No FDA Approved COVID-19 Vaccine Has Been Distributed in Louisiana
No FDA Approved COVID-19 Vaccine Has Been Distributed in Louisiana
With incredible malfeasance, Louisiana Department of Health claims EUA COVID-19 vaccines are the same as FDA approved.
On February 27, 2023, I submitted a public records request (PRR) of the Louisiana Department of Health (LDH). I copied verbatim a PRR submitted by Mitch Melancon a year ago, which had the same results. A simple summary of our request is:
Where and when were FDA approved COVID-19 vaccines distributed in Louisiana?
In a word salad that only highlights their incompetence, LDH states:
“Louisiana Immunization Program has received CDC distribution guidance regarding Comirnaty (Pfizer) and Spikevax (Moderna) vaccines, but we have not distributed the vaccines to our providers yet. Currently, in Louisiana, we have the FDA-approved (EUA) COVID-19 vaccines from Pfizer and Moderna available to providers, although they are not packaged under their respective branded names. It will take some time for the transition to the new packaging of these vaccines to reflect their product names (Pfizer-Comirnaty, Moderna-SpikeVax).”
No, LDH, that’s not how this works.
What this response tells us is: to date, no FDA approved COVID-19 vaccine has been distributed in Louisiana, although LDH - in violation of federal law - is stating otherwise.
We addressed LDH’s violations of the EUA’s “Conditions for Authorizations” in our previous article, LA Dept. of Health's COVID-19 Vaccine Promotional Material Violates Terms of EUA. With the response to our PRR - and undoubtedly an untold number of other inquires/communications - LDH is once again in violation of the “Conditions for Authorization” specified in the letter granting emergency use, which stipulates in Section Y that all descriptive printed matter, including a public records response, must state:
“The Pfizer-BioNTech COVID‐19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA. . .”
Additionally, Section A specifies:
“PfizerInc. and authorized distributor(s) will ensure that the authorized Pfizer- BioNTech COVID‐19 Vaccine and Pfizer-BioNTech COVID‐19 Vaccine, Bivalent are distributed, as directed by the U.S. government, including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets) will be made available to vaccination providers, recipients, and caregivers consistent with the terms of this letter.”
What do the Fact Sheets say?
Note the Fact Sheet stipulates that information required to be provided to vaccine recipients includes:
“FDA has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine, which is not an FDA-approved vaccine.”
In clear violation of these stipulations established under federal law, Louisiana Department of Health states in the public records request response that the emergency use authorized (EUA) products are FDA approved!
Moreover, according to the EUA, the two products are "legally distinct" (pg 20), which has significance in regards to the experimental nature of EUA products and the means by which compensation is sought for injuries that result from their use.
Section G of the EUA specifies that Pfizer (and Moderna) are still reporting findings to the FDA via an Investigational New Drug application. According to the FDA, “an investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it.”
Unlike typical FDA approved or licensed drugs, emergency use authorized COVID-19 vaccines are covered under the PREP Act, meaning the manufacturer has no liability for any harm that may result from the use of their product, effectively removing Seventh Amendment protections and the right to seek recourse in a civil court. Instead, recipients must file for compensation through a government program called the Countermeasures Injury Compensation Program (CICP) within a year of receipt of the drug. (To date, of the 543 COVID-19 vaccine claims reviewed by CICP, 19 have been determined to be eligible for compensation yet no compensation amount has been determined or distributed, with 10,653 claims pending review.)
Again, misrepresenting an EUA COVID-19 vaccine product as FDA approved, as LDH has done, violates the EUA’s "Conditions of Authorizations,” which were established under federal law.
FDA APPROVEFD, CDC APPROVED means absolutely nothing to me. They are just a part of the depopulation NWO. They have proven to no longer be trusted. I've had my doubts about them for yrs anyway. Let me ask, how many medications for various illnesses has the FDA approved and later been recalled due to injuries , death or because the benefits didn't put weigh the risk for yrs now? Way way to many! Why? Because they ha e never really done the studies on drugs before they approved them. Fir yrs people have been their testing objects. I saw thus time and time again as a home health nurse and with my own treatment with certain medications. Although for yrs I've refused any and all new drugs from my factors because I wasn't going to be their guinea pig, which us exactly what I told my doctors. I would only take an antibiotic ir any drug that had been out for many yrs. A drug I knew and understood on a medical level. So I know just because the FDA approves a drug and the CDC cines behind them with their agreement means NOTHING to me. Now they are full blown corrupted.
So why are the people that are responsible for misdirecting, lying, to the public not in jail? i think that is part of our problem, we can point fingers with facts and data, but NOTHING ever happens to these Socialists... specifically Anthony Fauci (not worthy of title of MD), should be in jail, along with most of the employees of CDC, FDA, NIAID