1. There is a long list of serious (some life-threatening) adverse events. These "SAEs" are life-threatening or disabling events. They are listed on the package inserts of every vaccine.
2. On three occasions the Institute of Medicine (IOM) has been tasked with doing research reviews in order to determine if any of a set of SAEs commonly associated with particular vaccines were -- or were not -- caused by those vaccines. They reported on their reviews in 1991, 1994, and 2011. The results provided in those reports were as follows, respectively:
1. caused vs. didn't cause -- 6-4, 12-4, and 18-5 -- a lot of causality; but more concerning:
2. insufficient research found to determine causality/non-causality: 12, 38, and then 135 (!).

It was clear that in most cases, it was not possible to say the vaccine was safe -- i.e., that it didn't cause the SAE in question. In and of itself, this renders the assertion that "vaccines are safe" false. Acknowledging this, the IOM each time chastised the government -- in vain -- for failing to pursue sufficient research on vaccine safety.

3. The 1986 National Childhood Vaccine Injury Act (NCVIA) granted vaccine manufacturers immunity from vaccine injury-and-death litigation. To make up for this loss of safety incentive on the part of manufacturers, the Act tasked Health and Human Services (HHS) with actively pursuing research aimed at making the vaccine program safer, and reporting to Congress every two years on that research. However, last year, a lawsuit forced HHS to admit that in the entire 30 years since that requirement commenced, it had done zero safety studies and filed zero reports.
4. Pursuant to the NCVIA, HHS set up a standard Vaccine Injury Table, a list of vaccines and the SAEs that are acknowledged to be caused by those vaccines.
5. The NCVIA also set up the National Vaccine Injury Compensation Program, or "Vaccine Court," under the Health Resources and Services Administration (HRSA). It was intended to be a non-confrontational replacement for the industry liability eliminated under the Act. Vaccine injury/death plaintiffs instead sue the federal government, with
1. the full legal resources of the Department of Justice defending the government,
2. a very short statute of limitations for reporting (see the latency periods mentioned in #6a),
3. no jury: only a "special master" who might have ties to industry, or no vaccine expertise,
4. a requirement that the plaintiff prove causation for any SAE not listed on the Vaccine Injury Table,
5. no legal discovery that might find internal industry documents supporting such proof, and
6. a lengthy legal process averaging around 7 years.

These hurdles -- which violate the Court's original non-confrontational intent -- have caused about 2/3 of plaintiffs to either drop out or lose their case. Nevertheless, the Court has so far awarded $4 billion to people for injuries and deaths caused by vaccines.

6. The FDA considers vaccines "biologics" rather than "drugs." As a result, vaccine safety trials are not governed by the standards required of drug safety trials. In particular,
1. Duration -- Rather than 4-5 years, the trials generally last only a few weeks and, in cases like the two HepB vaccines, 4 and 5 days. It should be noted that research in recent years has been finding biological mechanisms of damage that involve sometimes long latency periods -- damage that would never be found in such trials.
2. Lack of true placebo -- An inert placebo is never used; instead, an earlier (equally non-placebo-tested) vaccine, or the adjuvant, or the vaccine formulation less the antigen, is used as a comparitor (wryly known as a no-cebo or a faux-cebo). It should be apparent to anyone familiar with drug safety studies that the probability that this approach would find any significant safety problems is very small.
3. Inappropriate cohort -- The trials exclude non-healthy children, who will nevertheless be given the vaccines if LD 798 passes; pregnant women are also excluded.
7. The only institutional post-marketing ("Phase IV") monitoring of adverse events is done via the CDC's Vaccine Adverse Events Reporting System (VAERS). Despite the federal requirement that doctors report all such events to VAERS, the large majority of doctors
1. don't know VAERS exists,
2. are unaware of the HRSA's Vaccine Injury Table that lists acknowledged SAEs, and
3. refuse to believe (since they are told "vaccines are safe") that SAEs occurring to their patients after vaccination -- events which are documented on the vaccine package inserts (which they don't read, or provide to patients)-- are in fact related to the vaccines, and thus do not report them.

As a result, a Harvard study sponsored by the CDC estimated than only about 1% of adverse events are reported to VAERS. Nevertheless, last year over 400 deaths, and almost 2000 SAEs were reported out of a total of 58,000 events.

8. Studies only in the last 7 or 8 years have elucidated a mechanism by which nano-particulate aluminum-salt adjuvants are selectively transferred by macrophages to the brain, resulting in an "immune-activation event" feedback cycle that, in the absence of an ability to clear aluminum, interferes with key brain developmental processes; and autopsies of autistic brains have shown unprecedentedly high levels of aluminum in the vital glial cells.

The basic point here is that each vaccine has a different safety profile -- most of which are unknown due to the lack of research cited above -- because of the wide variety of antigens and excipients and contaminants each contains, and whether or not an adjuvant is used, and at what age and frequency and combination with other vaccines it is given. Further, the entire CDC schedule has never been studied, either for safety or for long-term health outcomes as compared to unvaccinated children. In addition, each individual person has a different physiology and immune status and ability to detoxify, all of which produce a different response to each vaccine than will be seen in someone else. Thus, evaluation of safety can only be done on a case by case basis, which is inconsistent with one-size-fits-all vaccine mandates.

Given all this, it does not appear scientifically credible to make the unambiguous assertion "Childhood vaccines are safe," at least insofar as the general public understands the term "safe."