The FDA approval is a political decision that is not based on facts and customary process as this being the opinion of the Bermuda Freedom Alliance.
1. A long-term study has yet to be completed (they initially said it would be completed in 2023) and there are questions as to whether that is even feasible at this point since they allowed the control group to take the vaccine
2. There are still no studies on specific subgroups at risk like pregnant women, immuno-compromised, etc…
3. The FDA refused to present the case in front of a formal advisory committee of experts (customary process) to be debated prior to approval.
“If anything, the approval of the Pfizer-BioNTech COVID-19 Injection calls to question the credibility of the individuals making these decisions and the organizations they serve. Regardless of the severity of the situation or the advancement of the technology involved, how the FDA can suggest that they have completed a 10 – 15 year process in less than 12 months is mind boggling,” said BFA representative Eugene Dean.
Processes of this nature have always relied on time to provide the necessary data to draw conclusions. Unless we have found the means to predict what will happen in a year, two years, five years or even 10 years from now without needing to actually live through the experience, I’m not quite sure what difference this approval actually makes.
While the rigorous testing of facilities, processes, manufacturing quality and the in-depth analysis of data from short term clinical trials is all necessary, we are still in the early phases of the process and only part of the story has been told.
The other concern is the stark contrast between the reporting of adverse effects in the Pfizer clinical trials and the real time reporting recorded in the various adverse effects reporting databases around the world. From the information provided by the FDA, it appears that the deaths and adverse effects being reported globally were completely overlooked during their approval process.
I’m sure they are fully aware of the data and just as confident that they are capable of producing a well thought out reason for why the data has been overlooked. Though this may satisfy those who wish to instill confidence in the FDA’s approval process, it also increases concerns about how this process is being fast tracked during a time when the safety and effectiveness of the injection has become under more scrutiny than ever before…
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