Tag: adjuvants

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

How Are Vaccines Really Made?

Do you know how vaccines are made?

A lab worker injects flu virus into an egg, one of many steps in making our flu vaccines.
A lab worker injects flu virus into an egg, one of many steps in making our flu vaccines. Photo courtesy of the FDA

When we say that chickens are used to make flu vaccine, do you think that means that live chickens are actually infected with the flu to make the vaccine?

They aren’t.

Just like live monkeys aren’t injected with the polio virus to make the polio vaccine.

Those are just myths you see in vaccine scare videos on anti-vaccine websites.

How Are Vaccines Really Made?

So how are vaccines really made?

It depends, after all, there are a lot of different types of vaccines.

But instead of monkey cages and chicken coops in the labs of today’s vaccine manufacturers, you will find clean rooms with large scale, stainless steel bioreactors, master cell banks, seed fermenters, microcarriers, centrifuges, filtration and chromatography equipment, and filling and lyophilization equipment.

Do you picture a series of these large scale, stainless steel bioreactors when you think about how vaccines are made?
Do you picture a series of these large scale, stainless steel bioreactors when you think about how vaccines are made?

That doesn’t sound so scary or shocking, does it?

What’s shocking about the whole process of making a vaccine?

It takes a long time. Often one to three years! And that’s after all of the time that went into the research, testing, and licensing of the vaccine.

“Viruses are grown in cells, which can be either primary cells, such as chicken fbroblasts (e.g., yellow fever vaccine), or continuous cell lines, such as MRC-5 (e.g., hepatitis A vaccine). Bacterial pathogens are grown in bioreactors using medium developed to optimize the yield of the antigen while maintaining its integrity. Recombinant proteins can be manufactured in bacteria, yeast, or cell culture. ”

Plotkin’s Vaccines (Seventh Edition)

The only other shocking thing about making vaccines is how boring it all is, at least if you aren’t into biology, with most vaccines using the same basic steps:

  • decide on the type of antigen – vaccines can be made of attenuated live viruses, inactivated viruses or bacteria,  or just part of the virus or bacteria (subunit and conjugate vaccines)
  • generate an antigen – this is the thing in the vaccine that will stimulate an immune response and protect your child. It used to be what anti-vaccine folks were concerned about until we explained that kids today are exposed to far fewer antigens, even though they get more vaccines and more protection.
  • release and isolate the antigen – the antigen was either growing in cells or other medium and in this step, as much of the antigen is collected as possible.
  • purify the antigen – multiple steps are involved in removing many of the vaccine ingredients or excipients that were used up to this step by precipitation, ultrafiltration, and column chromatography, etc. That’s why many are said to remain only in residual amounts, like formaldehyde.
  • strengthen the antigen – in this step, an adjuvant might be added.
  • combine all of the ingredientsstabilizers and preservatives might also be added in this step.
  • last steps – finished vaccine is put in vials and syringes and then packaged
  • lot release and distribution – each lot is tested before it is released to make sure it meets FDA standards for potency, safety, and sterility.

None of that sounds as scary as injecting monkeys with smallpox, watching them die, and then harvesting their infected kidney cells though, does it? If you have watched any of the anti-vaccine scare videos, hopefully the first thing that came to mind is that the smallpox vaccine isn’t actually made with the smallpox virus! It is, of course, made with vaccinia virus and wouldn’t cause anyone, whether a monkey, cow, or person to actually get smallpox. And if you haven’t figured it out by now, monkeys aren’t used to make smallpox vaccines.

“Both vaccines are derived from the New York City Board of Health strain of vaccinia, but Dryvax was grown on the skin of calves and then essentially freeze-dried for storage. It was licensed by FDA in 1931 but is no longer manufactured. ACAM2000, a “second generation” smallpox vaccine, is derived from a clone of Dryvax, purified, and produced using modern cell culture technology.”

FDA on ACAM2000 (Smallpox Vaccine) Questions and Answers

In fact, most of today’s vaccines are made in bioreactors, not in cows or monkeys.

Flu vaccine is mostly still made using chicken eggs, specifically 11-day-old embryonated chicken eggs. The flu viruses are passed into the eggs, incubated for a time to allow them to grow, and then harvested, inactivated, and purified.

How purified do they get? So purified that even people with egg allergies can get a flu vaccine these days.

Vaccines are safe. Vaccines are made safely.

What to Know About How Vaccines Are Really Made

Vaccines are made using a very safe and scientific process that is heavily regulated that will neither scare nor shock you.

More on How Vaccines Are Really Made

Who is Dr. Yehuda Shoenfeld

Dr. Yehuda Shoenfeld is an immunologist who heads the Zabludowicz Center for Autoimmune Diseases, which was created by Poju Zabludowicz. He is also on the scientific advisory board for the Children’s Medical Safety Research Institute.

He claims to have discovered a novel vaccine-associated autoimmune disease – Autoimmune Syndrome Induced by Adjuvants (ASIA).

The History of Adjuvant Diseases

Shoenfeld’s Autoimmune Syndrome Induced by Adjuvants is not the first time that adjuvants have been blamed for causing diseases in people.

As far back as 1964, Kan Miyoshi had written about “human adjuvant disease” following augmentation with silicone breast implants. Silicone gel-filled breast implants were eventually removed from the market, following case reports describing an association and years of lawsuits against manufacturers, but more studies were done that found that “there was no evidence that silicone breast implants caused systemic health effects such as cancer or autoimmune disease.”

So gel-filled breast implants came back, but unfortunately, the idea of “human adjuvant disease” never really went away.

Dr. Yehuda Shoenfeld and Vaccines

Dr. Shoenfeld is the latest to blame adjuvants for causing disease.

“At present, there is no evidence to suggest that ASIA syndrome is a viable explanation for unusual autoimmune diseases.”

David Hawkes on Revisiting adverse reactions to vaccines: A critical appraisal of Autoimmune Syndrome Induced by Adjuvants (ASIA)

It has helped him to become very well known among the modern anti-vaccine movement, a hero to some, who use his new vaccine-associated autoimmune diseases as a reason to scare parents away from vaccinating and protecting their kids.

That’s despite the fact that ASIA has been rejected by the NVICP as a basis for vaccine injury and is dismissed by most medical experts.

Dr. Yehuda Shoenfeld Studies

Among the studies published by Dr. Yehuda Shoenfeld include:

  • Human papilloma virus and lupus: the virus, the vaccine and the disease.
  • Journal of Autoimmunity. Seasonality and autoimmune diseases: The contribution of the four seasons to the mosaic of autoimmunity.
  • Current Opinions in Rheumatology. Autoimmune/Inflammatory Syndrome Induced by Adjuvants and Thyroid Autoimmunity.
  • Lupus.Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome) – An update.
  • Immunologic Research. Phospholipid supplementation can attenuate vaccine-induced depressive-like behavior in mice.
  • Behavioral abnormalities in female mice following administration of aluminum adjuvants and the human papillomavirus (HPV) vaccine Gardasil.
  • Immunologic Research. Pancreatitis after human papillomavirus vaccination: a matter of molecular mimicry.
  • Israel Medical Association Journal. Autoimmune/Inflammatory Syndrome Induced by Adjuvants and Sjögren’s Syndrome.
  • Immunologic Research. Adjuvants and lymphoma risk as part of the ASIA spectrum.
  • Journal of Autoimmunity. Immunization with hepatitis B vaccine accelerates SLE-like disease in a murine model.
  • Postural Orthostatic Tachycardia With Chronic Fatigue After HPV Vaccination as Part of the “Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants”: Case Report and Literature Review.
  • Immunity, autoimmunity and inflammatory bowel disease.
  • Lupus. When APS (Hughes syndrome) met the autoimmune/inflammatory syndrome induced by adjuvants (ASIA).
  • Brief report: immune factors in autism: a critical review.

So, among the things that Shoenfeld seems to link to vaccine adjuvants include the development of primary ovarian insufficiency, depression, autism, pancreatitis, rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, Hashimoto’s thyroiditis, subacute thyroiditis, antiphospholipid syndrome, transverse myelitis, lymphoma, POTS, and antiphospholipid antibody syndrome.

How does he do it? Mostly through experiments on mice and small case reports.

Also it seems, sometimes by a little misdirection.

“A cohort study was performed to assess the risk of new onset autoimmune disease in young women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom (55). The study reported an incidence rate ratio (95% CI) of 3.75 (1.25–11.31) for autoimmune thyroiditis among females.”

Yehuda Shoenfeld on Autoimmune/Inflammatory Syndrome Induced by Adjuvants and Thyroid Autoimmunity

Shoenfeld’s article on “Autoimmune/Inflammatory Syndrome Induced by Adjuvants and Thyroid Autoimmunity,” actually cites a study which concluded that “There was no evidence of an increased risk of AD in women aged 9 to 25 years after AS04-HPV-16/18 vaccination.”

Dr. Yehuda Shoenfeld Controversies

The CMSRI funded the research and sponsored the conference that showcased Shoenfeld's work.
The CMSRI funded the research and sponsored the conference that showcased Shoenfeld’s work.

Among the biggest problems with the work of Dr. Shoenfeld are claims that:

  • he receives funding for his research from the Children’s Medical Safety Research Institute, who’s founder once said that “Vaccines are a holocaust of poison on our children’s brains and immune systems.” Even his book, Vaccines and Autoimmunity, was funded by the CMSRI. His conferences are also sponsored by the CMSRI, including the International Congress on Autoimmunity and the International Symposium on Vaccines.
  • he seems to get many of his studies published in what experts describe as predatory open access journals
  • he seems to get many of his studies published in journals on which he sits on the journal’s editorial board, a potential conflict of interest, including Autoimmunity Reviews (founder and editor), the Journal of Autoimmunity (co-editor), and the Israel Medical Association Journal (founder and editor), Immunologic Research (topic editor for Immunoregulation and Autoimmunity), Lupus (Editorial Board). It is usually considered a better practice to get an outside editor in these situations, instead of editing your own articles.
  • at least one of the journals he edits, Autoimmunity Reviews, is said to be very sympathetic to anti-vaccine studies
  • he serves as an expert witness in vaccine injury lawsuits, another potential conflict of interest
  • at least one Shoenfeld study was retracted after it was published
  • none of his ASIA studies are in more high impact journals, such as The Journal of Allergy and Clinical Immunology, Annals of the Rheumatic Diseases, or Annual Review of Immunology, etc.
  • many of his collaborators are also funded by CMSRI

The biggest issue is that adjuvants in vaccines are being made to be seen as a problem by anti-vaccine folks, even as Shoenfeld claims that “vaccines are beneficial for the vast majority of subjects including those who suffer from autoimmune-rheumatic diseases,” and even he finds problems in only “a small minority of individuals.”

“It reminds us that due to the ubiquitous nature of the innate and adaptive response, that there are a large number of diseases that have either an inflammatory and/or specific autoimmune response, we have to keep an open eye because everything is potentially autoimmune until proven otherwise.”

Yehuda Shoenfeld on Everything is Autoimmune Until Proven Otherwise

It was another Shoenfeld study that suggested that the HPV vaccine could cause primary ovarian insufficiency. Shoenfeld’s “link” between the HPV vaccine and primary ovarian insufficiency was based on a review of only three case studies, for which he was the expert witness in lawsuits for two of the cases!

Shoenfeld's article in Vaccine about behavioral problems after HPV vaccination was withdrawn because of serious concerns regarding the scientific soundness of the article.
Shoenfeld’s article in Vaccine about behavioral problems after HPV vaccination was withdrawn because of “serious concerns regarding the scientific soundness of the article.”

Most importantly, many studies have failed to confirm Shoenfeld’s link between the HPV vaccine and primary ovarian insufficiency and much of his other work:

Like his idea of novel vaccine-associated autoimmune disease (ASIA), which he still pushes, it was proven otherwise.

Dr. Shoenfeld Is on the Wrong Side of the Vaccine Debate

Dr. Shoenfeld’s characterization of the vaccine debate will likely surprise many of his followers.

“On the one hand, we find anti-vaccination movements, which divulge and disseminate misleading information, myths, prejudices, and even frauds, with the main aim of denying that vaccination practices represent a major public health measure, being effective in controlling infectious diseases and safeguarding the wellbeing of entire communities.”

Shoenfeld et al. on Debate on vaccines and autoimmunity: Do not attack the author, yet discuss it methodologically

His characterization that most vaccine safety research is potentially biased because it is “mainly financed and sponsored by pharmaceutical industries” is also surprising, or maybe just ironic, considering of where he gets his funding.

“Instead of focusing on methodological issues and content, the ‘‘prevailing wisdom” has put to rest any view that would contradict the sacred ‘‘doctrine” of vaccinology.”

Shoenfeld et al. on Debate on vaccines and autoimmunity: Do not attack the author, yet discuss it methodologically

His conclusions of why his studies are criticized are also very wrong.

“…we feel that the continued presentation of a theory without evidence in both medico-legal and scientific forums is detrimental to the exploration of further understanding of the causational factors of a patient’s condition.”

D. Hawkes et al. on Response to: HPV vaccine and autoimmunity

It is the “actual science” of his studies that is “being methodologically assessed and critiqued.” And it has been found to be lacking.

What To Know About Dr. Yehuda Shoenfeld

With funding from the CMSRI and the Zabludowicz Center for Autoimmune Diseases, Dr. Yehuda Shoenfeld has folks falsely believing that adjuvants in vaccines are causing autoimmune diseases – his Autoimmune Syndrome Induced by Adjuvants (ASIA).

More About Dr. Yehuda Shoenfeld

Who Is Tetyana Obukhanych?

It isn’t very hard to figure out who Tetyana Obukhanych really is.

Who Is Tetyana Obukhanych?

Every anti-vaccine article you read that is either about her, or by her, goes out of their way to make sure that you know that she:

  • has a Ph.D. in Immunology: working in the lab of Dr. Michel Nussenzweig, she presented her thesis on Immunologic Memory to Polysaccharide Antigens to the faculty of The Rockefeller University in 2006, in which she proved that vaccines work
  • trained at Harvard: started her postdoctoral training at Harvard Medical School, which can lead to a tenure-track faculty position (it didn’t)
  • trained at Stanford: did some of her postdoctoral training in the Department of Psychiatry & Behavioral Science at the Stanford University School of Medicine, which again, can lead to a tenure-track faculty position (it didn’t)
  • has 8 published peer-reviewed research articles: that she co-authored with many others and only one has her as the primary author, in which she concluded that “As the generation and regulation of immunologic memory is central to vaccination, our findings help explain the mode of action of the few existing polysaccharide vaccines and provide a rationale for a wider application of polysaccharide-based strategies in vaccination.”
  • wrote a book about vaccines: that she self-published for the Kindle
  • frequently lectures about vaccines: which are basically interviews and talks that push classic anti-vaccine misinformation, despite her having “studied immunology in some of the world’s most prestigious medical institutions”

Not surprisingly, the modern anti-vaccine movement loves her.

“All throughout my PhD training I was a faithful believer in vaccination. I believed for almost two decades that the reason I had contracted measles and whooping cough during my teenage years was because I wasn’t vaccinated against these diseases. Then, when I had to check my childhood vaccination records, I discovered that I was in fact fully vaccinated for both measles and whooping cough, and the resulting contradiction necessitated me to reexamine all my previous beliefs about the immunologic theory behind vaccination.”

Tetyana Obukhanych, Ph.D.

While getting a vaccine-preventable disease after being vaccinated might make some folks question the whole “immunologic theory behind vaccination,” for most others, they would simply question other factors that might have led to this possible vaccine failure.

Was she fully vaccinated according to the US immunization schedule (two doses of a measles containing vaccine and four doses of a pertussis containing vaccine, with a booster as a teenager)? Were the vaccines equivalent? Were there outbreaks going on?

Outbreaks?

Although it is not clear when she came to the United States to pursue her education, Tetyana Obukhanych was born in Ukraine and likely lived through the “massive epidemic” of diphtheria and other vaccine-preventable diseases in the Newly Independent States of the former Soviet Union in the early 1990s.

“This epidemic, primarily affecting adults in most Newly Independent States of the former Soviet Union, demonstrates that in a modern society diphtheria can still spread explosively and cause extensive illness and death.”

Diphtheria in the Former Soviet Union: Reemergence of a Pandemic Disease

In Ukraine alone, there were 17,387 cases of diphtheria and 646 deaths from 1992 to 1997. Also high, were cases of measles (over 23,000 cases in 1993) and pertussis (almost 7,000 cases in 1993).

Even if she had already left Ukraine, those outbreaks are great evidence that vaccines work and that vaccines are necessary.

Tetyana Obukhanych on Vaccines

Instead of discussing them, Tetyana Obukhanych operates using an appeal to authority to scare parents away from vaccinating and protecting their kids.

As an immunologist, isn’t she really an authority though?

Consider that even though she might be a Harvard trained immunologist with a PhD, there are:

  • over 7,600 members of the American Association of Immunologists
  • just over 8,000 residents and postdoctoral fellows at Harvard
  • 1,279 postdocs at Standford School of Medicine

and few, if any, agree with anything she says about vaccines.

“Research has repeatedly confirmed that vaccinations are safe and highly effective for all healthy children and adults, and any suggestions to the contrary have been discredited. Ongoing vaccine research continually reaffirms its safety and efficacy, including the number of vaccines administered at any one time and the recommended vaccination schedule.”

The American Association of Immunologists Statement on Vaccines

Now if “more than 7,600 basic and clinical immunologists, strongly support the use of vaccines to prevent disease,” then why would you even think about listening to just one who doesn’t?

We actually know why.

It’s called confirmation bias.

“Many questions in science and medicine are confusing and frustrating, but fortunately, the question of vaccination need not be one of them. Because for vaccines, the verdict is already in: guilty of being safe, effective, powerful, and highly recommended.”

Vivian Chou is a Ph.D. student in the Biological and Biomedical Sciences Program at Harvard Medical School.

So what does Tetyana Obukhanych think about vaccines?

  • A pic of a cherry on the cover would have been more appropriate, as a lot of cherry picking of studies and references goes on in the book.
    A pic of a cherry on the cover would have been more appropriate, as a lot of cherry picking of studies and references goes on in her e-book.

    that experts overlooked that the smallpox vaccine didn’t provide life-long immunity, even though it was known by the end of the 19th century that boosters could be needed and that was well before any other vaccine was developed

  • that Immunology has no theoretical or evidence-based explanation for immunity – she should read the book Immunity by William E. Paul, MD – an internationally renowned immunologist
  • that instead of simply helping vaccines work better, adjuvants are necessary to help vaccines work at all, because “purified protein antigens do not have an ability to induce antibody production in humans or animals (the recipients) on their own.”
  • that adjuvants are necessary to develop allergies, including food allergies – because “without an adjuvant, there will be no immune response to a food protein or peptide, and it will not become an allergen.”
  • that vaccines are only monitored for two or three weeks to make sure they are safe
  • that titer tests or “a positive serological test is a proof of immunity only in the absence of vaccination. In vaccinated individuals, a serological test of immunity is biologically meaningless.”
  • that we have created a so-called vaccine paradox, in which “vaccines reduce the overall incidence of childhood diseases, yet make them infinitely more dangerous for the next generation of babies.”
  • that homeopathy works
  • that “for most communicable viral diseases there is no herd immunity in the post – elimination era.”

Being Harvard trained can certainly be a big deal. After all, John Enders, “The Father of Modern Vaccines,” who won the Nobel Prize for his work on the cultivation of the poliomyelitis viruses and who developed the first live measles vaccine, trained at Harvard.

“The apparent absence of major viral epidemics in the U.S. is now due to the absence of endemic viral exposure, not herd immunity.”

Tetyana Obukhanych, PhD on Vaccine Illusion

Some would wonder if Tetyana Obukhanych even knows who John Enders was…

Tragically, as Dr. Tetyana Obukhanych, the Harvard trained immunologist from Ukraine goes on and on about how vaccines don’t work, Ukraine is facing outbreaks of measles and other vaccine-preventable diseases due to parents not vaccinating their kids and limited supplies of vaccines.

Unfortunately, they aren’t lucky enough to have an “absence of endemic viral exposure,” or in other words, herd immunity.

What To Know About Tetyana Obukhanych

While she is a Harvard trained immunologist with a PhD, Tetyana Obukhanych pushes classic misinformation about vaccines that you would be hard pressed to get any other immunologist or Harvard grad to agree.

More on Tetyana Obukhanych

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.

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Vaccine Induced Diseases

In addition to autism, many anti-vaccination ‘experts’ continue to claim that vaccines cause other diseases and conditions, including SIDS and Shaken Baby Syndrome.

Vaccine Injuries

Are there any real vaccine induced diseases?

There is vaccine-associated paralytic poliomyelitis (VAPP), which can rarely occur after getting the oral polio vaccine.

And there are other conditions that are listed as table injuries under the NVICP, including brachial neuritis, Guillain-Barré syndrome, thrombocytopenic purpura, and encephalitis, etc.

Vaccine Induced Diseases

Vaccines can also sometimes cause fainting and febrile seizures.

Most other ‘vaccine induced diseases’ that are supposed to be caused by a vaccine injury have been proven to not be though.

These include:

  • ADHD
  • Alzheimer’s disease
  • ASIA
  • seasonal allergies
  • asthma
  • Celiac disease
  • diabetes
  • Down syndrome (Trisomy 21)
  • eczema
  • Graves disease
  • Gulf War Syndrome
  • Henoch-Schoenlein purpura
  • infertility
  • Kawasaki syndrome
  • leprosy
  • Lou Gehrig’s disease
  • multiple sclerosis
  • myasthenia gravis
  • obesity
  • Parkinson’s disease
  • peanut allergies
  • POTS
  • SSPE

The NVIC even provides “new evidence for a connection” between diabetes and vaccination reactions – from 1998.

And many sites claim they can ‘heal’ your child’s vaccine induced diseases (VIDS) with homeopathy or detox plans scams.

What To Know About Vaccine Induced Diseases

Vaccines are not 100% safe, but it is rare for them to cause serious conditions, and they certainly do not cause all of the ‘vaccine induced diseases’ that some folks try to scare you about.

More About Vaccine Induced Diseases

HPV Vaccine Myths

Few vaccines have generated as many myths as the HPV vaccine. Well at least not since folks falsely started to blame the MMR vaccine for causing an autism epidemic.

The HPV vaccines get their own myths though, from the idea that they encourage kids to have unprotected sex (they don’t) to the creation of a new disorder – ASIA (which most people think doesn’t exist).

Discussing the HPV vaccine on the Ricki Lake Show, Dr. Jay Gordon said that:

I don’t like this vaccine… Heaven help us if we have a generation of kids who get a hepatitis B vaccine and a HPV vaccine and they think that now unprotected sex is okay…

I don’t think it is really clear that this vaccine is really as safe as they say it is and it is certainly not as dangerous as they say it is, but I recommend against it in my practice.

Not surprisingly, studies have confirmed that HPV vaccines are safe and they don’t encourage kids to unprotected sex.

And this is the vaccine that Rep. Michele Bachmann said caused mental retardation:

She told me that her little daughter took that vaccine, that injection. And she suffered from mental retardation thereafter.

The president of the AAP had to correct her on that one.

Most parents now understand that the HPV vaccines are well studied and in continuing studies have only been found to cause mild side effects, just like most other vaccines.

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