Tag: package inserts

Diagnosing Vaccine Injuries

Vaccines are often described as one of the greatest public health achievements of the 20th century.

That great benefit also leaves no doubt for most people that getting vaccinated and fully protected far outweighs the very small risks that vaccines might have.

Vaccine Injuries vs Vaccine Side Effects

Vaccines can certainly have side effects.

Fever, pain at the injection site, and redness and swelling where the shot was given are all common, mild problems that can be associated with almost any vaccine.

Some vaccines might also commonly cause fussiness, tiredness or poor appetite, and vomiting within 1 to 3 days of getting the vaccine. Others can cause a rash, headache, or muscle and joint pain for a few days.

Even syncope or fainting can commonly occur within 15 minutes of teens getting a vaccine.

Other vaccine side effects can include persistent crying, nodules at the injection site, limb swelling, and febrile seizures, etc.

These are well known vaccine side effects that are often minor and temporary though.

Is It a Vaccine Injury?

Although the term is typically associated with the anti-vaccine movement, as they tend to think everything is a vaccine injury, it is important to understand that vaccine injuries, although rare, are indeed real.

After all, vaccines are not 100% safe.

In addition to the milder side effects listed above, vaccines can very rarely cause more serious types of adverse events or injuries, including:

  • life threatening allergic reactions
  • brachial neuritis (shoulder pain and then weakness) following a tetanus containing vaccine
  • encephalopathy/encephalitis following a measles, mumps, or rubella, or pertussis containing vaccine
  • chronic arthritis following a rubella containing vaccine
  • thrombocytopenic purpura (ITP) following a measles containing vaccine
  • vaccine-strain measles viral infection in an immunodeficient recipient following a measles containing vaccine
  • intussusception – following a rotavirus vaccine
  • shoulder injury related to vaccine administration – SIRVA

Keep in mind that some of these are just table injuries and are not necessarily proven as being caused by vaccines.

And while vaccines are associated with some serious adverse events, the research is clear that vaccines are not associated with autism, SIDS, and shaken baby syndrome, type 1 diabetes, multiple sclerosis, inflammatory bowel disease, or other so-called vaccine induced diseases.

Or Is It Just a Coincidence?

Dr. Samuel Johnson once said that “It is incident to physicians, I am afraid, beyond all other men, to mistake subsequence for consequence.”

How does this apply to diagnosing vaccine injuries?

Too often we forget that just because one event is subsequent (happens after) another, it does not mean that it was a consequence (was caused by) the first event. It is another way of saying that correlation does not imply causation.

This is also highlighted by missed vaccine stories, events that would surely be blamed on a vaccine injury, except that a vaccine was never actually given for one reason or another.

Most pediatricians have these types of missed vaccine stories, such as:

  • an infant who begins vomiting on the way home from a well appointment and is diagnosed with intussusception (9 month old visit and didn’t get any vaccines)
  • a 4 year old who developed encephalitis just one week after his well check up (no vaccines – DTP had been deferred to his 5 year old visit)
  • a 2 month old who died of SIDS on the night of his scheduled well child visit (no vaccines as they had forgotten to go to the appointment)
  • a 4 month old who had a seizure at his well child visit (no vaccines were given yet as they were still being drawn up)

Or they have kids who begin to have symptoms or are diagnosed with a condition right around the time of a check up when they would routinely get one or more vaccines, but haven’t yet. From diabetes and POTS to transverse myelitis, some parents would have blamed their child’s vaccines if they had actually been vaccinated at that time and subsequently got diagnosed.

My own son started getting migraines when he was 12 years old and about to start 7th grade. Should I blame his headaches on his middle school booster shots? While it would be convenient, it is more likely that genetics are to blame. I started getting migraines at about the same age, and he began getting them just before he got his booster shots.

Diagnosing Vaccine Injuries

How do you know if your child had a true vaccine injury?

Does the reaction fit into the vaccine injury type AND “time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration” as described in the NVICP vaccine injury tables?

That time period, also known as a risk interval, is when “individuals are considered at risk for the development of a certain adverse event following immunization (AEFI) potentially caused by the vaccine.”

For example, did your child develop an anaphylactic reaction within four hours of getting the DTaP vaccine? While a reaction 14 hours after the vaccine would be much less likely to be caused by the vaccine, if it occurred within 4 hours, that could certainly be a vaccine injury.

How about a child who developed thrombocytopenic purpura 90 days after getting his MMR vaccine? That is unlikely to be a vaccine injury, as the MMR vaccine typically causes TTP within 7 to 30 days.

If you think that your child has had a vaccine injury, be sure to talk to your pediatrician. You should also report any vaccine reaction to Vaccine Adverse Event Reporting System (VAERS) and if you truly believe that your child has been injured by a vaccine, you can file a claim with the National Vaccine Injury Compensation Program (VICP).

“You may file a claim if you received a vaccine covered by the VICP and believe that you have been injured by this vaccine.”

What You Need to Know About the National Vaccine Injury Compensation Program (VICP)

How will your pediatrician figure out if it is a vaccine injury? Among the things that they will consider when evaluating a reaction after a vaccine will be the answers to some key questions, including:

  • Is there any evidence that something else caused the reaction? While getting a vaccine could cause an anaphylactic reaction, so could the fact that your child just eat a peanut butter and jelly sandwich.
  • Is there a known causal association between the reaction and the vaccine?
  • Is there strong evidence against a causal association between the reaction and the vaccine?
  • Is there a laboratory test that implicates the vaccine as a cause of the reaction?
  • If the reaction is an infection, did it have a vaccine or wild type origin?

Your pediatrician will also consider other factors when making a decision, including whether other patients were affected (might implicate a contaminated vaccine), and will make sure that the original diagnosis is correct.

Being able to answer all of these questions often puts pediatricians in the unique position of correctly evaluating potential vaccine injuries. There is even a standardized algorithm that can help your pediatrician collect and interpret all of the data they will get when evaluating a possible vaccine injury.

Another algorithm can help evaluate and manage suspected allergic reactions, including immediate or type 1 hypersensitivity reactions and delayed type 3 hypersensitivity reactions. If the reaction is consistent with an allergic reaction and additional doses of the vaccine are still needed, possible next steps in this algorithm include serologic testing for immunity and skin testing with the vaccine or vaccine components.

For extra help, your pediatrician can consult an allergist or immunologist before considering giving your child another vaccine, if necessary. Experts at the Clinical Immunization Safety Assessment (CISA) are also available for consults about suspected vaccine injuries.

Over-Diagnosing Vaccine Injuries

In addition to vaccine side effects and vaccine injuries, it is much more common for children and adults to develop health problems and symptoms after getting a vaccine that have nothing to do with the vaccine. These are events, sometimes tragic, that would have happened even if they had not been vaccinated.

Anytime we see a post about vaccines and SIDS, we know what happened, an anti-vaccine Facebook group is taking advantage of a grieving family.
Anytime we see a post about vaccines and SIDS, we know what happened, an anti-vaccine Facebook group is taking advantage of a grieving family.

Despite the evidence against it, some parents may still think that their child has been injured or damaged by a vaccine, especially if they:

  • believe all of the vaccine injury stories they hear on the Internet
  • misuse vaccine package inserts
  • believe that VAERS reports have all been confirmed to be true
  • think that vaccine injuries can occur months or years after getting a vaccine
  • find a case report in PubMed and think that is convincing evidence of causality, even though it is really nothing more than a glorified anecdote
  • have found their way into a Facebook group where folks think vaccines always injure kids
  • go to a homeopath, chiropractor, or holistic practitioner who told them the child was injured

For example, studies have repeatedly shown that “vaccination does not increase the overall risk of sudden infant death (SIDS),” and that “the risk of SIDS in vaccinated cases and controls is neither increased nor reduced during the early post-vaccination period.”

What should you do if you really think that your child has a vaccine injury?
Just what a parent needs when their baby dies of SIDS, someone to reach out and tell them it was because they had him vaccinated… 

So a VAERS report of SIDS on the night that an infant received his 4 month vaccines, while tragic, would likely not end up being classified as a true vaccine injury.

Neither should a case report or package insert about SIDS influence your thinking about SIDS being associated with a vaccine injury.

Still, it is easy to understand why many like to blame vaccines.

Vaccines are an easy target, especially as most vaccine-preventable diseases are under fairly good control compared to the pre-vaccine era. And in some cases of SIDS, a new case of diabetes, or the sudden death of an older child, etc., it may happen soon after the child was vaccinated, and that correlation is hard to ignore for some folks.

At least it is hard to ignore and easy to be influenced by anti-vaccine folks if you don’t understand the background rate of these diseases – or the fact that a certain number of children will be affected no matter what, and because many kids get vaccinated, it is only a matter of chance that the two get correlated together. 

Vaccines are safe.

They don’t typically cause serious vaccine injuries.

If you do think that your child has a vaccine injury, talk to your pediatrician. Don’t get diagnosed in a Facebook forum…

More on Diagnosing Vaccine Injuries

Is AFM a Form of Transverse Myelitis?

Acute Flaccid Myelitis (AFM) is a form of acute flaccid paralysis.

“AFM can be difficult to diagnose because it shares many of the same symptoms as other neurologic diseases, like transverse myelitis and Guillain-Barre syndrome. With the help of testing and examinations, doctors can distinguish between AFM and other neurologic conditions.”

About Acute Flaccid Myelitis

AFM is not transverse myelitis, Guillain-Barre syndrome (GBS), or Acute Disseminated Encephalomyelitis (ADEM) though, although anti-vaccine folks are trying hard to make a connection.

Is AFM a Form of Transverse Myelitis?

AFM is similar to transverse myelitis, in that they both affect a person’s spinal cord, but a big difference is that TM results from “an immune-mediated inflammatory attack of a person’s spinal cord.”

“This report and others indicate that AFM represents a unique subset of acute flaccid paralysis distinct from GBS and transverse myelitis. GBS typically presents with an ascending paralysis and can be associated with facial paralysis and sensory symptoms. Children with transverse myelitis have weakness and prominent sensory loss, often manifest as a spinal sensory level. By contrast, the majority of children with AFM have focal, poliomyelitis-like spinal cord paralysis with minimal or no sensory symptoms.”

Recognition and Management of Acute Flaccid Myelitis in Children

And AFM has different symptoms from both TM and GBS.

So why try to connect AFM with TM, GBS, and ADEM? Because they think that vaccines cause TM, GBS, and ADEM.

They don’t. Just like vaccines don’t cause AFM.

There is no proof in package inserts that vaccines cause AFM.
There is no proof in package inserts that vaccines cause AFM.

But can’t you find some of these things listed in the package insert for some vaccines?

Yes, but when mentioned in a vaccine’s package insert, like for autism, SIDS, or meningitis, it is in the section where it is clear that it is “without regard to causality.”

AFM is not transverse myelitis and neither are caused by vaccines.

We will hopefully learn what is causing the latest cases of AFM soon.

More on AFM and Transverse Myelitis

Why Do Some People Think That Vaccines Cause AFM?

So we know that vaccines don’t cause acute flaccid myelitis.

Consider a five-year-old in Maryland who recently came down with symptoms of AFM.

Was he recently vaccinated?

Nope. It had been some time since his four-year-old vaccines. Almost a year. And he had not gotten a flu vaccine yet.

What he did have were worsening symptoms about two weeks after he had seemed to get over a cold, something he has in common with most other kids with AFM.

“To try to pin a tragic yet uncommon neurological condition caused by enteroviruses on vaccines is dangerous and puts more kids at risk.”

Scott Krugman, MD

As with this case, the CDC reports no correlation with vaccines in the cases that they have investigated.

And remember, some of these kids have been unvaccinated!

That makes you wonder why some folks actually think that vaccines are associated with AFM, doesn’t it?

Why Do Some People Think That Vaccines Cause AFM?

That’s right, as you are likely suspecting, the usual suspects are pushing anti-vaccine propaganda and promoting the idea to scare parents away from vaccinating and protecting their kids.

“…there are many other reasons to suspect vaccine-related mechanisms of causation for AFM in the U.S., a primary one being that the scientific literature has documented paralysis as an adverse reaction to vaccination for decades!”

The Non-Polio Illness That “Looks Just Like Polio” by Lyn Redwood, RN, MSN, President, Children’s Health Defense

If any of these kids had recently gotten the oral polio vaccine, then sure, an adverse reaction to the vaccination would be at the top of the list of possible causes. After all, we know that VAPP can occur after OPV, but that vaccine hasn’t been used in the United States since 2000, when we switched to IPV.

Why do these folks think that they have it all figured out?

Vaccines are not causing AFM because of needle puncture wounds or tonsillectomies.
Vaccines are not causing AFM because of needle puncture wounds or tonsillectomies.

The AFM outbreaks happen at the beginning of the school year, when kids are all getting their shots, right?

Nope. They happen during the summer and early fall, peaking in August. And despite what some folks think, most parents don’t wait until the end of summer, just before school starts, to vaccinate their kids. Plus, most kids don’t even need vaccines before the start of the school year. Kids typically only get vaccines before starting kindergarten and middle school.

But the outbreaks do coincide with the when kids get their flu shots, right?

How many kids get flu shots in June and July?

If it was flu shots, the peak would be in October and November, when most kids get their flu shots and we would continue to see cases through December and January.

Many anti-vaccine websites and Facebook groups are pushing the idea that vaccines cause AFM.
Many anti-vaccine websites and Facebook groups are pushing the idea that vaccines cause AFM.

Of course, there is absolutely no evidence that flu vaccines, or any other vaccines, cause AFM.

What about the journal article that Brandy Vaughan posts as evidence?

“By reviewing vaccine-associated inflammatory diseases of the central nervous system, this study describes the current knowledge on whether the safety signal was coincidental, as in the case of multiple sclerosis with several vaccines, or truly reflected a causal link, as in narcolepsy with cataplexy following pandemic H1N1 influenza virus vaccination.”

Vaccine-associated inflammatory diseases of the central nervous system: from signals to causation

Even if you just read the abstract, as many folks do, you get a good idea where they are going with the article. It talks about how the claims of an association between multiple sclerosis and vaccines were proven to be purely coincidental.

Remember, correlation does not imply causation.

With AFM, you don’t even have much correlation to imply causation though!

Most cases occur just before we start giving flu vaccines and they don’t occur every year or in every state.

But doesn’t the article mention myelitis?

“Most of the published associations are based on individual case reports or small series of patients.”

Vaccine-associated inflammatory diseases of the central nervous system: from signals to causation

It does mention myelitis, just like it mentions MS – where an association has been shown to be purely coincidental.

Remember, case reports are not good evidence.

“…there are many other reasons to suspect vaccine-related mechanisms of causation for AFM in the U.S., a primary one being that the scientific literature has documented paralysis as an adverse reaction to vaccination for decades!”

The Non-Polio Illness That “Looks Just Like Polio” by Lyn Redwood, RN, MSN, President, Children’s Health Defense

But isn’t acute flaccid myelitis listed as a possible side affect in the package inserts for our vaccines?

Uh, TRANSVERSE myelitis and ACUTE DISSEMINATED ENCEPHALOmyelitis are not the same as acute flaccid myeltitis.
Uh, TRANSVERSE myelitis and ACUTE DISSEMINATED ENCEPHALOmyelitis are not the same as acute flaccid myelitis.

While it should be clear that AFM isn’t the same as ADEM and TM, it is very important to understand that even when those other conditions are listed in a package insert, it is in the section that is marked “without regard to causality.”

This isn’t evidence that vaccines cause AFM!

But didn’t the BMJ publish a study about Vaccines and the U.S. Mystery of Acute Flaccid Myelitis?

BMJ seems to allow anyone to publish responses to their articles online...
BMJ seems to allow anyone to publish responses to their articles online…

Nope. What they did is let someone publish what is essentially an online letter to the editor. And anti-vaccine folks are spreading it around like it is an actual BMJ study…

Surprised?

You shouldn’t be.

This is how anti-vaccine propaganda works.

Why are vaccine injury lawyers talking about AFM?
Why are vaccine injury lawyers talking about AFM?

It’s no coincidence that anti-vaccine folks are trying so hard to associate the outbreaks of AFM with vaccines. What better way to scare folks and make them think that vaccines are dangerous?

AFM is all that anti-vaccine folks are talking about these days...
AFM is all that anti-vaccine folks are talking about these days…

How are ‘we’ working on a vaccine for AFM if we don’t even know what causes AFM???

But that’s how many anti-vaccine folks think. Everything is a vaccine injury. Everything is a conspiracy.

Don’t believe them. Vaccines are safe and necessary.

More on Anti-Vaccine Propaganda About AFM

 

Myths About Warnings and Adverse Reactions in the MMR Package Inserts

Have you heard that the MMR package insert “contains 42 paragraphs of warning and adverse reactions?”

And some of those warnings include “seizures, encephalitis, pneumonia, deafness, death and MEASLES?”

Measles? From the measles vaccine?

Myths About Warnings and Adverse Reactions in the MMR Package Inserts

Is that really in the MMR package insert?

Package inserts aren't so scary once you learn what's really in them.
Package inserts aren’t so scary once you learn what’s really in them.

Let’s see, 42 paragraphs of warning and adverse reactions???

Nope.

Anti-vaccine propaganda is not informed consent.
Anti-vaccine propaganda is not informed consent.

The Warning Section, which lists all adverse reactions and safety hazards that may occur after getting a vaccine and what you should do if they occur, actually only contains five paragraphs!

There are 23 more paragraphs in the Adverse Reactions section, but as most folks understand, this section includes clinical trials experience, postmarketing experience, and voluntary reports, so it is not always possible to establish a causal relationship to vaccination for the adverse effects listed here.

What does the MMR package insert say about seizures, encephalitis, hearing loss, and death?

“Measles is also known as rubeola. It is a serious illness. Measles virus can be passed to others if you have it. Measles can give you a high fever, cough, and a rash. The illness can last for 1 to 2 weeks. In rare cases, it can also cause an infection of the brain. This could lead to seizures, hearing loss, mental retardation, and even death.

Mumps can also be passed to others. This virus can cause fever and headache. It also makes the glands under your jaw swell and be painful. The illness often lasts for several days. Sometimes, mumps can make the testicles swell and be painful. In some cases, it can cause meningitis, which is a mild swelling of the coverings of the brain and spinal cord.

Rubella is also known as German measles. It is often a mild illness. Rubella virus can cause a mild fever swollen glands in the neck, pain and swelling in the joints, and a rash that lasts for a short time. It can be very dangerous if a pregnant woman catches it. Women who catch German measles when they are pregnant can have babies who are stillborn. Also, the babies may be blind or deaf, or have heart disease or mental retardation.”

So the package insert is telling folks to get vaccinated and protected to avoid seizures, encephalitis, and death. Why don’t anti-vaccine folks ever mention that part of the package insert?

Don’t listen to anti-vaccine propaganda about vaccine package inserts.

Learn the risk of misinformed consent and following bad advice – leaving your kids unvaccinated and unprotected.

More on Myths About Warnings and Adverse Reactions in the MMR Package Inserts

Is Meningitis a Side Effect of Vaccines?

Most folks know that there are several meningitis vaccines.

Hib, Prevnar, MMR, and the meningococcal vaccines, for example, all protect folks against meningitis.

Is Meningitis a Side Effect of Vaccines?

So why would some people think that vaccines could actually cause meningitis?

Is meningitis listed on the package insert of any vaccines?
Is meningitis listed on the package insert of any vaccines?

Meningitis is listed as a possible adverse event in the package insert of some vaccines, but only in the section that includes spontaneously reported data from post-marketing experience, where it “may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.”

It is just like when folks find autism or SIDS in a vaccine’s package insert and think that it is evidence that vaccines are associated with autism or SIDS.

SIDS and autism are listed in Tripedia package insert, but are not causally linked to the vaccine.
SIDS and autism are listed in Tripedia package insert, but are not causally linked to the vaccine.

It isn’t.

These adverse reactions are listed “because of the seriousness OR frequency of reporting.” They are not included because they are serious AND frequent, as some anti-vaccine sites like to proclaim.

How Could a Vaccine Cause Meningitis?

When you think about it, how could a vaccine actually cause someone to develop meningitis?

Why would you even think this is true?

Meningitis is typically caused by a virus, bacteria, parasite, or fungus, etc.

While a live virus vaccine might rarely be able to cause an infection, few of the meningitis vaccines are live virus vaccines. Prevnar, Hib and the meningococcal vaccines are all sub-unit vaccines. Since only a part of bacteria (antigens) is actually present in the vaccine, it is not possible for them to cause an infection.

What about the live virus vaccines, like MMR, chicken pox, and rotavirus?

Since these viral infections rarely cause meningitis, except for mumps, you wouldn’t expect the rare vaccine induced infection to cause meningitis either. A natural measles infection, for example, is more likely to cause encephalitis instead.

“…there is no evidence to link Jeryl Lynn mumps vaccine to aseptic meningitis.”

MMR Package Insert

What about the chicken pox vaccine? There is a case report of a vaccinated child who later developed shingles and meningitis, caused by vaccine strain chicken pox virus. He recovered fully and it is important to note that folks with natural chicken pox are thought to be even more likely to develop shingles, and they too can develop meningitis.

The bottom line is that if someone has meningitis, even if they were recently vaccinated, you shouldn’t be blaming the vaccines.

Like they do with VAERS reports, misusing package inserts is a common method that anti-vaccine folks use to scare parents away from vaccinating and protecting their kids.

What to Know About Meningitis and Vaccine Package Inserts

Although included in some vaccine package inserts, except for rare circumstances with some live virus vaccines, none actually claim that vaccines cause meningitis.

More on Meningitis and Vaccine Package Inserts

Can Vaccines Cause Cancer?

We know that several vaccines can prevent cancer, including the human papillomavirus (HPV) vaccines and hepatitis B vaccine.

A cancer treatment vaccine, Provenge, has also been approved by the FDA to treat metastatic prostate cancer. Others are in development.

What Causes Cancer?

It seems like everything causes cancer, doesn’t it?

Did you see the media reports about coffee?

“Cancer is a complex group of diseases with many possible causes.”

American Cancer Society on What Causes Cancer?

Some of the most common causes of cancer include:

  • genetic mutations
  • smoking and tobacco
  • heavy alcohol use
  • unprotected exposure to UV rays in sunlight
  • infections

Fortunately, we can protect ourselves from many of these common causes of cancer.

Can Vaccines Cause Cancer?

Vaccines don’t cause cancer, but that doesn’t stop anti-vaccine websites from saying that they do.

“Cancer is part of our new normal. One in two men and one in three women will receive a cancer diagnosis in their lifetimes. But it’s not just adults. If you can’t bring yourself to focus on this topic for you, please do it for your children.”

Louise Kuo Habakus (Fearless Parent) on Do Vaccines Cause Cancer?

Cancer can definitely become part of your “new normal” if you or a friend or family member gets diagnosed.

National Cancer Institute Surveillance, Epidemiology, and End Results Program cancer statistics.
National Cancer Institute’s Surveillance, Epidemiology, and End Results Program cancer statistics.

Fortunately, cancer rates have been stable, with declining mortality rates. In children, cancer rates have been rising, but only slightly, and nothing like the boom in rates that some folks describe.

Anti-vaccine folks promote the idea that more people are sick, more people have cancer, and in general, everyone is unhealthy, because it fits with their idea that vaccines are dangerous for everyone.

How do they link vaccines and cancer?

They often push the idea that vaccines cause cancer because the original polio vaccines were found to be contaminated with SV40, or simian virus 40. SV40 has not been linked to cancer though.

What about formaldehyde?

Some vaccines contain formaldehyde and formaldehyde is carcinogenic, so how can you say that vaccines don’t cause cancer?

While some vaccines do contain formaldehyde, remember that it is also naturally found in our bodies.

“Carcinogens do not cause cancer at all times, under all circumstances.”

American Cancer Society

It is the long-term exposure to high amounts of formaldehyde, usually inhaled formaldehyde, that is the big concern. Those most at risk would be workers who might be exposed to inhaled formaldehyde. The small amount of formaldehyde in vaccines is safe and does not cause cancer.

Another anti-vaccine talking point? Misusing vaccine package inserts to make you think that vaccines aren’t properly evaluated for mutagenicity and carcinogenicity.

“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

They are.

Vaccines are safe and necessary. They don’t cause cancer.

What to Know About Vaccines and Cancer

Several vaccines can prevent cancer and there is even a vaccine that can treat cancer. Vaccines don’t cause cancer though.

More on Vaccines and Cancer

Abuse of Vaccine Exemptions

Every state has laws mandating vaccines to attend school and daycare.

Every state also allows exemptions to those mandates, including:

The way that  these laws and exemptions are set up leaves a lot of room for abuse though.

Abuse of Religious Exemptions

How many religions are actually against kids getting vaccinated?

That’s right, almost none.

So why are there so many religious vaccine exemptions in most states, especially in states that don’t have a personal belief exemption?

Right again.

Folks who don’t want to vaccinate their kids, and can’t use a personal belief exemption, just say that vaccinating them would be against their religion.

Abuse of Medical Exemptions

There are some children who shouldn’t be vaccinated.

These children can get a true medical exemption to one or more vaccines because they have a real contraindication or precaution to getting vaccinated.

“If a child has a medical exemption to immunization, a physician licensed to practice medicine in New York State must certify that the immunization is detrimental to the child’s health. The medical exemption should specify which immunization is detrimental to the child’s health, provide information as to why the immunization is contraindicated based on current accepted medical practice, and specify the length of time the immunization is medically contraindicated, if known.”

Dear Colleague letter regarding guidelines for use of immunization exemptions

Fortunately, these medical reasons to skip or delay vaccines are not very common and are often temporary. They can include the contraindications and precautions listed in the package insert for each vaccine and by the Advisory Committee on Immunization Practices, with the most common medical exemptions being:

  • a severe allergic reaction to a previous dose
  • a severe allergic reaction to a vaccine component
  • a known severe immunodeficiency and live vaccines
  • a moderate or severe acute illness with or without fever (precaution)
  • a progressive neurologic disorder (precaution)

A family history of these conditions would not be a reason to skip or delay any vaccines.
Although it will get you a medical exemption for just $120 in California, a family history of these conditions would not be a reason to skip or delay any vaccines.

Most other things are “incorrectly perceived as contraindications to vaccination” and should not be a medical exemptions, including having :

  • a mild acute illness with or without fever
  • a mild to moderate local reaction
  • relatives with allergies
  • a family history of seizures
  • a stable neurologic condition
  • an autoimmune disease
  • a family history of an adverse event after DTP or DTaP administration

A medical exemption can also exist if your child already had the disease and so has natural immunity. In most cases, except for chicken pox disease, titers will likely need to be done to prove that your child already has immunity.

Stopping the Abuse of Vaccine Exemptions

We know that vaccine exemptions are being abused.

How do you stop it?

“Permitting personal belief exemptions and easily granting exemptions are associated with higher and increasing nonmedical US exemption rates. State policies granting personal belief exemptions and states that easily grant exemptions are associated with increased pertussis incidence.”

Omer et al on Nonmedical exemptions to school immunization requirements: secular trends and association of state policies with pertussis incidence.

You likely have to make it harder to get a vaccine exemption.

Strong exemption laws, which are needed in many states, make it clear that:

  • many exemptions are temporary
  • medical exemptions are based on ACIP guidelines, current accepted medical practice, and evidence based medicine – not anecdotes
  • religious exemptions specifically exclude philosophical exemptions and must reflect a sincere religious belief
  • exempted students will be excluded from school during outbreaks
  • exemptions should include a signed affidavit that is notarized
  • exemptions should be recertified each year
  • a separate exemption application will be needed for each vaccine

Getting an exemption shouldn’t be easier than getting vaccinated! And it should include some degree of education against the myths and misinformation that scares parents away from vaccinating their kids.

“Because rare medically recognized contraindications for specific individuals to receive specific vaccines exist, legitimate medical exemptions to immunization requirements are important to observe. However, nonmedical exemptions to immunization requirements are problematic because of medical, public health, and ethical reasons and create unnecessary risk to both individual people and communities.”

AAP on Medical Versus Nonmedical Immunization Exemptions for Child Care and School Attendance

You could also get rid of nonmedical vaccine exemptions.

Of course, for that to work, you can’t allow just anything to count as a medical exemption.

“Review of all medical exemption requests will be conducted at the Mississippi State Department of Health by the State Epidemiologist or Deputy State Epidemiologist.”

Mississippi Medical Exemption Policy

In Mississippi, for example, where medical exemptions are reviewed and approved by the State Epidemiologist or Deputy State Epidemiologist, there were just 208 medical exemptions in the whole state during the 2016-17 school year.

In some states, rates of medical exemptions might be six or seven times higher. This is mostly seen in states that don’t allow personal belief exemptions and make it difficult to get a religious exemption.

That seems to be the case in Nebraska, where there are no personal belief exemptions and you have to submit a notarized statement to get a religious exemptions. Their high rates of medical exemptions likely reflect some abuse and the fact that medical exemptions aren’t reviewed or approved by anyone, they just reflect “that, in the health care provider’s opinion, the specified immunization(s) required would be injurious to the health and well – being of the student or any member of the student’s family or household.”

As we are seeing, that simply invites vaccine exemption abuse.

Very few states currently require that exemption applications go to the health department for review. Those that do include Alabama, Arkansas, Michigan, Minnesota, Mississippi, and West Virginia.

California is notably absent. I guess they didn’t see the potential for abuse when they passed their latest vaccine law. I mean, who could have guessed that doctors would actually be selling medical exemptions to parents based on unrelated conditions, like a family history of diabetes, celiac disease, or autism?

The non-medical vaccine exemption form in Colorado includes information on the risks of each vaccine-preventable disease.
The non-medical vaccine exemption form in Colorado includes information on the risks of each vaccine-preventable disease.

At the very least, until we have stronger exemption laws, parents who want to get a nonmedical exemption should acknowledge that they understand the risks they are taking when they skip or delay their child’s vaccines.

What to Know About Abuse of Vaccine Exemptions

While medical exemptions are necessary for kids who have true contraindications to getting vaccinated, stronger laws can help decrease the abuse we see in medical, religious, and personal belief vaccine exemptions.

More Information on Abuse of Vaccine Exemptions