Vaccines are “Safe and Effective” – How do they do it?
Vaccine horror stories are everywhere these days: Stories of young girls fainting in the doctor offices after receiving the HPV vaccines. Stories of mothers taking a healthy child for a round of shots to their pediatrician returning home with a severely sick or dead child. Stories of children receiving the chicken pox vaccine and experiencing severe cases of chicken pox months later. A 1:50 rate of autism in the United States, increasing autoimmune disorders, seizures, allergies and many other illnesses and disorders. Despite all this, your pediatrician, health officials, governments and pharmaceutical companies proclaim that vaccines are very safe. Did you ever wonder how they derive at such faulty conclusions?
Scientifically Wrong Vaccine Safety Studies
Any trained scientist or statistician understands that you want to use a null hypothesis to disprove a possible causal relationship between two correlated events. The null hypothesis in this case would be: There is no causal connection between vaccinations and their alleged adverse short-term and long-term side effects.
If we were going to test this hypothesis, I would randomly sample research subjects (a large sample size of perhaps 100,000 would help exclude other factors) and divide the subjects into two groups. One group will get the vaccine, and the other group would receive a saline shot. Both groups would then be monitored for at least four weeks to observe whether short-term side effects were more prevalent in the vaccinated group than in the placebo group.
To determine whether or not there is a causal link between vaccinations and longterm medical complications would be a little more difficult. Nonetheless, if one group of subjects has received a placebo and the other has received the vaccine, it would be possible to mail a questionnaire to randomly selected parents who have chosen to immunize their children and to an equal-sized group of those who haven’t. A phone interview could also take place. This would be a good starting point to see whether there are differences in the long-term health and development of vaccinated children versus that of non-vaccinated children. If no significant differences are found between the two groups in either the short term or long term, then the pro-vaccine factions can rejoice, because they’ve disproven the anti-vaccinators’ claims and proved that the vaccine in question does not cause short-term or long-term complications.
If researchers wanted to know the truth about vaccines’ effects, it would be easy enough to discover. Let’s take a look at what methodology the pharmaceutical industries use to obtain the results they desire. Here it is, as explained in the package inserts for the hepatitis B vaccine by GlaxoSmithKline:
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. In thirty-six clinical studies, a total of 13,495 doses of ENGERIX-B were administered to 5,071 healthy adults and children who were initially seronegative for hepatitis B markers and healthy neonates. All subjects were monitored for four days post-administration. (1)
What the pharmaceutical company should have done is inject one group with the vaccine and the other group with a non-vaccine placebo (i.e., saline). What the pharmaceutical company did, instead, was inject one group with the hepatitis B vaccine, and the other group with a different vaccine. Then they monitored both groups and found that the recipients of their vaccine had “no significant difference in the frequency or severity of adverse experiences” as compared to the recipients of other vaccines. Which tells us nothing, really. Imagine McDonald’s touting their Big Macs as being “no more lethal than the Whopper.”
This is exactly what the pharmaceutical company has done here—they’ve avoided the real question about adverse reactions to vaccinations by announcing that their vaccine causes no more adverse reactions than…other vaccines. But make no mistake about it… adverse reactions occurred in both groups.
Let’s take a close look at the package inserts of various drug companies and the vaccines they manufacture. More importantly, let’s look at how the pharmaceutical companies manipulate safety results.
Sanofi Pasteur and the HIB Vaccine
In a randomized, double-blind US clinical trial, ActHIB vaccine was given concomitantly with DTP to more than 5,000 infants, and hepatitis B vaccine was given with DTP to a similar number. In this large study, deaths due to sudden infant death syndrome (SIDS) and other causes were observed, but were not different in the two groups. In the first forty-eight hours following immunization, two definite and three possible seizures were observed after ActHIB vaccine and DTP in comparison with none after hepatitis B vaccine and DTP. (2)
In order for us to know how safe the HIB vaccine is, the vaccine should have been compared to a placebo. Only then would we know how safe the vaccine truly is. But in order to muddy the results, not only did they not compare the HIB vaccine to a placebo, but they combined the HIB vaccine with another vaccine, and then tested it against two other combined vaccines. Imagine a drug company testing the safety of infant Tylenol by mixing it with another drug and then comparing it to a mixture of two other drugs. How would we ever be able to tell whether Tylenol is safe to give to our children?
Merck and Hepatitis B Vaccine
In the pivotal, randomized, multicenter study, 882 infants were assigned in a 3:1 ratio to receive either COMVAX or PedvaxHIB plus RECOMBIVAX HB at separate injection sites at 2, 4, and 12–15 months of age. Children may have also received routine pediatric immunizations. The children were monitored daily for five days after each injection for injection-site and systemic adverse experiences. During this time, adverse experiences in infants who received COMVAX were generally similar in type and frequency to those observed in infants who received PedvaxHIB plus RECOMBIVAX HB. (3)
In this study, Merck figured it would be best to compare its hepatitis B vaccine to a mixture of two other vaccines. Why would they do this? Because if a single vaccine is compared to a mixture of vaccines, the likelihood of adverse reactions in the “mixture of vaccine group” is likely to be higher, therefore making the hepatitis B vaccine look relatively safer. This is manipulation at its best.
Sanofi Pasteur and the Polio Vaccine
In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed. Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures of ≥39°C (≥102°F) were reported in 38% of vaccinees. Other symptoms included irritability, sleepiness, fussiness, and crying. Because IPV was given in a different site but concurrently with diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV. Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV. (4)
It is interesting to know that the vaccine grows in monkey kidney cells. I wonder what impact this has on our children. In this study, the pharmaceutical company tells us that the experienced side effects can’t be attributed to the polio vaccines, as it was tested by mixing the polio vaccine and then comparing it to the mixture of two other vaccines. This is simply beyond words.
All the package inserts can be accessed by going to: http://www.vaccinesafety.edu/package_inserts.htm.
In order to show how ridiculously vaccine safety studies are designed, here is a comparison: I want to find out whether eating huge quantities of Hershey kisses can lead to a bellyache. What I should do is get two groups of large sizes together and give one group large amounts of Hershey kisses and the other group a placebo. If there are significantly more bellyaches in the Hershey kiss group, I can confidently say that it isn’t safe to eat large quantities of Hershey kisses. Instead, I randomly sample two large groups and give one group large quantities of Hershey kisses and the other group large quantities of gummy bears or, perhaps, as some study designs by the pharmaceutical industry suggest, the placebo group receives large quantities of gummy bears and ice cream at the same time. Now I have belly aches in both groups (as we all know eating too much chocolate or gummy bears isn’t good), however, because I have an equal amount of reactions in both groups, I argue that it is therefore safe to eat large amounts of Hershey kisses, as there are not significantly more bellyaches in the Hershey kiss group.
Conclusions
Most middle school students are familiar with the design of a cause and effect study. The pharmaceutical companies are getting around ethically and fairly designed studies by claiming that it would be unethical to withhold a lifesaving medical intervention such as vaccines. This despite the fact that short term studies never included a ‘true’ placebo and vaccinated children have never been compared to non-vaccinated children in long term studies.
As you now are familiar with faulty research designs falsely concluding vaccines are safe for your children and protect your children from illness you may want to question the entire notion of vaccination. Many parents to vaccinated and non-vaccinated children will attest to the fact that the non-vaccinated child claims superior health to the vaccinated child. If large and correctly designed studies were conducted it is likely that pediatricians, health officials, government and pharmaceutical companies would derive at the same conclusion. This of course would expose them and therefore those choosing to vaccinate their children will have to continue to rely on studies proving a pre-determined outcome.
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[feature_box style=”33″ title=”Sources” alignment=”center”]- Engerix-b (hepatitis b vaccine recombinant). (n.d.). Retrieved from http://www.rxlist.com/engerix-b-drug/side-effects-interactions.htm
- “Haemophilus B Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine.” Web. <http://www.merck.com/product/usa/pi_circulars/c/comvax/ comvax_pi.pdf>.
- “Haemophilus B Conjugate Vaccine.” Web. <https://www.vaccineshoppe.com/image.cfm? doc_id=11167&image_type=product_pdf>.
- “Poliovirus Vaccine Inactivated.” Web. <https://www.vaccineshoppe.com/image.cfm? doc_id=5984&image_type=product_pdf>.