Tag: Vaccine Safety Datalink

Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

It is a common anti-vaccine argument that fewer than 1% of vaccine injuries are reported to VAERS.

I've found that fewer than 1% of anti-vaccine signs are true...
I’ve found that fewer than 1% of anti-vaccine signs are true…

They even think that they have evidence from Harvard to support their claim!

Are Fewer Than 1% of Vaccine Injuries Reported to VAERS?

Do they?

Are fewer than 1% of vaccine injuries reported to VAERS?

It has long been suspected that reports to VAERS are under-reported, as it is a passive reporting system.

The original claims for under-reporting to VAERS were based on an old study about drug reactions and were not specific to vaccines though.

Is that the Harvard study?

Nope.

“Restructuring at CDC and consequent delays in terms of decision making have made it challenging despite best efforts to move forward with discussions regarding the evaluation of ESP:VAERS performance in a randomized trial and comparison of ESP:VAERS performance to existing VAERS and Vaccine Safety Datalink data. However, Preliminary data were collected and analyzed and this initiative has been presented at a number of national symposia.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

They are talking about a report, Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS), that was conducted at Harvard Pilgrim Health Care, Inc.

“Preliminary data were collected from June 2006 through October 2009 on 715,000 patients, and 1.4 million doses (of 45 different vaccines) were given to 376,452 individuals. Of these doses, 35,570 possible reactions (2.6 percent of vaccinations) were identified.”

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS)

It is very important to note that all the study found is that all possible reactions, including minor reactions, like pain and fever, are not common.

They didn’t actually finish the report to see how commonly those reactions were reported to VAERS.

But we already know that more serious reactions are reported to VAERS much more routinely.

“Sensitivities ranged from 72% for poliomyelitis after the oral poliovirus vaccine to less than 1% for rash and thrombocytopenia after the MMR vaccine.”

Rosenthal et al on The reporting sensitivities of two passive surveillance systems for vaccine adverse events

And there has even been a more recent report, Advanced Clinical Decision Support for Vaccine Adverse Event Detection and Reporting, which also used an ESP-VAERS system, that found great improvements in reporting of adverse events to VAERS.

Even more importantly, even with it’s limitations, VAERS works!

“Despite its limitations, VAERS effectively detected a possible problem soon after introduction of RRV-TV in the United States.”

Lynn R. Zanardi, et al on Intussusception Among Recipients of Rotavirus Vaccine: Reports to the Vaccine Adverse Event Reporting System

Although it would be ideal to have even more reports sent to VAERS, time and again, we have seen that VAERS works.

“On November 23, 2010, the combination of the coding term “febrile convulsion” and the Fluzone(®) TIV product exceeded a predetermined threshold in the VAERS database. By December 10, we confirmed 43 reports of febrile seizure following TIV in children aged 6-23 months. Clinical features of most reports were consistent with typical uncomplicated febrile seizures, and all children recovered. Further epidemiologic assessment of a possible association between TIV and febrile seizures was undertaken in a separate, population-based vaccine safety monitoring system.”

Leroy et al on Febrile seizures after 2010-2011 influenza vaccine in young children, United States: a vaccine safety signal from the vaccine adverse event reporting system.

As we have seen, for VAERS to work, we don’t need all side effects and reactions to be reported.

“VAERS is primarily a safety signal detection and hypothesis generating system. Generally, VAERS data cannot be used to determine if a vaccine caused an adverse event. VAERS data interpreted alone or out of context can lead to erroneous conclusions about cause and effect as well as the risk of adverse events occurring following vaccination.”

Shimabukuro et al on Safety monitoring in the Vaccine Adverse Event Reporting System (VAERS).

Also, VAERS is not the only safety system that we have to make sure that our vaccines are safe.

The other thing that folks should understand? Most reports to VAERS are not actually vaccine injuries

More on the Percentage of Reports to VAERS

Why is the Tdap Vaccine in Category C?

The Tdap vaccine is routinely recommended for all pregnant women, so why would it be in the FDA Category C?

The FDA has actually removed the pregnancy categories.

We should start by stating that “risk-benefit decisions regarding use of a drug during pregnancy are more complex than the category designations suggest.”

Why is the Tdap Vaccine in Category C?

Anyway, the category designations are no longer being used on new drugs and vaccines.

“In December of 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule). The PLLR removes pregnancy letter categories – A, B, C, D and X. Instead, under the final rule, narrative summaries of the risks of a drug during pregnancy and discussions of the data supporting those summaries are required in labeling to provide more meaningful information for clinicians.”

Guidelines for Vaccinating Pregnant Women

So is it still Category C?

Yes, for now. Few vaccines have converted to the new labeling system yet, which still leaves us with:

  • Pregnancy Category B: Tdap (Boostrix) – Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus during the first trimester (and there is no evidence of risk in later trimesters).
  • Pregnancy Category C: Tdap (Adacel) – Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks OR Animal reproduction studies have not been conducted and there are no adequate and well-controlled studies in humans.

Of course, the Vaccine Safety Datalink has published more than 14 studies “related to pregnancy and vaccination during pregnancy” and has used “data to study the health of children born to women who were vaccinated during pregnancy.”

And many of these studies are about the Tdap vaccine!

“There are no theoretical or proven concerns about the safety of the Tdap vaccine (or other inactivated vaccines like Tdap) during pregnancy. The shot is safe when given to pregnant women.”

Frequently Asked Questions for Pregnant Women Concerning Tdap Vaccination

This will likely be reflected when we get new labels for these vaccines, with wording that makes it clear that Tdap vaccines are safe in pregnancy.

what to know about the tdap vaccines and their category c designation

Tdap vaccines still have a Category C designation simply because their labels haven’t been updated to reflect the latest safety studies.

More on Tdap Vaccines and Category C

Are Vaccines Causing Long-Term Health Problems?

Did the CDC say that it is impractical to find out of vaccines are causing an epidemic of brain injury and other long-term health problems?

I’m guessing they didn’t…

Are Vaccines Causing Long-Term Health Problems?

Why does anyone think that they did?

The latest anti-vaccine propaganda about vaccines causing long-term health problems.
The latest anti-vaccine propaganda about vaccines causing long-term health problems.

Oh, anti-vaccine folks are sharing a cherry-picked quote from the CDC to scare parents away from vaccinating and protecting their kids.

Would you like to see the full quote?

“Observing vaccinated children for many years to look for long-term health conditions would not be practical, and withholding an effective vaccine from children while long-term studies are being done wouldn’t be ethical. A more practical approach is to look at health conditions themselves and at the factors that cause them. Scientists are already working to identify risk factors that can lead to conditions like cancer, stroke, heart disease, and autoimmune diseases such as lupus or rheumatoid arthritis. Thousands of studies have already been done looking at hundreds of potential risk factors. If immunizations were identified as a risk factor in any of these studies, we would know about it. So far, they have not.

We learn about a vaccine’s safety during clinical trials before it is licensed, and monitor it continually as millions of doses are administered after it is licensed. We also know there is not a plausible biologic reason to believe vaccines would cause any serious long-term effects. Based on more than 50 years of experience with vaccines, we can say that the likelihood that a vaccine will cause unanticipated long-term problems is extremely low.

Parents’ Guide to Childhood Immunizations

So no, the CDC didn’t say that it was impractical to find out of vaccines are causing an epidemic of brain injury.

Instead, they said that it was just impractical to do a study in which you give a child a vaccine and watch him for 20 years to see if he develops a problem, like leukemia, diabetes, or autism, all the while not giving the vaccine to other kids until your study is over. Of course, that’s because a lot of kids would get the potentially life-threatening disease that the vaccine is protecting those kids against while you were waiting to complete those long-term studies.

That’s not to say that we aren’t concerned about these types of long-term health problems occurring after a child is vaccinated.

Plenty of long-term safety studies have been done. It’s just more practical to do the studies on the diseases you are concerned about, sometimes after noticing safety signals, and see if vaccines truly are a risk factor.

Here is one example:

“In this large, population-based, case-control study, we did not find an increased risk of type 1 diabetes associated with any of the routinely recommended childhood vaccines.”

DeStefano et al on Childhood vaccinations, vaccination timing, and risk of type 1 diabetes mellitus.

In that study, they found all of the kids with diabetes born during 1988 through 1997 in the 4 health maintenance organizations (HMOs) that participate in the Vaccine Safety Datalink project of the Centers for Disease Control and Prevention, compared them to matched controls, and did not find an increased risk of type 1 diabetes associated with any of the routinely recommended childhood vaccines.

There are many more…

And that’s how we know vaccines aren’t causing long-term health problems.

Well at least those of us who did our research, looked for the original quote, and saw through this anti-vaccine propaganda.

More on Vaccines and Long-Term Health Problems

More Vaccinated vs Unvaccinated Studies

Anti-vaccine folks continue to call for vaccinated vs unvaccinated studies.

A vaccinated vs unvaccinated study that anti-vaccine folks don't talk about...
A vaccinated vs unvaccinated study that anti-vaccine folks don’t talk about…

Not surprisingly, they ignore all of the studies that have already been done.

More Vaccinated vs Unvaccinated Studies

Listening to these anti-vaccine folks, you would actually think that the only vaccinated vs unvaccinated “study” that has ever been done is the survey about homeschoolers that they always talk about

That leaves out a lot of other vaccinated vs unvaccinated studies, including:

Do we need even more studies on vaccinated vs unvaccinated children?

We already know that unvaccinated kids get sick more and they have more severe disease. Who is going to approve of or want to do a study that only puts kids at risk to get a vaccine-preventable disease?

Vaccines are safe, with few risks, and they are obviously necessary.

More on Vaccinated vs Unvaccinated Studies