DECEPTIVE MEDIA PART II: Despite Fact-Checkers, Pfizer-BioNTech Vaccine Still NOT FULLY APPROVED
Dear USA TODAY’s Ministry of Truth, with all due respect, we do not get confused.
Imagine this: What would you think if a used-car salesman told you that a car was “fully approved by our mechanics!” Then, when taking the car off the lot, the breaks gave out or the transmission stalls. Stuff happens, so you drive it to a nearby place to check it out. But the car turns out to be a total clunker, costing more to repair than it was worth. Common sense would question what kind of full approval was it? This analogy is not perfect. So let’s look at the facts further. Because the consequences of reality are vast and unknown.
In the first part of this unintended series, we laid out the law, facts, and evidence as presented by all relevant parties regarding the vaccine’s “full approval.” That is, the FDA. We discussed how we came to our conclusions. And how the FDA came to the same one. Pursuant to its own press release. Said press release being thirteen pages, we preferred to quote and present the most relevant information for brevity. Though, that was not enough for fact-checkers. Neither was our follow-up email when we were asked for comment. Therefore, we will set the record straight, again. The third time is the charm.
With all due respect to USA TODAY, we do not engage in deliberately misconstruing the truth. The same cannot be said about USA TODAY’sMinistry of Truth. The vaccine did not receive full approval.
THE FDA PRESS RELEASE
Section II: Scope of Authorization
Beginning on page five, the FDA’s statement is clear as day. The FDA concludes, pursuant to Section 564(d)(1) of the Federal Food, Drug, and Cosmetic Act (the “Act”), the scope of the Emergency Use Authorization (“EUA”). As we explained in our email to USA TODAY, Section 564 of the Act is the same as21 U.S.C. § 301. This latter statute authorizes the Secretary of Health and Human Services their power to authorize biological products for limited emergency uses.
Further, the EUA was expanded. Now it allows the use of COMIRNATY (COVID-19 Vaccine, MRNA) to only be used for individuals ages 12-15. Or to provide a third dose to people ages 12 and older who have undergone solid organ transplantation or are diagnosed with conditions that are considered to have an equal level of immunocompromise.
When something is “limited” in its use, such as the FDA directs, it baffles common sense to state it is “fully authorized.”
Section III: Conditions of Authorization
Again, we find the FDA authorizing more underthe same Section of the Act. That is, the Emergency Use Authorization statutes. One of these is that Pfizer must submit Investigational New Drug EUA application safety reports. A drug is not new or investigational if it is fully authorized. Plain and simple. Moreover, Pfizer is required to continue to submit EUA “Certificates of Analysis.”
We could bore you with going over and over and over every single time the FDA press release states “this EUA.” You can click the link and CTRL-F for yourself.
Lastly, we end on the most important statement. It defies rationale and logic if this somehow does not put the final nail in the coffin of “misinformation.” We turn your attention to the top of page 12:
There it is. In a court of law, this is what a prosecutor would call a smoking gun. Decide for yourself. We can only present the facts and evidence we have. What better source than the beast itself? It may be a long document, but ignorance is not a winning argument. Especially for USA TODAY.
We appreciate our valiant fact-checkers for attempting to set the record straight. Their perceived limited knowledge of the law is common. Not everyone goes to law school and pursues that career.
As we stated, we do not get confused.