Tag: package inserts

Vaccines and Autism Redux

Is it true that only one ingredient (thimerosal) and one vaccine (MMR) has ever been looked at for its relationship to autism?

No, as you can probably guess, it is not.

“This meta-analysis of five case-control and five cohort studies has found no evidence for the link between vaccination and the subsequent risk of developing autism or autistic spectrum disorder. Subgroup analyses looking specifically at MMR vaccinations, cumulative mercury dosage, and thimerosal exposure individually were similarly negative, as were subgroup analyses looking specifically at development of autistic disorder versus other autistic spectrum disorder.”

Taylor et al on Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies

Since much of the original focus about vaccines and autism was on the MMR vaccine and thimerosal, that’s where a lot of the research to reassure parents went first.

Other research has been done though too, so it really is safe to say that vaccines are not associated with autism, even though some may continue to see a correlation.

“To try to isolate the effects of thimerosal from other vaccine constituents, we performed a subanalysis comparing risks associated with diphtheria-tetanus-whole cell pertussis vaccine or diphtheria-tetanus-acellular pertussis vaccine and Haemophilus influenzae type b vaccine given separately or combined.”

Verstraeten et al on Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of Computerized Health Maintenance Organization Databases

The great majority of parents know that:

  • it is not the MMR vaccine
  • it is not thimerosal or thimerosal containing vaccines
  • it is not the overall number of vaccines that are given to a child
  • it is not the timing of when the vaccines are given to children

And it hasn’t been just one or two studies that have shown that there is no association between vaccines and autism. There are dozens. There is also a comprehensive review by the Institute of Medicine and a very large meta-analysis that have come to the same conclusion.

Vaccines are not associated with autism.

Vaccines and Autism Redux

Could it be aluminum though?

Why aluminum? Because anti-vaccine experts cite some poorly done studies that try to say it is.

Bob Sears appeared on Fox & Friends in 2010 for the segment "Vaccines: A Bad Combination?"
Bob Sears appeared on Fox & Friends in 2010 for the segment “Vaccines: A Bad Combination?”

Aluminum has become the new formaldehyde, which used to be the new thimerosal. It is apparently where the goalposts have shifted when some folks talk about vaccines and autism now that every knows it is not the MMR vaccine, thimerosal, vaccine overload, or the timing of vaccines.

But if studies have shown that it is neither the number of vaccines nor the timing of vaccines, then how could it be aluminum, an adjuvant in many vaccines?

It isn’t.

Aluminum is not the smoking gun or the missing puzzle piece that anti-vaccine folks will continue to look for.

What other myths about vaccines and autism have been coming up lately?

Have you heard the one about the court ruling confirming a vaccine autism link? It didn’t.

Did you know that the FDA officially announced that vaccines are causing autism? They didn’t, but do you know why some folks are now saying they did? Because of the old package insert for the Tripedia vaccine, which lists autism as a possible adverse event (without evidence of causation). The vaccine was discontinued years ago, but it continues to pop up as ‘new’ evidence for some as an association between vaccines and autism.

Or maybe you have heard these other new theories from the anti-vaccine movement as they desperately try to prove an association between vaccines and autism:

  • vaccines block folate uptake
  • MTHFR gene mutations
  • maternal immune activation
  • cytokine storms
  • glutathione depletion
  • glyphosate
  • DNA fragments
  • microbiota alterations
  • GI barrier defects
  • blood brain barrier permeability problems

You don’t even have to pick just one theory anymore (the fact that the MMR vaccine doesn’t contain thimerosal or aluminum kind of puts these theories into opposition with each other, doesn’t it?). You can choose for any or all of them to be true if you want. Using synergistic toxicity, you pick a few of your favorite theories and make them 100 times more likely to damage your child! Not really, but that’s how some anti-vaccine folks think.

“Autism is not an immune-mediated disease. Unlike autoimmune diseases such as multiple sclerosis, there is no evidence of immune activation or inflammatory lesions in the CNS of people with autism. In fact, current data suggest that genetic variation in neuronal circuitry that affects synaptic development might in part account for autistic behavior. Thus, speculation that an exaggerated or inappropriate immune response to vaccination precipitates autism is at variance with current scientific data that address the pathogenesis of autism.”

Gerber et al on Vaccines and Autism: A Tale of Shifting Hypotheses

Of course, none of them are true.

Vaccines are still not associated with autism.

What to Know About Vaccines and Autism

Vaccines are still not associated with autism, even though anti-vaccine folks continue to come up with new ideas for how it might be, from glyphosate and DNA fragments in vaccines to MTHFR mutations and maternal immune activation.

More on Vaccines and Autism

100 Myths About Vaccines

Are there really 100 myths about vaccines that folks push to scare parents away from vaccinating and protecting their kids?

To make a long story short - flu vaccines don't contain a vaginal spermicide.
That flu vaccines contain a vaginal spermicide is a new myth being pushed by anti-vaccine folks.

Let’s see…

Actually, when you start to think about it, there are hundreds, as the modern anti-vaccine movement moves the goalposts and continuously comes up with new anti-vaccine talking points.

100 Myths About Vaccines

  1. My intentionally unvaccinated kids don’t put your kids at risk. – Of course they do, because some kids are too young to be vaccinated or fully vaccinated, some kids can’t be vaccinated, including those with immune system problems, and vaccines don’t work 100% of the time.
  2. Vaccines do cause autism. It’s the MMR vaccine. – Of all the competing theories of how vaccines are associated with autism (even though they aren’t), Wakefield‘s theory that it is the combined MMR vaccine was the first.
  3. Recently vaccinated kids shed virus for weeks or months and can infect unvaccinated kids. – While shedding is real for some live vaccines, like oral polio and rotavirus, it is rarely a problem.
  4. Vaccines don’t even work. – While some folks are worried about risks and side effects, others don’t even believe that vaccines work – ever. That’s understandable though, as it explains how they deal with the cognitive dissonance of leaving their kids unprotected from potentially life-threatening vaccine-preventable diseases. So instead of vaccines eradicating or controlling diseases, they come up with theories about improved sanitation and better nutrition doing all of the work. But of course, we know that vaccines work.
  5. It’s good to get measles and other vaccine-preventable diseases. – While some people think that getting measles and polio was once a welcome rite of passage for kids, they seem to forget that vaccine-preventable diseases are life-threatening and can leave survivors with serious disabilities.
  6. The shingles vaccine causes shingles. – The shingles vaccine won’t cause you to develop shingles, but if you got it and never had chicken pox, then like the chicken pox vaccine, it is thought that the shingles vaccine could theoretically cause a latent infection that reactivates = shingles.
  7. Vaccines do cause autism. It’s thimerosal. – Vaccines are not associated with autism.
  8. Getting too many vaccines too soon can overwhelm an infant’s immature immune system. Not true. Considering all of the germs that they are challenged with on a daily basis, it is easy to see that an infant’s immune system can handle all of the vaccines on the immunization and much more.
  9. Package inserts for vaccines admit that they cause autism. – While Tripedia, a DTaP vaccine that was discontinued in 2011, did list autism in the adverse reactions section part of the package insert, it also stated that “it is not always possible to reliably estimate their frequencies or to establish a causal relationship.”
  10. Vaccines aren’t safe because the package insert says that they aren’t evaluated for mutagenicity, carcinogenicity and impairment of fertility. – All necessary pre-clinical or nonclinical testing is done on vaccines and their components.
  11. Big Pharma, or the pharmaceutical industry, is the one making all of the decisions about vaccines, including what goes in them, when you should get them, and deciding if they are really safe. – Of course there is no world-wide conspiracy about vaccines led by the pharmaceutical industry that involves doctors, health departments, the CDC, and the WHO, etc.
  12. Vaccines still contain mercury. The Kennedy Vaccine Gambit
  13. Antifreeze is a toxic ingredient in vaccines. – Antifreeze (ethylene glycol) is not, and has never been an ingredient in vaccines. Some vaccines do contain a similar sounding ingredient, 2-phenoxyethanol, but it isn’t antifreeze. Saying that some vaccines contain an ingredient that sounds like antifreeze isn’t as scary though.
  14. Alternative immunization schedules are better. The Bob Sears Snare
  15. Vaccines contain aborted fetal tissue. – While some vaccines are made with fetal embryo fibroblast cells from cell lines that are derived (the original cells have been copied over and over again) from two electively terminated pregnancies in the 1960s, the cells are removed from the final vaccine and no aborted fetal tissue is in any vaccine.
  16. Many people don’t vaccinate. – There is a very vocal minority of people who do their best to push misinformation and conspiracy theories about vaccines and vaccine dangers, but except for pockets of susceptibles and clusters of unvaccinated kids and adults, most people are vaccinated.
  17. The CDC says that you should stop breastfeeding to boost vaccine efficacy. – They have never said that. Neither has the WHO or any other group of experts. This myth about breastfeeding relates to a study done that suggested that delaying breastfeeding for an hour after getting the rotavirus vaccine might help it work better in developing countries.
  18. Vaccines aren’t tested. – Vaccines are well tested for both safety and efficacy before they are approved and are added to the immunization schedule.
  19. Herd immunity isn’t real. – Understanding just how wrong anti-vaccine folks are about herd immunity will help you go a long way towards understanding how they get most things about vaccines wrong. Herd immunity from vaccines is real.
  20. Vaccines are contaminated with brain-eating ameobas. – Viera Scheibner is a micropaleontologist who claims that that it is ‘well-established’ that vaccines are contaminated with amoebas. They aren’t.
  21. I have a link arsenal from Pubmed that show vaccines are dangerous. – PubMed is simply an index of articles in medical journals. Any medical journals, even they predatory, pay to publish medical journals. Being in Pubmed doesn’t mean that it is a good study. And cherry picking articles and abstracts from Pubmed doesn’t mean that you have done your research about vaccines or that you have found any proof that vaccines aren’t safe. It probably just means that you need to do a little more research.
  22. The vaccine schedule has ballooned since 1983 and kids now get too many shots! – While the vaccine schedule has certainly grown over time, that is simply because kids today are protected from many more diseases. While kids got fewer vaccines in 1983, that was also the pre-vaccine era for Hib, hepatitis B, pneumococcal disease, meningococcal disease, rotavirus, hepatitis A, HPV, and chicken pox, etc.
  23. Package inserts for vaccines admit that they cause SIDS. – Tripedia, a DTaP vaccine that was discontinued in 2011, does list SIDS in the adverse reactions section part of the package insert, but also states that “it is not always possible to reliably estimate their frequencies or to establish a causal relationship.”
  24. The US has higher infant mortality rates than other industrialized countries because we give more vaccines. – Higher infant mortality rate in the US than some other industrialized countries are thought to be because we use different methods to calculate the infant mortality rate. They are also at the lowest level ever.
  25. MSG is a toxic ingredient in vaccines. – MSG is an ingredient in some vaccines, but it is safe and not toxic.
  26. Since adults don’t get vaccines or boosters, there can’t be herd immunity. – Most adults either already have natural immunity or have already been vaccinated, so this isn’t true. There are actually very few booster shots that adults need, but seniors do need a few extra vaccines.
  27. Sick people can just stay home, so it doesn’t matter if they are vaccinated. – That’s kind of how quarantines work, but the main problem with this theory is that with many diseases, including some that are the most contagious, you can actually be contagious even before you show symptoms and you know you are sick. That’s why they often talk about people being at school, on the train, shopping at Walmart, or even at the beach when they have measles and have exposed others in an outbreak.
  28. The media just scares people about outbreaks. – The media, with their vaccine scare stories, did once influence a lot of parents about vaccines, but it was more to make them afraid to get their kids vaccinated and protected. Alerting people of an outbreak in their area isn’t a scare tactic or hype. It is one of the ways to help control outbreaks, so that folks know when a disease is present in their community.
  29. Vaccinations are not immunizations. – While kind of catchy, like other anti-vaccine slogans, it is meaningless. Vaccines work.
  30. There is no Pharma liability. You can’t sue if a child is injured by a vaccine. – You can sue, you just have to go through Vaccine Court first.
  31. Many religions are against vaccines. – Very few religions actually object to immunizations, which makes it very surprising how many folks get religious vaccine exemptions.
  32. Measles and other vaccine preventable diseases aren’t that serious anymore. – They, of course, can still be life-threatening, even in this day of modern medicine.
  33. Over 99% of vaccine side effects from vaccines are not reported by doctors to VAERS. – That’s not really true. Although most common side effects probably are underreported, more moderate and serious side effects are reported. For example, one study found that while a rash after measles, a known mild, side effect, was not commonly reported, vaccine-associated polio was often reported to VAERS. It is also imported to keep in mind that VAERS isn’t the only way that the safety of vaccines is monitored.
  34. Many experts are against vaccines. – The so-called experts of the anti-vaccine movement are mostly doctors who are practicing way out of their field of expertise, including many who are not medical doctors, or whose ideas are not supported by the great majority of real experts on vaccines, infectious disease, and immunology.
  35. Vaccinated kids cause most outbreaks. – Not true. Although vaccines don’t always work 100% of the time and so vaccinated kids sometimes get caught up in outbreaks, they are not the cause of most outbreaks.
  36. Infants have an immature immune system and are too young to be vaccinated. – Not true. Although a baby’s immune system is immature, as compared to older kids and adults, vaccines work well to help protect them as their immune system continues to develop and mature.
  37. Vaccines cause shaken baby syndrome. – Vaccines do not cause shaken baby syndrome.
  38. The chicken pox vaccine has caused an epidemic of shingles. – Not true. It has been shown that the rise in shingles cases started before we started routinely giving chicken pox vaccines, did not continue to increase after we started routinely giving chicken pox vaccines, and also increased in countries that don’t give the chicken pox vaccines.
  39. The United States gives more vaccines than any other country. – While there would be nothing wrong with that, as it would mean we were protecting our kids from more vaccine-preventable diseases, if you take any time to look at the immunization schedules from other countries, you can see it isn’t true.
  40. Pediatricians can get up to $3 million in bonuses for vaccinating kids. – Pediatricians are not getting big bonuses, bribes, or kickbacks to vaccinate kids.
  41. Glyphosate is contaminating our vaccines and will help make 50% kids autistic by 2025. – Glyphosate is not in vaccines and Stephanie Seneff‘s theory that 1/2 of kids will be autistic in 8 years doesn’t make much sense either.
  42. Formaldehyde is a toxic ingredient in vaccines. – While formaldehyde is an ingredient in vaccines, it is also naturally found in all of our bodies and in some foods. The formaldehyde in vaccines is not toxic.
  43. Vaccines aren’t tested together. – Yes, they are. Pediarix (combo vaccine with DTaP, hepB, and IPV) was tested with Hib and Prevnar and the hepatitis A vaccine was tested together with DTaP, IPV, Hib, and hepatitis B. Most vaccination combinations have been tested together, including the flu shot.
  44. I’m not anti-vaccine, I’m pro-safe vaccine. – You can call yourself whatever you want, either pro-safe vaccine or pro-vaccine choice, but if you push anti-vaccine propaganda, then you are anti-vaccine.
  45. It can be safer to wait to get vaccinated. The Jay Gordon Maneuver
  46. $3.5 billion in vaccine court payouts prove that vaccine injuries are real. – No one says that vaccines are 100% safe or that vaccine injuries aren’t real. It is also important to keep in mind that the $3.5 billion in vaccine court payouts have been since 1988, during which billions of doses of vaccines have been given.
  47. Vaccines cause resistance in viruses and bacteria. – Not true. Vaccines are not causing an increase in vaccine-resistant bacteria or viruses and can actually help us fight the growing problem of antibiotic resistant bacteria.
  48. Unvaccinated kids are healthier. – A large study has shown that unvaccinated kids are not healthier than those who are vaccinated, they just get more vaccine-preventable diseases.
  49. People never used to worry about measles. – A Brady Bunch episode about measles doesn’t mean that people weren’t worried about measles in the old days. There are plenty of newspaper headlines describing how measles epidemic once closed entire school districts for weeks at a time. When a measles epidemic hit New York City in 1951, a headline on the front page of the New York Times read “City in Grip of Measles Epidemic; Unusually Severe Siege Forecast.” And remember when Lassie had to save Timmy when he had measles? Sounds like they were worried…
  50. Epigenetics explains many vaccine injuries. – No, it doesn’t.
  51. The one-size-fits-all immunization schedule makes kids sick. – Vaccines are not given using any kind of one-size-fits-all policy. Flexibility of when some vaccines can be given and the existence of contraindications and medical exemptions make that clear to most people.
  52. Herd immunity doesn’t apply to vaccines. – Uh. Yes it does.
  53. Doctors don’t learn anything about vaccines. – Doctors learn a lot about vaccines and vaccine-preventable disease. What they do need to learn more about are the latest anti-vaccine talking points, so that they can readily address your concerns about vaccines and things that you might have read or heard that have scared you about vaccines.
  54. The American Academy of Pediatrics “recommends that parents use the availability of HPV vaccines to usher in a discussion on human sexuality in a way consistent with their culture and values at a time when they determine their child is ready to receive that information.” It’s a fringe group of pediatricians, the American College of Pediatricians who said this, not the AAP, who recommends that all kids get vaccinated and protected with the HPV vaccines.
  55. Vaccines are made for adults, not kids. – Vaccines are made for both kids and adults. Some vaccines even have different formulations for kids than for adults, including hepatitis A, hepatitis B, and flu shots, etc. And think about how the DTaP (kids) and Tdap (teens and adults) shots are different, but protect against the same diseases. But vaccines work locally, where the shot was given, which is why it doesn’t really matter that kids or adults of different sizes get the same dose.
  56. The HPV vaccine just encourages kids to have sex. – Studies have confirmed that HPV vaccines are safe and they don’t encourage kids to unprotected sex, one of many HPV vaccine myths.
  57. Aluminum replaced thimerosal as the latest toxic ingredient in vaccines. – Aluminum in vaccines is not toxic and as an adjuvant, it did not replace the thimerosal, a preservative, in any vaccines.
  58. Hepatitis B is a STD vaccine, so newborn babies don’t need it. – Tragically, many infants still get perinatal hepatitis B infections because of missed opportunities to get vaccinated and when they are exposed in non-high risk situations. Don’t skip your baby’s hepatitis B shot.
  59. Correlation equals causation. – Many people think that their child is vaccine injured because they showed symptoms right around the time they received a vaccine. They correlate getting the vaccine with causing the vaccine injury. The correct phrase isn’t correlation equals causation though, it is “correlation does not imply causation. Just because two things seem to be related by time doesn’t mean that one caused the other.
  60. SV40 contamination of vaccines causes cancer. – While the SV40 virus did contaminate some early vaccines, it has been shown that this contamination did not cause cancer.
  61. Dr. Julie Gerberding, the first woman to lead the CDC, admitted that vaccines cause autism during an interview with Sanjay Gupta on CNN. – While discussing the Hannah Polling decision, Dr. Julie Gerberding did not say that vaccines can cause autism. She even went out of her way to mention all of the studies that “have concluded that there really is no association between vaccines and autism.”
  62. Vaccines don’t work to get rid of any diseases. They just make the diseases disappear by changing their names. – This has to be one of the silliest myths about vaccines. Yes, some folks believe that smallpox wasn’t eradicated. It was instead renamed to monkeypox. Polio became acute flaccid paralysis. And measles became roseola. Of course, that didn’t happen because vaccines do work.
  63. The first deaf Miss America suffered a vaccine injury. – Not true. While they initially blamed her being deaf on the DTP vaccine, it turns out that she had a reaction to the antibiotic Gentamycin that she was receiving for a Hib infection, a now vaccine-preventable disease.
  64. Diane Harper was a lead researcher for the HPV vaccine who came out against the HPV vaccines. – Diane Harper‘s comments about the HPV vaccine have been overblown and mischaracterized. She supports the HPV vaccines and believes that they are safe.
  65. Vaccines don’t work against pertactin-negative pertussis bacteria. – While we are finding more pertactin-negative pertussis bacteria, this doesn’t seem to be why we are seeing more pertussis or whooping cough. Pertussis vaccines work against other components of the pertussis bacteria besides pertactin and pertussis vaccines continue to be effective against pertactin-negative Bordetella pertussis bacteria.
  66. There are graphs and charts that prove that vaccines didn’t save us and that vaccines don’t work – Those mortality graphs are pure propaganda and do not show how cases of vaccine preventable diseases (morbidity) were not affected by overall improvements in mortality rates in the early 20th century (a lot of people still got sick even as more of them survived) or how the effects of improved sanitation, nutrition, and health care peaked by the 1940s (for example, they use death rates instead of just absolute numbers of deaths to hide the fact that measles killed about 400 people each year in 1960).  Vaccines work.
  67. Johns Hopkins warns cancer patients to avoid children who were recently vaccinated. – They did once, but Johns Hopkins and other hospitals updated their instructions as new information became available. Hospitals no longer warn patients about restricting exposure to people who have recently been vaccinated.
  68. Andrew Wakefield was proven right. – Wakefield has not been proven right. Studies have never confirmed his findings. He is still not allowed to practice medicine in the UK.
  69. The shocking revelations of the CDC Whistleblower proves that vaccines cause autism. – What was supposed to be the biggest anti-vaccine conspiracy story of all time, the CDC Whistleblower, must have been the biggest let down for the anti-vaccine movement. He didn’t really blow the whistle on anything or anyone and didn’t even appear in Vaxxed, the CDC Whistleblower movie! While being secretly recorded, he basically complained about the way his coauthors of a study on vaccines and autism dealt with some data that he felt was statistically significant.
  70. The Leicester Method proves that good sanitation and quarantines – not the smallpox vaccine – eradicated smallpox. – In addition to quarantines, they used vaccines in Leicester. They just didn’t use universal vaccination. They used ring vaccination – making sure all of the contacts of the person with smallpox got a smallpox vaccine. The Leicester Method of dealing with smallpox does not support the idea that smallpox was eradicated solely with good sanitation and quarantining folks with smallpox.
  71. That vaccines have been legally called unavoidably unsafe means that they are dangerous. – Not true.
  72. Vaccinating a child is like taking a child out of their perfectly functioning carseat and strapping them into a seat with dental floss. – Actually, the proper analogy would be that vaccinating a child is like protecting them with an age appropriate car seat. Skipping or delaying your child’s vaccines is like driving them around without a car seat or seat belts, so that they are unprotected if you get in a car accident.
  73. The HPV vaccine isn’t safe, isn’t even necessary, and is probably the most dangerous vaccine every made. – Of course this is not true. Fortunately, more and more parents are coming to understand that the over-the-top anti-vaccine rhetoric about the HPV vaccine isn’t true. The HPV vaccines are safe and necessary and they work to prevent cancer.
  74. Parents are losing their choice about vaccines and are being forced to vaccinate their kids. – While slogans about choice are catchy, new vaccine laws and mandates do not force anyone to get vaccinated.
  75. Vaccines cause ADHD. – Yes, you can add ADHD to the long list of so-called vaccine-induced diseases, but like the others, it isn’t true. Vaccines do not cause ADHD.
  76. Polio epidemics were caused by spraying of the pesticide DDT. – The only connection between DDT and polio is that some folks were so scared of polio, that once an outbreak came to town, because they didn’t know what caused it yet, they sprayed with DDT thinking it might be spread by mosquitoes. So polio first and then DDT spraying.
  77. You should skip or delay vaccinating your premature baby. – Except in some situations when preterm babies weigh less than 2000g and mom is known to be hepatitis B negative, your preterm baby should be vaccinated according to the standard immunization schedule.
  78. There are no double-blind, placebo-controlled randomized clinical trials for vaccines. – Placebos are used in many vaccine trials and there are many double-blind, placebo-controlled randomized clinical trials for vaccines.
  79. Homeopathic vaccines are a safe and effective alternative to real vaccines. – While they might not cause many side effects, homeopathic vaccines or nosodes aren’t going to do much else either. They certainly aren’t going to protect your child from any vaccine-preventable diseases.
  80. You should follow a Paleo vaccine schedule. – Like other non-standard, parent-selected, delayed protection vaccine schedules, the Paleo vaccine schedule is a made-up alternative to the standard immunization schedule and will leave your kids unprotected from vaccine-preventative diseases.
  81. People who are anti-vaccine don’t hurt autistic families. – While I’m sure they tell themselves that, in addition to pushing the idea that autistic kids are damaged by vaccines, there are many other ways that the anti-vaccine movement hurts autistic families.
  82. Vegans don’t vaccinate their kids. – While there are few vegan vaccines, most vegans do indeed vaccinate their kids.
  83. The measles vaccine doesn’t protect against all measles strains. – All currently used measles containing vaccines, including the MMR vaccine, do actually protect against all measles strains. There is only one main type of measles virus, despite the many small changes in the virus that can help us identify different strains and genotypes.
  84. There are over 100 vaccine/autism research papers that prove that vaccines cause autism. – No matter how high the count of research papers gets to, they still don’t support a link between vaccines and autism.
  85. The anti-vaccine movement is supported by science and research. – The beliefs of the anti-vaccine movement, from germ theory denialism to ideas about detoxing and chemtrails, are only supported by pseudoscience and conspiracy theories.
  86. A tetanus shot won’t help after you have already been cut, stabbed, or bitten. – Well, if you are fully vaccinated, you might not even need a tetanus shot after a cut, because you are already protected. If you are unvaccinated or if it has been more than 5 years since your last shot, a tetanus shot and tetanus immune globulin will indeed work to protect against tetanus spores germinating, growing and producing their exotoxin that produces the symptoms of tetanus.
  87. Vaccine immunity isn’t long lasting. – While that is true for some vaccines, vaccines do protect you during critical times, in most cases they do provide long lasting protection.
  88. Immigrants and refugees are spreading disease in the United States and are putting us at risk for a new pandemic disease outbreak. – Immigrants and refugees are not spreading disease in the United States.
  89. Parents have to pay the Vaccine Excise Tax to fund the Vaccine Injury Compensation Trust Fund. – The Vaccine Excise Tax is actually a tax that the U.S. Department of the Treasury collects from vaccine manufacturers.
  90. Pediatricians are just vaccine pushers. – If that were true, then how come pediatricians don’t push all of the FDA approved vaccines on kids, such as the adenovirus vaccine, BCG vaccine, typhoid vaccine, or yellow fever vaccine?
  91. Chiropractors aren’t anti-vaccine. – Maybe some aren’t, but most chiropractors seem to believe in germ theory denialism, push anti-vaccine talking points, and don’t vaccinate their own kids.
  92. There are 300 new vaccines in the pipeline. – While new vaccines are always being researched and developed, we are not getting 300 new vaccines anytime soon. At least 1/3 of those are therapeutic vaccines for cancer. And 1/4 are for the same four infectious diseases – HIV, flu, RSV, and Ebola. So no, we aren’t getting 300 new vaccines.
  93. Most celebrities don’t vaccinate their kids. – While anti-vaccine celebrities seem to make the news a lot, there are many celebrities who advocate for vaccines.
  94. Breastfeeding is better than vaccines at preventing infections. – While breastfeeding is great and has a lot of benefits, including providing some passive immunity, it won’t protect your child from most vaccine-preventable diseases. Breastmilk contains IgA antibodies, and not the IgG antibodies that vaccines trigger in our bodies and which do cross the placenta and protect our babies for a short time. Breastmilk can help protect a child against some viruses and bacteria that cause diarrhea and respiratory infections, but it is not better than vaccines at preventing vaccine-preventable diseases.
  95. Ingredients in vaccines are toxic because they are injected directly into a child’s bloodstream and aren’t ingested and filtered by the body’s natural defenses. – The ingested vs injected argument comes up a lot, but doesn’t make much sense. For one thing, vaccines aren’t injected into the bloodstream.
  96. I used Google University to research vaccines, just like other medical professionals use google to look up medical information. – While it is true that many medical professionals are likely turning to the internet more than textbooks when they need to look something up, they are often using online medical textbooks or other reputable sites. They aren’t cherry picking information from sites that simply confirm their biases against vaccines.
  97. Vaccines aren’t tested for use in pregnancy. – They are and pregnant women should get a seasonal flu vaccine and a Tdap vaccine each and every pregnancy.
  98. DNA in vaccines can cause autism. – While highly fragmented (mostly destroyed) DNA has been found in some vaccines, it can’t cause harm.
  99. The Amish don’t get autism. – The Amish do get autism. They also do vaccinate – sometimes. They also get vaccine-preventable diseases as we saw in the large Ohio measles outbreak of 2014.
  100. The flu shot contains a vaginal spermicide. – It doesn’t.

Get educated about vaccines so you don’t get taken in by any of these myths.

Vaccines work. Vaccines are safe. Vaccines are necessary.

More On Vaccine Myths

 

Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

Spend much time on anti-vaccine websites or forums and you will soon be warned that vaccines are not evaluated for mutagenicity, carcinogenicity or impairment of fertility.

Actually, you can often read that simply by reading a vaccine’s package insert.

Mutagenicity, Carcinogenicity and Impairment of Fertility

What are these term exactly?

  • mutagenicity – being known or suspected of causing mutations in our DNA, which can lead to cancer
  • carcinogenicity – being known or suspected of being able to cause cancer
  • impairment of fertility

And why are they listed in Section 13 of a vaccine’s package insert?

The Section 13 Vaccine Conspiracy?

More importantly, why do some folks talk about Section 13.1 of a vaccine’s package insert like it is Area 51 or Agenda 21?

“13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, mutagenesis, impairment of fertility. This subsection must state whether long term studies in animals have been performed to evaluate carcinogenic potential and, if so, the species and results. If results from reproduction studies or other data in animals raise concern about mutagenesis or impairment of fertility in either males or females, this must be described. Any precautionary statement on these topics must include practical, relevant advice to the prescriber on the significance of these animal findings. Human data suggesting that the drug may be carcinogenic or mutagenic, or suggesting that it impairs fertility, as described in the “Warnings and Precautions” section, must not be included in this subsection of the labeling.”

CFR – Code of Federal Regulations Title 21

So no material for a vaccine conspiracy?

Just information on studies in animals?

“The goals of the nonclinical safety evaluation generally include a characterization of toxic effects with respect to target organs, dose dependence, relationship to exposure, and, when appropriate, potential reversibility. This information is used to estimate an initial safe starting dose and dose range for the human trials and to identify parameters for clinical monitoring for potential adverse effects. The nonclinical safety studies, although usually limited at the beginning of clinical development, should be adequate to characterize potential adverse effects that might occur under the conditions of the clinical trial to be supported.”

FDA on Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals 

It still sounds important though…

Are Vaccines Evaluated for Mutagenicity, Carcinogenicity or Impairment of Fertility?

As important as vaccines are, no one wants them to mutate our children, cause cancer, or keep them from having babies.

Fortunately, they don’t!

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

And that’s because vaccines are safe and well tested.

Then why do anti-vaccine folks scare parents into thinking that vaccines are missing necessary testing when the package insert states that they are “not evaluated for mutagenicity, carcinogenicity or impairment of fertility?”

Cancer is caused by a host of factors. Vaccines have a role in preventing and potentially treating some types of cancer. Components of vaccines and their associated cell lines that viruses are grown in are safe and have not been shown to induce cancer in the vaccinated host.
“Cancer is caused by a host of factors. Vaccines have a role in preventing and potentially treating some types of cancer. Components of vaccines and their associated cell lines that viruses are grown in are safe and have not been shown to induce cancer in the vaccinated host.”

Probably because it sounds scarier than saying that vaccines have a low risk of inducing tumors and that there are very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

That means that if  a package insert says that it has “not been evaluated,” it is simply because it was not necessary or appropriate. It is not because they just didn’t want to do it and left those tests out.

That doesn’t sound as scary though.

All necessary pre-clinical or nonclinical testing is done on vaccines and their components. You just don’t see long term testing that would be listed in the package insert unless the initial tests found a problem.

Also remember that vaccines are monitored through several passive and active safety systems that would detect issues with mutagenicity, carcinogenicity, and impairment of fertility.

And several vaccines actually prevent cancer!

What to Know About Vaccines and Mutagenicity, Carcinogenicity and Impairment of Fertility

Vaccines are appropriately evaluated for mutagenicity, carcinogenicity and impairment of fertility, when necessary, as a part of pre-clinical or nonclinical studies that occur even before the first phase one studies on people.

More About Vaccines and Mutagenicity, Carcinogenicity and Impairment of Fertility

 

How to Read a Package Insert for a Vaccine

The highlights of prescribing information of the package insert offers a nice summary of each section, with more details in the full prescribing information section that follows.
The Highlights of Prescribing Information of the package insert offers a nice summary of each section, with more details in the Full Prescribing Information section that follows.

Show me the package insert!

If you are going to ask for a package insert, you should know what’s in it and how it should be read.

Otherwise, it is easy to get misled by antivaccine propaganda, like when Mike Adams claimed he discovered “a vaccine document on the FDA’s own website that openly admits vaccines are linked to autism.”

He really just found the widely available vaccine package insert that said no such thing.

How to Read a Package Insert for a Vaccine

What goes into a package insert is dictated by the FDA, specifically the Code of Federal Regulations Title 21, and Section 314 of the NCVIA, after consultation with the Advisory Commission on Childhood Vaccines.

Much like the package inserts for other medicines, a vaccine package insert includes up to 17 major sections, including:

  1. Indications and Usage – what the vaccine is used for
  2. Dosage and Administration – the recommended dose of vaccine, when and where it should be given, and how to mix it
  3. Dosage Forms and Strengths – available dosage forms
  4. Contraindications – all situations when the vaccine should not be given
  5. Warning and Precautions – all adverse reactions and safety hazards that may occur after getting the vaccine and what you should do if they occur
  6. Adverse Reactions – this section includes clinical trials experience, postmarketing experience, and voluntary reports, and it is very important to understand that it is not always possible to establish a causal relationship to vaccination for these adverse effects. So just because something is listed here, whether it is SIDS, autism, drowning, or a car accident, doesn’t mean that it was actually caused by the vaccine.
  7. Drug Interactions – any reactions you might expect between the vaccine and other drugs
  8. Use in Specific Populations – can include recommendations for use in pregnancy, nursing mothers, pediatric use, and geriatric use
  9.  Drug abuse and dependence – usually blank
  10.  Overdosage – usually blank
  11. Description – general information about the vaccine, including how it was made and all vaccine ingredients.
  12. Clinical Pharmacology – how the vaccine works, including how long you might expect protection to last
  13. Nonclinical Toxicology – must include a section on carcinogenesis, mutagenesis, impairment of fertility, even if it is to say that the vaccine “has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.”
  14. Clinical Studies – a discussion of the clinical studies that help us understand how to use the drug safely and effectively
  15. References – when necessary, a list of references that are important to decisions about the use of the vaccine
  16. How Supplied/Storage and Handling
  17. Patient Counseling Information – information necessary for patients to use the drug safely and effectively

In addition to not having sections 9 and 10, some vaccines don’t have a section 13. It is not a conspiracy. Some older vaccines, like Varivax, do not have to have a section 13 per FDA labeling rules.

Myths About Package Inserts

Just as important as what’s listed in a vaccine package insert, is what the package insert doesn’t say.

Or what you might be led to believe it says.

“To ensure the safety of new vaccines, preclinical toxicology studies are conducted prior to the initiation of, and concurrently with, clinical studies. There are five different types of preclinical toxicology study in the evaluation of vaccine safety: single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any adverse effects are observed in the course of these studies, they should be fully evaluated and a final safety decision made accordingly. ”

M.D. Green on the Preclinical Toxicology of Vaccines

When reading a package insert, don’t be misled into thinking that:

  • you should be worried if a package insert states that a vaccine has not been evaluated for carcinogenic (being known or suspected of being able to cause cancer) or mutagenic (being known or suspected of causing mutations in our DNA, which can lead to cancer) potential or impairment of male fertility. Vaccines don’t cause cancer or impair male fertility, or female fertility for that matter. And as you probably know, many vaccines actually prevent cancer. Formaldehyde is the only vaccine ingredient on the list of known carcinogens, but it is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is carcinogenic, not the residual amounts you might get in a vaccine over short amounts of time.
  • any vaccine actually causes SIDS or autism
  • pediatricians are trying to keep parents from reading package inserts. Your pediatrician is probably just confused as to why you want it, as the VIS is designed for parents, not the package insert. But if even if your pediatrician doesn’t hand you a package insert for each and every vaccine your child is going to get, they are readily available from the FDA and many other websites.

Better yet, just don’t be misled by anti-vaccine misinformation.

“Based on previous experience, carcinogenicity studies are generally not needed for adjuvants or adjuvanted vaccines.”

WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines

Vaccines are thoroughly tested for both efficacy and safety before they are approved.

It is also important to understand that the WHO Guidelines on Nonclinical Evaluation of Vaccine Adjuvants and Adjuvanted Vaccines and the European Medicines Evaluation Agency both state that mutagenicity and carcincogenicity studies are typically not required for vaccines.

Why not?

It is because vaccines have a low risk of inducing tumors.

There are also very specific guidelines and rules for when a manufacturer needs to perform fertility studies.

So, as expected, there are no surprises in vaccine package inserts. You can be sure that everything that needs to be tested to show that a vaccine is safe has been done. If it has “not been evaluated,” it is simply because it was not necessary.

Get educated about vaccines and get your family vaccinated and protected against vaccine preventable diseases.

What to Know About Reading Vaccine Package Inserts

Learn how to read vaccine package inserts so that you aren’t misled by many of the myths about what they do and don’t say, including why they are likely missing information on the vaccine’s potential to cause carcinogenicity, mutagenicity, or impairment of fertility.

More on How to Read a Package Insert for a Vaccine:

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: