Recent headlines have popped up in the past several days that the FDA will push for the approval of the Pfizer shot. However, if approved this approval will be spotty at best at worst completely illegal. Contrary to what most people think, just because a drug or device is FDA-approved, it does not mean the product is guaranteed to be safe. In fact, manufacturers recall about 4,500 drugs and medical devices annually. While the FDA has efforts in place to minimize these safety risks, there are still occurrences where drugs or devices may come to market quickly and lead to safety concerns and it seems that the shot will be one that will have significant safety risks attached to it.
By the FDA approval protocols after the drug has been tested four steps are required so the FDA can deem a drug ready for approval.
- The drug’s test results
- Manufacturing information to demonstrate the company can properly manufacture the drug
- Data gathered during the animal studies and human clinical trials
- The company’s proposed label for the drug, which includes uses for which it has been shown to be effective, possible risks and how to use it
The only problem here is that Pfizer has not supplied any clinical animal study data. They have however supplied a preclinical non peer reviewed paper published in Sept 2020 that has been left of the shelf since with no other results been addressed to the media or the FDA. The paper goes on to detail the effectiveness of the shot from a short time frame, what the paper fails to do is point out the long term effects of the test animals. Why the silence, what are the ongoing results of this preclinical trail? It seems Pfizer and the FDA would rather that topic of discussion be left in the dark as the FDA is now focused on violating their own approval protocols to push the shot out to the mass public.
In short the FDA seems to be running against an unseen clock. Do they have data that suggest that something bigger is coming hence the rushed approval? With the recent turmoil across the globe in countries like Australia and France, the general population can see the next step in the order of chaos, mandates. If this rushed approval indeed turns out to be for the sake of mandates one must question why especially for a drug that has no long term study effects and from the stand point based on the FDA’s own protocol approvals methods would be deemed illegally approved.
For our readers we have attached the paper and the press release of the preclinical trail from Pfizer.
https://www.biorxiv.org/content/10.1101/2020.09.08.280818v1.full
We are about to enter some real world version of “I am Legend” & “Children of Men.” smh