We are trained to reflexively outsource our critical thinking to anonymous technocrats called “the experts” — except, apparently, when they encourage recognizing health risks associated with Pfizer products.
On Jan. 31, 2023, a pharmaceutical industry watchdog group called Coalition Advocating for Adequately Labeled Medicines (CAALM) issued a petition to the U.S. Food and Drug Administration (FDA), requesting changes to the Moderna and Pfizer mRNA injections.
Via the petition document:
Incomplete, inaccurate, or misleading labeling of any medical product can negatively impact the health and safety of Americans, with global ramifications considering the international importance of FDA decisions. For these reasons, and due to the compelling need to ensure the safety and efficacy of any COVID-19 vaccine licensed by the FDA and to allow Petitioner the opportunity to seek emergency judicial relief should the instant Petition be denied, it is respectfully requested that FDA act on the instant Petition by April 30, 2023.
The petition makes ten labeling demands of the Pfizer and Moderna injections, which are enumerated below:
- 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.
- Add language clarifying that the immunobridging surrogate endpoint used in multiple authorized indications has not been validated to predict clinical efficacy.
- Add safety and efficacy results data from manufacturer randomized trials of current bivalent boosters that reported results after EUA was granted.
- 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.
- 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.
- Add a clear statement that Pfizer vaccine efficacy wanes after 2 months following dose 2 according to the Pfizer phase III randomized trial.
- 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.
- 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.
- Add frequency data for clinical and subclinical myocarditis.
- Labeling should present trial results on serious adverse events in tables with statistics, as is done for non-serious adverse events.
The FDA recently answered and was unsurprisingly unsympathetic to the demands.
On April 18, the FDA released its official response to the petition, in which it denies a correlation between the mRNA shots and sudden cardiac death, claiming that the evidence “is not sufficient to demonstrate a causal association between sudden cardiac death and vaccination.”
Perhaps the petition’s authors didn’t provide an exhaustive enough summary of the evidence in the public domain, but the claim that there is not sufficient evidence to tie cardiac sudden death to the injections is not consistent with the record. Myocarditis is a condition that causes cardiac death. The COVID-19 shots, in turn, have been heavily implicated in myocarditis cases in young men for over a year at this point. Even the corrupt CDC, due to the overwhelming volume of quality evidence, has been forced to concede on this issue.
Also of note in the document is that the FDA maintains the fiction that the COVID-19 pandemic is ongoing despite evidence going back a year or more that the infection is now endemic and despite the Brandon entity’s explicit proclamation on national television that the pandemic is over:
There is currently a pandemic of respiratory disease, COVID-19, caused by a novel coronavirus, SARS-CoV-2. The COVID-19 pandemic presents an extraordinary challenge to global health. The Secretary of the Department of Health and Human Services (HHS) has determined that there is a public health emergency, or a significant potential for a public health emergency, related to COVID-19. In addition, the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic.
Far be it for any serf to dispense advice to the Public Health™ authorities. However, the pharmaceutical industry-funded FDA’s refusal to acknowledge both basic, observable reality and documented potential negative health impacts of highly lucrative pharmaceutical products probably doesn’t go very far toward instilling a deep and abiding respect of The Science™ in the public consciousness.
