Tag: package inserts

Side Effects and Adverse Events Following Immunizations

Vaccines are safe, but they do have some side effects, mostly mild, and they rarely cause some serious and severe adverse reactions.

Vaccine adverse events can be reported to VAERS online or using a downloadable form.
Vaccine adverse events can be reported to VAERS online or using a downloadable form.

To help keep our vaccines safe, it is important that all “clinically important adverse events that occur after vaccination of adults and children” be reported to VAERS, not just the ones that are known to be side effects.

Wait.

Isn’t an adverse event the same as a side effect?

Adverse Events Following Immunizations

To better understand that, let’s first look at how we define an adverse event following immunization (AEFI):

“An Adverse event following immunization (AEFI) is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.”

Classification of AEFIs

So it should be clear that not all adverse events are actually caused by vaccines.

Many are coincidental events that simply occur after a vaccine is given.

What’s the Difference Between Side Effects and Adverse Events Following Immunizations?

Others are true vaccine reactions though, including fever, pain, fainting, and allergic reactions, etc.

“A side effect is any health problem shown by studies to be caused by a vaccine. Like any medication, vaccines can cause side effects. Usually vaccine side effects are minor (for example, a sore arm where a shot was given or a low-grade fever after a vaccine) and go away on their own within a few days.”

Understanding Side Effects and Adverse Events

These are the reactions that we call side effects or adverse reactions of the vaccine.

Still, just because a sign or symptom can be a side effect of a vaccine doesn’t mean that it always will be.

“A vaccine reaction is an individual’s response to the inherent properties of the vaccine, even when the vaccine has been prepared, handled and administered correctly.”

Vaccine reactions – WHO Vaccine Safety Basics

Here are some other definitions:

  • adverse event – Medical occurrence temporally associated with the use of a medicinal product, but not necessarily causally related.
  • adverse reaction/side effect – A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
  • unexpected adverse reaction – Not consistent with applicable product information or characteristics of drug.
  • severe adverse event or reaction – are rarely life-threatening and usually do not result in long-term problems
  • serious adverse event or reaction – Any untoward medical occurrence that at any dose is life-threatening, results in death, requires inpatient hospitalization or prolongation of existing hospitalization, or results in persistent of significant disability or incapacity

Does understanding those definitions make it easier to see why you should be skeptical when folks try to scare you with VAERS reports and data from package inserts?

“Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.”

Guide to Interpreting VAERS Data

They both can include reports about adverse events, not just side effects. So they both include events that can very well be coincidental, and not caused by a vaccine.

So when doing your research about vaccines, focus on real side effects, or things that are known to be caused by vaccines. You will find that most vaccine side effects are mild and that more serious or severe side effects are very rare.

More on Side Effects and Adverse Events

Does the CDC Determine Medical Exemptions for Vaccines?

California’s new vaccine law has some folks arguing about medical exemptions again.

Yes, the CDC does not determine medical exemptions for vaccines. That's not news.
Yes, the CDC does not determine medical exemptions for vaccines. That’s not news.

Some want very broad guidelines and are confused about how doctors determine who should get a medical exemption.

Does the CDC Determine Medical Exemptions for Vaccines?

Bob Sears even thinks he has a bombshell revelation that clears everything up.

An email from the CDC!

You can be sure that the "medical provider's prerogative" does not include any reason they think up, even those that have no evidence to back them up.
You can be sure that the “medical provider’s prerogative” does not include any reason they think up, even those that have no evidence to back them up.

The thing is, no one has ever said that ACIP contraindications and precautions to vaccination are the one and only factor that should determine whether or not a child should get a medical exemption.

“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

So no one should really be surprised by an email that says the CDC does not determine medical exemptions.

What Qualifies as a Vaccine Medical Exemption?

What are the other big factors, in addition to ACIP contraindications and precautions?

“A medical exemption is allowed when a child has a medical condition that prevents them from receiving a vaccine.”

What is an Exemption and What Does it Mean?

Medical exemptions for vaccines should be based on AAP and ACIP guidelines, current accepted medical practice, and evidence based medicine.

“Medical exemptions are intended to prevent adverse events in children who are at increased risk of adverse events because of underlying conditions. Many of these underlying conditions also place children at increased risk of complications from infectious diseases. Children with valid medical exemptions need to be protected from exposure to vaccine-preventable diseases by insuring high coverage rates among the rest of the population. Granting medical exemptions for invalid medical contraindications may promote unfounded vaccine safety concerns. Although states may wish to allow parents who make decisions based on poor science or perceptions to withhold vaccines from their children, these exemptions should be distinguished from valid medical exemptions.”

Salmon et al on Keeping the M in Medical Exemptions: Protecting Our Most Vulnerable Children

For example, in addition to kids who may have had a severe allergic reaction to a vaccine, there are often children with immune system problems or who have a moderate or severe illness who can’t get one or more vaccines, at least temporarily.

These are among the common conditions that the AAP says should NOT delay vaccination and which are often mistakenly thought to qualify someone for a medical exemption.
These are among the common conditions that the AAP says should NOT delay vaccination and which are often mistakenly thought to qualify someone for a medical exemption.

Medical exemptions for vaccines should not be based on anecdotes or simply because a vaccine-friendly doctor has scared a parent away from vaccinating and protecting their kids.

There are very few family history issues that would make a child have to skip or delay getting a vaccine.
There are very few family history issues that would make a child have to skip or delay getting a vaccine.

They should rarely be done based on family history of reactions or what some people think are vaccine reactions.

This is what a fake medical exemption will get you - a life-threatening disease.
The child’s medical exemption was for “cytotoxic allergies secondary to immunization,” without any evidence that it was necessary. In addition to a fake medical exemption, he got tetanus.

In general, they should rarely be given, as the AAP states in their policy statement, Medical Versus Nonmedical Immunization Exemptions for Child Care and School Attendance, “only a very small proportion of children have medical conditions prohibiting specific immunizations…”

That’s why rates of medical exemptions should be low.

“Between the 2009-2010 and 2016-2017 school years, the national median prevalence of medical exemptions has remained constant, between 0.2% to 0.3%, with state-level ranges showing little heterogeneity over time, never exceeding the range of 0.1% to 1.6% over this period.”

Bednarczyk et al on Current landscape of nonmedical vaccination exemptions in the United States: impact of policy changes

And why you shouldn’t have schools with high rates of medical exemptions or doctors writing a lot of medical exemptions.

More on Vaccine Medical Exemption Guidelines

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