It’s time to shine the spotlight on the lesser-known facts of vaccine development. And there’s no better way to do this than by comparing vaccine development standards with standards for common prescription medication, as both substances are held to be (largely) safe to put in our body.
Let’s start with prescription medication. In the drug trials, there are two groups: the group that receives the pharmaceutical product, known as the experimental group, and the control group that receives an inert placebo, such as a saline solution or sugar pill. The control group, as suggested by the name, provides the baseline that allows comparison of symptoms, allergies or adverse reactions that may occur in the vaccinated group.
For example, in a study involving a medication for asthma patients, the researchers can be assured that the improvement in the condition of the participants is caused by the medication and not by factors like change in weather and/or season. This is because the weather would have affected all the participants, those in the experimental group and those in the control group. Likewise, with deterioration in health. The researchers can look at the percentage increase in detrimental health conditions between the groups. If the experimental group suffers significantly more, alarm bells will ring for the researchers and they can adjust dosing or ingredients in the prescription medication.
The other key aspect of prescription medication safety trials is their length. Pharmaceutical companies must monitor adverse events in the participants for 4-7 years. An adverse event is an injury resulting from the pharmaceutical product. These are more serious and longer lasting than side effects such as a fever or rash. Adverse events include conditions like anaphylaxis, hypersensitivity, encephalitis (brain inflammation), immune disorders, musculoskeletal and connective tissue disorders, seizures.
Let’s look at a few examples: The pre-licensure trials for Enbrel, a medication for arthritis, followed trial participants for up to 6.7 years. The control group received a saline injection. The pre-licensure trials for Lipitor, a type of Statin medication for cholesterol lowering, followed trial subjects for a median of 4.8 years. The control group received a sugar pill.
We should note that even with these safety trials, there are often still significant problems with prescription medication. A case in point is Lipitor. There are so many lawsuits being brought against Lipitor for injury, that there is a special class of lawyers who specialise in them.
Now to focus on vaccines. For the purpose of testing and approval by regulatory bodies, vaccines are classified as “biologics”, not drugs. Other medical products in this category include blood products, plasma and anti-venoms. The pre licensure safety follow up period for adverse events for “biologics” is not years like prescription medication, but anywhere from 4-60 days.
Furthermore, the control group in vaccine testing typically does not receive an inert placebo, unlike safety trials for prescription medication. The control group will receive either a previously licenced vaccine or an adjuvant. An adjuvant is a component of the vaccine that is added to stimulate the immune response.
Let’s look at a few examples: ProQuad, the Measles, Mumps, Rubella + Varicella (Chicken Pox) vaccine followed trial participants for 42 days and the control group received the previously licenced M-M-R II and VARIVAX vaccines as the “placebo”. Engerix-B, a Hepatitis B vaccine, followed study subjects for 4 days and the control group received “plasma derived vaccines” as the “placebo”.
This means that the manufacturers are only testing to see if the new vaccine is roughly as safe as an existing one. They are not testing to truly measure side effects because the control group also receives a medical product that may cause side effects. The vaccines tested with the control group given an aluminium adjuvant as the “placebo” are the worst of all because aluminium adjuvants are a known cause of autoimmune diseases. These are some of the very conditions the vaccine safety testing is supposed to be measuring. When you mess with the control group this way, the data you collect is seriously flawed. There cannot be an accurate measure of the degree of harm caused by the vaccine, if all known active ingredients are not removed from the placebo.
It is also well established that biochemical processes, and therefore potential adverse reactions in the body, take time to occur. Therefore, safety trials need to be of sufficient duration. By anyone’s standards, 5 days or even 42 days is woefully short.
To even further muddy the water, sometimes the very vaccine that is being tested is offered to the control group at the end of the safety trial. This happened in the safety trial of the Haemophilus Influenza B (Hib) in the United States. Presumably the vaccine manufacturer thought the participants in the control group were “missing out” on the benefits of protection and encouraged uptake. But how can you compare the long-term health outcomes between the groups - control group versus experimental group - if the control group get vaccinated as well? Obviously, one cannot. These practices pass for “science”, a science that any grade six student could tell you is an insult to our intelligence.
The first Covid 19 vaccine approved for emergency use in Australia is made by Pfizer Inc. It is a new type of vaccine that uses mRNA technology. We have discussed this technology here. Normal vaccines take in total 10-12 years to develop, even though the follow up period in the safety trials is very short. The development of the Pfizer vaccine is estimated to take 2-3 years in total to develop, and we are still in the developmental stage, as the study completion date is January 2023. We have already written about the vast gaps in safety data and serious areas of concern. However, what is not as well known, is that, like the Hib vaccine, Pfizer vaccine participants “who originally received placebo will be offered the opportunity to receive BNT162b2 at defined points as part of the study”. Every control group participant who receives the vaccine – especially during the course of the study – represents a reduction in proper safety data on the vaccine.
So, one might ask, why is the science required for prescription medication approval so much more rigorous than the science applied to vaccine approval? The answer is simple: Liability. Pharmaceutical companies are liable for any damage caused by their prescription medication. This means that they will be financially penalised, they will have to pay compensation money to the injured person if it is ruled that their prescription medication caused this injury. Hence, they are motivated to carry out rigorous and lengthy safety trials. These safety trials are costly, but it means there is a reduced likelihood of injury and potentially lawsuits for them.
What you may not know is that the very same pharmaceutical companies are not liable for injuries caused by their vaccines. This immunity to responsibility for their product has been granted to them by Government regulators, primarily in the US. Clearly this has reduced the motivation for conducting expensive long-term monitoring of participants in vaccine trials. Why spend the money, when any safety problems that arise from omitting such studies, are not sheeted back to you?
This was not always the case. Prior to 1986, vaccine manufacturers were liable for injuries due to their products. However, due to the rising costs of lawsuits and payouts to families of vaccine injured children in the civil courts, several companies were forced to end their research and development programs, as well as stop producing already licensed vaccines. Instead of letting market forces compel vaccine manufacturers to create safer vaccines, Ronald Reagan pushed the National Childhood Vaccine Injury Act (the 1986 Act) through US Congress.
This act granted pharmaceutical companies financial immunity from injuries caused by vaccines recommended by the CDC. As part of this Act, a “no fault” compensation program was established, which recognised that there are inherent risks in vaccines and that a certain percentage of children would always be injured. While WHO urged other countries to follow suit, Australia is the only high income WHO member country who does not have such a compensation program. Many Australian doctors and scientists are calling for the urgent establishment of a vaccine injury compensation scheme (VICS), before the rollout of the COVID-19 vaccines.
The Australian government is planning to mass-vaccinate the population with new tech mRNA vaccines that are being rushed through the development process. There has not yet been a study of the medium term or long- term effects of this vaccine, that is going to work in our bodies in a totally new way. The long-term effects will be studied, but in reality, we are the test subjects. The government also makes no secret of the fact that those unwilling to be vaccinated will be denied many services, creating a new class of “have” and “have nots”. And all of this, without providing a safety net for this experimental vaccine, still in the development and testing phase.
Are you willing to “trust the science” and take part?