Why I Won't Vax

"clinical trials are almost always too small to provide useful information on serious rare events""
-the Committee on Government Reform

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.

"The U.S. Food and Drug Administration (FDA) ensures the safety, effectiveness, and availability of vaccines for the United States. Before the FDA licenses (approves) a vaccine, the vaccine is tested extensively by its manufacturer. FDA scientists and medical professionals carefully evaluate all the available information about the vaccine to determine its safety and effectiveness."

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
HEPATITIS B VACCINE SAFETY TESTED FOR JUST FIVE DAYS

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.

Watch More

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."

ICAN DEMANDS FDA WITHDRAW HEP B VACCINE

The Informed Consent Action Network (icandecide.org) 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.”

SEE THE FULL REPORT HERE

VARIVAX

Package insert states that Varivax was tested for safety in a double blind placebo controlled study however the placebo given to the control group was actually the vaccine minus the viral component.

immunogenicity followed for 10 years but safety endpoints were monitored for 6 weeks

TDVAX

Insert states "Data on adverse reactions following fluid and adsorbed preparations of
MassBiologics’ TDVAX with various doses of the diphtheria and tetanus components have been reported
in a series of studies." It gives no other details regarding clinical trials.

TENIVAC

Participants age 11-59 all received TENIVAC. Participants age 60 and older received TENIVAC or DECAVAC and the study was unblinded to pharmacists and vaccination nurses

3 days-30 days

Boostrix

BOOSTRIX or
Td vaccine or comparator Tdap vaccine. The safety of vaccinating during pregnancy was evaluated in a study where The placebo recipients received the non-U.S. formulation
of BOOSTRIX postpartum. "The rates of reported solicited adverse reactions 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 postpartum."

subjects were monitored for solicited adverse events using standardized diary
cards during the 4 days (Days 0 to 3), 8 days (Days 0 to 7), or 15 days (Days 0 to 14) following
vaccination. Unsolicited adverse events were monitored for the 31-day period following
vaccination (Days 0 to 30)

Adacel

Adacel or Td vaccine

Up to 6 months

RotaTeq

The insert states subjects in the clinical trials received placebo. The description of the placebo was removed from licensing documents. Documents show that one clinical trial the placebo used was the Vaccine minus the antigen. Licensing documents also show that all participants also received several other vaccines concomitantly.

42 days up to 1 year

ROTARIX

Insert mentions a placebo but licensing documents show that the placebo was actually the vaccine being tested minus the antigen component.

8 -31 days

IPOL

Tested in 1980-1983 control group received the oral polio vaccine. All participants also received DTP vaccine. The second study on 114 children participants received either IPOL, OPV, or a combination of both along with DPT vaccine.

PNEUMOVAX 23

Tested on adults age 50-64yo. Subjects in each cohort were randomized to receive intramuscular injections of PNEUMOVAX 23
followed by placebo (saline containing 0.25% phenol), or placebo followed by PNEUMOVAX 23

Prevnar 13

Tested against Prevnar

unsolicited and serious adverse events were collected up to 6 months during a scripted telephone interview

BEXSERO

Insert mentions a trial where ; 97 participants received saline placebo, however the placebo was then followed by administration of MENVEO. Another two studies which had a PLACEBO subjects received at least 1 dose of placebo containing aluminum hydroxide.

7 days- 12 months

MenQuadfi

Participants received MenQuadfi or Menveo, MenQuadfi alone or MenQuadfi concomitantly with several other vaccines or U.S.-licensed comparator meningococcal vaccine, or MenQuadfi or Menomune®

7 days

MENVEO

participants received varying doses of MENVEO or comparator vaccines usually concomitant with other vaccine(s)

In most trials, solicited local and systemic adverse reactions were monitored daily for 7 days

Menactra

Received Menactra or Menomune®

Participants were monitored after each vaccination for 20 or 30 minutes for immediate reactions, depending on the study. Solicited injection site and systemic reactions were recorded in a diary card for 7 consecutive days after each vaccination. Participants were monitored for 28 days (30 days for infants and toddlers) for unsolicited adverse events and for 6 months post-vaccination for visits to an emergency room, unexpected visits to an office physician, and serious adverse events.

M-M-R II

Package insert does not mention any safety trials. There were eight trials done in the 1970s where all of the control groups received either the MMR, MR, or Rubella vaccines.

A total of about 850 children received MMRII during phase 3 clinical trials

GARDASIL 9

Subjects randomized to receive Gardasil 9 or Gardasil, Gardasil 9 with concomitant Menactra and Adacel, Gardasil 9 in subjects previously vaccinated with the qHPV vaccine, or Gardasil 9 concomitant administration with a non-U.S.-licensed vaccine (Repevax)

RECOMBIVAX HB

Received RECOMBIVAX HB in varying dose schedules

5 days

ENGERIX-B

Doesn't mention any control groups

4-30 days

VAQTA

Describes a double-blind, placebo-controlled efficacy trial where participants received VAQTA or PLACEBO, the placebo group was actually given Aluminum Diluent.

1-14 days

HIBERIX

Two control groups received another Hib vaccine or DTap-Polio-Hib along with several other vaccines. Remaining clinical trials had no control group.

Doesn't specifically state a follow-up period but does mention a serious adverse event that occurred 31 days after vaccination.

ActHIB

Received either ActHIB alone or concomitantly with other vaccines, received ActHIB
vaccine or a previously licensed Haemophilus b conjugate vaccine

48 hours- 30 days

INFANRIX

Control groups all received Infanrix in varying dose schedules or DTP vaccine and coadministered with other vaccines

4 days- 30 days

DAPTACEL

In all Phase 3 Clinical Trials control groups received Daptacel or combinations of DTap or DTP vaccines sometimes concurrently with other vaccines. No placebo groups in any Phase 3 Clinical Trails were done.

Follow up periods from 24 hours up to 2 months

NONCLINICAL TOXICOLOGY

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.

The Vaccine Inserts

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