Introduction

On November 14, 1986, President Ronald Reagan signed into law the National Childhood Vaccine Injury Act , removing all liability from vaccine manufacturers related to harm caused by their products, and transferring that burden to taxpayers through the National Vaccine Injury Compensation Program .

On the day of signing, according to the schedule from the Centers for Disease Control and Prevention (CDC), American children received eight vaccines before the age of two, and a total of 11 before the age of 18. Today, the schedule calls for a staggering number of vaccines: up to 35 by age two and a further 22 before adulthood . Along with this expansion of vaccinations we have seen numerous disorders including the horrifying statistic that now 1 in 59 American children have a diagnosis of autism .

The pejorative “anti-vax” label given to anyone who questions current vaccine policy implies that those in the movement are uninformed and anti-science, and that they believe that nobody should ever get any vaccine. This is simply not the case. The vast majority of so-called “anti-vaxxers” came to their position from doing their own research after a son, daughter, or other loved one was seriously harmed after receiving a routine vaccination. The number of mothers who are told that it is a pure coincidence that their happy, healthy, extroverted child lost eye contact, speech, or even life after getting a routine shot is both insulting and astonishing. We must all be advocates for scientifically established vaccine safety and champions for informed consent.

While we know there can be great benefits from vaccines, but there can also be great harm. The truth of the matter is that, at present, we do not have enough information to accurately weigh the risk of vaccination against the benefits. Our regulatory agencies have and continue to fail us by simply rubber-stamping vaccines based on manufacturers’ safety studies which are, in reality, poorly designed, inadequately executed, or have findings that are blatantly misrepresented. Moreover, there is little to no substantive follow-up done on health outcomes after a new product is added to the childhood vaccination schedule.

A serious problem in understanding health outcomes lies in the Vaccine Adverse Events Reporting System (VAERS) run by the U.S. Department of Health and Human Services (HHS) which is woefully inadequate for capturing the details and extent of injuries resulting from vaccination. How so? This information is critical not only for medical professionals and parents making decisions for their children, but also for panels making wide-reaching public health policies that impact all of our communities. Without detailed and accurate data and scientific analysis there can be no such thing as truly informed consent.

The sad fact is that vaccines are not as safe as we have been led to believe.

How many hours has the average American spent reading vaccine inserts and other packaging? We’ve spent the time.

How many have scrutinized vaccine safety studies, studied the VAERS database, or reviewed the payouts from the National Vaccine Injury Compensation Program (“Vaccine Court”)? We have.

This prospectus is the result of a deep dig into the medical research, public records, government programs, and raw data on the safety of vaccines and we urge you to consider the obvious conclusions:

• Vaccine injury is real. It is also common and the consequences can be severe.

• Safety studies regarding vaccines are woefully insufficient.

• Many rigorous, peer-reviewed studies support the link between vaccines and neuro-developmental disorders and other chronic illnesses.

• Dissenting voices, in both our regulatory agencies and the medical profession, are intentionally and callously sidelined.

• Finally, first-hand accounts of vaccine injury can no longer be dismissed.

When it comes to vaccines, a phrase that gets continuously repeated is that vaccines are “safe and effective”. Industry experts tell us that adverse vaccination events are minor in nature (for example, merely “fever or swelling at the injection site”) and small in number (“one in a million”) but it only takes a limited amount of research into the available data to realize that these assertions are simply not true. To get a handle on the problem of vaccine safety, the first question that needs to be asked is:

How Many Vaccine Injuries Occur in the United States Every Year?

This question is far more difficult to answer than it should be due to the poor tracking and reporting of health outcomes. For example, the reporting of vaccine injuries to the VAERS system is problematic on many levels, but there are two key issues:

• Medical professionals are not required to report a confirmed or suspected injury due to vaccines, which means that many injuries are simply not reported.

• Because anyone (not just medical professionals) can submit a report, the quality of the data is poor. The VAERS website itself admits “Reports vary in quality and completeness. They often lack details and sometimes can have information that contains errors.”

If you search the VAERS database for events reported during all of 2016, you will see a total of 59,117 incidents reported including:

• 432 deaths

• 1,091 permanent disabilities

• 4,132 hospitalizations

• 10,284 emergency room visits

In 2000, the congressional report “The Vaccine Injury Compensation Program: Addressing Needs and Improving Practices / Sixth Report” by the Committee on Government Reform discussed the failings of VAERS, stating:

The quality of VAERS data has been questioned. Because reports are submitted from a variety of sources, some inexperienced in completing data forms for medical studies, many reports omit important data and contain obvious errors. Assessment is further complicated by the administration of multiple vaccines at the same time, following currently recommended vaccine schedules, because there may be no conclusive way to determine which vaccine or combination of vaccines caused the specific adverse event.

In addition, the report identifies severe limitations in the knowledge and research capability on vaccine safety:

• Inadequate understanding of biologic mechanisms underlying adverse events

• Insufficient or inconsistent information from case reports and case series

• Inadequate size or length of follow- up of many population- based epidemiological studies

• Limitations of existing surveillance systems to provide persuasive evidence of causation

• Few published epidemiological studies

The study warns that:

If research capacity and accomplishments [are] not improved, future reviews of vaccine safety [will be] similarly handicapped.

In an attempt to better understand how to solve the problem of tracking vaccine safety, in 2006 the U.S. Department of Health and Human Services gave Harvard Medical School a $1 million dollar grant to track VAERS reporting at Harvard Pilgrim Healthcare for 3 years, and to “create a generalizable system to facilitate detection and clinician reporting of vaccine adverse events, in order to improve the safety of national vaccination programs.” The researchers concluded that:

Adverse events from drugs and vaccines are common, but underreported. […] Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of ‘problem’ drugs and vaccines that endanger public health […and that…] new surveillance methods for drug and vaccine adverse events are needed.

So, what happened to this project? The researchers summed up the results in the report’s abstract as:

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.

In other words, nothing. The project died.

If you extrapolate from the study’s estimation that “fewer than 1% of vaccine adverse events are reported”, it implies that the real figures are truly astonishing. For example, it implies the totals for 2018 are more like 5,911,700 adverse vaccine events, including”

• 43,200 deaths

• 109,100 permanent disabilities

• 413,200 hospitalizations

• 1,028,400 emergency room visits

The December 1, 2018 update by the U.S. Health Resources and Services Administration reported that that the total amount awarded through the National Vaccine Injury Compensation Program to individuals who had been injured or died after receiving federally recommended vaccines, had surpassed $4 billion .

Although the woefully inadequate VAERS data and astoundingly high VCIP awards do not prove causation per se, they should raise red flags to anyone looking into vaccine safety. Until we have a high-quality, mandatory reporting system that gives a clear understanding of the scope and severity of the vaccine injuries suffered, the banner “safe and effective” is a lie and cannot be trusted.