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Liquid Bubbles

Inadequate Safety Testing

Most people have probably never given much thought as to how vaccines are tested before being licensed.  We are told they are "Safe and Effective", and so we assume they must have gone through strict testing by our regulatory agencies to assure that they in fact are. However, our regulatory agencies don't do any pre-licensing tests to determine the safety and efficacy of vaccines.  They rely on the vaccine manufacturers to do their own safety studies. 

How Are Pharmaceutical Products Tested?

A placebo is defined as an innocuous or inert medication, such as saline. Using a placebo is also important as helps to determine what types of adverse events may be related to the substance being tested.  It helps to distinguish between correlation or causation. 


If there is a statistically significant difference in the number of adverse events in the group receiving the substance being tested, compared to the number of adverse events in the group receiving a placebo, then there is a likelihood that the adverse events were caused by the substance being tested.  The same idea would be used to check for efficacy.  

This type of study seems like it would be the common sense way to test a new pharmaceutical product.  Surprisingly, none of the vaccines currently on the childhood immunization schedule, with the exception of the newly added Covid-19 vaccine, have ever been tested in a randomized double blind placebo study. 

On this page I will show each vaccine that is currently licensed and on our CDC childhood vaccine schedule, highlighting what was used in the control groups for each of the pre-licensing studies.  I will also add articles and information regarding the lack of safety testing done on vaccines.

The "Gold Standard" when it comes to testing new pharmaceuticals is a Randomized Double Blind Placebo Study.  Participants are randomly selected to receive the substance being tested or a placebo. Double blind means that neither the participants, nor the researchers know which participants are receiving which substance.  This study design helps protect the results from bias. 

From The Highwire

Dr. Stanley Plotkin, widely considered the world’s leading authority on vaccines, is questioned by ICAN Lead Attorney Aaron Siri, Esq. about the pre-licensure safety testing of the Hepatitis B vaccine, a vaccine given to babies in their first days of life in the U.S. FDA Documents reveal the vaccine was followed for safety for just five days in the trials.

FDA Approves Vaccine for Use During Third Trimester of Pregnancy to Prevent Whooping Cough in Infants Younger Than Two Months of Age

"The safety of Boostrix administered during the third trimester of pregnancy was assessed in a randomized, placebo-controlled study with a non-U.S. formulation of Boostrix.  The study included approximately 680 pregnant individuals of whom about 340 received the non-U.S. formulation of Boostrix and of whom about 340 received saline placebo. After childbirth, the placebo recipients were then vaccinated with the non-U.S. formulation of Boostrix. The rates of reported side effects following receipt of the non-U.S. formulation of Boostrix administered during pregnancy were consistent with the rates following receipt of the non-U.S. formulation of Boostrix administered to study participants after childbirth."

From The Highwire


The Informed Consent Action Network ( has filed a petition, under penalty of perjury, demanding the FDA withdraw licensure for Hepatitis B vaccines due to non-compliance with applicable federal and statutory regulatory requirements. Both Hepatitis B vaccines licensed in the United States were tested for safety for a maximum of 5 days post injection.

From The Children's Health Defense

The Truth About HPV Vaccination, Part 3: Can It Prevent Cervical Cancer?

There are no valid studies showing the vaccine for the human papillomavirus, or HPV, prevents cervical cancer. However, there are studies suggesting the vaccine could increase the risk of cancer.

  • Most of the HPV’s interventional clinical trials have too short a follow-up time to draw a concrete conclusion.

  • Lack of long-term follow-up is a common issue for most clinical trials to prove the HPV vaccine’s effectiveness in preventing cervical cancer.

  • For example, a 2007 study found that Gardasil was effective in reducing HPV-associated cervical precancerous lesions rate by 20%.

  • This study followed their subjects for only an average of three years after administration of the first dose.

  • Meanwhile, the median time from CIN2/3 to transition to cancer is estimated to be 23.5 years.

From The Institute of Medicine Report

Adverse Effects of Pertussis and Rubella Vaccines

“In the course of its review, the committee encountered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immunization, insufficient or inconsistent information from case reports and case series, inadequate size or length of follow-up of many population-based epidemiologic studies, and limited capacity of existing surveillance systems of vaccine injury to provide persuasive evidence of causation. The committee found few experimental studies published in relation to the number of epidemiologic studies published. Clearly, if research capacity and accomplishment in these areas are not improved, future reviews of vaccine safety will be similarly handicapped.”


In addition to the lack of testing for adverse events, not a single one of these vaccines have been evaluated for carcinogenic or mutagenic potential or for impairment of fertility in males.  Occasionally there have been testing for impairment of fertility in females using animals.

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