Whenever the safety of any vaccine is brought into question, the standard response from health officials and the vaccine industry is that vaccines are safe and effective. For example, when a report came out that teenage girls were having serious adverse events following receiving the Gardasil shot, including 18 deaths (1), Merck and the CDC responded with the statement that “Gardasil is safe and effective”, and “appears safer than most vaccines.”(2) 

The question we must ask is what do vaccine manufacturers and health officials mean by “safe”? I figured the best place to look was the package inserts for each vaccine directly from the manufacturers. What I found surprised me to say the least.  

In all of the safety studies, none of the studies used a true placebo control group. They simply compared vaccinated kids to vaccinated kids. For example, one of the Hepatitis B vaccines, Engerix B (GlaxoSmithKline) listed the following results from their safety studies: 

“Ten double-blind studies involving 2,252 subjects showed no significant difference in the frequency or severity of adverse experiences between ENGERIX-B and plasma-derived vaccines.” (3)

That sounds all well and good except all that it tells us is that when they looked at two groups that were vaccinated with different vaccines, they both had similar adverse experiences. Well, what would the difference in adverse experiences be if we compared one group who received the vaccine and one group that received a placebo (nothing)? We don’t know because it is never done.

The reason manufacturers do this and health officials approve it, is that if a new vaccine can be proven no more dangerous than a vaccine already on the market (one already considered “safe”) then it is considered as safe as the current vaccine and approved for use.  The updated package insert no longer cites the above study for ENGERIX-B, and the safety studies cited have no control at all.

But how do they do safety studies on vaccines if they don’t compare it to an old or current vaccine targeted at the same disease? Let’s look at another example.

In 1999 RotaShield, a vaccine for rotavirus was taken off the market because it was found to cause intussusception (a type of bowel obstruction that occurs when the bowel folds in on itself). (4) Therefore a new vaccine was sought after and developed – RotaTeq.

In the RotaTeq clinical studies 71,725 infants were evaluated in 3 placebo controlled clinical trials. Serious adverse events occurred in 2.4% of recipients of RotaTeq when compared to 2.6% of placebo recipients within the 42-day period of a dose in the phase 3 clinical studies of RotaTeq. (5)

On the surface, the studies looked solid. They included a large number of infants, a placebo, and there were comparable adverse events for the recipients of RotaTeq as for those that received the placebo.

However if we look a little closer, we see the same old story. “In clinical trials, RotaTeq was administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine (PCV).” 

What does that mean? It means that the RotaTeq group received RotaTeq, DTaP, IPV, Hib, Hep B, and PCV vaccines while the “placebo” group received DTaP, IPV, Hib, Hep B, and PCV vaccines. So once again all these safety studies tell us is that two groups received multiple vaccinations and had similar adverse reactions.

So again we ask the question, are vaccines safe? The safety studies done simply compare vaccinated groups with vaccinated groups and tell us that vaccines have more or less adverse events when compared with each other.

To see more safety studies found in the product insert from vaccine manufacturers see “Vaccine Safety Studies”.

Another place we can look to consider the safety of vaccine is the Vaccine Adverse Events Reporting System, which was established in 1986 by the U.S. Government to track adverse events from vaccinations. (6)

In 2009, over 35,000 adverse events were reported. (7) Obviously the most serious adverse event that can occur from a vaccination is death. When looking at the VAERS data from 2009, 254 deaths were reported following vaccinations. Now these reports aren’t conclusive that the vaccination caused these deaths, but placed the events in temporal association, which means that the event of death followed the event of vaccination.

In looking deeper at this set of data by reading through each case, several of the cases can be rightly argued that it is inconclusive that the vaccine played a role in the death. A majority of these cases were in the elderly, where the person had many health conditions they were dealing with, and though it could be argued that the shot was too much for their compromised immune system to handle, it could also be argued that they would have died anyway.

This latter argument is much more difficult to accept in the cases of previously healthy infants. Of the 254 deaths, 105 occurred in infants 2 years or less.   Of these infant deaths, 81 occurred within one week of vaccination, 48 of these deaths occurred within two days of vaccination, and 34 of these deaths occurred within 1 day of vaccination.

These deaths are labeled as Sudden Infant Death Syndrome (SIDS), which is not a cause of death, simply a diagnosis that the baby died and they don’t know why.

This information is not given as a scare tactic, just simply an acknowledgement that these events do occur. And given that the FDA estimates that as few as 1% of serious adverse reactions to vaccines are reported (8,9), and the CDC admits that only about 10 % of such events are reported, (10) these events may be much more prevalent that we realize.

Part of the problem with vaccines being accepted as safe without the research to back it up, is that when these events do occur the connection between the adverse events are ignored. When doctors and parents believe that vaccines are 100% safe, then it is difficult to accept that these vaccines could play any role in the adverse event.

Webster’s Dictionary defines safe as “free from harm or risk.” (11) Vaccine manufacturers and health officials seem to have made up their own definition of safe. 

It is argued that these adverse events are so rare that they are not significant. I would argue that until true safety studies are done, and until parents and healthcare practitioners are aware that these events do occur, we will not know just how common these events may be.

If vaccinations are safe, then manufacturers shouldn’t have concerns about testing them in real safety studies against a true placebo. If vaccinations are safe, then health officials shouldn’t have to tell parents that the shots are mandatory when in fact most states they are not.

So if people choose to believe vaccines are safe (which they are entitled to do) they should understand that based on the safety studies, vaccines are more or less safe only relatively compared with other vaccines.