Tag: package inserts

Why Should Medical Exemptions Be Based on CDC Contraindications?

Getting a medical exemption for vaccines isn’t controversial.

Or at least it shouldn’t be.

Why Should Medical Exemptions Be Based on CDC Contraindications?

As many people know though, some people have been taking advantage of the fact that medical exemptions weren’t clearly defined in California’s vaccine law.

Who are the doctors handing out fake medical exemptions in California?
Who are the doctors handing out fake medical exemptions in California?

Are there just a few doctors taking advantage of the California law?

“But at 105 schools in the state, 10% or more of kindergartners had a medical exemption in the school year that ended last month, according to a Los Angeles Times analysis of state data.”

Pushback against immunization laws leaves some California schools vulnerable to outbreaks

Is 10% a lot?

In one recent report, Vaccination Coverage for Selected Vaccines, Exemption Rates, and Provisional Enrollment Among Children in Kindergarten — United States, 2016–17 School Year, the median rate of medical exemptions in the US was just 0.2%, with a range of <0.1 to 1.5%.

In West Virginia and Mississippi, states that don’t allow non-medical exemptions and where criteria for medical exemptions are fairly strict, the rates were 0.1 and 0.3% respectively.

And that’s about what you would expect, as there are very few true contraindications or precautions to getting vaccinated.

So yes, 10% is an awful lot and that’s a good sign that it is more than just a few doctors taking advantage of the law.

“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

Why do most other states have so few medical exemptions?

Mostly because there are very few true medical reasons to skip or delay a child’s vaccines!

They include, but aren’t limited to, the contraindications and precautions listed in the package insert for each vaccine (the contraindications and warnings sections…) and by the Advisory Committee on Immunization Practices.

They don’t include many other things that are “incorrectly perceived as contraindications to vaccination,” such as things in the family medical history of the child, eczema (unless they are getting the smallpox vaccine), colic, sleep apnea, or being a picky eater.

Is everything a vaccine injury?
Is everything a vaccine injury?

It should be obvious.

Medical exemptions for vaccines should be based on CDC criteria because some folks think that everything is a vaccine injury.

More on Medical Exemptions

Is the MMR Safe for 6-Month-Old Babies?

Most parents understand that the first dose of the MMR vaccine is routinely given to children when they are 12 to 15 months old, at least in the United States.

In some other countries, the first dose is routinely given as early as 8 to 9-months of age.

And in high-risk situations, the MMR can safely be given to infants as early as age 6-months.

Is the MMR Safe for 6 Month Old Babies?

An early MMR, is that safe?

This type of pure anti-vaccine propaganda is what caused the measles outbreaks in New York in the first place...
This type of pure anti-vaccine propaganda is what caused the measles outbreaks in New York in the first place…

Yes, it is safe.

What about the package insert?

“Local health authorities may recommend measles vaccination of infants between 6 to 12 months of age in outbreak situations. This population may fail to respond to the components of the vaccine. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established. The younger the infant, the lower the likelihood of seroconversion (see CLINICAL PHARMACOLOGY). Such infants should receive a second dose of M-M-R II between 12 to 15 months of age followed by revaccination at elementary school entry.”

MMR II Package Insert

The package insert says to give infants who get an early dose another dose when they are 12 to 15 months old! It doesn’t say to not protect these babies!

But what about the idea that the safety and effectiveness of MMR hasn’t been proven for infants under 12 months of age?

In general, the package insert is only going to list studies that the manufacturer used to get FDA approval for their vaccine. Since it is an off-label recommendation of the ACIP, they would not include the studies that show that an early MMR is safe and effective.

“In conclusion, this study indicated that the MMR was well tolerated and immunogenic against measles, mumps and rubella with schedule of first dose both at 8 months and 12 months age. Our findings strongly supported that two doses of MMR can be introduced by replacing the first dose of MR in current EPI with MMR at 8 months age and the second dose at 18 months in China.”

He et al on Similar immunogenicity of measles-mumps-rubella (MMR) vaccine administrated at 8 months versus 12 months age in children.

Before 8 months, an early MMR isn’t likely to be as effective as giving it later. That’s because some maternal antibodies might linger in a baby’s system and can interfere with the vaccine working, even after six months. How many antibodies and how much interference?

It’s almost impossible to tell for any one child, but the risk that this maternal protection has begun to wear off and these infants are at risk to develop measles is too great. That’s the reason that they get an early MMR, even though we know it won’t be as effective as a dose given later and we know it will have to be repeated.

Is this early dose safe?

“This review did not identify any major safety concerns. These findings may facilitate discussions about the risks and benefits of vaccinating infants who are potentially exposed to this life-threatening disease.”

Woo et al on Adverse Events After MMR or MMRV Vaccine in Infants Under Nine Months Old

Of course! Although the complications of measles can be serious, even deadly, we aren’t going to recommend something that is even worse.

“Early MMR vaccination is well tolerated, with the lowest AE frequencies found in infants aged 6-8 months. It is a safe intervention for protecting young infants against measles.”

van der Maas et al on Tolerability of Early Measles-Mumps-Rubella Vaccination in Infants Aged 6-14 Months During a Measles Outbreak in The Netherlands in 2013-2014.

So an early MMR is safe, with few risks, and is likely effective at preventing measles.

And by now you know what’s not safe. That’s right, getting measles.

More on Early MMR Vaccines

Bob Sears Doubles Down Against California Vaccine Laws

Bob Sears wasn’t a fan of SB 277, the vaccine law that removed non-medical exemptions in California.

Not surprisingly, he is actively rallying folks against a new bill that would close a loophole in that law. It seems that some doctors were writing medical exemptions for anything and everything, from eczema to swollen lymph nodes.

Bob Sears is pushing misinformation that SB 276 takes away all medical exemptions.
Bob Sears is pushing misinformation that SB 276 takes away all medical exemptions.

Of course, the new law wouldn’t take away medical exemptions. It would just take away fake medical exemptions.

Is everything a vaccine injury?
Is everything a vaccine injury?

Yes, take a long hard look at their list…

A very few actually are actually standard contraindications and precautions to commonly used vaccines, so could likely get you a medical exemption to one or more vaccines. GBS within 6 weeks of a flu shot, a precaution, not a contraindication, would be an example. But even in this case, the exemption would be for flu shots, not all vaccines.

“Events or conditions listed as precautions should be reviewed carefully. Benefits of and risks for administering a specific vaccine to a person under these circumstances should be considered. If the risk from the vaccine is believed to outweigh the benefit, the vaccine should not be administered. If the benefit of vaccination is believed to outweigh the risk, the vaccine should be administered. “

Vaccine Recommendations and Guidelines of the ACIP

What about all of the rest of the diseases or “severe reactions” on Bob’s list, like pneumonia, palpitations, eczema, hair loss, IBD, difficulty swallowing, skin infections, testicular pain, HSP, Multiple Sclerosis, and Kawasaki disease, etc.

These are not vaccine injuries, even though they are sometimes in a package insert. I’m surprised that he didn’t list SIDS and autism too…

And this is why California needs to fix their vaccine law… Folks, including pediatricians, pushing the idea that everything is a vaccine injury.

More on Bob Sears and California Vaccine Laws

How an Anti-Vaccine Safety Handbook Has Caused the Longest Measles Outbreak in Recent History

Can you believe that there were only 37 measles cases in 2004?

This year, we sometimes get reports of 37 cases in a week.

What happened?

A rise in measles cases all over the world happened. And since folks do travel, that led to outbreaks in any community that doesn’t have high rates of vaccination.

How an Anti-Vaccine Safety Handbook Has Caused the Longest Measles Outbreak in Recent History

And that’s where the PEACH Vaccine Safety Handbook comes into play.

Since at least 2014, the PEACH project folks and have been distributing their magazines filled with misinformation about vaccines in Orthodox Jewish communities.

In addition to Lakewood, the PEACH magazine was sent to “a mailing list that included a comprehensive directory of Pittsburgh families affiliated with various branches of Orthodoxy.”

And it found its way to Brooklyn and other Orthodox communities. Many of the same communities where we are now seeing the largest measles outbreaks in recent history, although there are plenty of outbreaks in other places too.

Surprisingly, PEACH is pure PRATT – anti-vaccine points refuted a thousand times.

Folks really should read the package insert of vaccines and should understand what they say. They don’t say that vaccines are associated with autism.

The cartoons were a nice touch, but should have been a tip-off that none of it was true! There is even a cartoon about the HAZMAT myth.

It all does look very official and sounds scary though, so it is easy to see how parents could be mislead by the magazine, especially when they seem to cite references for all of their “facts.”

This PEACH timeline was originally posted on several anti-vaccine websites back in 2007…

But let’s look at some of the facts in the above timeline:

  • is there any reason why Germany might have seen a rise in diphtheria cases in 1945?
  • Ghana was not declared measles-free in 1967. Unfortunately, Ghana is still not measles-free…
  • while the SV40 virus did contaminate some polio vaccines, it has not been associated with causing cancer or any other problems
  • whooping cough cases rose in Sweden and the UK because they stopped using the DPT vaccine in the late 1970s and 80s over fears of side effects. Of course, we now know that these fears were unfounded and many kids suffered because those fears were hyped by a few doctors, the media, and players from the start of the modern anti-vaccine movement
  • frivolous lawsuits over DPT side effects is what led to the rise in DPT prices
  • Jonas Salk testified that “mass inoculation against polio was the cause of most polio cases in the USA since 1961” because the Salk and Sabin polio vaccines had already controlled wild polio in the United States!!!
  • What about the idea that “the February 1981 issue of the Journal of the American Medical Association found that 90% of obstetricians and 66% of pediatricians refused to take the rubella vaccine?” That’s actually kind of true. But it was just a survey of a small number of employees at Los Angeles County University of Southern California Medical Center, most of whom believed that they actually were immune because they had likely been exposed to rubella so much in the past.

The rest of the magazine continues with the same kind of propaganda, trying to make folks think that vaccines don’t work, vaccines aren’t necessary, and that vaccines are dangerous.

Their experts?

From Russell Blaylock and Mark Geier to Tim O’Shea and Sherri Tenpenny, it is a who’s who of the worst folks in the modern anti-vaccine movement. They are certainly not the kind of folks you should be turning to for advice about vaccines, or anything else.

I wonder what they say about Shaken Baby Syndrome? Is it a vaccine injury too?!?

As we have seen with these growing measles outbreaks, although it makes a catchy slogan, you can’t always vaccinate later. You can wait until it is too late.

“I can only conjecture. But it has to be a combination a propensity towards conspiracy theories and religiosity gone awry based on bad information and in my view a gross misunderstanding of Halacha.”

AntiVaxxers – Religious Views Gone Awry

And that’s how you end up with the longest lasting measles outbreak in the United States in nearly 20 years.

More on How an Anti-Vaccine Safety Handbook Has Caused the Longest Measles Outbreak in Recent History

Fact Checking an Anti-Vaccine Measles Outbreak Quiz

Anti-vaccine folks have gotten pretty good at pushing propaganda to keep you scared to vaccinate and protect your kids.

Now, they even have quizzes to help test how much of that misinformation you remember!

Fact Checking an Anti-Vaccine Measles Outbreak Quiz

A quiz about measles outbreaks by the ironically named Physicians for Informed Consent was recently promoted by Dr. Bob Sears.

How did Dr. Bob get 12 out of 12 correct if most of the answers are really wrong?
How did Dr. Bob get 12 out of 12 correct if most of the answers are really wrong?

Let’s take a look at some of the questions and the anti-vaccine answers…

There is only so much that better hygiene, sanitation, and nutrition can do, which is why about 400 to 500 people were dying of measles in the 1950s and early 1960s just before the first measles vaccines were developed.
There is only so much that better hygiene, sanitation, and nutrition can do, which is why about 400 to 500 people were dying of measles in the 1950s and early 1960s just before the first measles vaccines were developed.

While mortality rates did indeed decline for most diseases and conditions in the early part of the 20th century because of advancements in living conditions, nutrition, and health care, that effect had plateaued by the mid-1930s.

Being unvaccinated and unprotected is the main reason why people in underdeveloped countries die from measles, not low vitamin A…

It is true that vitamin A deficiency increases the risk for more severe complications and death from measles, which is why it can be more deadly in undeveloped countries where malnutrition is a big problem.

“Because of gaps in vaccination coverage, measles outbreaks occurred in all regions, while there were an estimated 110 000 deaths related to the disease.”

Measles cases spike globally due to gaps in vaccination coverage

Unfortunately, the other big problem in many of these countries is that these kids are unvaccinated because of a lack of access to vaccines.

This child doesn’t appear to have measles…

Immune globulin is a treatment option if you have been exposed to measles, but it is not actually a treatment once you have measles. And high dose vitamin A mainly benefits those with a vitamin A deficiency, which is unlikely in an industrial country, like the United States.

The only benefit of having measles, which you have to earn by having measles and surviving without complications, is that you will have developed immunity to measles.

In addition to having no other benefits, you will then be at risk for SSPE and may have wiped out your immune system for a few years.

While you are at risk for encephalitis and seizures after a natural infection, after getting a dose of MMR, one risk is a febrile seizure, which is typically thought to be benign.

The risk of having a febrile seizure after the first dose of the MMR vaccine is about 1 in 2,500 doses. There is also a small risk of having a febrile seizure if the flu vaccine is given at the same time as a Prevnar or DTaP vaccine.

It is important to note that vaccines are not the only reason that children have febrile seizures. Many infections, including vaccine preventable infections, can trigger febrile seizures, in addition to causing more serious types of non-febrile seizures.

This is not true.

It is very unlikely that any of the kids who develop febrile seizures after a vaccine will later develop epilepsy.

“Febrile seizures can be frightening, but nearly all children who have a febrile seizure recover quickly, are healthy afterwards, and do not have any permanent neurological damage. Febrile seizures do not make children more likely to develop epilepsy or any other seizure disorder.”

Febrile Seizures Following Childhood Vaccinations, Including Influenza Vaccination

Without any risk factors (parent or sibling with epilepsy, having complex febrile seizures, or abnormal development), a child with febrile seizures has the same risk of developing epilepsy has any other child.

Do anti-vaccine folks really read the inserts?

Like many other vaccines, the package insert for MMR does say that it has “has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.” That doesn’t mean that it hasn’t undergone safety studies for its potential to cause cancer, genetic mutations, and impaired fertility though.

Wait, what? Yeah, all vaccines have preclinical toxicology studies, including single and/or repeat dose, reproductive and developmental, mutagenicity, carcinogenicity, and safety pharmacology. If any issues are found, further studies are done.

The only way to think that a natural measles infection is safer than the MMR vaccine is if you believe that all reports to VAERS have been confirmed as being caused by the vaccine (they aren’t) and you don’t think about the fact that relatively few people get measles any more (so you don’t see or hear about many measles deaths) because most folks are vaccinated and protected!

How did you do on the quiz?

Did you easily spot all of the anti-vaccine propaganda?

More on Fact Checking an Anti-Vaccine Measles Outbreak Quiz

Dr. Baker Says to Stop Worrying About Measles!

Are you worried about measles?

Are you less worried because a chiropracter on the Internet told you to stop worrying?

Dr. Baker Says to Stop Worrying About Measles!

I have no idea who “Dr” Baker really is, but let’s take a look at his copypasta “evidence” for why you shouldn’t worry about measles.

What’s missing from his list?

All of the studies that say that vaccines aren’t associated with autism!

The study, Long-term measles-induced immunomodulation increases overall childhood infectious disease mortality, which found that measles had an affect on non-measles deaths (causing more of them) through “measles-induced immune damage.”

And lots of other evidence that says that the MMR vaccine is safe, effective, and necessary.

If you really don’t want to have to worry about measles, get your kids vaccinated and protected.

Unfortunately, some folks don’t have that option, as their kids might be too young to get vaccinated or might have a true medical contraindication to getting vaccinated.

They have to worry about measles, no matter what “Dr.” Baker says, mostly because of your unvaccinated kids…

More on Worrying about Measles

Show Me the Vaccine Insert!

Have you ever wondered why anti-vaccine folks always ask about vaccine inserts?

It will soon be obvious that anti-vaccine folks don't really read vaccine inserts...
It will soon be obvious that anti-vaccine folks don’t really read vaccine inserts…

Would they really be happy if we handed them the entire vaccine insert before every visit?

Would they read the entire vaccine insert?

Which part of the vaccine insert do anti-vaccine even read?
Which part of the vaccine insert do anti-vaccine folks even read?

Or would they continue to only believe the parts that they think justify their decisions to leave their kids unvaccinated, unprotected, and at risk for getting life-threatening diseases?

Show Me the Vaccine Insert!

Let’s see what’s really in these package inserts…

“Measles, mumps, and rubella are three common childhood diseases, caused by measles virus, mumps virus (paramyxoviruses), and rubella virus (togavirus), respectively, that may be associated with serious complications and/or death. For example, pneumonia and encephalitis are caused by measles. Mumps is associated with aseptic meningitis, deafness and orchitis; and rubella during pregnancy may cause congenital rubella syndrome in the infants of infected mothers”

MMR II Package Insert

Wait a second!

How can anti-vaccine folks say that measles is a mild disease if the vaccine insert says that it “may be associated with serious complications and/or death.”

Have they really read this thing?

“The impact of measles, mumps, and rubella vaccination on the natural history of each disease in the United States can be quantified by comparing the maximum number of measles, mumps, and rubella cases reported in a given year prior to vaccine use to the number of cases of each disease reported in 1995. For measles, 894,134 cases reported in 1941 compared to 288 cases reported in 1995 resulted in a 99.97% decrease in reported cases; for mumps, 152,209 cases reported in 1968 compared to 840 cases reported in 1995 resulted in a 99.45% decrease in reported cases; and for rubella, 57,686 cases reported in 1969 compared to 200 cases reported in 1995 resulted in a 99.65% decrease”

MMR II Package Insert

Full stop!

How can they say vaccines don’t work when the package insert provides these stats showing it does and goes on to say that “M-M-R II is highly immunogenic and generally well tolerated.”

“The recommended age for primary vaccination is 12 to 15 months.”

MMR II Package Insert

Why are some of these folks delaying or skipping their child’s MMR vaccine? The package insert says to give it at 12 to 15 months!

“Individuals first vaccinated at 12 months of age or older should be revaccinated prior to elementary school entry.”

MMR II Package Insert

That’s the part of the package insert that says to give a second dose before kids enter kindergarten.

“There are no reports of transmission of live attenuated measles or mumps viruses from vaccinees to susceptible contacts.”

MMR II Package Insert

And that’s the part that says they can stop talking about shedding.

Maybe we should make anti-vaccine folks read these inserts…

“The following adverse reactions are listed in decreasing order of severity, without regard to causality, within each body system category and have been reported during clinical trials, with use of the marketed vaccine, or with use of monovalent or bivalent vaccine containing measles, mumps, or rubella:”

MMR II Package Insert

Do anti-vaccine folks understand that some of the things that are listed in the adverse reactions section of the package insert haven’t actually been proven to be caused by the vaccine? They are listed “without regard to causality.”

When you see them talk about SIDS and autism and package inserts, this is what they are talking about.

What about all of the “hidden” ingredients that are listed in the package insert?

Vaccine ingredients are not hard to find.

The ingredients that are so well hidden, they are listed right in the vaccine’s insert? Where does it mention all of the toxins that anti-vaccine folks are always talking about?

“…M-M-R II is highly immunogenic and generally well tolerated.”

MMR II Package Insert

The MMR vaccine works and it is safe.

It says so in the package insert.

Vaccinate your kids.

More on Vaccine Inserts