We are told over and over again that vaccines are thoroughly tested for safety. But this is widely disputed, so let’s look at evidence.
It is acknowledged that the only way to be really sure if a new drug is safe is to conduct a double-blind, placebo-controlled, randomised controlled trial (RCT), that has a large number of subjects and lasts several years, generally up to 10 years.
- A “controlled” study is one where the effect of a drug is compared to the effect of another substance, known as the “control”, by having two groups of subjects, a test group and a control group.
- “Placebo” means a completely inert substance; saline is used as the placebo to test an injected product.
- “Placebo-controlled” means the control substance is a placebo (rather than some other chemical).
- “Randomised” means subjects are allotted to the two groups randomly.
- “Double-blind” means both researchers and subjects don’t know who got the drug and who got the control.
Pre-licensing safety studies.
Before being licensed and coming to market, new vaccines are tested on animals in laboratories. If the vaccines appear to be safe and produce the antibodies required, they are given to relatively small groups of people, typically around 20 adults, and then larger groups of about a couple of hundred. In these trials subjects are observed for reactions.
If all is well, the vaccines are tested in RCTs in larger groups of people. The RCTs are held in different age groups, racial groups, locations and so on. These are known as phase III trials, and are said to be trials of many thousands of subjects.
Testing
In a vaccine safety RCT, the rate of adverse events in the test vaccine group is compared to the rate of adverse events in the control group, and if there is no difference, the test vaccine is deemed to be safe.
The control substance is meant to be completely inactive, like saline is. Unfortunately, in some vaccine safety studies researchers use potentially dangerous chemicals for the control and say they are a placebo. We say saline is a “true placebo”.
It’s a huge problem if the control is a vaccine or chemical that happens to be unsafe; in this case, both the vaccine group and the control group could have high rates of adverse events, and if the rates are about the same, the test vaccine would be declared safe.
Watch Stanley Plotkin, one of the world’s foremost authorities on vaccines, agree that to see if vaccines are safe, they need to be tested in placebo-controlled studies.
VIDEO: Hepatitis B vaccine safety tested for just 5 days – Stanley Plotkin deposition
Post-licensing safety studies
Vaccines on the Australian immunisation schedule, with the exception of flu vaccines, are manufactured overseas. After licensing overseas, vaccines are given to whole populations of millions of people. Then they may be tested further, in trials involving thousands of people.
But these post-licensing studies of thousands are *not* placebo-controlled RCTs. They may be prospective studies where adverse events are recorded as they occur, either by collecting the data passively, where families elect to report problems, or actively, where families are contacted and questioned. There are also retrospective studies where health records of large populations are investigated.
In all these cases there is no control group for comparing the rate of adverse events, because it is considered unethical to give some children saline instead of a licensed vaccine; the worry is that by missing a vaccine, the subjects would not be protected from disease.
Health authorities may look into data if there are many injuries and deaths reported with a particular vaccine, but unless they have RCTs of large groups they can’t know if there really is a problem, so the injuries often get labelled as coincidence.
In Australia
When vaccines are considered for our population, they are approved for use in Australia by the Therapeutic Goods Association (TGA).
The TGA itself does not do safety studies on vaccines as part of the approval process; they decide which vaccines to approve by reviewing available information about them, including pre- and post-licensing trials run by the manufacturers.
In Australia the NCIRS does vaccine trials. The NCIRS “leads, coordinates and participates in vaccine-related clinical research, in collaboration with other research institutions in Australia”. Results of these trials could support the TGA’s approval of a vaccines. See trials being done by the NCIRS here: Clinical research
You can also research Australian clinical trials here: Australian Clinical Trials
Health and science bodies in Australia say phase III safety trials are done on thousands of people before a vaccine is registered here. Here’s one example: How safe are vaccines?
We will see in this article that not all vaccines approved by the TGA undergo placebo-controlled RCTs of thousands of people. Whatever trials the TGA are looking at for their approval process, unless they are placebo-controlled RCTs of very large groups, they are next to useless.
It’s important to note that the TGA is 100% funded by the industry it regulates.
After vaccines are registered by the TGA, the Department of Health is responsible for putting them onto the Australian immunisation schedule, advised by their group the Australian Technical Advisory Group on Immunisation (ATAGI). The Minister for Health and Aged Care appoints ATAGI members.
We are told by Australian authorities that surveillance programs ensure the safety of vaccines once they are in use. There are many problems with these systems; the US equivalent program is VAERS, and it has been shown by a Harvard-Pilgrim study to pick up less than 1% of actual vaccine adverse events.
Problems with surveillance systems:
- most doctors believe vaccines are extremely safe, so don’t report adverse events, believing they are unrelated to vaccines
- doctors are risking being targeted by health authorities if they report a lot of problems
- the public don’t know that surveillance systems exist
- the public don’t know how to find the relevant system or how to use it
- families often don’t connect an adverse event to vaccination, so don’t report it, because 1) people generally believe vaccines are safe, 2) vaccine reactions don’t always happen immediately after vaccination
- victims are in a state of turmoil after a serious adverse reaction to themselves or their family
Adequacy of pre-licensing safety studies
Please see the table below, which looks at vaccines on the Australian Immunisation Schedule (excluding flu vaccines and vaccines for some specific groups). Pre-licensing vaccine safety studies are reported on the package insert (product sheet) that comes with each vaccine vial.
Visit or download the table Vaccine pre-licensing safety testing PDF, it has live links and is easier to read than the following image. Find a US version of this table here, put together by ICAN.
Things to notice:
- The follow-up periods are only a few days to six months, which is not long enough to detect whether a vaccine could cause issues that take longer to develop and diagnose, such as autoimmune conditions, neurological conditions, developmental delays, cancers and allergies.
- There’s no comparison to a true placebo for any of the vaccines; the vaccines were compared to other vaccines or various chemicals, all of which could be dangerous, or there was no control group at all. This means a test vaccine could easily be deemed safe when it is not.
Click on the product sheets on the table PDF to see the studies for yourself.
Also, if you examine the product sheets, you’ll see there doesn’t appear to be any RCTs involving thousands of people; these RCTs have several hundred subjects per trial at the most. Where it’s stated there are many thousands of subjects in RCTs, the researchers could actually be referring to the total number of subjects across many trials.
The Infanrix hexa product sheet talks about a trial with 16,000 subjects, but this doesn’t appear to be a RCT, as a control is not mentioned.
Perhaps you are thinking there were surely other safety studies done besides the ones on these product sheets, before a vaccine is licensed and given to whole populations.
We know that’s not likely the case because US activists have asked to see any other pre-licensing safety studies the US health authorities have, and they are unable to provide any any. Read about this on ICAN’s page Vaccine Safety Debate; there are 4 documents to download, I suggest you download the third one, Dec 31 2018, and look particularly at section 1, parts A and B.
To settle this question for vaccines that are used in Australia, but are not on the US list, would take further freedom of information requests here, to the TGA.
There is a relatively new surveillance program run by AusVaxSafety, an NCIRS led collaboration; they are making quite a big deal of this program, with its fancy graphics.
They say: “This page reflects data from people who received a vaccine at a participating clinic and responded to an AusVaxSafety SMS a few days after vaccination.”
A few days?
Safety myths
Authorities justify the use of older licensed vaccines as a control, rather than saline, by saying these vaccines have already been determined to be safe, suggesting they are equivalent to saline for safety.
But this is a fantasy, because the older licensed vaccines weren’t ever tested properly either. This methodology is repeated all the way back to the first vaccines which were simply given to people. See this excellent book: Turtles All The Way Down: Vaccine Science and Myth
Much is made of how it has taken many years to develop most of the older vaccines before they came to market, and many people think this means they must be safe. However, those long years were not spent doing safety studies, but in getting the vaccines to work so they would produce the antibodies required.
Since the inception of vaccines there have been many personal stories of vaccine injury, but these have not been widely believed for various reasons, and mostly not reported in the press. These factors have also contributed to the perception that the older vaccines are safe.
Capitulation?
Curiously, a group of high-powered vaccine scientists, including Stanley Plotkin, recently published an article in the prestigious New England Journal of Medicine, July 6, 2024, declaring vaccines in general have not been properly tested for safety, and they are asking for money to fund some safety studies they are proposing.
Here is their letter:
Funding Postauthorization Vaccine-Safety Science
PDF version
They explain:
Postauthorization studies are needed to fully characterize the safety profile of a new vaccine, since prelicensure clinical trials have limited sample sizes, follow-up durations, and population heterogeneity [Reference 1]. It is critical to examine adverse events following immunization (AEFIs) that have not been detected in clinical trials, to ascertain whether they are causally or coincidentally related to vaccination.
It is rather strange they are claiming their proposed studies are so very essential (critical even!) after they have maintained for years that vaccines are thoroughly tested and are very safe, with injuries being extremely rare.
Watch Del Bigtree on The Highwire discussing this surprising development, below:
VIDEO: Experts concede vaccine safety is unfunded and inadequate
Leave a Reply