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FDA Makes Confession Regarding COVID-19 Jab Labeling

The Coalition Advocating for Adequately Labeled Medicines (CAALM) petitioned the U.S. Food and Drug Administration (FDA) to “require that the sponsors of Comirnaty, Spikevax, Pfizer-BioNTech COVID-19 Vaccine, and Moderna COVID-19 Vaccine (collectively, ‘Pfizer and Moderna COVID-19 vaccines’) amend current product labeling.”

One of the requests in the petition was to add language clarifying that phase III trials were “not designed to determine and failed to provide substantial evidence of vaccine efficacy against SARS-CoV-2 transmission or death.”

The petition also stated the following:

2. Add language clarifying that the immunobridging surrogate endpoint used in multiple authorized indications has not been validated to predict clinical efficacy.

3. Add safety and efficacy results data from manufacturer randomized trials of current bivalent boosters that reported results after EUA was granted.

4. Add a clear statement that FDA authorized a new Pfizer vaccine formulation containing Tris buffer without requiring clinical studies to evaluate efficacy, safety or bioequivalence to the formulation containing phosphate buffer.

5. Add a clear statement disclosing that a Pfizer phase III randomized trial in pregnant women (NCT04754594) was completed as of July 2022 but there have been no results reported.

6. Add a clear statement that Pfizer vaccine efficacy wanes after 2 months following dose 2 according to the Pfizer phase III randomized trial.

7. The following adverse event types should be added to the Adverse Reactions section of labeling:
a. multisystem inflammatory syndrome (MIS) in children;
b. pulmonary embolism; c. sudden cardiac death;
d. neuropathic and autonomic disorders.

8. The following reproductive health and lactation related adverse event types should be added to the Adverse Reactions section of labeling:
a. decreased sperm concentration;
b. heavy menstrual bleeding;
c. detection of vaccine mRNA in breastmilk.

9. Add frequency data for clinical and subclinical myocarditis.

10. Labeling should present trial results on serious adverse events in tables with statistics, as is done for non-serious adverse events.” 

The FDA made an interesting confession in its response letter to the January 31, 2023 petition.

The regulatory agency is not required for ‘vaccines’ to demonstrate the prevention of transmission and infection.

The FDA’s exact quote reads: “It is important to note that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission.”

It adds: “There is no requirement that the vaccine also prevents infection with the pathogen that can cause the disease or transmission of that pathogen to others.”

The FDA admits it doesn’t have to appropriately label experimental shots on their effectiveness to prevent transmission and infection.

And the agency doesn’t want to include the extremely serious, life-threatening adverse reactions that have been reported since the COVID-19 jab rollout.

The FDA states: “Thus, the scientific sources cited in the Petition do not provide a basis for the requested actions. As an additional matter, FDA’s own safety monitoring does not support the requests. To date, the Agency’s systems for monitoring COVID-19 vaccine safety have not identified evidence that provides a sufficient basis to believe that there is a causal relationship between these outcomes and the use of the Pfizer and Moderna COVID-19 vaccines that would justify the labeling revisions. Therefore, at this time FDA is not aware of sufficient information about MIS in children, pulmonary embolism, sudden cardiac death, and neuropathic and autonomic disorders to support adding these events to the Adverse Reactions section of the labeling for the Pfizer and Moderna COVID-19 vaccines, and the Petition has not provided such information. These requests are denied. FDA will continue to closely monitor reports of all adverse events and will consider labeling changes as warranted.”

Read the complete FDA response HERE.


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