Tag: VAERS

Bobby Kennedy’s Vaccine Injury Debate

Why do some folks think that vaccine injuries are so common?

Unlike Bobby Kennedy, the CDC explains that severe injuries from vaccines are very rare.
Unlike Bobby Kennedy, the CDC explains that severe injuries from vaccines are very rare.

Oh, the usual suspects…

Bobby Kennedy’s Vaccine Injury Debate

Hopefully everyone sees what Bobby Kennedy is doing here.

He is mixing up a lot of different things, hoping you won’t notice and that you will walk away scared to vaccinate and protect your kids.

First things first.

Does the CDC say that 1 in 1,000,000 may be injured by shots?

Actually, no.

That sounds like the rate for severe vaccine injuries, like anaphylaxis and death.

What Bobby Kennedy is talking about though, that Federal Study, is 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)

The study identified all possible reactions, including minor reactions, like pain and fever, and wasn’t looking at just vaccine injuries, unless that is what you consider to be a vaccine injury. And since the study was looking at VAERS and possible reactions, they were not even necessarily causally related to the vaccines that the kids were given.

What else does Bobby Kennedy say?

“Slide 3 is a table from HHS’s 2016 Neiss-Cades survey published in JAMA reporting an astonishing 19.5% of children under five who are admitted to emergency rooms for drug reactions are suffering vaccine injuries.”

Bobby Kennedy

What kind of vaccine injuries?

They are vaccination reactions – any adverse effect from a vaccine. They could be fever, hives, or a febrile seizure – we don’t know. Importantly, only a very small percentage of those kids who went to the ER were hospitalized.

Lastly, Bobby Kennedy wonders how a pediatrician might claim to have never seen a vaccine injury.

It’s easy to understand his confusion.

Getting listed in a vaccine insert doesn't automatically make something a vaccine injury.
Getting listed in a vaccine insert doesn’t automatically make something a vaccine injury.

Most people reserve the term vaccine injury for the more severe reactions covered under the Vaccine Injury Table, like anaphylaxis, VAPP, thrombocytopenic purpura, and intussusception.

And they use the term side effects for the more temporary reactions that are thought to be caused by a vaccine.

All of these vaccine adverse events can be reported to VAERS online or using a downloadable form.
All of these vaccine adverse events can be reported to VAERS online or using a downloadable form.

That’s very unlike those folks who consider anything and everything that happens after a child is vaccinated, even if it is many months later, to be a vaccine injury, including things like ADHD, diabetes, and autism, etc.

More on Vaccine Injuries

Are Vaccines Only Tested for 4 or 5 Days?

Where do some folks get the idea that vaccines are only tested for 4.5 days?

Anti-vax protestors often carry signs that say vaccines are only tested for 4.5 days. Don't believe them.
Anti-vax protestors often carry signs that say vaccines are only tested for 4.5 days. Don’t believe them.

The usual suspects…

Are Vaccines Only Tested for 4 or 5 Days?

But who gave them the idea to put it on their sign?

Again, the usual suspects…

Did the idea that vaccines are only tested for 4.5 days come from JB Handley, Children’s Health Defense Director and Co-Founder of Generation Rescue?
Did the idea that vaccines are only tested for 4.5 days come from JB Handley, Children’s Health Defense Director and Co-Founder of Generation Rescue?

Before we actually look to see if the original clinical trials for the hepatitis B vaccines only “solicited adverse reactions” for four or five days after vaccination, lets see what the safety studies have shown since these vaccines were approved in the 1980s.

These and other studies have shown that the hepatitis B vaccines are safe.

What about the idea that we only know what happens in the first four or five days after the vaccine is given?

Hepatitis B Vaccine Safety Testing

That’s not true. There are plenty of long term studies and safety studies typically collect safety information for weeks and months after a child is vaccinated.

“Open-ended diaries were provided to the parent(s) or guardian of the child before the vaccination program began in which to record any health problems that occurred 1 month before and 1 month following each of the 3 doses of vaccine, whether or not a health professional was consulted.”

De Serres et al on Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children.

Still, it is important to note that the further you get from a vaccination, the less likely that an adverse event is actually going to be caused by the vaccine though.

Consider the study by De Serres, Importance of attributable risk in monitoring adverse events after immunization: hepatitis B vaccination in children, in which they looked at the reports of adverse events both before and after vaccination and concluded that “postimmunization incidence systematically overestimates the risk of adverse events.”

Vaccines are tested very carefully, starting with small phase I and phase II trials, before moving to larger and longer lasting phase III trials.
Vaccines are tested very carefully, starting with small phase I and phase II trials, before moving to larger and longer lasting phase III trials.

It is also very important to note that like other vaccines, the hepatitis B vaccine was well tested before it was approved.

Although this was an efficacy trial, it included a double blind, placebo control and the researchers did notice any side effects.
Although this was an efficacy trial, it included a double blind, placebo control and the researchers did notice any side effects.

And many of the studies did include a placebo group.

A lot of folks in the placebo group for the hepatitis B vaccine trials got hepatitis B.
A lot of folks in the placebo group for the hepatitis B vaccine trials got hepatitis B.

Unfortunately, a lot of the folks in the placebo groups ended up getting hepatitis B.

In one study, Hepatitis B vaccine: efficacy in high-risk settings, a two-year study, which included an unvaccinated control group – “The control group was comprised of 31 patients and 24 staff members who had not been in contact with HBV until they entered the units and who did not wish to be vaccinated.”

What happens when you do a vaccinated vs unvaccinated study?
What happens when you do a vaccinated vs unvaccinated study?

Importantly, this study found “no local or general reaction to the immunization. A monthly biological and clinical survey of the vaccinated subjects showed no evidence of complication due to vaccination, especially no sign of auto­immunity.”

So why do we still hear the myth that vaccines are only tested for 4.5 days?

Anti-vax folks need to convince their followers that vaccines aren’t safe.

A careful look at all that went into the development of the hepatitis B vaccines shows that they are.

It also shows that vaccines are very necessary.

More on Hepatitis B Vaccine Safety Testing

How the Anti-Vax Movement Takes Advantage of SIDS and SUDC Families

Unfortunately, we have gotten used to the modern anti-vaccine movement doing some horrible things. What’s one of the very worst? Taking advantage of the parents of children who have recently died of SIDS or SUDC.

We commonly see anti-vaccine folks seek out parents whose children have very recently died to make them think that vaccines were the cause.
We commonly see anti-vaccine folks seek out parents whose children have very recently died to make them think that vaccines were the cause.

Making parents think that their baby died because of vaccines.

How the Anti-Vax Movement Takes Advantage of SIDS and SUDC Families

Although we have seen folks like Larry Cook do this time and again, it isn’t what is best for these families.

“When a child dies unexpectedly, a family may feel a flood of emotions, including guilt, anger and lack of control. The clinician’s role is to offer stable support, information and compassionate care. In order to provide the most appropriate care for families in these situations, it is necessary to understand the complexities of the grief and trauma response and to recognize that the families’ needs will change over time.”

Caring for the SUDC Family: Medical and Bereavement Information for the Clinicians’ Consideration

What do anti-vax folks offer to these grieving families?

“During an open investigation, do not speculate on the cause of death with the family. Although this may feel supportive, it often undermines the relationship with the Medical Examiner/Coroner who is legally charged with determining cause of death and adds stress for the family when clinicians and the investigating authorities disagree. It is optimal that clinicians and Medical Examiners/Coroners communicate directly for the best interests of the family. “

Caring for the SUDC Family: Medical and Bereavement Information for the Clinicians’ Consideration

They offer an answer…

“Sudden Unexplained Death in Childhood (SUDC) is a category of death in children between the ages of 1 and 18 that remains unexplained after a thorough investigation, including an autopsy.”

Facts About Sudden Unexplained Death in Childhood

Often when answers haven’t been available.

“Dealing with the sudden, unexpected death of a baby to any cause is devastating – but in the case of a death for which no specific cause can be found, the lack of answers about why your baby has died can be overwhelming.”

Surviving the Sudden Death of a Baby

And whether it is Sudden Infant Death Syndrome (SIDS), Sudden Unexpected Infant Death (SUID), or SUDC, invariably, the “answer” that they offer is that they should blame vaccines.

Of course, they shouldn’t.

Vaccines are safe, with few risks.

Vaccines are not associated with SIDS.

Vaccines are not associated with SUID.

Vaccines are not associated with SUDC.

Shame on these folks for making grieving parents think that they are.

These families would get much better help from organizations like the SUDC Foundation and first candle.

More on Caring for SIDS and SUDC Families

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