Tag: mercury

Are Package Inserts Evidence That Vaccines Cause SIDS and Autism?

Mike Adams has uncovered another conspiracy about vaccines!

He has discovered “a vaccine document on the FDA’s own website that openly admits vaccines are linked to autism.”

What document?

It’s the package insert for Tripedia, a DTaP vaccine that was discontinued in 2011.

Like his finding mercury in a flu shot that was not thimerosal free, the only thing that is “shocking” about this stuff that is that people fall for it.

What Package Inserts Say About SIDS and Autism

So what did he find in that package insert for Tripedia?

He found autism.

SIDS and autism are listed in Tripedia package insert, but are not causally linked to the vaccine.
SIDS and autism are indeed listed in Tripedia package insert, but are not causally linked to the vaccine.

But like SIDS, it was at the end of the section of Adverse Reactions where they were very clear that “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.”

These adverse reactions are listed “because of the seriousness OR frequency of reporting.” They are not included because they are serious AND frequent, as some anti-vaccine sites like to proclaim.

“These lists of “adverse events” can look scary because they include so many problems, ranging from minor to life-threatening. The thing to remember is that this section lists everything that happened to or was reported by people taking the medicine, regardless of whether it had any connection to the medicine.”

Epilepsy Foundation on How to Read A Package Insert

And that they are listed is certainly not evidence that they are caused by the vaccine. Antivaccine sites typically leave out this part of the package insert – “it is not always possible to reliably estimate their frequencies or to establish a causal relationship.”

In fact, many studies have found that vaccines are not associated with either SIDS or autism.

What Else Do Package Inserts Say

Package inserts (in the Adverse Events section) must include everything that happens during the clinical trials for the vaccine.

You wouldn’t think that a motor vehicle accident or accidental drowning would really be caused by a vaccine, would you? But they are also listed in the Tripedia package insert.

Vaccine inserts have to list any serious events, especially deaths, that happened in the clinical trials for the vaccine, even if they might not be related to the vaccine itself.
Vaccine inserts have to list any serious events, especially deaths, that happened in the clinical trials for the vaccine, even if they might not be related to the vaccine itself.

Vaccine package inserts do have a lot of good information. Although designed for use by health professionals, they are readily available for parents to read too.

But don’t let folks misuse them to scare you away from vaccinating and protecting your kids. Get educated about what is and what isn’t in a package insert and what it all means.

What To Know About What Package Inserts Really Say

Although included in some vaccine package inserts, none actually claim that vaccines cause SIDS or autism.

More on What Package Inserts Say About SIDS and Autism:

About Those Research Papers Supporting the Vaccine/Autism Link

Have you heard about the ever growing list of research papers that ‘support’ a link between vaccines and autism?

Over 1,000 studies support the fact that vaccines do not cause autism.
Over 1,000 studies support the fact that vaccines do not cause autism!

They don’t.

Are you surprised?

On the other hand, there is plenty of evidence that vaccines do not cause autism.

Research Papers ‘Supporting’ the Vaccine/Autism Link

The list of research papers that supposedly support a link between vaccines and autism has now grown to 131.

That is a lot of research.

“Even though anti-vaccers claim to have lengthy lists of papers supporting their position, most of those papers are irrelevant, used weak designs, and had small sample sizes.”

The Logic of Science

So what’s wrong with the list?

Why doesn’t it really support a link between vaccines and autism?

As pointed out in this review, “Vaccines and autism: A thorough review of the evidence,” the papers on the list include:

  • papers that aren’t about vaccines!
  • papers that aren’t about autism!
  • papers that are about research done on cells or tissues in a petri dish (in vitro trials)
  • animal trials (how do you show that an animal has autism?)
  • papers about elemental mercury or methyl-mercury, even though thimerosal, which was removed from almost all vaccines in 1999, is ethyl-mercury
  • conference abstracts (these haven’t made it into a medical journal yet)
  • case reports (basically a story about a patient)
  • opinion papers
  • non-research papers
  • reviews that “are deceptively only showing the papers that support their position while ignoring all of the papers that refute it”
  • a few that were retracted!

What’s wrong with animal trials and in vitro studies? They are simply among the weakest type of study you can do. The evidence is considered to be much stronger if you can a meta-analysis or systemic review or a randomized control trial.

So they are left with about a dozen studies that are about vaccines and autism, including:

  • SeneffEmpirical Data Confirm Autism Symptoms Related to Aluminum and Acetaminophen Exposure – misuses the VAERS database, so the reports of autism are unconfirmed
  • DeisherImpact of environmental factors on the prevalence of autistic disorder after 1979 – has a ton of problems with the way it analyzed its data
  • NevisonA comparison of temporal trends in United States autism prevalence to trends in suspected environmental factors – tries to correlate autism rates with a list of environmental factors, from maternal obesity, pollution, and glyphosate on foods to aluminum adjuvants in vaccines
  • Tomlejenovic and ShawDo aluminum vaccine adjuvants contribute to the rising prevalence of autism? – “yet another association study. It cannot demonstrate causation,” with tons of other problems
  • Gallagher and GoodmanHepatitis B triple series vaccine and developmental disability in US children aged 1–9 years – a small study that used parental surveys, and although the study found higher levels of early intervention or special education services in vaccinated boys than in unvaccinated boys, it found significantly lower levels of early intervention or special education services in vaccinated girls than in unvaccinated girls?!?
  • Gallagher and GoodmanHepatitis B vaccination of male neonates and autism diagnosis, NHIS 1997–2002 – used a “weak experimental design with a tiny sample size,” just 33 autistic kids
  • Singh – Serological association of measles virus and human herpesvirus-6 with brain autoantibodies in autism – a poorly done paper with so many problems that it has been labeled “fraudulent” and which found “no significant difference in viral levels in the autistic and non-autistic group (which is the opposite of what you would expect if exposure to the virus caused autism)”
  • Singh – Abnormal Measles-Mumps-Rubella Antibodies and CNS Autoimmunity in Children with Autism – discredited by several papers which found No Evidence of Persisting Measles Virus in Peripheral Blood Mononuclear Cells From Children With Autism Spectrum Disorder
  • Kawashti – Possible immunological disorders in autism: concomitant autoimmunity and immune tolerance – while trying to link autism to the formation of autoantibodies to casein and gluten antibodies and the immune response to the MMR vaccine, they state that “at this stage, we can conclude that M.M.R. vaccine may not be a cause of autism”
  • MumperCan Awareness of Medical Pathophysiology in Autism Lead to Primary Care Autism Prevention Strategies? – a poorly done “retrospective study with no control group” with a very small sample size
  • KawashimaDetection and sequencing of measles virus from peripheral mononuclear cells from patients with inflammatory bowel disease and autism – a study that was done with Andy Wakefield
  • DeisherEpidemiologic and molecular relationship between vaccine manufacture and autism spectrum disorder prevalence – the study talks about residual human fetal DNA fragments in vaccines and that somehow “fetal DNA in these vaccines can recombine with infant DNA to cause autism.” It can’t.

What about any new studies they say supports a link between vaccines and autism?

Are they about vaccines?

Are they about autism?

What kind of study was it?

What journal was it published in? A predatory, pay-to-publish journal with a low impact value or a real, peer-reviewed, medical journal like PLos One, Lancet, JAMA, or Pediatrics?

Although 6 or 7 studies were recently added to their list, most get excluded right off the bat using the above criteria (not about vaccines or autism, animal studies, in vitro studies, etc.). The one that gets included (and has already been retracted)?

  • MawsonPilot comparative study on the health of vaccinated and unvaccinated 6- to 12- year old U.S. children – published at Open Access Text (is that really a journal?) after it was retracted at another journal last year, this survey of homeschoolers is being billed as the “First Peer-Reviewed Study of Vaccinated versus Unvaccinated Children,” which is strange, as this study was done in 2011!

What were you expecting?

Do you really think that you will first read about a real study proving a link between vaccines and autism will be found on an anti-vaccine website or list?

What To Know About Research Papers Supporting the Vaccine/Autism Link

There is still no research supporting a link between vaccines and autism.

More About Research Papers Supporting the Vaccine/Autism Link

Updated on May 21, 2017

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Thimerosal in Vaccines

Although it was never actually linked to any real side effects, thimerosal (mercury) was removed from almost all childhood vaccines in 1999.

Thimerosal, a preservative, only remained in flu vaccines for a few years, but thimerosal free flu vaccines have been available since 2003.

That’s also the year that the remaining non-flu vaccines with thimerosal expired – January 2003.

And this year, at least “120 million doses of thimerosal-free or preservative-free influenza vaccine will be produced.” That means that over 75% of flu shots are thimerosal free, leaving only some multi-dose vials of flu shots to still have thimerosal, but making it easy to avoid if you want to.

Myth of Continued Exposure to Mercury in Vaccines

Although thimerosal was removed from vaccines in 1999, some anti-vax folks still claim that many vaccines contain mercury.
Although thimerosal was removed from vaccines in 1999, some anti-vax folks still claim that many vaccines contain mercury. Photo courtesy of Refutations to Anti-Vaccine Memes

Although most anti-vaccine groups have moved on to other conspiracy theories to scare parents, some still falsely claim that vaccines continue to be made with thimerosal and that thimerosal is dangerous.

Robert F. Kennedy Jr., for example, continues to claim that even though thimerosal has been removed from pediatric vaccines, “thimerosal levels remain virtually unchanged.” This is mostly, he claims, because of flu shots with thimerosal. Also, when a pregnant woman gets a flu shot, Kennedy claims that the fetus gets a bolus of thimerosal “that’s about 800 times the amount of mercury the CDC recommends.”

First, it is important to remember that the original concerns about thimerosal were because children who received a complete set of thimerosal containing vaccines (only hepatitis B, DTaP, and Hib ever had thimerosal) could get up to 187.5 micrograms of ethyl mercury by the time they were six months old, which exceeded the EPA limits for methyl mercury ingestion (but was less than the FDA limits). They aren’t the same type of mercury though, and thimerosal free versions of DTaP and Hib were already available in the late 1990s, so many kids likely got less than 187.5 micrograms of ethyl mercury.

Since thimerosal was removed from almost all vaccines beginning in 1999, that left flu vaccines as the main pediatric vaccine that still used thimerosal as a preservative. So did expanded flu shot recommendations for kids mean that they still got a lot of thimerosal over the years?

It is extremely unlikely that many kids have gotten each and every one of their yearly flu vaccines with thimerosal. It is more likely that they got just a few with thimerosal and the rest without, as thimerosal free flu vaccines became more widely available. After all, a flu vaccine with reduced thimerosal was available as early as 2002.

In 2003, thimerosal free flu shots became available and Flumist, a thimerosal free flu nasal spray vaccine was also approved. The supply of thimerosal free flu vaccines increased each and every year. For the 2014-15 flu season, over 100 million doses of flu vaccine are available that are thimerosal free or preservative free (with only trace amounts of thimerosal).

Even if kids did get flu vaccines with thimerosal each year though, would it matter? A 2008 study in Pediatrics, “Mercury Levels in Newborns and Infants After Receipt of Thimerosal-Containing Vaccines,” found that the half-life of ethyl mercury was about two days, “suggesting that exposure to thimerosal-containing vaccines does not result in an accumulation of mercury in blood.” And the highest blood level they found was less than 5-8 nanograms/ml, which is far less than the 187.5 micrograms that anti-vax groups continue to talk about, even in infants who had already received a cumulative dose of 162.5 micrograms of thimerosal.

What about flu shots in pregnancy?

A 2010 study in Pediatrics, “Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism,” found that “prenatal and early-life exposure to ethylmercury from thimerosal-containing vaccines and immunoglobulin preparations was not related to increased risk of” autism spectrum disorders. Two other studies have also found that prenatal exposure to thimerosal from immunoglobulin preparations, like Rho(D) immune globulin, during pregnancy were not associated with an increased risk for autism.

And also consider that fewer than 15 to 30% of pregnant women got flu shots before 2009. After 2009 and the H1N1 pandemic, rates did increase, but only to about 38 to 52%.

Although current recommendations don’t state a preference for the type of flu shot for pregnant women, it is likely that at least some of them got thimerosal free flu shots. In California, for example, since the passage of their Mercury Free Act in 2006, pregnant women and children younger than age 3 years have to get vaccines that are ‘mercury free.’

What To Know About Thimerosal in Vaccines

Thimerosal is a preservative that was removed from vaccines beginning in 1999, which means that most teens today got little or no exposure to thimerosal from vaccines.

More Information About Thimerosal in Vaccines:

Updated April 8, 2017