Tag: adjuvants

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 homepathy works
  • that “for most communicable viral diseases there is no herd immunity in 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.

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

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.

For more information:

Squalene in Vaccines

Is squalene really the “dirty little secret” in our flu vaccines?

Of course not.

For one thing, squalene, an adjuvant, isn’t even used in vaccines in the United States. That’s easy to figure out when you look at the package inserts for our vaccines, the presence of which would make it hard to keep an ingredient like squalene a secret anyway.

And while squalene is used in some flu vaccines in other countries, the WHO reports that squalene is “is manufactured in the liver of every human body and circulates in our bloodstream.”

So anti-vax types are fussing about a natural ingredient that isn’t even in our vaccines?

For more information:

Adjuvants

An adjuvant is classically defined as “an ingredient of a vaccine that helps create a stronger immune response in the patient’s body.”

The most commonly used adjuvant in vaccines in the United States is aluminum.

Aluminum is an adjuvant in many DTaP, hepatitis A, hepatitis B, Hib, HPV, pneumococcal, and Tdap vaccines.

Monophosphoryl lipid A is another adjuvant that is used in one brand of HPV vaccine.

Not all vaccines have adjuvants though. And other countries use different adjuvants.

The bottom line is that adjuvants in vaccines are safe.

For more information:

Aluminum in Vaccines

Aluminum is a metal that has become the latest ‘toxin’ that some people worry about since thimerosal was removed from vaccines.

Like thimerosal, there are many myths and much misinformation that surrounds aluminum and which scares some parents away from vaccinating their kids.

Aluminum in Vaccines

Aluminum is an adjuvant. It is present in low amounts in some vaccines.

Unlike thimerosal, which is a preservative that kept bacteria from growing in multi-dose vials of vaccines, aluminum is present in vaccines to help them produce a stronger immune response.

Aluminum is used in vaccines that protect kids against several vaccine-preventable diseases, including diphtheria-tetanus-pertussis (DTaP and Tdap), Haemophilus influenzae type b (Hib), hepatitis B, hepatitis A, HPV, and pneumococcal disease (Prevnar).

Although not a vaccine that is routinely given to children, the rabies vaccine also contains aluminum.

Keep in mind that aluminum is a ubiquitous compound. It is “present in the water we drink, the air we breathe and the food we eat.”

But even when you consider how much aluminum infants might get from ingestion of breast milk or infant formula, drinking water, getting vaccines, and other sources, it is clear that “the body burden of aluminum from vaccines and diet throughout an infant’s first year of life is significantly less than the corresponding safe body burden of aluminum modeled using the regulatory MRL (minimal risk levels).”

Aluminum Didn’t Replace Thimerosal

One common myth about aluminum is that it replaced thimerosal in vaccines. Of course, it didn’t.

Thimerosal is a preservative. Aluminum is an adjuvant. They serve totally didn’t purposes.

As wrong as this myth is, you can see how antivaccine folks came up with it.

Even though aluminum has been used in vaccines for over 100 years, a few new vaccines that use aluminum have been added to the immunization schedule since 2000, which is about the time that thimerosal was removed from vaccines:

  • Prevnar
  • HepA
  • Tdap
  • HPV

Only two of these are given to younger children though, and only one, Prevnar, is given to infants.

Other newer vaccines, including rotavirus vaccines, flu vaccines, and meningococcal vaccines, don’t use aluminum as an adjuvant.

But even though two vaccines with aluminum were added to the immunization schedule for younger children, twice as many with thimerosal were changed to thimerosal free versions (hepatitis B, DTaP, flu, and Hib vaccines). So why are anti-vaccine folks saying that autism rates didn’t drop after thimerosal was removed from vaccines because it was replaced with aluminum?

Aluminum and Autism

While aluminum didn’t replace thimerosal in vaccines, it did replace thimerosal as what they could blame for the autism epidemic.

But of course, aluminum in vaccines doesn’t cause autism.

In fact, “vaccines using aluminum adjuvants have a demonstrated safety profile of more than six decades.”

Studies have concluded that the risk of aluminum in vaccines to infants “is not significant” and that the “risk to infants posed by the total aluminum exposure received from the entire recommended series of childhood vaccines over the first year of life is extremely low.”

As you get educated about vaccines, you will hopefully understand that the presence of aluminum in vaccines is not a good reason to skip or delay getting your kids vaccinated and protected against vaccine-preventable diseases.

Misinformation about Aluminum in Vaccines

Why are some parents afraid of aluminum in vaccines, sometimes going so far as asking their pediatrician to order vaccines with lower levels of aluminum or only wanting to give their child one aluminum containing vaccine at a time?

It is likely a safe bet that they are getting the idea from Dr. Bob Sears, who goes on and on about the possible dangers of aluminum, all of the while using a reference that concludes that “we found no evidence that aluminum salts in vaccines cause any serious or long-lasting adverse events.”

Dr. Bob once wrote an article for Mothering Magazine, “Is Aluminum the New Thimerosal?” He seems to be working hard to make sure that it is, as a source of fear for parents who want to follow his non-standard, parent-selected, delayed protection vaccine schedule.

What To Know about Aluminum in Vaccines

Aluminum is an ingredient that is safe and helps vaccines work better.

More Information About Aluminum in Vaccines

Updated on April 6, 2017