Tag: IOM reports

Can Vaccines Cause Transverse Myelitis?

Transverse myelitis is not common, so most people probably haven’t heard of it.

“The term myelitis refers to inflammation of the spinal cord; transverse refers to the pattern of changes in sensation—there is often a band-like sensation across the trunk of the body, with sensory changes below.”

Transverse Myelitis Fact Sheet

The symptoms of transverse myelitis depend on where the inflammation occurs and sometimes, on the cause. They can include back pain, weakness or paralysis of the legs and arms, paresthesias (sensory alterations in the neck, arms, or legs), and bowel and bladder dysfunction.

What Causes Transverse Myelitis?

An MRI of a teen with transverse myelitis.
An MRI of a teen with transverse myelitis that resolved after total body irradiation therapy was stopped.

Many things can cause transverse myelitis.

Possible triggers can include:

  • infections – following bacterial, viral, fungal, and parasitic infections
  • immune system disorders
  • inflammatory disorders
  • vascular disorders

Unfortunately, it isn’t usually known what causes someone to develop transverse myelitis.

There are treatments though and many people with transverse myelitis have at least a partial recovery, although it may take months to years.

Transverse myelitis is not thought to be genetic and rates are highest in two age groups – those between 10 and 19 years (when many preteens and teens get vaccinated) and those between 30 and 39 years.

Can Vaccines Cause Transverse Myelitis?

Have you heard that vaccines can cause transverse myelitis?

“Vaccines currently routinely recommended to the general population in the U.S. have not been shown to cause transverse myelitis.”

Institute for Vaccine Safety on Do Vaccines Cause Transverse Myelitis?

While there are some case reports that tell of a temporal association between getting a vaccine and later developing transverse myelitis, the evidence does not support any association.

Why do we see these case reports?

Just like SIDS, autism, type 1 diabetes, and many other conditions, transverse myelitis has a background rate of disease or a number of cases that you can expect to occur in a given population. Once you know this background rate, you can then predict how many people will coincidentally develop transverse myelitis within one, seven, forty-two, or more days after they are vaccinated.

With a background rate of about 0.36 per 100,000 people, if one million get a vaccine, you would expect:

  • at least 1 to 2 of them to develop transverse myelitis coincidentally after 1 day
  • at least 1 to 2 of them to develop transverse myelitis coincidentally after 7 days
  • at least 2 to 4 of them to develop transverse myelitis coincidentally after 42 days

If the rate is higher than that, it could indicate a problem.

Let’s do the math.

There are about 1,400 new cases of transverse myelitis in the United States each year.

How many vaccines are given? About 286 million doses – each year. Some of those are given on the same day, but that would still mean that 100s of people should be getting transverse myelitis within 1 to 7 days if vaccines were a cause.

They aren’t.

“Correlation does not imply causation.”

In fact, an Institute of Medicine report, Adverse Effects of Vaccines: Evidence and Causality, dismissed most of the evidence for an associated between vaccines and transverse myelitis as insufficient and lacking.

And further studies found no association:

  • A Vaccine Safety Datalink study, Acute Demyelinating Events Following Vaccines: A Case-Centered Analysis, looked at nearly 64 million vaccine doses of vaccines and also “found no association between TM and prior immunization.”
  • Another study, Maternal safety of trivalent inactivated influenza vaccine in pregnant women, used “a large, geographically diverse, retrospective cohort of pregnant women” and found no cases of transverse myelitis.

Not only do vaccines not cause transverse myelitis, but many vaccine-preventable diseases can. So vaccines can likely protect you from developing transverse myelitis by protecting you from these diseases!

What to Know About Transverse Myelitis

Vaccines do not cause transverse myelitis, although many vaccine-preventable diseases can.

More on Transverse Myelitis

Vaccine Injury Stories That Scare Parents

It is not uncommon to hear about parents having ‘panic attacks’ over the idea of vaccinating their kids.

“…many parents are inundated with horror stories of vaccine dangers, all designed to eat away at them emotionally while the medical and scientific communities have mounted their characteristic response by sharing the facts, the data, and all of the reliable peer-reviewed and well-cited research to show that vaccines are safe and effective.”

Federman on Understanding Vaccines: A Public Imperative

Or simply becoming anxious over an upcoming appointment for routine immunizations or to get caught up on vaccines.

What’s fueling all of this anxiety?

Vaccine Injury Stories That Scare Parents

Some of it is likely from the vaccine injury stories that they read  or videos they watch.

As parents get better at spotting the myths and misinformation behind the anti-vaccine movement, we are seeing more and more vaccine injury stories pop up to scare them.

“…recognizes the importance of examples—testimonials and stories—that are the lifeblood of vaccine-hesitant beliefs.”

Nathan Rodriguez on Vaccine-Hesitant Justifications

Vaccine injury stories aren’t new though.

These types of anecdotal stories were very popular when folks used to think that the DPT vaccine was causing a lot of side effects. It wasn’t though. And it was soon proven that the DPT vaccine didn’t cause SIDS, encephalitis, non-febrile seizures, and many other things it was supposed to have caused.

“Anecdotes – about a new miracle cure, a drug that is not being made available on the NHS, or the side effects of treatment, or some environmental hazard – sell product. Data, on the other hand, which take us towards the truth about these things, are less popular. Anecdotes, however many times they are multiplied, do not point the way to reliable knowledge. As the aphorism says, “The plural of anecdote is not data”.”

Raymond Tallis on Anecdotes, data and the curse of the media case study.

That anecdotes “sell” better than data may be one reason why you see them so often on anti-vaccine websites. Another is that they simply don’t have any good data to use as evidence!

Are Vaccine Injury Stories True?

Vaccines are not 100% safe, so there is no doubt that some vaccine injury stories are true.

There is also no doubt that what many people perceive to be vaccine injuries have actually been proven to not be caused by vaccines, from allergies and eczema to autism and MS.

“In the absence of a specific etiology for ASDs, and a tendency among parents of children with a disability to feel a strong sense of guilt, it is not surprising that parents attempt to form their own explanations for the disorder in order to cope with the diagnosis.”

Mercer et al on Parental perspectives on the causes of an autism spectrum disorder in their children

Also keep in mind that in addition to the many so-called vaccine induced diseases, there are many historical vaccine injury stories that have been shown to be untrue:

  • the first deaf Miss America did not have a vaccine injury
  • Johnnie Kinnear supposedly began having seizures 7 hours after getting a DPT vaccine, when he was 14-months-old, but medical records actually shown that his seizures started 5 months after he received his vaccines
  • Dravet syndrome now explains many severe seizures associated with vaccinations

And at least one of Wakefield’s own followers – a mother who claimed that the MMR vaccine caused her son’s autism, was “dismissed as a manipulative liar” by a court in the UK.

Vaccine Injury Stories are Dangerous

Do vaccine injury stories have a purpose? They might help a parent cope with a diagnosis in the short term, but vaccine injury stories are dangerous in so many ways.

We have seen how they create anxiety for many parents, which can scare them away from vaccinating and protecting their kids from life-threatening vaccine-preventable diseases.

What else can they do?

Driving a wedge between parents and pediatricians does not help autistic kids.
Driving a wedge between parents and pediatricians does not help autistic kids.

They can certainly build up mistrust towards pediatricians and other health professionals. That is one way that the anti-vaccine movement continues to hurt autistic families. They also can lead parents to think that their “vaccine injured” child is “damaged” in some way.

And they push parents towards dangerous, unproven, unnecessary, and expensive alternative treatments. It shouldn’t be a surprise that many of the sites and forums that push vaccine injury stories also promote a lot of dangerous advice.

From recommending goat milk for your baby and skipping your baby’s vitamin K shot to various kinds of detoxing “treatments,” these are not the folks you want to trust with the health of your child.

What to Know About Vaccine Injury Stories

Vaccine injury stories prey on the fears of parents, help drive a wedge between them and their pediatricians, and are considered by many experts to be the lifeblood of the anti-vaccine movement.

More on Vaccine Injury Stories

What Is ADEM?

Have you ever heard of ADEM?

Most parents haven’t.

That’s probably good, because although you should be familiar with different things, if you know what it is, then you likely know someone who has been affected by it.

What Is ADEM?

ADEM, an autoimmune disease, is an acronym for Acute Disseminated Encephalomyelitis.

“Acute disseminated encephalomyelitis (ADEM) is characterized by a brief but widespread attack of inflammation in the brain and spinal cord that damages myelin – the protective covering of nerve fibers. ADEM often follows viral or bacterial infections, or less often, vaccination for measles, mumps, or rubella.”

Acute Disseminated Encephalomyelitis Information Page

Children and young adults with ADEM can have:

  • encephalopathy with confusion and irritability
  • hemiplegia – paralysis on one side of the body
  • ataxia – loss of full control of bodily movements leading to an unsteady walk
  • optic neuritis with vision impairment and vision loss
  • myelitis – inflammation in the spinal cord
  • speech impairment
  • hemiparesthesia – numbness on one side of the body and other sensory changes
  • seizures – especially in younger children

These symptoms typically follow a few days of fever, headache, nausea, vomiting, and feeling tired.

And to make the diagnosis, children with these symptoms of ADEM will have “focal or multifocal lesions predominantly involving white matter” on an MRI of their brain.

Fortunately, although ADEM can be life-threatening, there are treatments (steroids) for these kids and usually the outcome is good, with a complete or near complete recovery.

ADEM and Vaccines

Why do some folks associate ADEM with vaccines?

Mostly because some anti-vaccine websites like to try and associate ADEM with vaccines.

“ADEM is usually triggered by a preceding viral infection or immunization.”

Infection and Autoimmunity, Chapter 60

A lot of textbooks still list vaccines as a rare trigger too…

In this 2011 report, the IOM concluded that few health problems are caused by or clearly associated with vaccines.
In this 2012 report, the IOM concluded that few health problems are caused by or clearly associated with vaccines.

It is important to understand that ADEM most commonly occurs after a nondescript (not easily described), natural, viral or bacterial infection.

Interestingly, one of the first cases of ADEM was reported in 1790 – in a 23-year-old women who had just gotten over measles. Like many other serious complications of measles, ADEM is reported to occur after 1 in every 1,000 cases of measles.

What other infections can cause ADEM?

Most of them.

From HHV-6 (causes Roseola) and the coxsackievirus  (hand, foot, and mouth disease) to HIV and Dengue, they are all associated with ADEM. Many bacterial infections too, like Strep, Mycoplasma, and Salmonella.

“Older formulations of rabies vaccine did cause Acute Disseminated Encephalomyelitis (ADEM), but newer formulations of rabies vaccine have not been shown to cause ADEM, and rabies vaccine is not routinely recommended to the general population in the United States. Other vaccines that are currently routinely recommended to the general population in the U.S. have not been shown to cause ADEM.”

Institute for Vaccine Safety on Do Vaccines Cause Acute Disseminated Encephalomyelitis (ADEM)?

So what about vaccines?

Why do some folks still say that ADEM can follow getting vaccinated, especially after the 2012 IOM report on Adverse Effects of Vaccines: Evidence and Causality, found all of the evidence linking ADEM to vaccines “weak,” and in most cases, that the epidemiological evidence was “insufficient or absent to assess an association between” the vaccines and ADEM?

“Post vaccine aetiology was described for 5% of all ADEM cases and several vaccines have been described to be related to this condition. The incidence of ADEM onset ranges from 1/106 to 1/105 and may change between different vaccine formulations. Epidemiological data about this adverse event are still missing; this may be due to the rarity of post vaccine ADEM.”

Pellegrino et al on Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting Systems

At most, ADEM is a very rare, 1 in a million type (1/106) vaccine reaction that is mainly published about in case reports and by reviewing VAERS.

Interestingly, no trigger is reported in up to 30% of cases (they don’t recall having a recent infection or getting a vaccine) and an infectious agent (a virus or bacteria) is usually not isolated from these children once they develop symptoms of ADEM.

“Epidemiologic evidence from this study suggests an infectious cause for ADEM. The agent is most likely a difficult-to-diagnose winter/spring respiratory virus.”

Murty et al on Acute Disseminated Encephalomyelitis in Children

Being so rare, it is hard to prove that ADEM absolutely isn’t caused by vaccines, but it does seem clear that many vaccine-preventable diseases might, from measles, mumps, rubella, chicken pox, flu, to hepatitis A.

Want to try and avoid ADEM? Get vaccinated.

What To Know About ADEM and Vaccines

Although vaccines have rarely been thought to cause Acute Disseminated Encephalomyelitis historically, it is very important to keep in mind that the overwhelming majority of cases of ADEM are caused by natural infections, many of which are vaccine preventable.

More About ADEM and Vaccines

Are Vaccines Tested Together?

If you are on the Fence about vaccines, one issue that might have you scared is that the idea that vaccines aren’t tested together.

So maybe they tested the Prevnar vaccine, but did they test it with the Hib vaccine?

And did they test the Prevnar and Hib vaccine with the Pediarix vaccine?

After all, kids get all of those vaccines at their two, four, and six month well child checkups.

Vaccines Are Tested Together

It is not hard to find evidence that most combinations of vaccines are in fact tested together.

For example (and this is not a complete list):

  • Rotarix was tested with Pediarix (DTaP-HepB-IPV), Prevnar, and Hib
  • Prevnar 13 was tested with DTaP, IPV, hepatitis B and Hib
  • Prevnar 13 was tested with MMR, Varicella, and hepatitis A
  • MenC with DTaP-IPV-HepB-Hib
  • MenC with MMR
  • MMR and Varicella with Hib, Hepatitis B, and DTaP
  • hepatitis A and hepatitis B with either MMR or DTaP-IPV-Hib
  • HPV vaccine for babies
  • Flumist with MMR and Varicella
  • Kinrix (DTaP-IPV) with MMR and Varicella
  • HPV9 with Tdap and Meningococcal vaccines
  • Tdap with influenza vaccine
  • Meningococcal vaccine with influenza vaccine

And even after a vaccine is added to the immunization schedule and it is given together with other vaccines, our post-licensure vaccine safety monitoring systems, from VAERS to the Vaccine Safety Datalink, kick in to make sure that they are indeed safe and effective.

The Myth That Vaccines Aren’t Tested Together

If it is clear that vaccines are in fact tested together, then why do some folks still believe that they aren’t?

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

Hopefully everyone sees the irony in Dr. Bob saying something about vaccines being untested, as he is infamous for pushing his own made up and completely untested alternative vaccine schedule.

“Babies get as many as 6 or 7 vaccines altogether…and the CDC is admitting that they don’t always research them that way.”

Dr. Bob Sears on Fox & Friends Vaccines: A Bad Combination?

When did they admit that???

“We’ve researched the flu vaccine in great detail and it seems safe when it’s given alone, but the CDC has never researched the flu vaccine when you give it in conjunction with all the other infant shots…and that’s what we’re worried about. ”

Dr. Bob Sears on Fox & Friends Vaccines: A Bad Combination?

So, what about the flu vaccine?

A 2013 report from the Institute of Medicine found that there was no evidence that vaccines caused ADHD.
A 2013 report from the Institute of Medicine stated that “Each new vaccine considered for inclusion in the immunization schedule is tested within the context of the existing schedule and reviewed by clinical researchers, who analyze the balance of demonstrated benefits and risks.”

While most kids get their flu vaccine by itself, just before the beginning of flu season, some might get it when they see their pediatrician for a regular checkup, at the same time they are due for other vaccines.

Not surprisingly, Dr. Bob was wrong, and several studies have shown that the flu vaccine can be safely given with other vaccines.

And don’t forget, any problems with co-administration of vaccines would show up in post-licensure vaccine safety testing.

That’s how a very small increased risk of febrile seizures was found during the 2010-11 flu season in toddlers who received either DTaP or Prevnar and a flu shot at the same time.

The very small extra risk doesn’t mean that you still can’t get the vaccines at the same time if your child needs them all though. Remember that febrile seizures “are temporary and do not cause any lasting damage.”

It will be even more reassuring to some parents that another study “examined risk of febrile seizures (FS) after trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal conjugate vaccine (PCV13) during the 2010-2011 influenza season, adjusted for concomitant diphtheria tetanus acellular pertussis-containing vaccines (DTaP)” and found no extra risk for febrile seizures.

“Vaccines can generally be co-administered (i.e. more than one vaccine given at different sites during the same visit). Recommendations that explicitly endorse co-administration are indicated in the table, however, lack of an explicit co-administration recommendation does not imply that the vaccine cannot be co-administered; further, there are no recommendations against co-administration.”

Summary of WHO Position Papers – Recommendations for Routine Immunization

Also remember that “there are no recommendations against co-administration of vaccines,” unless of course, you are getting your advice from Bob Sears…

 

What To Know About Vaccines Being Tested Together

Vaccines are thoroughly tested for both safety and efficacy and they are also tested in many of the different combinations on the routine childhood immunization schedule.

More On Vaccines Being Tested Together