FDA decides to retain C19 mRNA injection package inserts that are obsolete, misleading and out of touch with regulators elsewhere
“Take the ongoing uncertainty over whether vaccines reduce viral transmission. We asked the FDA to clarify in labeling that there isn’t substantial evidence that mRNA vaccines reduce viral transmission. This was an easy ask — the FDA has repeatedly stated that effectiveness against transmission remains unproven. The agency said so in December 2020, when vaccines were first authorized, and again in August 2021, when it fully approved Pfizer’s vaccine. The agency still states on its website today: “While it is hoped this will be the case, the scientific community does not yet know if Comirnaty will reduce such transmission.”
Cominarty? That is only available in C19 prison colonies like Australia with that brand name.
“.. the FDA failed to follow the lead of regulators elsewhere, including in Europe and Japan. For instance, we cited the European regulator’s addition of heavy menstrual bleeding to product information as a potential vaccine adverse reaction. The FDA’s response was a sophisticated version of “who cares!”
So much for a coordinated global approach! No doubt the WHO will fix all those differences and will become “the only source of science”.
“The FDA also failed to warn about the documented risk of sudden death, even though myocarditis is now a well-recognized side effect, particularly among young men. “
“.. we asked the FDA to add seven adverse event types to product labeling: multisystem inflammatory syndrome in children (MIS-C), pulmonary embolism, sudden cardiac death, neuropathic and autonomic disorders, decreased sperm concentration, heavy menstrual bleeding and detection of vaccine mRNA in breastmilk.”
“The FDA rejected our request, once again arguing that causality had not been definitively established. In other words, the FDA is not following its own rules. In refusing to add these adverse events to the label, the FDA invokes the strictest of standards (demonstrating causality), contradicting federal law that calls for using the “some basis to believe” standard.”
“As to whether the vaccines block viral transmission, we thought it was fairly obvious ..”
“.. the CDC’s website still informs people the vaccines are effective at “limiting the spread of the virus.”
The FDA replied “Your Petition also does not account for countervailing statements made by some of these officials,” that is - Fauci and Walensky.
“.. one point the FDA did grant: our request to add data on the results from the manufacturers’ randomized trials of bivalent boosters. “
For Pfizer only – not Moderna.
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