Tag: package inserts

Is the MMR Vaccine Licensing Being Called into Question?

Why do some folks think that the MMR vaccine licensing is being called into question?

Yup. That’s what the usual suspects are trying to make you think.

Is the MMR Vaccine Licensing Being Called into Question?

Taking advantage of the fact that many sites publish all press releases, these folks want you to think that a major news site is following their latest bombshell, which of course is just another dud.

The MMR was licensed in 1971. The ICAN papers are from 1978…

You mean there really isn’t an FDA coverup?

“Clinical studies of 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II is highly immunogenic and generally well tolerated.”

MMR II Package Insert

Not only is the package insert very transparent about the studies used to approve the MMR II vaccine they are talking about, since only a minor change was made to the original MMR vaccine, which was approved in 1971, it isn’t surprising that larger trials weren’t required at the time.

So there were earlier, larger trials?

Yup.

But did they use a saline control group?

Nope.

A Vaccinated vs Unvaccinated Study - Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies.
A Vaccinated vs Unvaccinated Study – Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies

The control group was actually unvaccinated.

It is also important to keep in mind that this study, and a few other MMR studies, followed much, much larger studies of the individual measles, mumps, and rubella vaccines.

“The large majority of children in the United States have been vaccinated against measles and a sizable portion have been given mumps and rubella vaccines. It is estimated by us based on vaccination distribution that about 41 million children have received measles vaccine, 7 million mumps vaccine, and 21 million rubella vaccine. The combined triple vaccine provides a simple, safe, and effective immunization procedure using a single vaccine dose against three important diseases in children who have not yet been immunized.”

Stokes et al on Trivalent combined measles-mumps-rubella vaccine. Findings in clinical-laboratory studies.

Much larger double-blind, placebo-controlled studies of the individual measles, mumps, and rubella vaccines.

This is why you don’t routinely do vaccinated vs unvaccinated studies anymore. It is unethical to let kids get measles, mumps, rubella or other diseases.

The bottom line is that the measles (1968), mumps (1967), and rubella (1969) vaccines were safe when they were approved by the FDA.

The MMR (1971) was safe when it was approved by the FDA.

And MMR-II (1978) was safe when it was approved by the FDA.

Since then, there have also been studies showing that getting a second dose of MMR-II is safe and effective and that ProQuad, the combination measles, mumps, rubella, and chickenpox vaccine is safe and effective, although it is associated with a small increased risk of febrile seizures if given as a first dose.

There is no FDA coverup. No bombshell.

Just anti-vaccine folks continuing to try and scare you away from vaccinating and protecting your kids.

More on the Licensing of the MMR Vaccine

Who Gets SSPE?

Have you heard that you can get SSPE from the MMR?

Apparently it’s in the vaccine insert

Who Gets SSPE?

Subacute sclerosing panencephalitis (SSPE) occurs after a natural measles infection.

You won't get SSPE if you don't get measles.

It is not caused by MMR or any measles containing vaccine.

Of course, the measles vaccine is not 100% effective, so it is possible that you could still get measles after being vaccinated. And those folks who get measles after getting vaccinated could be at risk to get SSPE, but even then, their SSPE would be caused by wild measles virus, not a vaccine strain.

“Available epidemiological data are consistent with a directly protective effect of vaccine against SSPE mediated by preventing measles.”

Subacute sclerosing panencephalitis and measles vaccination

Again, SSPE is caused by natural measles infections and the wild type measles virus.

Tragically, after big outbreaks of measles, we start to see more cases of SSPE, with the greatest in children who get measles at a young age.

And SSPE is universally fatal in these children, who develop symptoms about six to eight years after recovering from having measles.

That the symptoms of SSPE don’t develop until long after you have recovered from measles is why the condition is often described as a time-bomb.

A time-bomb that you can’t stop.

Want to avoid getting SSPE? Get vaccinated and protected against measles.

More on Getting SSPE

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