Schroeder, a spokeswoman for Sanofi Pasteur, told PolitiFact that the company’s last shipment of Tripedia occurred in 2012.
"Tripedia is not in use today," she said.
The company’s pamphlets for current vaccines for DTaP, Daptacel, Pentacel and Quadracel, do not list autism as a potential adverse event. They do show data from clinical trials about side effects such as the percentage of children who got a fever, or became drowsy.
Tripedia was originally licensed by the FDA in the early 1990s, FDA spokeswoman Megan McSeveney told PolitiFact. The drug maker had to follow what was at the time broad label requirements for adverse events. More recent federal regulations about drug labeling approved in 2006 are now more narrow and state that the only adverse events that have to be reported are those "for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event."
The scientific evidence does not support a link between any vaccine, including Tripedia (DTaP), and autism or other developmental disorders, McSeveney said.
The truthcommand.com website states that it aims "to raise awareness to issues ignored by the media." We contacted the email address listed on the website and did not get a reply. Part way through our reporting the story was no longer accessible on the website. The misleading story has circulated at least since March 2016 when Snopes debunked it.
Truthcommand.com stated "Now it’s official: FDA announced that vaccines are causing autism."
But the FDA did no such thing. The evidence Truthcommand.com cited is taken out of context, inaccurate or out of date. We rate this claim Pants on Fire.
Truthcommand.com, "Now it’s official: FDA announced that vaccines are causing autism," Nov. 21, 2017
Sanofi Pasteur Inc., Diphtheria and Tetanus DTaP Toxoids and Acellular Pertussis Vaccine Adsorbed Tripedia, December 2005
Centers for Disease Control and Prevention, Diphtheria, Tetanus, and Pertussis (DTaP) VIS, Updated Oct. 18, 2016
U.S. Department of Health and Human Services, About VAERS, Accessed Dec. 14, 2017
Sanofi Pasteur Inc. press release, "U.S. FDA licenses Sanofi Pasteur’s new pediatric combination vaccine, pentacel(R)," (Accessed in Nexis) June 23, 2008
Snopes, "Shot in the dark," March 22, 2016
PolitiFact, "Megyn Kelly: Measles vaccine safety is settled science," Feb. 3, 2015
PolitiFact, "Viral image perpetuates misconception that vaccines cause autism," Aug. 29, 2016
PolitiFact, "CDC accepts all manner of reported vaccination effects--even symptoms of the Hulk," May 11, 2017
PolitiFact, "Anti-vax measles claim misinterprets data," March 3, 2015
PolitiFact, "Michele Bachmann says HPV vaccine can cause mental retardation," April 16, 2011
PolitiFact’s Trump-O-Meter, "Change the vaccination schedule," Sept. 26, 2017
Interview, Marie McCormick, Professor of Maternal and Child Health, Harvard School of Public Health, Dec. 12, 2017
Interview, Megan McSeveney, U.S. Food and Drug Administration spokeswoman, Dec. 13, 2017
Interview, Cristine K. Schroeder, Head of US Vaccines Communication, Sanofi Pasteur, Dec. 13, 2017
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No, the FDA didn't hide information linking vaccine to autism
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