Tag: vaccine safety systems

The National Vaccine Injury Compensation Program Payouts Prove that Vaccines are Dangerous

Have you heard this argument?

Misinformation about the NVICP, like from this Focus for Health article, likely helps confuse and scare many parents.
Misinformation about the NVICP, like from this Focus for Health article, likely helps confuse and scare many parents.

Apparently, some folks think that because we have a National Vaccine Injury Compensation Program that compensates those who have serious problems after a vaccine, even deaths, then it must mean that vaccines are dangerous.

Do the National Vaccine Injury Compensation Program Payouts Prove that Vaccines are Dangerous?

To most other people, that argument doesn’t hold water.

Why?

Because we know that:

  • the National Vaccine Injury Compensation Program is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions
  • of over 3.1 billion doses of vaccines that were distributed in the United States between 2006 and 2016, there were 3,749 compensated claims through the NVICP
  • almost 80% of all compensated awards by the NVICP come as a “result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”
  • the NVICP settlements are funded by an excise tax on vaccines
  • the NVICP cases are published by the U.S. Court of Federal Claims, so all information is disclosed to the public and no safety concerns are hidden

So what does the National Vaccine Injury Compensation Program (VICP) really prove?

It proves that true vaccine injuries are very rare – about 1 in a million rare.

It proves that while vaccines are not 100% safe, they are very safe.

Certainly safer than the complications of a vaccine-preventable disease.

And it proves that anti-vaccine arguments are very easy to refute

More on the NVICP and Vaccine Safety

Do Vaccines Cause Tics or Tourette Syndrome?

One thing to understand when talking about tics and Tourette Syndrome is that tics are not Tourette Syndrome.

Instead, Tourette Syndrome is a type of tic disorder.

What Causes Tics and Tourette Syndrome?

You should also understand that tics are common.

In fact, about 20% of school age kids get tics, although few have them for more than a year. These motor or vocal tics (involuntary eye blinking, head jerking, shoulder shrugging, humming, sniffing, grunting, throat clearing, or yelling out a word or phrase) are most common when kids are between the ages of 10 to 12 years old, but may start as early as age 6 to 7 years.

Not only are these tics common, but they are thought to be normal and very often go away without treatment. About 97% of kids have complete resolution of their tics within a year or so.

The rest might go on to have a persistent motor or vocal tic disorder though.

And some kids with persistent motor and vocal tics might have Tourette Syndrome.

Why?

“While environmental factors and illness may influence ticcing, the weight of evidence argues that tic disorders and their comorbidities are inherited/genetic. The inheritance pattern can be subtle and unexpected. In clinic, we often see a parent, while either indicating that they experienced childhood tics that remitted or that no one in the immediate family ever had tics, demonstrating frequent subtle tics.”

Kids and Tics: What’s “Normal” and When to see a Specialist

That’s right. Genetics.

Tics and Tourette Syndrome often run in families.

Do Vaccines Cause Tics or Tourette Syndrome?

As you might suspect, vaccines do not cause tics or Tourette Syndrome.

Neither does thimerosal, which used to be a common preservative in vaccines.

That’s not surprising, as neither tics nor Tourette Syndrome are new conditions.

Why can you find studies that try to link thimerosal and vaccines to tics and Tourette Syndrome? Because they are poorly done studies by folks who routinely do studies that try to make it look like vaccines cause everything from autism and tics to ADHD.

Other studies have found no link between thimerosal and tics, including the study Neuropsychological Performance 10 Years After Immunization in Infancy With Thimerosal-Containing Vaccines.

Even the studies that found some association weren’t very convincing.

“With the possible exception of tics, there was no evidence that thimerosal exposure via DTP/DT vaccines causes neurodevelopmental disorders.”

Andrews et al on Thimerosal exposure in infants and developmental disorders: a retrospective cohort study in the United kingdom does not support a causal association.

One study, for example, did actually find some association between thimerosal and tics.

Maybe.

Infants who received one dose of DTP with thimerosal had a higher rate of tics than infants who didn’t. The strange thing about the study though is that infants who had two or three doses also had a higher rate than getting just one dose and a similar rate as kids who didn’t get any vaccines with thimerosal.

“We did find one statistically significant association between exposure to thimerosal-containing vaccines and the presence of tics among boys, however, this association was not replicated in girls. Previous associations between thimerosal containing vaccines and tics were found by Verstraeten et al. (2003) and Andrews et al. (2004) but the findings were not sex specific. Our tic finding was also consistent with the tic finding reported in the original study (Thompson et al., 2007).”

John Barile et al on Thimerosal Exposure in Early Life and Neuropsychological Outcomes 7–10 Years Later

None of this sounds like evidence that vaccines cause tics, does it?

No.

None of these studies found clinically significant evidence that vaccines cause tics or Tourette Syndrome.

What about other thimerosal-free vaccines? There have been no reports of increased rates of tics or Tourette Syndrome with any thimerosal-free vaccines either.

“There were 17 reports of Tourette’s disorder. Two patients developed movement disorders following 4vHPV with symptoms similar to Tourette’s, but did not have a definitive clinical diagnosis of Tourette’s disorder from a specialist (i.e., a neurologist or psychiatrist). In three additional reports, patients had a Tourette’s diagnosis or displayed symptoms of Tourette’s prior to vaccination. The remaining 12 reports were submitted by one physician who read on internet websites about possible Tourette disorder occurring after vaccines, but he had no firsthand information on any patient. None of these 12 reports could be verified.”

Arana et al on Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.

There is no evidence that vaccines cause tics or Tourette Syndrome.

In fact, at the December 2017 meeting of the Advisory Committee on Childhood Vaccines, there was a petition to add tics as a vaccine table injury. After reviewing all available evidence, including the work of William Thompson, the so-called CDC Whistleblower, the committee voted 5-1 for the option to not add tics as an injury to the Table. They also didn’t add asthma or PANDAS to the vaccine injury table, despite some folks petitioning them to do so.

Tics have not been added as a table injury.
Tics have not been added as a table injury.

That’s likely not a surprise to folks who know that vaccines are safe.

What to Know About Tics and Tourette Syndrome

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

There is a new meme going around suggesting that folks have no business telling anyone to vaccinate and protect their kids unless they can answer a series of questions.

I bet answers from anti-vaccine folks aren't the same as the answers from the rest of us...
I bet answers from anti-vaccine folks aren’t the same as the answers from the rest of us…

While it is certainly good to be educated about vaccines, their questions seem rather loaded.

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

Since it is immoral and dangerous to push misinformation that scares parents away from vaccinating and protecting their kids, it would be nice if anti-vaccine folks would answer these questions before they tried to persuade anyone to not get vaccinated:

  1. Name 5 vaccine ingredients that you think are toxic and how exactly they can be toxic at the amounts present in vaccines.
  2. Name 5 possible complications of a vaccine-preventable disease.
  3. Are doctors and alternative health care providers who push non-standard, parent-selected, delayed protection vaccine schedules able to be held liable if their intentionally unvaccinated child suffers a vaccine-preventable disease or starts an outbreak, infecting other people?
  4. How many children died of vaccine-preventable diseases in the early 1980s, before the vaccine schedule grew to include the new vaccines we give today?
  5. Is it true that no one can force you to get vaccinated?
  6. What percentage of reports to VAERS are actually caused by vaccine reactions?
  7. How many doses of vaccines have been given since the Vaccine Court began paying for vaccine injury cases?
  8. Which vaccines must be avoided because of shedding or other concerns if you have a child with an immunodeficiency in your home?
  9. Why do some folks think that many vaccines still contain thimerosal?
  10. If today’s vaccines already contain far fewer antigens than they did in the old days, what would be the extra benefit of splitting them up even further into separate shots for each vaccine-preventable disease?
  11. Have you read all of studies on the safety and effectiveness of combination vaccines, including those that are double-blinded and placebo controlled, and the current vaccine schedule?
  12. Can you give me one other interesting fact about vaccines or vaccine-preventable diseases that was not already asked or discussed?

What’s my interesting fact?

Many on-the-fence and vaccine hesitant parents do change their mind about vaccines and decide to make the right choice and get their kids vaccinated and protected.

More Things Anti-Vaxxers Should Know

VigiAccess Numbers in Context

Most people are familiar with VAERS, the Vaccine Adverse Event Reporting System.

They sometimes forget that it is only the Vaccine Adverse Event Reporting System for the United States.

Other countries have their own vaccine safety systems.

VigiAccess Numbers in Context

One of the biggest is VigiBase, the World Health Organization’s  global database for suspected adverse drug reactions, maintained by the Uppsala Monitoring Centre in Sweden.

“Information on suspected ADR should not be interpreted as meaning that the medicinal product in question, or the active substance(s), generally causes the observed effect or is unsafe to use.”

Not surprisingly, folks misuse VigiBase numbers, just like they misuse VAERS reports.

JB Handley needs help understanding VigiAccess reports.
JB Handley needs help understanding VigiAccess reports.

To look at the VigiBase reports, you can use VigiAccess.

“VigiAccess has a search interface that allows visitors to retrieve summary statistics on suspected adverse reactions to medicines and vaccines.”

Uppsala Monitoring Centre

While VigiBase “is at the heart of UMC’s signal detection and scientific research,” you aren’t going to learn much from VigiAccess.

“Geographically, only continent-level statistics are shown, due to issues relating to patient confidentiality and data protection in individual countries.”

Uppsala Monitoring Centre

The biggest problem?

You don’t know how many vaccines were given to all of those people.

For example, while it might sound like there have been a lot of adverse drug reaction reports for the DTaP vaccine, with 179,447 reports in VigiAccess, since those are worldwide reports since 1968, it is likely among many billions of doses of vaccines being given.

Most importantly though, as with VAERS, “The reports in VigiBase result from suspicions of a relationship between a drug and a reaction. No causal relation has been confirmed.”

So how do you put the numbers from VigiBase and VigiAccess in context?

If you consider that reports and safety signals from VigiBase, VigiMatch, VigiRank, and other tools used by the Uppsala Monitoring Centre continue to find that vaccines are safe, then to put the DTaP numbers in context, they help us know that vaccines are being well monitored for safety.

And since we know that these diseases haven’t disappeared, any further context, if you need it, would be that since vaccines are safe and necessary, then you should get yourself and your family vaccinated and protected.

More on VigiBase and VigiAccess

 

About the Cochrane HPV Controversy

Have you heard about the Cochrane HPV controversy?

What controversy?

Well, yeah, but anti-vaccine folks are crowing about what is essentially a letter that was published in BMJ Evidence-Based Medicine journal.

About the Cochrane HPV Controversy

What’s the controversy?

Seems that the folks at Cochrane Reviews recently published a review, Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors, which concluded that the HPV vaccines work and that they are safe.

That doesn’t sound controversial…

Well, it seems that some other folks, associated with the Nordic Cochrane Center, disagreed. They published an “analysis” in BMJ Evidence-Based Medicine, The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias.

So who do we believe when we have Cochrane vs Cohrane?

Who is the Nordic Cochrane Centre?

Some people will be familiar with the Nordic Cochrane Centre because of their involvement in complaints about the HPV vaccine that were investigated by the European Medicines Agency.

Cochrane Nordic has been filing multiple complaints with the EMA about HPV vaccine safety for years.
Cochrane Nordic has been filing multiple complaints with the EMA about HPV vaccine safety for years.

Complaints that were initially triggered by a case series that was published by Dr. Louise Brinth, when she was head of the Danish Syncope Group, but who is now part of the Nordic Cochrane Centre.

While the Cochrane Collaboration has a very good reputation, you can't really say the same about the Nordic Cochrane Centre.
While the Cochrane Collaboration has a very good reputation, you can’t really say the same about the Nordic Cochrane Centre.

Complaints that were not approved by the Cochrane Collaboration and that were not an official Cochrane viewpoint!

“…we highlight here how academic colleagues, under the purported banner of a respected authority, raise concerns about the HPV vaccine but they cite an evidence base of small and poor quality studies and ignore the extensive wealth of global literature that vividly demonstrate the excellent efficacy and safety record of the vaccine.”

Head et al on Inadvisable anti-vaccination sentiment: Human Papilloma Virus immunisation falsely under the microscope

Complaints that had already been investigated and dismissed by the European Medicines Agency.

“In conclusion, in clinical trials conducted in the 9 to 26-year- old age range, vaccination was generally well tolerated with no apparent adverse health impact following completion of the vaccination regimen.”

Block et al Clinical trial and post-licensure safety profile of a prophylactic human papillomavirus (types 6, 11, 16, and 18) l1 virus-like particle vaccine.

Complaints that are also refuted by many other studies.

So we don’t actually have Cochrane vs Cochrane…

The Cochrane HPV Review

Once you read the complaint against the Cochrane HPV review, you realize that this isn’t even just about the Cochrane HPV review.

The main faults that the Nordic Cochrane Centre folks found is that the Cochrane review left out a bunch of what they consider to be eligible HPV vaccine trials, even though “twenty-six randomised trials were identified that contained data on vaccine efficacy and/or safety, which all together enrolled 73,428 women.”

But if this was just about a systemic review which didn’t stick to protocol about which studies to include, then why do the Nordic Cochrane Centre folks go on and on about placebos and active comparators?

“The Cochrane authors mistakenly used the term placebo to describe the active comparators.”

Lars Jørgensen et al. on The Cochrane HPV vaccine review was incomplete and
ignored important evidence of bias

Would you be surprised to know that one of Nordic Cochrane Centre’s arguments to the EMA was about placebos?

“In all the vaccine trials apart from a small one, the “placebo” contained aluminium adjuvant, which is suspected of being neurotoxic.”

Cochrane Nordic Complaint to the European Medicines Agency (EMA) over maladministration at the EMA

Why do they talk about placebos?

Most of these folks want pure saline placebos to be used in clinical trials, even though doing so would make it hard to keep the trials blinded.

Placebos don’t have to be inert though. The BMJ and the Nordic Cochrane Centre authors mistakenly corrected the Cochrane authors on their use of the term placebo.

They make plenty of other mistakes too.

“The Cochrane authors did not mention a study from 2017 by the WHO UMC that found serious harms following HPV vaccination overlapping with two syndromes: postural orthostatic tachycardia syndrome (POTS) and complex regional pain syndrome (CRPS).”

Lars Jørgensen et al. on The Cochrane HPV vaccine review was incomplete and
ignored important evidence of bias

What study?

Jørgensen cites a commentary that describes “a signal based on both spontaneous reports and published case series that is best characterized as a potential association between HPV vaccination and dysfunction of the autonomic nervous system.”

“There is currently no conclusive evidence to support a causal relationship between the HPV vaccine and POTS. It is of utmost importance to recognize that although temporal associations may be observed, conclusions of causality cannot be drawn from case reports and case series due to the small sample size and lack of control population inherent to this type of scientific literature. If POTS does develop after receiving the HPV vaccine, it would appear to do so in a small subset of individuals and would be difficult to distinguish from the normal prevalence and incidence of the disorder.”

Butts et al on Human Papillomavirus Vaccine and Postural Orthostatic Tachycardia Syndrome: A Review of Current Literature

So who do you believe?

Researchers who published a systemic review as part of the Cochrane Review Groups that confirms that the HPV works and that it is safe, or a group who seems to have an axe to grind against the HPV vaccines?

Update on the Cochrane HPV Controversy

Apparently, Cochrane has taken the Nordic Cochrane Centre complaints seriously enough to launch an investigation.

“Our current investigations appear to show that there may be a handful of missed but potentially eligible studies, but that this falls substantially below ‘nearly half of the eligible trials’.”

David Tovey, editor-in-chief of the Cochrane Library

And not surprisingly, Tovey stated that “To date, we also have no reason to believe that the main conclusions of the review relating to benefit and serious adverse effects are unsafe.”

And yet, as with their complaints to the EMA, resources get wasted as the attacks are put down.

More on the Nordic Cochrane Centre HPV Attacks

Did the US Government Lose a Landmark Vaccine Lawsuit?

Have you heard the big news in the anti-vaccine world?

The anti-vaccine world thinks that they won some landmark lawsuit.

Reagan didn’t do much for vaccines, but it isn’t fair to pin this one on him.

It seems that some folks think that the Department of Health and Human Services hasn’t been complying with federal vaccine safety mandates for 30 years.

The 1986 National Childhood Vaccine Injury Act includes a mandate for safer vaccines.
The National Childhood Vaccine Injury Act of 1986 includes a mandate for safer vaccines.

Really?

Which ones?

Did the US Government Lose a Landmark Vaccine Lawsuit?

While anti-vaccine folks are pushing this lawsuit victory (?) to make folks think that HHS has done absolutely nothing to promote vaccine safety in the last 30 years, that is obviously nonsense.

The lawsuit was actually just about the reporting requirements of paragraph (c) of section 2127 of the National Childhood Vaccine Injury Act of 1986.

It should be clear that the HHS has done plenty to promote vaccine safety though.

HHS Secretary Donna Shalala reported to the Senate Committee on Health Education Labor and Pensions in 1998.
HHS Secretary Donna Shalala actually reported to the Senate Committee on Health Education Labor and Pensions in 1998.

Even if no formal reports were filed, the HHS secretary did report to and appear before Congress. Come to think of it, they even sent some reports to Congress.

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, has commissioned almost a dozen reports about vaccine safety over the years.
The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, has commissioned almost a dozen reports about vaccine safety over the years.

And the Health and Medicine Division (HMD) division (previously known as the Institute of Medicine (IOM) of the National Academies of Sciences, Engineering, and Medicine has published a number of vaccine safety reviews and reports under commission of HRSA, an agency of HHS.

Where do folks think that all of those IOM vaccine safety reports and reviews come from? Were they sent to Congress?

The Assistant Secretary for Health leads development of HHS-wide public health policy recommendations, oversees 11 core public health offices — including the Office of the Surgeon General and the U.S. Public Health Service Commissioned Corps, which has approximately 6,500 uniformed health officers who serve in nearly 600 locations around the world to promote, protect and advance the health and safety of our nation and our world. He also oversees three Presidential and 11 Secretarial advisory committees.
The Assistant Secretary for Health leads development of HHS-wide public health policy recommendations, oversees 11 core public health offices and three Presidential and 11 Secretarial advisory committees. We have had a National Vaccine Plan since 1994.

And also consider that:

Most importantly, new vaccines have been approved that protect our kids against many more now vaccine-preventable diseases.

HHS Settles Lawsuit Over Vaccine Safety Reporting

But wait, did the HHS even lose the lawsuit?

Not saying I'm surprised, but even Dr. Bob has bought into the idea that this lawsuit against HHS means something big.
Not saying I’m surprised, but even Dr. Bob has bought into the idea that this lawsuit against HHS means something big.

They actually didn’t.

They did settle a lawsuit though, a lawsuit which was then dismissed.

So like the CDC whistleblower movie that didn’t include a whistleblower, anti-vaccine folks think that they have a smoking gun about vaccine safety reports, except that it is very obvious that all kinds of reports about vaccine safety have been done over the years.

Vaccines are still safe. And they are still necessary.

What to Know About the HHS Vaccine Lawsuit

Although it does seem like HHS didn’t file the required formal reports and keep to the strict letter of the National Childhood Vaccine Injury Act of 1986, there is abundant evidence that they have actually done all of the work required to make sure that our vaccines are safe.

More on the HHS Vaccine Lawsuit

Vaccines and Sudden Unexplained Death in Children

Can a child be fine one day and then die the next?

Tragically, they can.

There is even a name for it – sudden unexplained death in childhood.

Sudden Death in Children

Although 10% of deaths in children over age 12 months are classified as sudden death, most have explanations, such as asthma, epilepsy, or a heart problem (congenital malformations and arrhythmias). Unfortunately, some of these conditions, especially some infections and heart problems, aren’t discovered until after the child dies.

“Most sudden cardiac deaths that remain unexplained after necropsy are probably caused by primary cardiac arrhythmias.”

Sudden death in children and adolescents

About 16% of these sudden deaths don’t have any explanation though.

Surprisingly, these types of sudden, unexplained deaths are the 5th leading cause of death in children between the ages of 1 and 4 years. That adds up to about 400 deaths a year in the United States alone!

Vaccines and Sudden Unexplained Death in Children

Have you guessed the connection with vaccines?

If up to 16% of children who die suddenly don’t have a good explanation for why they died, then that leaves some to blame vaccines, often with a little help with myths and misinformation from anti-vaccine folks.

“…making general assumptions and drawing conclusions about vaccinations causing deaths based on spontaneous reports to VAERS – some of which might be anecdotal or second-hand – or from case reports in the media, is not a scientifically valid practice.”

Miller et al on Deaths following vaccination: What does the evidence show?

That’s despite the fact that both our safety monitoring systems and other studies have shown that vaccines are not associated with sudden unexplained deaths. In fact, deaths after vaccines are very rare.

“As for vaccines causing death, again so few deaths can plausibly be attributed to vaccines that it is hard to assess the risk statistically.”

WHO on Six common misconceptions about immunization

Studies have even shown a protective effect of getting vaccinated against SIDS.

“At the present time there is not enough known about the underlying mechanisms of death in SUDC to allow prediction of which children might die suddenly and unexpectedly. Additionally, there is no way to prevent SUDC since its cause is unknown. Through research, we strive to discover the risk factors and underlying causes of SUDC that will lead to its prevention. In the meantime, optimal pediatric care recommendations, including attending well child visits, maintaining current vaccinations, and obtaining appropriate health care when clinically indicated, should be followed.”

SUDC Foundation on Frequently Asked Questions

And it’s not just SIDS. We also see a “healthy vaccinee effect” in older kids, who have lower mortality rates than the general population, which includes some folks who aren’t vaccinated.

We don’t know what causes sudden unexplained death in children, although with continued research we hopefully soon will, and can then learn to prevent them. Until then, parents should feel confident that it is not caused by the vaccines, which are safe and necessary and work to protect them from many life-threatening vaccine-preventable diseases.

What to Know About Vaccines and Sudden Unexplained Death in Children

Vaccines are not associated with sudden unexplained death in children.

More on Vaccines and Sudden Unexplained Death in Children