Vaccine Safety Studies

The following vaccine safety studies were the studies in the product inserts from the manufacturers for the childhood vaccines.
One consistent factor you will find in each of the studies is that none of the studies used a true placebo. The studies simply compare vaccinated groups with vaccinated groups. Therefore all that can be drawn from the studies is that all vaccines have adverse reactions, some more than others.
The only exception was with Gardasil. However, they also had an additional control group, and then combined the control group with the placebo in their results, thus negating the true placebo.
The vaccination program lives by the slogan that “vaccines are safe and effective". In regards to vaccine safety, you have to ask the question, what do they mean by safe? For more on that question, see “Are Vaccines Safe?”
Hepatitis B vaccine
ENGERIX-B (Recombinant Vaccine) – GlaxoSmithKline – Product Insert
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.”
They simply found that there were no significant differences in adverse reactions between different vaccines, and therefore is considered “safe.” Also, subjects were only monitored for 4 days.
Tetanus Vaccine
Sanofi Pasteur – DT Product Insert
Two studies were done, one with 20 subjects and the other with 40. The second study, compared infants given DTP, DT, DTP at 2,4, and 6 months, compared to infants who were give vaccine to kids who were given DTP, DTP, DT at the same ages. (The order of shots was varied.) 
They found the incidence of adverse reactions was significantly lower following the DT administration. Therefore it’s “safe” based on 60 infants and no control group.
Sanofi Pasteur - DECAVAC Product Description (for ages 7 or older)
Safety Study: Involved only 58 people.
DTaP (Diphtheria, Tetanus, Pertussis vaccine)
DEPTACEL (DTaP) – Sanofi Pasteur – Product Insert
Clinical studies compared DEPTACEL, DT, and DPT. The “placebo” was DT.
Infanrix (DTaP) – GlaxoSmithKline - Product Insert
Clinical Studies compared INFANRIX with Whole-Cell DTP Vaccine (See Tables 1, 2, 6, 7). Studies showed that local adverse reactions increased with successive doses of INFANRIX (See Tables 3 & 4). 
In one study of 29,000 kids there were 14 deaths, 9 of which were SIDS. They compare rates of SIDS in two studies with the rate of SIDS in the U.S., attempting to show that by chance alone the kids in the study could have died of SIDS. However, kids in the U.S. are highly vaccinated, so this comparison tells us nothing. It is simply like every other vaccine safety study, comparing vaccinated kids with vaccinated kids.
Tripedia (DTaP) – Sanofi Pasteur – Product Insert
In regards to the clinical studies, Tripedia was compared to whole-cell DTP similar to the other brands of DTaP. A similar level of SIDS was also seen the Tripedia studies, and similar adverse reactions were also noted.
Haemophilus Influenzae type B vaccine
PedvaxHIB – Merck – Product Insert
Safety studies compared liquid PedvaxHIB to lyophilized PedvaxHIB and followed for 3 days. DTP and OPV were given at the same time. Reactions included fever, Erythema and swelling.
Streptococcus pneumoniae (Pneumococcus) vaccine
Prevnar – Pneumococcal 7-valent Conjugate Vaccine – Wyeth – Product Insert
In one study (Kaiser Efficacy study) there were 11 deaths (4 SIDS) that occurred among subjects receiving Prevnar. In comparison, in the control group there were 21 deaths (8 SIDS). 
However, the control group received an investigational meningococcal group C conjugate vaccine, so all this tells us that the latter vaccine was twice as deadly as Prevnar. 
It was noted that the number of SIDS deaths in kids from California during the same time period (1995-1997) was similar as seen in the efficacy study, which again tells us nothing as those children would have been vaccinated with the routine childhood vaccines. (See page 21)
Flu Shot
FluMist – live attenuated influenza vaccine (LAIV) – MedImmune – Product Insert
In a placebo controlled safety study conducted in 9689 children 1-17 years of age an increase in asthma events was observed in children less than 5 years of age. (Page 2 – Adverse Reactions in Clinical Trials)
In a separate placebo controlled trial in children 9-17 years of age, abdominal pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients. (Page 2 - Adverse Reactions in Clinical Trials)
Hepatitis A Vaccines – HAVRIX and VAQTA
HAVRIX – GlaxoSmithKline – Product Insert
“Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of HAVRIX could reveal adverse reactions not observed in clinical trials.”
VAQTA – Merck – Product Insert
In combined clinical trials involving 706 healthy children 12-23 months of age, there were 7 children who experienced 9 seizures during the study period. Seizures were reported between 9 days and 81 days following the administration of VAQTA. Some subjects had received concomitant or nonconcomitant immunization with M-M-R II and VARIVAX.
Other serious events that occurred during the study included bronchiolitis, dehydration, RLL (Right Lower Lobe) pneumonia, asthma, and asthma exacerbation. These events occurred 9 days to 46 days following the administration of VAQTA. Some subjects received concomitant or nonconcomitant immunization with M-M-R II, and VARIVAX or TRIPEDIA, and/or oral or inactivated polio vaccine.
RotaTeq – Merck – Product Insert
No safety or efficacy data are available for the administration of RotaTeq to infants who are potentially immunocompromised. (Page 1)
No safety or efficacy data are available for the administration of RotaTeq to infants with a history of gastrointestinal disorders (e.g., active acute gastrointestinal illness, chronic diarrhea, failure to thrive, history of congenital abdominal disorders, abdominal surgery and intussusception). (Page 1)
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.
GARDASIL – Merck – Product Insert
Overall Summary of Adverse Reactions
Headache, fever, nausea, and dizziness; and local injection site reactions (pain, swelling, erythema, pruritus, and bruising) occurred after administration with GARDASIL. Syncope has been reported following vaccination with GARDASIL and may result in falling with injury; observation for 15 minutes after administration is recommended. Anaphylaxis has been reported following vaccination with GARDASIL. (Page 4)
In the clinical safety studies a saline placebo was actually used. However, the three groups of subjects were broken down as follows: 13,686 received GARDASIL, 11,004 received AAHS control, and 584 received the saline placebo.
AAHS is Amorphous Aluminum Hydroxyphosphate Sulfate. Therefore 24,690 subjects received an active substance and 584 received the placebo. The greater problem is that they did not compare the three groups separately, but compared the GARDASIL group to the AAHS group and the placebo together.
Furthermore, AAHS is the adjuvant (the portion of the vaccine that triggers the immune response) in GARDASIL, so the clinical studies were merely comparing GARDASIL to a toxic portion of itself.
There were 24 deaths in the clinical studies. The authors stated the events were consistent with events expected in healthy adolescent and adults populations. In light of the obvious flaws of the studies, it is interesting to note how they broke down:
GARDASIL                                       AAHS                                     Placebo
MVA (4)                                             MVA (3)                                 Meduloblastoma (1)
Overdose/Suicide (2)                          Overdose/Suicide (2)
Pulmonary Embolus/                           Pulmonary Embolus/
Deep Vein Thrombosis (1)                  Deep Vein Thrombosis (1)
Sepsis (2)                                             Asphyxia (1)
Pancreatic Cancer (1)                          Lymphocytic Leukemia (1)
Arrhythmia (1)
Pulmonary tuberculosis (1)
Hyperthyroidism (1)
Post-operative pulmonary
Embolism and acute renal
Failure (1)
Systemic Lymphocytic
Leukemia (SLE) (1)
_______________________              _____________________      __________________
            15                                                        8                                              1
If we take out the deaths from MVA and OD/Suicide, and also combine the AAHS group and the placebo as Merck did in their comparisons, more than twice as many people died in the GARDASIL group compared to the control group. This is only as scientific as the results that were used to prove Gardasil is safe. This table was not included in the Product Insert.
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