When a drug is brought to the market it goes through extensive testing and trials. Most drugs that undergo preclinical testing never even make it to human testing and review by the FDA. The drugs that do must undergo the agency’s MOST rigorous evaluation process, which scrutinizes everything about the drug from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.
It’s an industry understanding that bringing a drug to the market the FDA must be shown results of preclinical testing in laboratory animals and what they propose to do for human testing. At this stage, the FDA decides whether it is reasonably safe for the company to move forward with testing the drug in humans.
There are 5 phases in the testing that is performed when a new drug is brought to market, we will focus on the first 3 since these important phases specifically relate to the topic and contention at hand.
Phase 1 studies are usually conducted in healthy volunteers. The goal here is to determine what the drug’s most frequent side effects are and, often, how the drug is metabolized and excreted. The number of subjects typically ranges from 20 to 80.
Phase 2 studies begin if Phase 1 studies don’t reveal unacceptable toxicity. While the emphasis in Phase 1 is on safety, the emphasis in Phase 2 is on effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. Studies to test where an injected compound travels in the body, and which tissues or organs it accumulates in were not condcuted by Pfizer.
Phase 3 studies begin if evidence of effectiveness is shown in Phase 2. These studies gather more information about safety and effectiveness, studying different populations and different dosages and using the drug in combination with other drugs. The number of subjects usually ranges from several hundred to about 3,000 people.
Each clinical phase entails rigorous testing, double-blind studies, murder boards and meticulous peer reviews. These steps are essential to eliminate confirmation bias and to ensure perceived short-term benefits are not overcome by long-term risks. These prerequisite steps were bypassed for the first time when it came to Covid-19 “vaccines”, which is why many beleive we are seeing record numbers of injuries and deaths associated with them, over 7000 deaths reported in the US and those are only the ones that have been reported.
The implications of these findings are that Pfizer was trying to accelerate the vaccine development timeline based on pressures of the pandemic itself and Operation Light Speed that was to “fast track” the bringing to market of the vaccine under the “emergency use” provision.
The challenge is that the processes, such as Good Laboratory Practices, are of paramount importance for quality and ultimately for patient safety. If such important steps are skipped or fast-tracked, the outcomes are usually less than idea
The alarming number of post-“vaccination” injuries and deaths that are being reported in the Canada, UK, the United States are perhaps the tip of the iceberg as we have yet to assess the numbers for India.
It’s the clinical trials that take so long–usually several years,” says Sandra Kweder, M.D., deputy director of the Office of New Drugs in the CDER. “The emphasis on speed for FDA mostly relates to review time and timelines of being able to meet with sponsors during a drug’s development,”
It’s the clinical trials that take so long usually several years,” says Sandra Kweder, M.D., deputy director of the Office of New Drugs in the CDER. “The emphasis on speed for FDA mostly relates to review time and timelines of being able to meet with sponsors during a drug’s development,”
I have capture a few examples of drugs that I have pulled straight from the FDA, each had far less fatalities the we are seeing with the mRNA vaccine.
We need to be careful with the numbers here. Usually when statistics are reported, they use the numbers as in large impressive numbers, but now we are seeing percentages being used and the actual numbers played down, that is when it puts in a better light what is being reported. You see when it’s reporting like the following. “Less than .1 percent of the population has a negative reaction”, most people who don’t even think to interpret what that means thinks, “Wow, that is acceptable”. On the surface, perhaps it may, but if we were talking about a population of a few thousand that very well may be, but when we are talking hundreds of millions of people, perhaps even billions in totality, when something as low as benign .01% is reported when we take into account a billion people, that is in fact not inconsequential at all, because that is over one million people and that would be catastrophic. So don’t let the percentages fool you, we need to be smarter so that they are not misled or fooled.
Here is an example of just that published by the Canadian government.
This brings into question with over 7000 reported deaths so far in the US, has there been any consideration of at least pausing the vaccines or have we simply come too far for that to happen now? I fear that they will never do this as with even hint at a pause or regrouping, they would then be viewed as admitting something is wrong. The only thing that can stop this if either one of two things happens, either they come to their senses or the collateral damage becomes too much for the people to stomach.
The illustration below shows the expected duration to bring a new vaccine to the market. Clearly, the mRNA COVID vaccines must have made some serious concessions to have a vaccine developed and to market in the time that it did. Between phase 2 and phase 3 of testing is characterised by a high failure rate of usually around 93%. Would the COVID vaccines passed this test if it had done this to the extent that it should? Would there have been some issues that would need to be addressed before moving to phase 4 and 5?
They also will say, the mRNA has been in development for years prior to testing, however this can be said for pretty much all drugs that are brought to the FDA for approval. Companies don’t simply develop a drug together overnight and start testing and working with the FDA, that would and could never happen. Decades can take place before testing can even begin depending on the drug. In the case of the mRNA drugs, these are new and have never been used before which would lead someone to believe they would rely on the full gamut of testing to ensure or it’s efficacy.
When we hear about the vaccines for COVID there seems to be a playbook that those expected to comment follow as they all seem to sound alike and talk about this “gold standard” in testing that was performed when testing the vaccine, but make no mention of the 5 phases that are part of this gold standard” that is truly the bedrock of the FDA process to bringing a drug to market, but that being said, some feel the process is outdated, takes too long and needs an overhaul. There is a good article here.
One aspect of the testing that was conducted was the fact they actually drew from testing results of similar vaccines, one being the SARs vaccine to speed things along. Noting they now try to say the SARS vaccine not completed because the virus went away. This is not true, they ran out of time and could not develop a suitable vaccine in time to be used during the SARS epidemic.
One simple thing stands out that I just can’t settle in my mind and that is every other drug that the FDA approved all went through the hells of those 5 phases and years upon years were taken. The COVID vaccines were brought to market in less than a year. Show me someone who can improve efficiency like that and I show you someone who simply jumped over and skipped a few steps.
For many decades, the mRNAs attempted and failed in the laboratory, which is why there has been so much suspicion over the astonishing speed in which it got EUA. Two million people have in Israel were quickly injected under a program that ran daily from early morning until late night, even on Shabbat. They were and still are the leading country in vaccinations. However, the Israeli people were never given the information required to make a sufficient risk benefit analysis in this extraordinary endeavor. In fact, they were given the information at all and that included complete opacity of data on the unfolding outcomes of adverse reactions currently taking place today. Currently in Israel, they are seeing record numbers of cases and deaths as if they were not even vaccinated. This has Israel contemplating full lockdown at the time of this writing.
Lets put it this way, if you knew it took say 2 years for a vehicle go through all it’s testing to ensure that it is safe for you and your family to drive on the busy roads, would you buy a car that completed it’s testing in just a few weeks?
We claim an unbridled love of science and yet we are missing the crater sized gaps in the reasoning and decisions being made by those we trust. Currently being tested on an uninformed populace, this is turning out to not be a flag for public health and leaning heavily towards the largest mass drug distribution failure.
The use of the word “vaccine” has come to represent confounds to the discussion as many have no idea what they are injecting into their bodies. Many of us still holding the line, now face the sobering fact that what seems to be a totalitarian Vaccine Passport initiative, must choose which of my freedoms to concede, the loss of self determination or autonomy of body itself.